Moment

Package leaflet: Information for the user

MOMENT 200 mg chewable tablets

ibuprofen
Please read all of this leaflet carefully before taking this medicine, as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

1. What Moment is and what it is used for
2. What you need to know before taking Moment
3. How to take Moment
4. Possible side effects
5. How to store Moment
6. Contents of the pack and other information

1. What Moment is and what it is used for

Moment contains ibuprofen, a medicine belonging to the class of analgesic-anti-inflammatory drugs, that is,
medicines that fight pain and inflammation.
Moment is used in adults and adolescents from the age of 12 for:

• treatment of pain of various origin and nature (headache, toothache, neuralgia, osteo-articular and muscular pain, menstrual pain);
• reduction of symptoms associated with fever and flu-like conditions.
  Consult your doctor if you do not feel better or feel worse after 3 days of treatment.

2. What you should know before taking Moment

Do not take Moment

• If you are allergic to ibuprofen and/or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other anti-rheumatic medicines (e.g. acetylsalicylic acid, etc.), or medicines used to treat joint or muscle pain (see section “Other medicines and Moment”).
• If the patient is a child under 12 years of age.
• If you are in the last 3 months of pregnancy or are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).
• If you suffer from stomach or intestinal diseases (e.g., active or severe gastroduodenal ulcer).
• If you have previously experienced stomach or intestinal bleeding or perforation following the use of medications.
• If you have previously had two or more separate episodes of stomach ulcer or bleeding.
• If you have severe heart disease (severe heart failure).
• If you have severe liver or kidney disease.
• If you have lost a significant amount of fluids (severe dehydration) due to vomiting, diarrhoea, or insufficient fluid intake.
• If you suffer from a metabolic disorder of amino acids, which are the building blocks of proteins, called phenylketonuria.

Warnings and precautions – Be especially careful with Moment
What you should know before taking Moment
Allergic reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported. Stop taking Moment immediately and contact your doctor or emergency medical services right away if you notice any of these signs.
Skin reactions
Severe skin reactions have been reported with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop using Moment and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.

Consult your doctor or pharmacist before taking Moment:

• If you have previously experienced breathing difficulties (bronchospasm) after taking acetylsalicylic acid (aspirin) or other anti-inflammatory medicines.

• If you suffer from asthma, runny nose (chronic rhinitis), nasal polyps (nasal polyposis), inflammation of the mucous membranes of the paranasal sinuses (sinusitis), or suffer/have suffered from allergies, as you may develop breathing difficulties (bronchospasm), skin redness with itching (urticaria), or skin and throat swelling (angioedema), especially if you have previously had allergic reactions after using other medicines for joint or muscle pain, fever, or inflammation (NSAIDs).

• If you are taking other anti-inflammatory medicines, including selective COX-2 inhibitors (an enzyme involved in inflammatory processes), as the risk of ulcers and bleeding may increase (see section “Other medicines and Moment”).

• If you are elderly or have previously suffered from ulcers, especially if the ulcer was associated with bleeding or perforation (see section “Do not take Moment”), as the risk of bleeding, ulceration, or perforation is higher, particularly with higher doses of anti-inflammatory medicines. In such cases, treatment should be started with the lowest available dose, and you may need to consult your doctor for a medicine that protects the stomach (misoprostol or proton pump inhibitors). This should also be considered
  even if you are taking low doses of acetylsalicylic acid or other medicines that may increase the risk of
  stomach and/or intestinal diseases (see section “Other medicines and Moment”).

• If you have suffered from or currently suffer from chronic intestinal diseases (ulcerative colitis, Crohn’s disease), as these may worsen (see section 4 “Possible side effects”).

• If you have previously had stomach or intestinal problems related to medicine use, especially if you are elderly, you should inform your doctor of any unusual intestinal symptoms (especially bleeding), particularly during the initial stages of treatment.

• If you are taking other medicines that increase the risk of stomach or intestinal ulcer or bleeding, such as oral corticosteroids (e.g. cortisone), anticoagulants (e.g. warfarin), antidepressants (selective serotonin reuptake inhibitors), or antiplatelet agents (e.g. acetylsalicylic acid). See also section “Other medicines and Moment”. If gastrointestinal bleeding or ulceration occurs in patients taking Moment, treatment should be discontinued.

• If you have high blood pressure and your current medicines are not effectively lowering it, or if you have heart or circulatory diseases affecting the brain or other body areas, or if you think you may be at risk for such diseases (e.g. if you have high blood pressure, diabetes, high cholesterol, or if you smoke).

• If you have high blood pressure and/or heart disease, as fluid retention, increased blood pressure, and swelling have been observed following treatment with NSAIDs. NSAIDs may reduce the effectiveness of blood pressure-lowering medicines (see section “Other medicines and Moment”).

• If you have lost a significant amount of fluids or if swelling, heart problems, or high blood pressure occur.

• If you have reduced kidney function, heart or liver dysfunction, or if you are elderly or taking medicines for high blood pressure, as you may be more prone to kidney problems. Additionally, regular concurrent use of multiple painkillers may further increase this risk.

• If you have a blood clotting disorder or are taking medicines that slow blood clotting (anticoagulants) (see section “Other medicines and Moment”).

• If you suffer from a disease that can affect multiple organs and tissues (systemic lupus erythematosus) or a connective tissue disease present in many parts of the body, such as bones and cartilage, as symptoms of “aseptic meningitis” have been observed in rare cases in patients treated with ibuprofen. Although this is more likely in patients with systemic lupus erythematosus or related connective tissue disorders, it has also been observed in patients without concurrent chronic diseases.

• If you are taking medicines for pain, heart disease, or high blood pressure (see section “Other medicines and Moment”).

• If you are planning to become pregnant (see section “Pregnancy, breastfeeding and fertility”).

• If you have difficulty conceiving or are undergoing fertility investigations (see section “Pregnancy, breastfeeding and fertility”).

• If you have an infection – see section “Infections” below.

Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when administered at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking Moment if you have:

• heart problems, including heart attack, angina (chest pain), history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation to legs or feet due to narrowed or blocked arteries), or any type of stroke (including ‘mini-stroke’ or “TIA”, transient ischemic attack);
• high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker. Medicines such as Moment may:
• be associated with the development of kidney diseases, even severe ones (such as renal papillary necrosis, analgesic nephropathy, and renal failure); therefore, your doctor will monitor your kidney function;
• cause eye disorders; therefore, periodic eye examinations are recommended during prolonged treatment. Discontinue treatment with Moment if visual disturbances occur.

Infections
Moment may mask symptoms of infections such as fever and pain. Therefore, Moment could delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.

Adolescents
If an adolescent is dehydrated, there is a risk of developing kidney disease.

Other medicines and Moment
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Moment may affect or be affected by other medicines. For example:
Do not take Moment together with acetylsalicylic acid (e.g. aspirin) or other anti-inflammatory medicines (such as COX-2 inhibitors or other NSAIDs).
Consult your doctor before using Moment with other medicines, especially:

• corticosteroids (medicines used to treat inflammation, such as cortisone);
• medicines with anticoagulant effects (i.e. substances that slow blood clotting, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower high blood pressure (diuretics, ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan). Moment may reduce the effect of these medicines. If you are taking these medicines, are elderly, or have kidney disease, your doctor may advise you to drink adequate fluids to avoid dehydration and may request blood tests;
• selective serotonin reuptake inhibitors (medicines used to treat depression), as they may increase the risk of injury or bleeding. Your doctor may therefore prescribe a medicine to protect your stomach;
• lithium (a medicine used to treat mental disorders) or phenytoin (a medicine used to treat epilepsy). During treatment with these medicines, your doctor may request blood tests;
• methotrexate, a medicine used to treat cancer or rheumatoid arthritis;
• moclobemide, a medicine used to treat depression;
• aminoglycosides (antibiotic medicines);
• cardiac glycosides (medicines used to treat certain heart diseases). Medicines such as Moment may worsen heart conditions;
• cholestyramine (a medicine used to lower blood lipids);
• cyclosporine (a medicine used after organ transplantation), as medicines such as Moment may increase the risk of kidney damage;
• herbal extracts such as Ginkgo Biloba, as when taken together with medicines like Moment, they may increase the risk of gastrointestinal bleeding;
• mifepristone (a medicine used in women to induce abortion);
• quinolone antibiotics (medicines used to treat infections), as when taken together with medicines like Moment, there may be an increased risk of seizures;
• sulfonylureas, medicines used to treat diabetes; if concurrent treatment is necessary, your doctor may request blood tests;
• tacrolimus, a medicine used to prevent and treat organ transplant rejection; concomitant administration with Moment may increase the risk of kidney damage;
• zidovudine and ritonavir, medicines used to treat AIDS; if concurrent treatment is necessary, your doctor may request blood tests;
• probenecid, a medicine used to treat gout;
• CYP2C9 inhibitors, such as voriconazole and fluconazole (medicines used to treat fungal infections);
• bisphosphonates, medicines used to treat bone diseases, as they may increase gastrointestinal side effects;
• oxpentifylline (pentoxifylline), a medicine used to treat leg ulcers, as it may increase gastrointestinal side effects;
• baclofen, a medicine used to relax muscles.

Other medicines may also affect or be affected by treatment with Moment. Therefore,
always consult your doctor or pharmacist before using Moment with other medicines.
Moment and alcohol
Do not drink alcohol during treatment with Moment, as it may increase the risk of adverse effects.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Moment during the last 3 months of pregnancy, as it may cause serious heart, lung, and kidney problems in the fetus or cause complications during delivery. It may affect your and your baby’s tendency to bleed and delay or prolong labour more than expected. You should not take MOMENT during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor.
If treatment is needed during this period or while trying to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from the 20th week of pregnancy onwards, Moment may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios), or may cause narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk; therefore, do not take Moment if you are breastfeeding.
Fertility
If you have difficulty conceiving or are undergoing fertility investigations, discontinue use of Moment, as this medicine may temporarily impair fertility.

Driving and using machines
Normally, Moment does not affect the ability to drive or use machinery. However, if you perform activities requiring alertness, be cautious if you experience drowsiness, dizziness, or depression during treatment with Moment.

This medicine contains:

• Sorbitol: this medicine contains 1124 mg of sorbitol per tablet, equivalent to 1124 mg/1511.5 mg. Sorbitol is a source of fructose. If your doctor has informed you (or the child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot properly metabolize fructose, consult your doctor before taking this medicine. It may cause gastrointestinal disturbances and has a mild laxative effect.
• Aspartame: This medicine contains 40 mg of aspartame per tablet, equivalent to 40 mg/1511.5 mg. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine due to the body’s inability to properly eliminate it.

3. How to take Moment

Take this medicine exactly as indicated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Consult your doctor if you have noticed any recent changes in the characteristics of your condition.
Adults and adolescents over 12 years: the recommended dose is 1–2 chewable tablets, two to three times a day.
The tablets must not be swallowed whole, but chewed; this allows them to disintegrate quickly without leaving an unpleasant taste in the mouth.
Moment may be taken on an empty stomach. However, in individuals with gastric intolerance, it is preferable to take the medicine with food.
If there is no noticeable improvement after three days of treatment, consult your doctor.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, seek immediate medical advice should symptoms (e.g. fever and pain) persist or worsen (see section 2).
Do not exceed 6 chewable tablets per day. If you are elderly, adhere to the lower doses indicated above.
If you suffer from kidney and/or liver or heart disease, consult your doctor, who will determine the appropriate dose for you.
If you have severe liver disease, do not take Moment.

Use in the elderly
Consult your doctor, who will determine the appropriate dose for you, possibly reducing the recommended dose, especially if you have kidney and/or liver impairment.

Use in adolescents
Consult your doctor if use of the medicine is required for more than 3 days in an adolescent, or if symptoms worsen.

If you take more Moment than you should
If you have taken more Moment than you should, or if your child has accidentally ingested this medicine, always contact a doctor or the nearest hospital for advice on potential risks and necessary actions.
If you take an excessive dose (overdose) of ibuprofen, you may commonly experience the following symptoms: nausea, vomiting, stomach pain, deep sleep with reduced response to normal stimuli (lethargy), drowsiness, headache, dizziness, ringing in the ears (tinnitus), uncontrolled body movements (convulsions), and loss of consciousness. Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Rarely, you may experience: uncontrolled eye movements (nystagmus), lowered body temperature (hypothermia), kidney-related effects, gastrointestinal bleeding, deep loss of consciousness (coma), temporary cessation of breathing (apnea), diarrhoea, reduced activity of the nervous system (central nervous system depression), and reduced respiratory activity (respiratory depression).
Additionally, you may experience: disorientation, excitability, fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia).
In cases of severe poisoning, metabolic acidosis (increased acid levels in the blood) may occur.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with traces of blood), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, ringing in the ears, confusion, and uncontrolled eye movements. Furthermore, agitation, drowsiness, disorientation, or coma may occur. Occasionally, patients may develop seizures. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties may be reported.
In addition, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute kidney failure and liver damage may also occur. Asthma may be exacerbated in asthmatic patients. Moreover, low blood pressure and reduced respiratory function may occur.
If you have any doubts about the use of Moment, consult your doctor or pharmacist.

If you forget to take Moment
Do not take a double dose to make up for the forgotten tablet.

4. Possible side effects

Like all medicines, Moment can cause side effects, although not everyone experiences them.
The side effects of this medicine can be minimized by using the lowest dose among those recommended and by using the medicine only for the duration necessary to control your symptoms.
If you develop a stomach ulcer or gastrointestinal bleeding, or skin and/or mucosal lesions, you must stop treatment with Moment and consult your doctor. These side effects are usually more common in elderly patients.
The use of Moment may cause side effects, generally mild or moderate, or more serious reactions—including allergic reactions—although these are rare.
If you experience any of the following symptoms, STOP using Moment IMMEDIATELY and contact your doctor or go immediately to the nearest hospital, where you will receive appropriate and specific treatment:

• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome,
  • skin eruptions or lesions,
  • mucosal lesions,
  • signs of allergic reaction, even severe (erythema, itching, urticaria, asthma, swelling of the skin and mucous membranes, anaphylactic shock),
  • skin peeling,
  • flat, red, target-shaped or circular rashes on the trunk, often with central blisters, skin desquamation, ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis),
  • widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome),
  • widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized pustular eruption),
  • vision disturbances,
  • liver disease (hepatic dysfunction),
  • bleeding, ulceration, and perforation of the stomach and intestines, which can be fatal, particularly in the elderly.

In case of any of the above-mentioned allergic reactions, go to hospital immediately, as immediate access to emergency equipment, medications, and trained personnel is essential. Rarely, serious, sometimes fatal, adverse reactions have been reported following ibuprofen use, even in the absence of known allergy. The risk of experiencing such symptoms is higher in the early stages of treatment: in most cases, the reaction occurs within the first month of therapy.

Additionally, you may experience other side effects reported with medicines similar to Moment, listed below by frequency:

Common (may affect up to 1 in 10 people)

• dizziness
• malaise
• fatigue

Uncommon (may affect up to 1 in 100 people)

• inflammation of the stomach (gastritis)
• insomnia, anxiety
• numbness of limbs or other body parts (paresthesia), drowsiness
• inflammation of the nasal mucosa (rhinitis)
• breathing difficulties (bronchospasm, dyspnea)
• temporary interruption of breathing (apnea)
• visual disturbances
• hearing impairment
• ringing in the ears (tinnitus)
• vertigo
• liver disorders (altered liver function)
• inflammation of the liver (hepatitis)
• yellowing of the skin and eyes (jaundice)
• kidney diseases (impaired kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome, and renal failure)
• hypersensitivity reactions such as skin rash, urticaria, itching, red spots on the skin (purpura), swelling of the skin and mucous membranes (angioedema), breathing difficulties (bronchospasm or dyspnea), asthma attacks possibly with low blood pressure
• skin reactions to light (photosensitivity)

Rare (may affect up to 1 in 1,000 people)

• reduction in blood cells: reduced white blood cells (leukopenia, neutropenia, agranulocytosis), red blood cells (hemolytic anemia, aplastic anemia), or platelets (thrombocytopenia)
• reduced blood clotting ability
• depression, confusion, hallucinations
• inflammation of the optic nerve (optic neuritis)
• inflammation of the meninges, the membranes covering the brain (aseptic meningitis, especially in patients with pre-existing autoimmune disorders—see section “Warnings and precautions”), with symptoms such as neck stiffness, headache, nausea, vomiting, fever, or disorientation
• eye disorders with visual disturbances and optic nerve pathology (toxic optic neuropathy)
• swelling due to fluid accumulation in tissues
• a disease that may affect various organs and tissues of the body (lupus-like syndrome)
• worsening of inflammation caused by an existing infection (e.g., development of necrotizing fasciitis)
• high levels of nitrogen in the blood
• abnormal liver function tests (increased transaminases, increased alkaline phosphatase)
• abnormal blood tests (reduced hemoglobin, reduced hematocrit, prolonged bleeding time, decreased blood calcium, increased blood uric acid)

Very rare (may affect up to 1 in 10,000 people)

• inflammation of the pancreas, a gland involved in digestive processes (pancreatitis)
• awareness of your own heartbeat (palpitations)
• heart disease (heart failure)
• heart attack (myocardial infarction)
• fluid accumulation in the lungs (acute pulmonary edema)
• liver disease (liver failure)
• hypertension
• severe allergic reactions, which may include symptoms such as severe asthma, swelling of the face, tongue, and throat making breathing difficult, rapid heartbeat, severe and rapidly developing allergic reaction that can be fatal (anaphylaxis), severe skin rash or skin exfoliation (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme)
• severe skin infections and soft tissue disorders may occur during varicella infection

Not known (frequency cannot be estimated from available data)

• stomach heaviness
• nausea
• vomiting
• diarrhea
• flatulence
• constipation
• difficulty digesting
• abdominal pain
• heartburn
• blood in stools
• blood in vomit
• mouth sores
• worsening of inflammatory bowel diseases (colitis, Crohn's disease)
• increased risk of sudden reduction in blood flow to the brain (stroke)
• allergic reactions, anaphylaxis
• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome): a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell)
• a widespread, red, scaly rash with pustules under the skin and blisters, mainly localized on skin lesions, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption)

Stop using Moment if you develop these symptoms and contact your doctor immediately. See also section 2.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor.
You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Moment

Keep in the original packaging to protect the medicine from light and moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after Exp.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Moment contains

• The active substance is ibuprofen 200 mg.
• The other ingredients are sorbitol, grapefruit flavour, hydroxypropylmethylcellulose phthalate, aspartame, acesulfame K, anhydrous citric acid, diethyl phthalate, magnesium stearate, precipitated silica.

Description of the appearance of Moment and contents of the pack
Moment is presented as chewable tablets for oral use.
Each pack contains 12 or 24 chewable tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Angelini Pharma S.p.A.
Viale Amelia, 70 - 00181 Rome, Italy

Manufacturer
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona, Italy

N D E S
There are several types of pain, of various origins and nature, which more or less frequently affect everyone, such as headache and toothache, muscular and joint pain, and menstrual pain.
One of the most common types of pain is certainly headache. If you suffer from headache, it is important to identify the factors that may trigger it and try to prevent them (irregular eating habits, certain foods, smoking, alcohol, stress, excessive physical exertion, prolonged sun exposure, excessively loud noises, overly strong perfumes, etc.).
Menstrual pain, sometimes very intense, can be treated with painkillers that work by reducing the amount of prostaglandins—substances produced by the uterus and considered primarily responsible for this discomfort.

Package leaflet: Information for the user

MOMENT 200 mg orodispersible tablets

ibuprofen
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

1. What Moment is and what it is used for
2. What you need to know before taking Moment
3. How to take Moment
4. Possible side effects
5. How to store Moment
6. Contents of the pack and other information

1. What Moment is and what it is used for

Moment contains ibuprofen, a medicine belonging to the class of analgesic-anti-inflammatory drugs, i.e.
medicines that fight pain and inflammation.
Moment is used in adults and adolescents from 12 years of age for:

• treatment of pain of various origin and nature (headache, toothache, neuralgia, osteo-articular and muscular pain, menstrual pain);
• reduction of symptoms associated with fever and flu-like conditions.
  Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment.

2. What you should know before taking Moment

Do not take Moment

• If you are allergic to ibuprofen and/or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other anti-rheumatic medicines (e.g. acetylsalicylic acid, etc.), or medicines used to treat joint or muscle pain (see section “Other medicines and Moment”).
• If the patient is a child under 12 years of age.
• If you are in the last three months of pregnancy or are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).
• If you suffer from stomach or intestinal diseases (e.g. active or severe gastroduodenal ulcer).
• If you have previously experienced gastrointestinal bleeding or perforation following the use of medicines.
• If you have previously had two or more separate episodes of stomach ulcer or bleeding.
• In case of severe heart disease (severe heart failure).
• In case of severe liver or kidney disease.
• If you have lost a significant amount of fluids (severe dehydration) due to vomiting, diarrhoea, or insufficient fluid intake.
• If you suffer from a metabolic disorder of amino acids, the building blocks of proteins, called phenylketonuria (see section “Moment contains sucrose, sorbitol (E420) and aspartame (E951)”).

Warnings and precautions – Take special care with Moment
What you should know before taking Moment
Signs of an allergic reaction to this medicine, including breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen. Immediately stop treatment with Moment and contact your doctor or emergency medical services if you notice any of these signs.
Skin reactions
Severe skin reactions have been reported during treatment with ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop using Moment and contact your doctor immediately if you notice any symptoms related to these severe skin reactions described in section 4.
Consult your doctor or pharmacist before taking Moment:

• If you have previously experienced breathing difficulties (bronchospasm) after taking acetylsalicylic acid (aspirin) or other anti-inflammatory medicines.
• If you suffer from asthma, runny nose (chronic rhinitis), nasal polyps, inflammation of the mucosa of the paranasal sinuses (sinusitis), or suffer/have suffered from allergies, as you may develop breathing difficulties (bronchospasm), skin redness with itching (urticaria), or swelling of the skin and throat (angioedema), especially if you have previously had allergic reactions after using other medicines used to treat joint or muscle pain, fever, or inflammation (NSAIDs).
• If you are taking other anti-inflammatory medicines, including selective COX-2 inhibitors (an enzyme involved in inflammatory processes), as the risk of ulcers or bleeding may increase (see section “Other medicines and Moment”).
• If you are elderly and have previously suffered from ulcers, especially if the ulcer was associated with bleeding or perforation (see section “Do not take Moment”), as the risk of bleeding, ulceration, or perforation is higher, particularly with higher doses of anti-inflammatory medicines. In such cases, treatment should be started with the lowest available dose, and you may need to consult your doctor for a medicine that protects the stomach (misoprostol or proton pump inhibitors). This should also be considered

even if you are taking low doses of acetylsalicylic acid or medicines that may increase the risk of
stomach and/or intestinal disorders (see section “Other medicines and Moment”).

• If you have suffered from or currently suffer from chronic bowel diseases (ulcerative colitis, Crohn’s disease), as these may worsen (see section 4 “Possible side effects”).
• If you have previously had stomach or intestinal disorders related to medicine use, and especially if you are elderly, inform your doctor of any unusual intestinal symptoms (particularly bleeding), especially during the initial stages of treatment.
• If you are taking other medicines that increase the risk of stomach or intestinal ulcer or bleeding, such as oral corticosteroids (e.g. cortisone), anticoagulants (e.g. warfarin), antidepressants (selective serotonin reuptake inhibitors), or antiplatelet agents (e.g. acetylsalicylic acid). See also section “Other medicines and Moment”. If gastrointestinal bleeding or ulceration occurs in patients taking Moment, treatment must be discontinued.
• If you have high blood pressure and your medicines are not effectively lowering it, and/or you have heart or circulatory diseases affecting the brain or other body areas, or think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol, or smoke).
• If you suffer from high blood pressure and/or heart diseases, as fluid retention, increased blood pressure, and swelling have been observed following NSAID treatment. NSAIDs may reduce the effectiveness of medicines used to lower blood pressure (see section “Other medicines and Moment”).
• If you have lost a significant amount of fluids, or if swelling, heart problems, or high blood pressure occur.
• If you have reduced kidney function, heart or liver dysfunction, or are elderly or taking medicines for high blood pressure, as you may be more prone to kidney problems. Additionally, habitual concurrent use of multiple painkillers may further increase this risk.
• If you suffer from a blood clotting disorder or are taking medicines that slow blood clotting (anticoagulants) (see section “Other medicines and Moment”).
• If you suffer from a disease that can affect multiple organs and tissues (systemic lupus erythematosus) or a connective tissue disease present in many parts of the body, such as bones and cartilage, as symptoms of “aseptic meningitis” have been observed in rare cases in patients treated with ibuprofen. Although this is more likely in patients with systemic lupus erythematosus or related connective tissue disorders, it has also been observed in patients without chronic concomitant diseases.
• If you are taking medicines to treat pain, heart conditions, or high blood pressure (see section “Other medicines and Moment”).
• If you intend to become pregnant (see section “Pregnancy, breastfeeding and fertility”).
• If you have difficulty conceiving or are undergoing fertility investigations (see section “Pregnancy, breastfeeding and fertility”).
• If you have an infection – see section “Infections” below.
• Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when administered at high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss treatment with your doctor or pharmacist before taking Moment if you have:

• Heart problems, including heart attack, angina (chest pain), or a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation to legs or feet due to narrowed or blocked arteries), or any type of stroke (including ‘mini-stroke’ or “TIA”, transient ischemic attack);
• High blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker. Medicines like Moment can:
• Be associated with the development of kidney disorders, even severe ones (such as renal papillary necrosis, analgesic nephropathy, and renal failure); therefore, your doctor will monitor your kidney function;
• Cause eye disturbances; therefore, periodic eye examinations are recommended during prolonged treatment. If visual disturbances occur, discontinue treatment with Moment.
  Infections
  Moment may mask symptoms of infections such as fever and pain. Therefore, Moment could delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.
  Adolescents
  If an adolescent is dehydrated, there is a risk of developing kidney disease.

Other medicines and Moment
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
Moment may affect or be affected by other medicines. For example:
Do not take Moment together with acetylsalicylic acid (e.g. aspirin) or other anti-inflammatory medicines (such as COX-2 inhibitors or other NSAIDs).
Consult your doctor before using Moment with other medicines, particularly:

• Corticosteroids (medicines used to treat inflammation, such as cortisone);
• Medicines with anticoagulant effects (i.e. substances that slow blood clotting, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• Medicines that lower high blood pressure (diuretics, ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan). Moment may reduce the effect of these medicines. If you are being treated with these medicines, are elderly, or have kidney disease, your doctor may advise you to drink adequate fluids to avoid dehydration and may ask you to undergo blood tests;
• Selective serotonin reuptake inhibitors (medicines used to treat depression), as they may increase the risk of injury or bleeding. Your doctor may therefore prescribe a medicine to protect your stomach;
• Lithium (a medicine used to treat mental disorders) or phenytoin (a medicine used to treat epilepsy). During treatment with these medicines, your doctor may ask you to undergo blood tests;
• Methotrexate, a medicine used to treat cancer or rheumatoid arthritis;
• Moclobemide, a medicine used to treat depression;
• Aminoglycosides (antibiotic medicines);
• Cardiac glycosides (medicines used to treat certain heart conditions). Medicines like Moment may worsen heart disease;
• Cholestyramine (a medicine used to lower blood lipids);
• Cyclosporine (a medicine used if you have had an organ transplant), as medicines like Moment may increase the risk of kidney damage;
• Herbal extracts such as Ginkgo biloba, as when taken together with medicines like Moment, they may increase the risk of gastrointestinal bleeding;
• Mifepristone (a medicine used in women to induce abortion);
• Quinolone antibiotics (medicines used to treat infections), as when taken together with medicines like Moment, there may be an increased risk of developing seizures;
• Sulfonylureas, medicines used to treat diabetes; if simultaneous treatment is necessary, your doctor may perform blood tests;
• Tacrolimus, a medicine used to prevent and treat organ transplant rejection; concomitant administration with Moment may increase the risk of kidney damage;
• Zidovudine and ritonavir, medicines used to treat AIDS; if concomitant treatment is necessary, your doctor may perform blood tests;
• Probenecid, a medicine used to treat gout;
• CYP2C9 inhibitors, such as voriconazole and fluconazole (medicines used to treat fungal infections);
• Bisphosphonates, medicines used to treat bone diseases, as they may increase gastrointestinal side effects;
• Oxpentifylline (pentoxifylline), a medicine used to treat leg ulcers, as it may increase gastrointestinal side effects;
• Baclofen, a medicine used to relax muscles.

Other medicines may also affect or be affected by treatment with Moment. Therefore,
always consult your doctor or pharmacist before using Moment with other medicines.
Moment and alcohol
Do not drink alcohol during treatment with Moment, as it may increase possible side effects.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Moment during the last three months of pregnancy, as it may cause serious
problems in the fetus’s heart, lungs, and kidneys, or cause complications during delivery. It may
affect your and your baby’s tendency to bleed and delay or prolong labour more than expected. You should not take MOMENT during the first six months of
pregnancy unless absolutely necessary and advised by your doctor.
If treatment is needed during this period or while trying to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from the twentieth week of pregnancy onwards,
Moment may cause kidney problems in the fetus, leading to low levels of
amniotic fluid surrounding the baby (oligohydramnios), or may cause
narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk; therefore, do not take Moment if you are breastfeeding.
Fertility
If you have difficulty conceiving or are undergoing fertility investigations, discontinue use of Moment, as this medicine may temporarily impair fertility.
Driving and use of machines
Normally, Moment does not affect the ability to drive or use machinery. However, if you perform an activity requiring alertness, be cautious if you experience drowsiness, dizziness, or depression during treatment with Moment.
This medicine contains:

• Sucrose: if your doctor has diagnosed you with an intolerance to certain sugars (such as sucrose), contact them before taking this medicine.
• Sorbitol (E420): this medicine contains 55.93 mg of sorbitol per tablet, equivalent to 55.93 mg/1000 mg. Sorbitol is a source of fructose. If your doctor has told you (or your child) that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot properly metabolize fructose, consult your doctor before taking this medicine.
• Aspartame: this medicine contains 20 mg of aspartame per dose, equivalent to 20 mg/1000 mg. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine due to the body’s inability to properly eliminate it.
• Potassium: this medicine contains 1.26 mmol of potassium per dose. This should be considered in patients with reduced kidney function or those on a low-potassium diet.
• Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take Moment

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Consult your doctor if you have noticed any recent changes in the characteristics of your condition.
Adults and adolescents over 12 years: The recommended dose is 1–2 tablets, two to three times daily.
Let the tablet dissolve in your mouth without water, then swallow it without chewing.
Moment can be taken on an empty stomach. However, in individuals with gastric tolerance issues, it is preferable to take the medicine with food.
If there is no noticeable improvement after three days of treatment, consult your doctor.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, contact your doctor immediately if symptoms (e.g., fever and pain) persist or worsen (see section 2).
Do not exceed 6 tablets per day. If you are elderly, follow the lower doses indicated above.
If you suffer from kidney and/or liver or heart disease, consult your doctor, who will determine the appropriate dose for you.
If you have severe liver disease, do not take Moment.

Use in the elderly
Consult your doctor, who will determine the appropriate dose for you by reducing the recommended dose, especially if you have kidney and/or liver disorders.

Use in adolescents
Consult your doctor if use of the medicine is required for more than 3 days in adolescents, or if symptoms worsen.

If you take more Moment than you should
If you have taken more Moment than recommended, or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital immediately to obtain advice on the risk and necessary actions.
If you take an excessive dose (overdose) of ibuprofen, you may commonly experience the following symptoms: nausea, vomiting, stomach ache, deep drowsiness with reduced response to normal stimuli (lethargy), drowsiness, headache, dizziness, ringing in the ears (tinnitus), uncontrolled body movements (convulsions), and loss of consciousness. Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Rarely, you may experience: uncontrolled eye movements (nystagmus), lowered body temperature (hypothermia), kidney effects, gastrointestinal bleeding, deep loss of consciousness (coma), temporary cessation of breathing (apnea), diarrhea, reduced activity of the nervous system (central nervous system depression), and reduced respiratory activity (respiratory depression).
Additionally, you may also experience: disorientation, excited state, fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia).
In cases of severe poisoning, metabolic acidosis (increased acid levels in the blood) may occur.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with traces of blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, confusion, and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (especially in children), weakness, dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties may be reported.
Furthermore, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute kidney failure and liver damage may occur. Asthma may worsen in asthmatic patients. Additionally, low blood pressure and reduced respiratory function may occur.

If you have any doubts about how to use Moment, consult your doctor or pharmacist.

If you forget to take Moment
Do not take a double dose to make up for the missed tablet.

4. Possible side effects

Like all medicines, Moment can cause side effects, although not everyone experiences them.
The side effects of this medicine can be minimized by using the lowest dose among those recommended and only for the duration necessary to control your symptoms.
If you develop a stomach ulcer, gastrointestinal bleeding and/or perforation, or skin and/or mucosal lesions, you must stop treatment with Moment and consult your doctor immediately. These side effects are usually more common in elderly patients.
The use of Moment may cause side effects that are generally mild or moderate, as well as more serious reactions, including allergic reactions, although these are rare.
If you experience any of the following symptoms, STOP using Moment IMMEDIATELY and seek immediate medical attention from your doctor or the nearest hospital, where you will receive appropriate and specific treatment:

• chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome,
  • skin eruptions or lesions,
  • mucosal lesions,
  • signs of allergic reaction, even severe (erythema, itching, urticaria, asthma, swelling of the skin and mucous membranes, anaphylactic shock),
  • flat, non-elevated reddish spots, target-like or circular, on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, or eye ulcers. These serious skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis),
  • widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome),
  • widespread, red, scaly rash with subcutaneous bumps and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized pustular exanthema),
  • severe skin rash or skin exfoliation (toxic epidermal necrolysis, Stevens-Johnson syndrome),
  • visual disturbances,
• liver disease (hepatic dysfunction),
• bleeding, ulceration, and perforation of the stomach and intestines, which can be fatal, particularly in the elderly. In case of any of the above-mentioned allergic reactions, go to hospital immediately, as immediate access to emergency equipment, medications, and trained personnel is required, since severe, sometimes fatal, adverse reactions have been reported following ibuprofen use, even in the absence of known allergy.

The risk of experiencing such symptoms is higher during the initial stages of treatment: in most cases, reactions occur within the first month of therapy.
Additionally, you may experience other side effects that have also been reported with other medicines similar to Moment, listed below by frequency:
Common (may affect up to 1 in 10 people)

• dizziness
• malaise
• fatigue

Uncommon (may affect up to 1 in 100 people)

• inflammation of the stomach (gastritis)
• insomnia, anxiety
• numbness of limbs or other body parts (paresthesia), drowsiness
• inflammation of the nasal mucosa (rhinitis)
• breathing difficulties (bronchospasm, dyspnea)
• temporary interruption of breathing (apnea)
• visual disturbances
• hearing impairment
• ringing in the ears (tinnitus)
• vertigo
• liver disorders (altered liver function)
• inflammation of the liver (hepatitis)
• yellowing of the skin and eyes (jaundice)
• kidney diseases (impaired kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome, and renal failure)
• hypersensitivity reactions such as skin rash, urticaria, itching, red spots on the skin (purpura), swelling of the skin and mucous membranes (angioedema), breathing difficulties (bronchospasm or dyspnea), asthma attacks possibly with low blood pressure
• skin reactions to light (photosensitivity)

Rare (may affect up to 1 in 1,000 people)

• reduction in blood cell counts: reduction in white blood cells (leukopenia, neutropenia, agranulocytosis), red blood cells (hemolytic anemia, aplastic anemia), or platelets (thrombocytopenia)
• reduced blood clotting ability
• depression, confusion, hallucinations
• inflammation of the optic nerve (optic neuritis)
• inflammation of the meninges, the membranes covering the brain (aseptic meningitis, especially in patients with pre-existing autoimmune disorders; see section “Warnings and precautions”), with symptoms such as neck stiffness, headache, nausea, vomiting, fever, or disorientation
• eye disorders with visual disturbances and optic nerve pathology (toxic optic neuropathy)
• swelling due to fluid accumulation in tissues
• a disease that may affect various organs and tissues (lupus-like syndrome)
• worsening of inflammation caused by an existing infection (e.g., development of necrotizing fasciitis)
• high levels of nitrogen in the blood
• abnormal liver function tests (increased transaminases, increased alkaline phosphatase)
• abnormal blood tests (reduced hemoglobin, reduced hematocrit, prolonged bleeding time, decreased blood calcium, increased blood uric acid)

Very rare (may affect up to 1 in 10,000 people)

• inflammation of the pancreas, a gland involved in digestive processes (pancreatitis)
• awareness of your own heartbeat (palpitations)
• heart disease (heart failure)
• heart attack (myocardial infarction)
• accumulation of fluid in the lungs (acute pulmonary edema)
• liver disease (liver failure)
• hypertension
• severe allergic reactions, which may include symptoms such as severe asthma, swelling of the face, tongue, and throat making breathing difficult, rapid heartbeat, severe and rapidly developing allergic reaction that can be fatal (anaphylaxis), severe skin rash or skin exfoliation (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme)
• severe skin infections and soft tissue disorders may occur during varicella infection

Not known (frequency cannot be estimated from available data)

• feeling of stomach fullness
• nausea
• vomiting
• diarrhea
• flatulence
• constipation
• difficulty digesting
• abdominal pain
• heartburn
• blood in stools
• blood in vomit
• mouth lesions
• worsening of inflammatory bowel diseases (exacerbated colitis, Crohn's disease)
• increased risk of sudden reduction in blood flow to the brain (stroke)
• allergic reactions, anaphylaxis
• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome): a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell)
• a widespread, red, scaly rash with pustules under the skin and blisters, mainly on skin lesions, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular exanthema). Stop using Moment if you develop these symptoms and contact your doctor immediately. See also section 2.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Moment

Tube
Do not store above 25°C.
Keep in the original packaging.
Do not use this medicine after 6 months from first opening of the tube.
Blister
Do not store above 25°C.
Keep in the original packaging.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the box after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Moment contains

• The active substance is ibuprofen 200 mg.
• The other components are mannitol (E421), sorbitol (E420), sugar spheres ( sucrose , maize starch), methacrylic acid copolymer, orange flavour, hydrated colloidal silica, potassium carbonate, aspartame (E951) , stearic acid, sodium lauryl sulfate, magnesium stearate, polysorbate 20, simeticone (as emulsion).

Description of the appearance of Moment and contents of the pack
Moment is available as orodispersible tablets for oral use, packed in bottles or blisters.
Bottle
Each pack contains 12 or 24 tablets.
Blister
Each pack contains 6, 10, 12, 16, 20, 24, 30, 32 or 36 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Angelini Pharma S.p.A.
Viale Amelia, 70 - 00181 Rome
Manufacturer
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona
E-Pharma Trento S.p.A., Frazione Ravina - Via Provina, 2 – 38123 Trento (TN)
N D E S
There are several types of pain, of various origins and natures, that more or less frequently affect everyone, particularly headache and toothache, muscular and joint pain, and menstrual pain.
One of the most common types of pain is certainly headache . If you suffer from headaches, it is important to identify the factors that may trigger them and try to prevent them (irregular eating habits, certain foods, smoking, alcohol, stress, excessive physical exertion, excessive sun exposure, excessively loud noises, overly strong perfumes, etc.).
Menstrual pain , sometimes intense, can be treated with painkillers that work by reducing the amount of prostaglandins—substances produced by the uterus and considered primarily responsible for this discomfort.

Package leaflet: information for the user

MOMENT 200 mg coated tablets

ibuprofen
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

1. What Moment is and what it is used for
2. What you need to know before taking Moment
3. How to take Moment
4. Possible side effects
5. How to store Moment
6. Contents of the pack and other information

1. What Moment is and what it is used for

Moment contains ibuprofen, a medicine belonging to the class of analgesic-anti-inflammatory drugs, that is,
medicines which combat pain and inflammation.
Moment is used in adults and adolescents from the age of 12 for:

• treatment of pain of various origin and nature (headache, toothache, neuralgia, osteo-articular and muscular pain, menstrual pain);
• relief of symptoms associated with fever and flu-like conditions.
  Consult a doctor if you do not feel better or feel worse after 3 days of treatment.

2. What you should know before taking Moment

Do not take Moment

• If you are allergic to ibuprofen and/or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other anti-rheumatic medicines (e.g. acetylsalicylic acid, etc.), or medicines used to treat joint or muscle pain (see section “Other medicines and Moment”).
• If the patient is a child under 12 years of age.
• If you are in the last 3 months of pregnancy or are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).
• If you suffer from stomach or intestinal diseases (e.g., active or severe peptic ulcer).
• If you have previously experienced gastrointestinal bleeding or perforation following the use of medicines.
• If you have previously had two or more separate episodes of stomach ulcer or bleeding.
• If you have severe heart disease (severe heart failure).
• If you have severe liver or kidney disease.
• If you have lost a significant amount of fluids (severe dehydration) due to vomiting, diarrhoea, or insufficient fluid intake.

Warnings and precautions – Take special care with Moment
What you should know before taking Moment
Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen. Stop taking Moment immediately and contact your doctor or emergency medical services right away if you notice any of these signs.
Skin reactions
Severe skin reactions have been reported during treatment with ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop using Moment and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.

Consult your doctor or pharmacist before taking Moment:

• If you have experienced breathing difficulties (bronchospasm) after taking acetylsalicylic acid (aspirin) or other anti-inflammatory medicines.
• If you suffer from asthma, runny nose (chronic rhinitis), nasal polyps, inflammation of the mucous membranes of the paranasal sinuses (sinusitis), or have/have had allergies, as you may develop breathing difficulties (bronchospasm), skin redness with itching (urticaria), or swelling of the skin and throat (angioedema), especially if you have previously had allergic reactions after using other medicines for joint or muscle pain, fever, or inflammation (NSAIDs).
• If you are taking other anti-inflammatory medicines, including selective COX-2 inhibitors (an enzyme involved in inflammatory processes), as the risk of ulcers and bleeding may increase (see section “Other medicines and Moment”).
• If you are elderly or have had ulcers, especially if the ulcer was associated with bleeding or perforation (see section “Do not take Moment”), as the risk of bleeding, ulceration, or perforation is higher, particularly with higher doses of anti-inflammatory medicines. In such cases, treatment should be started with the lowest available dose, and you may need to consult your doctor for a medicine that protects the stomach (misoprostol or proton pump inhibitors). This should also be considered

even if you are taking low doses of acetylsalicylic acid or medicines that may increase the risk of
stomach and/or intestinal disorders (see section “Other medicines and Moment”).

• If you have or have had chronic bowel diseases (ulcerative colitis, Crohn’s disease), as these may worsen (see section 4 “Possible side effects”).
• If you have had stomach or intestinal disorders related to medicine use, especially if you are elderly, inform your doctor of any unusual intestinal symptoms (especially bleeding), particularly during the initial stages of treatment.
• If you are taking other medicines that increase the risk of stomach or intestinal ulceration or bleeding, such as oral corticosteroids (e.g. cortisone), anticoagulants (e.g. warfarin), antidepressants (selective serotonin reuptake inhibitors), or antiplatelet agents (e.g. acetylsalicylic acid). See also section “Other medicines and Moment”. If gastrointestinal bleeding or ulceration occurs in patients taking Moment, treatment must be discontinued.
• If you have high blood pressure and your medicines are not controlling it effectively, or if you have heart or circulatory diseases affecting the brain or other body areas, or if you think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol, or smoke).
• If you have high blood pressure and/or heart disease, as fluid retention, increased blood pressure, and swelling have been observed following NSAID treatment. NSAIDs may reduce the effectiveness of medicines used to lower blood pressure (see section “Other medicines and Moment”).
• If you have lost a significant amount of fluids, or if swelling, heart problems, or high blood pressure occur.
• If you have reduced kidney function, heart or liver dysfunction, or if you are elderly or taking medicines for high blood pressure, as you may be more susceptible to kidney problems. Additionally, the regular concurrent use of multiple painkillers may further increase this risk.
• If you have a blood clotting disorder or are taking medicines that slow blood clotting (anticoagulants) (see section “Other medicines and Moment”).
• If you have a disease affecting multiple organs and tissues (systemic lupus erythematosus) or a connective tissue disorder affecting various parts of the body, such as bones and cartilage, as symptoms of “aseptic meningitis” have been observed in rare cases in patients treated with ibuprofen. Although this is more likely in patients with systemic lupus erythematosus or related connective tissue disorders, it has also been observed in patients without chronic concomitant diseases.
• If you are taking medicines to treat pain, heart conditions, or high blood pressure (see section “Other medicines and Moment”).
• If you are planning to become pregnant (see section “Pregnancy, breastfeeding and fertility”).
• If you have difficulty conceiving or are undergoing fertility investigations (see section “Pregnancy, breastfeeding and fertility”).
• If you have an infection – see section “Infections” below.

Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased
risk of heart attack or stroke, especially when administered at high doses. Do not exceed the recommended
dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking Moment if you have:

• heart problems, including heart attack, angina (chest pain), history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including ‘mini-stroke’ or TIA, transient ischemic attack);
• high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.

Medicines like Moment can:

• be associated with the development of kidney disorders, even severe ones (such as renal papillary necrosis, analgesic nephropathy, and renal failure); therefore, your doctor will monitor your kidney function;
• cause eye disorders; therefore, periodic eye examinations are recommended during prolonged treatment. Discontinue treatment with Moment if visual disturbances occur.
  Infections
  Moment may mask symptoms of infections such as fever and pain. Therefore, Moment could delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and the symptoms persist or worsen, contact your doctor immediately.

Adolescents
If an adolescent is dehydrated, there is a risk of developing kidney disease.
Other medicines and Moment
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
Moment may affect or be affected by other medicines. For example:
Do not take Moment together with acetylsalicylic acid (e.g. aspirin) or other anti-inflammatory medicines (such as COX-2 inhibitors or other NSAIDs).
Consult your doctor before using Moment with other medicines, particularly:

• corticosteroids (medicines used to treat inflammation, such as cortisone);
• medicines with anticoagulant effects (i.e. substances that slow blood clotting, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower blood pressure (diuretics, ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan). Moment may reduce the effectiveness of these medicines. If you are taking these medicines, are elderly, or have kidney disease, your doctor may advise you to drink adequate fluids to avoid dehydration and may request blood tests;
• selective serotonin reuptake inhibitors (medicines used to treat depression), as they may increase the risk of injury or bleeding. Your doctor may therefore prescribe a medicine to protect your stomach;
• lithium (a medicine used to treat mental disorders) or phenytoin (a medicine used to treat epilepsy). During treatment with these medicines, your doctor may request blood tests;
• methotrexate, a medicine used to treat cancer or rheumatoid arthritis;
• moclobemide, a medicine used to treat depression;
• aminoglycosides (antibiotic medicines);
• cardiac glycosides (medicines used to treat certain heart conditions). Medicines like Moment may worsen heart disease;
• cholestyramine (a medicine used to lower blood lipids);
• cyclosporine (a medicine used after organ transplantation), as medicines like Moment may increase the risk of kidney damage;
• herbal extracts such as Ginkgo biloba, as taking them together with medicines like Moment may increase the risk of gastrointestinal bleeding;
• mifepristone (a medicine used in women to induce abortion);
• quinolone antibiotics (medicines used to treat infections), as taking them together with medicines like Moment may increase the risk of seizures;
• sulfonylureas, medicines used to treat diabetes; if concurrent treatment is necessary, your doctor may perform blood tests;
• tacrolimus, a medicine used to prevent and treat organ transplant rejection; concurrent administration with Moment may increase the risk of kidney damage;
• zidovudine and ritonavir, medicines used to treat AIDS; if concurrent treatment is necessary, your doctor may perform blood tests;
• probenecid, a medicine used to treat gout;
• CYP2C9 inhibitors, such as voriconazole and fluconazole (medicines used to treat fungal infections);
• bisphosphonates, medicines used to treat bone diseases, as they may increase gastrointestinal side effects;
• oxpentifylline (pentoxifylline), a medicine used to treat leg ulcers, as it may increase gastrointestinal side effects;
• baclofen, a medicine used to relax muscles. Other medicines may also affect or be affected by treatment with Moment. Therefore, always consult your doctor or pharmacist before using Moment with other medicines.

Moment and alcohol
Do not drink alcohol during treatment with Moment, as it may increase the risk of adverse effects.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Moment during the last 3 months of pregnancy, as it may cause serious
heart, lung, and kidney problems in the fetus or cause complications during delivery. It may
affect the tendency for you and your baby to bleed and delay or prolong labour more than expected. You should not take MOMENT during the first 6 months of
pregnancy unless absolutely necessary and advised by your doctor.
If treatment is needed during this period or while trying to conceive, the lowest effective dose for the shortest possible duration should be used. If taken for more than a few days from the 20th week of pregnancy onwards,
Moment may cause kidney problems in the fetus, leading to low levels of
amniotic fluid surrounding the baby (oligohydramnios), or may cause narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk; therefore do not take Moment if you are breastfeeding.
Fertility
If you have difficulty becoming pregnant or are undergoing fertility investigations, discontinue
use of Moment, as this medicine may temporarily impair fertility.
Driving and use of machines
Normally, Moment does not affect the ability to drive or operate machinery. However, if you perform activities requiring alertness, be cautious if you experience drowsiness, dizziness, or depression during treatment with Moment.
This medicine contains:

• Sucrose: if your doctor has diagnosed you with an intolerance to certain sugars (such as sucrose), contact him/her before taking this medicine.
• Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take Moment

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Consult your doctor if you have noticed any recent changes in the characteristics of your condition.
Adults and adolescents over 12 years of age: The recommended dose is 1–2 tablets, two to three times daily.
Take the tablet with a glass of water.
Moment can be taken on an empty stomach. However, in individuals with gastric intolerance issues, it is preferable to take the medicine with food.
If there is no noticeable improvement after three days of treatment, consult your doctor.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, contact your doctor immediately if symptoms (e.g., fever and pain) persist or worsen (see section 2).
Do not exceed 6 tablets per day. If you are elderly, adhere to the lower doses indicated above.
If you suffer from kidney and/or liver or heart disease, consult your doctor, who will determine the appropriate dose for you.
If you have severe liver disease, do not take Moment.

Use in the elderly
Consult your doctor, who will determine the appropriate dose for you by reducing the recommended dose, especially if you have kidney and/or liver disorders.

Use in adolescents
Consult your doctor if the use of this medicine is required for more than 3 days in an adolescent, or if symptoms worsen.

If you take more Moment than you should
If you have taken more Moment than you should, or if your child has accidentally ingested this medicine, contact a doctor or the nearest hospital immediately to assess the risk and receive advice on necessary actions.
If you take an excessive dose (overdose) of ibuprofen, you may commonly experience the following symptoms: nausea, vomiting, stomach pain, deep drowsiness with reduced response to normal stimuli (lethargy), drowsiness, headache, dizziness, ringing in the ears (tinnitus), uncontrolled body movements (convulsions), and loss of consciousness. Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Rarely, you may experience: uncontrolled eye movements (nystagmus), lowered body temperature (hypothermia), kidney-related effects, gastrointestinal bleeding, profound loss of consciousness (coma), temporary interruption of breathing (apnea), diarrhea, reduced activity of the nervous system (central nervous system depression), and reduced respiratory activity (respiratory depression).
Additionally, you may also experience: disorientation, excited state, fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia).
In cases of severe poisoning, metabolic acidosis (increased acid levels in the blood) may occur.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with traces of blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, confusion, and uncontrolled eye movements. Furthermore, agitation, drowsiness, disorientation, or coma may occur. Occasionally, patients may develop seizures. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (especially in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing problems may be reported.
In addition, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute kidney failure and liver damage may occur. Asthma may worsen in patients with asthma. Moreover, low blood pressure and reduced respiratory function may occur.

If you have any questions about the use of Moment, consult your doctor or pharmacist.

If you forget to take Moment
Do not take a double dose to make up for the missed tablet.

4. Possible side effects

Like all medicines, Moment can cause side effects, although not everyone experiences them.
The side effects of this medicine can be minimized if you use the lowest dose among those recommended and only for the duration necessary to control your symptoms.
If you develop an ulcer, or experience bleeding from the stomach and/or intestines, or skin and/or mucosal lesions, you must stop treatment with Moment and consult your doctor. These side effects usually occur more frequently in elderly patients.
The use of Moment may cause side effects that are generally mild or moderate, or more serious reactions, including allergic reactions, although these are rare.
If you experience any of the following symptoms, STOP using Moment IMMEDIATELY and contact your doctor or go immediately to the nearest hospital, where you will receive appropriate and specific treatment:

• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome,
• skin rashes or lesions,
• mucosal lesions,
• signs of an allergic reaction, even severe (erythema, itching, urticaria, asthma, swelling of the skin and mucous membranes, anaphylactic shock),
• skin peeling,
• flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin desquamation, ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis),
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome),
• widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized pustular eruption),
• vision disturbances,
• liver disease (hepatic dysfunction),
• bleeding, ulceration, and perforation of the stomach and intestines, which can be fatal, especially in elderly patients. In case of any of the allergic reactions listed above, go to hospital immediately, as immediate access to emergency equipment, medications, and trained personnel is required, since serious, sometimes fatal, adverse reactions have been reported following the use of ibuprofen, even in the absence of known allergy.

The risk of experiencing such symptoms is higher during the initial stages of treatment: in most cases, the reaction occurs within the first month of treatment.
In addition, you may experience other side effects that have also been reported with medicines similar to Moment, listed below by frequency:
Common (may affect up to 1 in 10 people)

• dizziness
• malaise
• fatigue

Uncommon (may affect up to 1 in 100 people)

• inflammation of the stomach (gastritis)
• insomnia, anxiety
• numbness of limbs or other body parts (paresthesia), drowsiness
• inflammation of the nasal mucosa (rhinitis)
• difficulty breathing (bronchospasm, dyspnea)
• temporary interruption of breathing (apnea)
• vision disturbances
• hearing impairment
• ringing in the ears (tinnitus)
• vertigo
• liver disorders (altered liver function)
• inflammation of the liver (hepatitis)
• yellowing of the skin and eyes (jaundice)
• kidney diseases (impaired kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome, and renal failure)
• hypersensitivity reactions such as skin rash, urticaria, itching, red spots on the skin (purpura), swelling of the skin and mucous membranes (angioedema), difficulty breathing (bronchospasm or dyspnea), asthma attacks possibly with low blood pressure
• skin reactions to light (photosensitivity)

Rare (may affect up to 1 in 1,000 people)

• reduced number of blood cells: reduced white blood cells (leukopenia, neutropenia, agranulocytosis), red blood cells (hemolytic anemia, aplastic anemia), platelets (thrombocytopenia)
• reduced blood clotting ability
• depression, confusion, hallucinations
• inflammation of the optic nerve (optic neuritis)
• inflammation of the meninges, the membranes covering the brain (aseptic meningitis, especially in patients with pre-existing autoimmune disorders; see section “Warnings and precautions”), with symptoms such as neck stiffness, headache, nausea, vomiting, fever, or disorientation
• eye disorders with visual disturbances and optic nerve pathology (toxic optic neuropathy)
• swelling due to fluid accumulation in tissues
• a disease that can affect various organs and tissues of the body (lupus-like syndrome)
• worsening of inflammation caused by an existing infection (e.g., development of necrotizing fasciitis)
• high levels of nitrogen in the blood
• abnormal liver function tests (increased transaminases, increased alkaline phosphatase)
• abnormal blood tests (reduced hemoglobin, reduced hematocrit, prolonged bleeding time, decreased blood calcium, increased blood uric acid)

Very rare (may affect up to 1 in 10,000 people)

• inflammation of the pancreas, a gland involved in digestive processes (pancreatitis)

• awareness of your own heartbeat (palpitations)

• heart disease (heart failure)

• heart attack (myocardial infarction)

• fluid accumulation in the lungs (acute pulmonary edema)

• liver disease (hepatic failure)

• hypertension, severe allergic reactions, which may include symptoms such as severe asthma, swelling of the face, tongue, and throat causing breathing difficulties, rapid heartbeat, severe and rapidly developing allergic reaction that can be fatal (anaphylaxis), severe skin rash or skin peeling (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme)

• severe skin infections and soft tissue disorders may occur during varicella infection

Not known (frequency cannot be estimated from the available data)

• feeling of heaviness in the stomach
• nausea
• vomiting
• diarrhea
• flatulence
• constipation
• difficulty digesting
• abdominal pain
• heartburn
• blood in the stool
• blood in vomit
• mouth sores
• worsening of inflammatory bowel diseases (colitis, Crohn's disease)
• increased risk of sudden reduction in blood flow to the brain (stroke)
• allergic reactions, anaphylaxis
• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome): a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell).
• a widespread, red, scaly rash with pustules under the skin and blisters, mainly localized on skin lesions, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using Moment if you develop these symptoms and contact your doctor immediately. See also section 2.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You can also report side effects directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Moment

This medicine does not require any special storage temperature.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Moment contains

• The active substance is ibuprofen 200 mg.
• The other components are maize starch, sodium carboxymethyl starch, povidone, anhydrous colloidal silica, talc, hydroxypropylcellulose, gum arabic, sucrose, Macrogol 6000, light magnesium carbonate, titanium dioxide.

Description of the appearance of Moment and contents of the package
Moment is presented as film-coated tablets for oral use.
Each pack contains 6, 10, 12, 20, 24, 30, 32 or 36 tablets.
The pack containing 6 film-coated tablets also includes a blister saver.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Angelini Pharma S.p.A.
Viale Amelia, 70 - 00181 Rome
Manufacturer
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona
Famar Italia S.p.A., Via Zambelletti, 25 - 20021 Baranzate di Bollate (MI)

N D E S
There are several types of pain, of various origins and natures, that all of us encounter with greater or lesser frequency, such as headache and toothache, muscle and joint pain, and menstrual pain.
One of the most common types of pain is certainly headache. If you suffer from headache, it is important to identify the factors that may trigger it and try to prevent them (irregular eating habits, specific foods, smoking, alcohol, stress, excessive physical exertion, prolonged sun exposure, excessively loud noises, overly strong perfumes, etc.).
Menstrual pain, sometimes very intense, can be treated with analgesics that work by reducing the amount of prostaglandins—substances produced by the uterus and considered primarily responsible for this condition.
By scanning the QR code on the carton or visiting the website http://leaflet.angelini.it/L01, you can access the updated, multilingual package leaflet.

Package leaflet: information for the user

MOMENT 200 mg soft capsules

ibuprofen
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

1. What Moment is and what it is used for
2. What you need to know before taking Moment
3. How to take Moment
4. Possible side effects
5. How to store Moment
6. Contents of the pack and other information

1. What Moment is and what it is used for

Moment contains ibuprofen, a medicine belonging to the class of analgesic-anti-inflammatory drugs, i.e.
medicines that combat pain and inflammation.
Moment is used in adults and adolescents from the age of 12 for:

• treatment of pain of various origins and nature (headache, toothache, neuralgia, osteo-articular and muscular pain, menstrual pain);
• reduction of symptoms associated with fever and flu-like conditions.
  Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment.

2. What you should know before taking Moment

Do not take Moment

• If you are allergic to ibuprofen and/or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other anti-rheumatic medicines (e.g. acetylsalicylic acid, etc.), or medicines used to treat joint or muscle pain (see section “Other medicines and Moment”).
• If the patient is a child under 12 years of age.
• If you are in the last 3 months of pregnancy or are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).
• If you suffer from stomach or intestinal diseases (e.g., active or severe gastroduodenal ulcer).
• If you have previously experienced gastrointestinal bleeding or perforation following the use of medicines.
• If you have previously had two or more separate episodes of stomach ulcer or bleeding.
• If you have severe heart disease (severe heart failure).
• If you have severe liver or kidney disease.
• If you have lost a significant amount of fluids (severe dehydration) due to vomiting, diarrhoea, or insufficient fluid intake.

Warnings and precautions – Be especially careful with Moment
What you should know before taking Moment
Signs of an allergic reaction to this medicine, including breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen. Stop taking Moment immediately and contact your doctor or emergency medical services if you notice any of these signs.
Skin reactions
Severe skin reactions have been reported with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop using Moment and contact your doctor immediately if you notice any symptoms related to these severe skin reactions described in section 4.
Talk to your doctor or pharmacist before taking Moment:

• If you have previously experienced breathing difficulties (bronchospasm) after taking acetylsalicylic acid (aspirin) or other anti-inflammatory medicines.
• If you suffer from asthma, runny nose (chronic rhinitis), nasal polyps (nasal polyposis), inflammation of the mucous membranes of the paranasal sinuses (sinusitis), or suffer/have suffered from allergies, as you may experience breathing difficulties (bronchospasm), skin redness with itching (urticaria), or swelling of the skin and throat (angioedema), especially if you have previously had allergic reactions after using other medicines used to treat joint or muscle pain, fever, or inflammation (NSAIDs).
• If you are taking other anti-inflammatory medicines, including selective COX-2 inhibitors (an enzyme involved in inflammatory processes), as the risk of ulcers and bleeding may increase (see section “Other medicines and Moment”).
• If you are elderly or have previously suffered from ulcers, especially if the ulcer was associated with bleeding or perforation (see section “Do not take Moment”), as the risk of bleeding, ulceration, or perforation is higher, particularly with higher doses of anti-inflammatory medicines. In such cases, treatment should be started with the lowest available dose, and you may need to consult your doctor for a medicine that protects the stomach (misoprostol or proton pump inhibitors). This should also be considered if you are taking low-dose acetylsalicylic acid or other medicines that may increase the risk of stomach and/or intestinal diseases (see section “Other medicines and Moment”).
• If you have had or currently suffer from chronic intestinal diseases (ulcerative colitis, Crohn’s disease), as these may worsen (see section 4 “Possible side effects”).
• If you have previously experienced stomach or intestinal problems related to medicines, especially if you are elderly, inform your doctor of any unusual intestinal symptoms (especially bleeding), particularly during the initial stages of treatment.
• If you are taking other medicines that increase the risk of stomach or intestinal ulcer or bleeding, such as oral corticosteroids (e.g. cortisone), anticoagulants (e.g. warfarin), antidepressants (selective serotonin reuptake inhibitors), or antiplatelet agents (e.g. acetylsalicylic acid). See also section “Other medicines and Moment”. If gastrointestinal bleeding or ulceration occurs in patients taking Moment, treatment must be discontinued.
• If you have high blood pressure that is not controlled by your current medication, or if you have heart or cerebrovascular disease or other circulatory disorders, or if you think you may be at risk for such conditions (e.g. if you have high blood pressure, diabetes, high cholesterol, or if you smoke).
• If you have high blood pressure or heart disease, as fluid retention, increased blood pressure, and swelling have been observed following treatment with NSAIDs. NSAIDs may reduce the effectiveness of medicines used to lower blood pressure (see section “Other medicines and Moment”).
• If you have lost a significant amount of fluids or develop swelling, heart problems, or high blood pressure.
• If you have reduced kidney function, heart or liver dysfunction, or if you are elderly or taking medicines for high blood pressure, as you may be more prone to kidney problems. Additionally, habitual concurrent use of multiple painkillers may further increase this risk.
• If you have a blood clotting disorder or are taking medicines that slow blood clotting (anticoagulants) (see section “Other medicines and Moment”).
• If you have a disease that can affect multiple organs and tissues (systemic lupus erythematosus) or a connective tissue disease affecting many parts of the body, such as bones and cartilage, as symptoms of “aseptic meningitis” have been observed in rare cases in patients treated with ibuprofen. Although this is more likely to occur in patients with systemic lupus erythematosus or related connective tissue disorders, it has also been observed in patients without concomitant chronic diseases.
• If you are taking medicines to treat pain, heart conditions, or high blood pressure (see section “Other medicines and Moment”).
• If you are planning to become pregnant (see section “Pregnancy, breastfeeding and fertility”).
• If you have difficulty conceiving or are undergoing fertility investigations (see section “Pregnancy, breastfeeding and fertility”).
• If you have an infection – see section “Infections” below.

Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when administered at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking Moment if you have:

• heart problems, including heart attack, angina (chest pain), or a history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrowing or blockage of arteries), or any type of stroke (including ‘mini-stroke’ or “TIA”, transient ischemic attack);
• high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker. Medicines like Moment can:
• be associated with the development of kidney diseases, even severe ones (such as renal papillary necrosis, analgesic nephropathy, and renal failure); therefore, your doctor will monitor your kidney function;
• cause eye disorders; therefore, periodic eye examinations are recommended during prolonged treatment. If you experience visual disturbances, discontinue treatment with Moment.
  Infections
  Moment may mask symptoms of infections such as fever and pain. Therefore, Moment could delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and the symptoms persist or worsen, contact your doctor immediately.

Adolescents
If an adolescent is dehydrated, there is a risk of developing kidney disease.
Other medicines and Moment
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Moment may affect or be affected by other medicines. For example:
Do not take Moment together with acetylsalicylic acid (e.g. aspirin) or other anti-inflammatory medicines (such as COX-2 inhibitors or other NSAIDs).
Consult your doctor before using Moment with other medicines, particularly:

• corticosteroids (medicines used to treat inflammation, such as cortisone);
• medicines that have an anticoagulant effect (i.e. substances that slow blood clotting, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower high blood pressure (diuretics, ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan). Moment may reduce the effect of these medicines. If you are being treated with these medicines, are elderly, or have kidney disease, your doctor may advise you to drink adequate fluids to avoid dehydration and may ask you to have blood tests;
• selective serotonin reuptake inhibitors (medicines used to treat depression), as they may increase the risk of injury or bleeding. Your doctor may therefore prescribe a medicine to protect your stomach;
• lithium (a medicine used to treat mental illness) or phenytoin (a medicine used to treat epilepsy). During treatment with these medicines, your doctor may ask you to have blood tests;
• methotrexate, a medicine used to treat cancer or rheumatoid arthritis;
• moclobemide, a medicine used to treat depression;
• aminoglycosides (antibiotic medicines);
• cardiac glycosides (medicines used to treat certain heart conditions). Medicines like Moment may worsen heart disease;
• colestyramine (a medicine used to lower blood lipids);
• cyclosporine (a medicine used after organ transplantation), as medicines like Moment may increase the risk of kidney damage;
• herbal extracts such as Ginkgo biloba, as taking them together with medicines like Moment may increase the risk of gastrointestinal bleeding;
• mifepristone (a medicine used in women to induce abortion);
• quinolone antibiotics (medicines used to treat infections), as taking them together with medicines like Moment may increase the risk of seizures;
• sulfonylureas, medicines used to treat diabetes; if concurrent treatment is necessary, your doctor may order blood tests;
• tacrolimus, a medicine used to prevent and treat organ transplant rejection; concurrent administration with Moment may increase the risk of kidney damage;
• zidovudine and ritonavir, medicines used to treat AIDS; if concurrent treatment is necessary, your doctor may order blood tests;
• probenecid, a medicine used to treat gout;
• CYP2C9 inhibitors, such as voriconazole and fluconazole (medicines used to treat fungal infections);
• bisphosphonates, medicines used to treat bone diseases, as they may increase gastrointestinal side effects;
• oxpentifylline (pentoxifylline), a medicine used to treat leg ulcers, as it may increase gastrointestinal side effects;
• baclofen, a medicine used to relax muscles.
  Other medicines may also affect or be affected by treatment with Moment. Therefore, always consult your doctor or pharmacist before using Moment with other medicines.

Moment and alcohol
Do not drink alcohol during treatment with Moment, as it may increase the possible side effects.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Moment during the last 3 months of pregnancy, as it may cause serious problems in the fetus’s heart, lungs, and kidneys, or cause complications during childbirth. It may affect your and your baby’s tendency to bleed and delay or prolong labour more than expected. You should not take MOMENT during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor.
If treatment is needed during this period or while trying to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from the 20th week of pregnancy onwards, Moment may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios), or may cause narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk; therefore, do not take Moment if you are breastfeeding.
Fertility
If you have difficulty conceiving or are undergoing fertility investigations, stop using Moment, as this medicine may temporarily impair fertility.
Driving and using machines
Moment generally does not affect the ability to drive or operate machinery. However, if you engage in activities requiring alertness, be cautious if you experience drowsiness, dizziness, or depression during treatment with Moment.
This medicine contains:

• Sorbitol: this medicine contains 14.83 mg of sorbitol per capsule, equivalent to 14.83 mg/651 mg. Sorbitol is a source of fructose. If your doctor has informed you (or the child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.
• Ponceau 4R (E124): may cause allergic reactions.

3. How to take Moment

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Consult your doctor if you have noticed any recent changes in the characteristics of your condition.
Adults and adolescents over 12 years of age: The recommended dose is 1–2 soft capsules, two to three times daily.
Take the capsule with a glass of water.
Moment may be taken on an empty stomach. However, in individuals with gastric intolerance, it is preferable to take the medicine with food.
If there is no noticeable improvement after three days of treatment, consult your doctor.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
Do not exceed 6 soft capsules per day. If you are elderly, adhere to the lower recommended dosages.
If you suffer from kidney and/or liver or heart disease, consult your doctor, who will determine the appropriate dose for you.
If you have severe liver disease, do not take Moment.

Use in the elderly
Consult your doctor, who will determine the appropriate dose for you by reducing the recommended dose, especially if you have kidney and/or liver disorders.

Use in adolescents
Consult your doctor if use of the medicine is required for more than 3 days in an adolescent, or if symptoms worsen.

If you take more Moment than you should
If you have taken more Moment than you should, or if your child has accidentally ingested this medicine, contact a doctor or the nearest hospital immediately for advice on the potential risk and the necessary actions to take.
If you take an excessive dose (overdose) of ibuprofen, you may commonly experience the following symptoms: nausea, vomiting, stomach pain, deep drowsiness with reduced response to normal stimuli (lethargy), drowsiness, headache, dizziness, ringing in the ears (tinnitus), uncontrolled body movements (convulsions), and loss of consciousness. Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Rarely, you may experience: uncontrolled eye movements (nystagmus), lowered body temperature (hypothermia), kidney-related effects, gastrointestinal bleeding, deep loss of consciousness (coma), temporary interruption of breathing (apnea), diarrhoea, reduced activity of the nervous system (central nervous system depression), and reduced respiratory activity (respiratory depression).
Additionally, you may experience: disorientation, state of excitement, fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia).
In cases of severe poisoning, metabolic acidosis (increased acid levels in the blood) may occur.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood traces), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, ringing in the ears, confusion, and uncontrolled eye movements. Furthermore, agitation, drowsiness, disorientation, or coma may occur. Occasionally, patients may develop convulsions. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (especially in children), weakness, dizziness, blood in urine, low potassium levels in blood, feeling cold, and breathing problems may be reported.
In addition, prothrombin time/INR may be prolonged, probably due to interference with circulating coagulation factors. Acute kidney failure and liver damage may occur. Asthma may be exacerbated in asthmatic patients. Moreover, low blood pressure and reduced respiratory function may occur.
If you have any doubts about how to use Moment, consult your doctor or pharmacist.

If you forget to take Moment
Do not take a double dose to make up for the missed capsule.

4. Possible side effects

Like all medicines, Moment can cause side effects, although not everyone gets them.
The side effects of this medicine can be minimized by using the lowest dose among those recommended and by using the medicine only for the duration needed to control your symptoms.
If you develop a stomach ulcer or experience gastrointestinal bleeding and/or skin and/or mucosal lesions, you must stop treatment with Moment and consult your doctor. These side effects are usually more frequent in elderly patients.
The use of Moment may cause side effects that are generally mild or moderate, or more serious reactions—including allergic reactions—although these are rare.
If you experience any of the following symptoms, STOP using Moment IMMEDIATELY and contact your doctor or go immediately to the nearest hospital, where you will receive appropriate and specific treatment:

• chest pain, which may be a sign of a potentially serious allergic reaction known as Kounis syndrome
• skin rashes or lesions
• mucosal lesions
• signs of an allergic reaction, even severe (erythema, itching, urticaria, asthma, swelling of the skin and mucous membranes, anaphylactic shock)
• skin peeling
• flat, non-elevated reddish spots, target-shaped or circular, on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome)
• widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized pustular eruption)
• vision disturbances
• liver disease (hepatic dysfunction)
• bleeding, ulceration, and perforation of the stomach and intestines, which may be fatal, especially in elderly patients. In case of any of the allergic reactions listed above, go to hospital immediately, as immediate access to emergency equipment, medications, and trained personnel is necessary. Serious, sometimes fatal, adverse reactions have been reported following ibuprofen use, even in the absence of known allergy.

The risk of experiencing such symptoms is higher during the initial stages of treatment: in most cases, the reaction occurs within the first month of therapy.
Additionally, you may experience other side effects that have been reported with other medicines similar to Moment, listed below by frequency:
Common (may affect up to 1 in 10 people)

• dizziness
• malaise
• fatigue

Uncommon (may affect up to 1 in 100 people)

• inflammation of the stomach (gastritis)
• insomnia, anxiety
• numbness of limbs or other body parts (paresthesia), drowsiness
• inflammation of the nasal mucosa (rhinitis)
• breathing difficulties (bronchospasm, dyspnea)
• temporary interruption of breathing (apnea)
• vision disturbances
• hearing impairment
• ringing in the ears (tinnitus)
• vertigo
• liver disorders (altered liver function)
• inflammation of the liver (hepatitis)
• yellowing of the skin and eyes (jaundice)
• kidney diseases (impaired kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome, and renal failure)
• hypersensitivity reactions such as skin rash, urticaria, itching, red spots on the skin (purpura), swelling of the skin and mucous membranes (angioedema), difficulty breathing (bronchospasm or dyspnea), asthma attacks possibly with low blood pressure
• skin reactions to light (photosensitivity)

Rare (may affect up to 1 in 1,000 people)

• reduction in blood cells: reduced white blood cells (leukopenia, neutropenia, agranulocytosis), reduced red blood cells (hemolytic anemia, aplastic anemia), reduced platelets (thrombocytopenia)
• reduced blood clotting ability
• depression, confusion, hallucinations
• inflammation of the optic nerve (optic neuritis)
• inflammation of the meninges, the membranes covering the brain (aseptic meningitis, especially in patients with pre-existing autoimmune disorders; see section “Warnings and precautions”), with symptoms such as neck stiffness, headache, nausea, vomiting, fever, or disorientation
• eye disorders with visual disturbances and optic nerve pathology (toxic optic neuropathy)
• swelling due to fluid accumulation in tissues
• a disease that may affect various organs and tissues of the body (lupus erythematosus syndrome)
• worsening of inflammation caused by an existing infection (e.g., development of necrotizing fasciitis)
• high levels of nitrogen in the blood
• abnormal liver function tests (increased transaminases, increased alkaline phosphatase)
• abnormal blood tests (reduced hemoglobin, reduced hematocrit, prolonged bleeding time, decreased blood calcium, increased blood uric acid)

Very rare (may affect up to 1 in 10,000 people)

• inflammation of the pancreas, a gland involved in digestive processes (pancreatitis)
• awareness of your own heartbeat (palpitations)
• heart disease (heart failure)
• heart attack (myocardial infarction)
• accumulation of fluid in the lungs (acute pulmonary edema)
• liver disease (liver failure)
• hypertension
• severe allergic reactions, which may include symptoms such as severe asthma, swelling of the face, tongue, and throat making breathing difficult, rapid heartbeat, severe and rapidly developing allergic reaction that may be fatal (anaphylaxis), severe skin rash or skin peeling (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme)
• severe skin infections and soft tissue disorders may occur during varicella infection

Not known (frequency cannot be estimated from the available data)

• feeling of heaviness in the stomach
• nausea
• vomiting
• diarrhea
• flatulence
• constipation
• difficulty digesting
• abdominal pain
• heartburn
• blood in the stool
• blood in vomit
• mouth sores
• worsening of inflammatory bowel diseases (colitis, Crohn's disease)
• increased risk of sudden reduction in blood flow to the brain (stroke)
• allergic reactions, anaphylaxis
• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome): a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell). A widespread, red, scaly rash with pustules under the skin and blisters, mainly on skin lesions, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using Moment if you develop these symptoms and contact your doctor immediately. See also section 2. Reporting of side effects If you experience any side effect, including those not listed in this leaflet, please consult your doctor. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Moment

Store below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp."
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to safely dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Moment contains

• The active substance is ibuprofen 200 mg.
• The other components are Macrogol 600, potassium hydroxide, gelatin, sorbitol liquid partially dehydrated, purified water, Ponceau 4R (E124), lecithin, fractionated coconut oil.

Description of the appearance of Moment and pack contents
Moment is available as soft capsules for oral use.
Each package contains one or two PVC/PVDC/Al blisters, each containing 10 soft capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Angelini Pharma S.p.A.
Viale Amelia, 70 - 00181 Rome, Italy
Manufacturer
Catalent Germany Eberbach GmbH, Gammelsbacher Str. 2
69412 Eberbach/Baden - Germany

N D E S
There are several types of pain, of various origins and nature, which more or less frequently affect everyone, such as headache and toothache, muscle and joint pain, and menstrual pain.
One of the most common types of pain is certainly headache. If you suffer from headaches, it is important to identify the factors that may trigger them and try to prevent them (irregular eating habits, specific foods, smoking, alcohol, stress, excessive physical exertion, prolonged sun exposure, loud noises, strong perfumes, etc.).
Menstrual pain, sometimes very intense, can be treated with painkillers that work by reducing the amount of prostaglandins—substances produced by the uterus and considered primarily responsible for the discomfort.
By scanning the QR Code on the carton or visiting the address http://leaflet.angelini.it/L03, you can access the updated, multilingual patient information leaflet.

Package leaflet: information for the user

MOMENT 200 mg 20 g/100 ml oral solution drops

ibuprofen
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

1. What Moment is and what it is used for
2. What you need to know before taking Moment
3. How to take Moment
4. Possible side effects
5. How to store Moment
6. Contents of the pack and other information

1. What Moment is and what it is used for

Moment contains ibuprofen, a medicine belonging to the class of analgesic-anti-inflammatory drugs, i.e.
medicines that combat pain and inflammation.
Moment is used in adults and adolescents from the age of 12 for:

• treatment of pain of various origin and nature (headache, toothache, neuralgia, osteo-articular and muscular pain, menstrual pain);
• reduction of symptoms associated with fever and flu-like conditions.
  Consult a doctor if you do not feel better or feel worse after 3 days of treatment.

2. What you need to know before taking Moment

Do not take Moment

• If you are allergic to ibuprofen and/or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other anti-rheumatic medicines (e.g. acetylsalicylic acid, etc.), or medicines used to treat joint or muscle pain (see section "Other medicines and Moment").
• If the patient is a child under 12 years of age.
• If you are in the last 3 months of pregnancy or are breastfeeding (see section "Pregnancy, breastfeeding and fertility").
• If you suffer from stomach or intestinal diseases (e.g. active or severe gastroduodenal ulcer).
• If you have previously experienced bleeding or perforation of the stomach or intestine after taking medicines.
• If you have previously had two or more separate episodes of stomach ulcer or bleeding.
• If you have severe heart disease (severe heart failure).
• If you have severe liver or kidney disease.
• If you have lost a significant amount of fluids (severe dehydration) due to vomiting, diarrhoea or insufficient fluid intake.

Warnings and precautions – Be especially careful with Moment
What you need to know before taking Moment
Signs of an allergic reaction to this medicine, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported with ibuprofen. Stop taking Moment immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
Skin reactions
Severe skin reactions have been reported during treatment with ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop using Moment and contact your doctor immediately if you notice any symptoms related to these severe skin reactions described in section 4.
Talk to your doctor or pharmacist before taking Moment:

• If you have experienced episodes of breathing difficulties (bronchospasm) after taking acetylsalicylic acid (aspirin) or other anti-inflammatory medicines.
• If you suffer from asthma, runny nose (chronic rhinitis), nasal polyps (nasal polyposis), or inflammation of the mucous membranes of the paranasal sinuses (sinusitis), or if you suffer/have suffered from allergies, as you may develop breathing difficulties (bronchospasm), skin redness with itching (urticaria), or swelling of the skin and throat (angioedema), particularly if you have previously had allergic reactions after using other medicines used to treat joint or muscle pain, fever, or inflammation (NSAIDs).
• If you are taking other anti-inflammatory medicines, including selective COX-2 inhibitors (an enzyme involved in inflammatory processes), as the risk of ulcers and bleeding may increase (see section "Other medicines and Moment").
• If you are elderly or have previously suffered from ulcers, especially if the ulcer was associated with bleeding or perforation (see section "Do not take Moment"), as the risk of bleeding, ulceration or perforation is higher, particularly with higher doses of anti-inflammatory medicines. In such cases, treatment should be started with the lowest available dose, and you may need to consult your doctor for a medicine that protects the stomach (misoprostol or proton pump inhibitors). This possibility should also be considered if you are taking low-dose acetylsalicylic acid or medicines that may increase the risk of stomach and/or intestinal diseases (see section "Other medicines and Moment").
• If you have suffered from or currently suffer from chronic intestinal diseases (ulcerative colitis, Crohn's disease), as these may worsen (see section 4 "Possible side effects").
• If you have previously had stomach or intestinal diseases related to medicine use, and especially if you are elderly, you should inform your doctor of any unusual intestinal symptoms (especially bleeding), particularly in the early stages of treatment.
• If you are taking other medicines that increase the risk of stomach or intestinal ulcer or bleeding, such as oral corticosteroids (e.g. cortisone), anticoagulants (e.g. warfarin), antidepressants (selective serotonin reuptake inhibitors), or antiplatelet agents (e.g. acetylsalicylic acid). See also section "Other medicines and Moment". If gastrointestinal bleeding or ulceration occurs in patients taking Moment, treatment must be discontinued.
• If you have high blood pressure and your medicines are not effectively lowering it, or if you have heart or blood circulation diseases affecting the brain or other body areas, or if you think you may be at risk for these diseases (e.g. if you have high blood pressure, diabetes, high cholesterol, or if you smoke).
• If you suffer from high blood pressure and/or heart diseases, as fluid retention, increased blood pressure, and swelling have been observed following treatment with NSAIDs. NSAIDs may reduce the effectiveness of medicines used to lower blood pressure (see section "Other medicines and Moment").
• If you have lost a significant amount of fluids, or if swelling, heart problems, or high blood pressure occur.
• If you have reduced kidney function, heart or liver dysfunction, or if you are elderly or being treated with medicines for high blood pressure, as you may be more prone to kidney problems. Also, habitual concurrent use of multiple painkillers may further increase this risk. If you suffer from a coagulation disorder or are taking medicines that slow blood clotting (anticoagulants) (see section "Other medicines and Moment").
• If you suffer from a disease that may affect multiple organs and tissues in the body (systemic lupus erythematosus) or a connective tissue disease present in many parts of the body, such as bones and cartilage, as symptoms of "aseptic meningitis" have been observed in rare cases in patients treated with ibuprofen. Although this is more likely to occur in patients with systemic lupus erythematosus and related connective tissue disorders, it has also been observed in patients without concomitant chronic diseases.
• If you are taking medicines to treat pain, heart diseases, or high blood pressure (see section "Other medicines and Moment").
• If you intend to become pregnant (see section "Pregnancy, breastfeeding and fertility").
• If you have difficulty conceiving or are undergoing fertility investigations (see section "Pregnancy, breastfeeding and fertility").
• If you have an infection – see section "Infections" below. Anti-inflammatory/painkillers such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when administered at high doses. Do not exceed the recommended dose or duration of treatment. You should discuss treatment with your doctor or pharmacist before taking Moment if you have:
• heart problems including heart attack, angina (chest pain), or a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation to legs or feet due to narrowing or blockage of arteries), or any type of stroke (including 'mini-stroke' or "TIA", transient ischemic attack);
• high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Medicines such as Moment can:

• be associated with the development of kidney diseases, even severe ones (such as renal papillary necrosis, analgesic nephropathy, and renal failure); therefore, your doctor will monitor your kidney function;
• cause eye disorders; therefore, periodic eye examinations are recommended during prolonged treatment. If visual disturbances occur, discontinue treatment with Moment.
  Infections
  Moment may mask symptoms of infections such as fever and pain. Therefore, Moment could delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.

Adolescents
If the adolescent is dehydrated, there is a risk of developing kidney disease.
Other medicines and Moment
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Moment may affect or be affected by other medicines. For example:
Do not take Moment together with acetylsalicylic acid (e.g. aspirin) or other anti-inflammatory medicines (such as COX-2 inhibitors or other NSAIDs).
Consult your doctor before using Moment with other medicines, particularly:

• corticosteroids (medicines used to treat inflammation, such as cortisone);
• medicines with anticoagulant effects (i.e. substances that slow blood clotting, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower blood pressure (diuretics, ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan). Moment may reduce the effect of these medicines. If you are being treated with these medicines, are elderly, or have kidney disease, your doctor may advise you to drink adequate fluids to avoid dehydration and may request blood tests;
• selective serotonin reuptake inhibitors (medicines used to treat depression), as they may increase the risk of injury or bleeding. Your doctor may therefore prescribe a medicine to protect your stomach;
• lithium (a medicine used to treat mental illnesses) or phenytoin (a medicine used to treat epilepsy). During treatment with these medicines, your doctor may request blood tests;
• methotrexate, a medicine used to treat cancer or rheumatoid arthritis;
• moclobemide, a medicine used to treat depression;
• aminoglycosides (antibiotic medicines);
• cardiac glycosides (medicines used to treat certain heart diseases). Medicines such as Moment may worsen heart diseases;
• cholestyramine (a medicine used to lower blood lipids);
• cyclosporine (a medicine used if you have had an organ transplant), as medicines such as Moment may increase the risk of kidney damage;
• herbal extracts such as Ginkgo biloba, as taking them together with medicines such as Moment may increase the risk of gastrointestinal bleeding;
• mifepristone (a medicine used in women to induce abortion);
• quinolone antibiotics (medicines used to treat infections), as taking them together with medicines such as Moment may increase the risk of seizures;
• sulfonylureas, medicines used to treat diabetes; if concurrent treatment is necessary, your doctor may request blood tests;
• tacrolimus, a medicine used to prevent and treat organ transplant rejection; concomitant administration with Moment may increase the risk of kidney damage;
• zidovudine and ritonavir, medicines used to treat AIDS; if concurrent treatment is necessary, your doctor may request blood tests;
• probenecid, a medicine used to treat gout;
• CYP2C9 inhibitors, such as voriconazole and fluconazole (medicines used to treat fungal infections);
• bisphosphonates, medicines used to treat bone diseases, as they may increase gastrointestinal side effects;
• oxpentifylline (pentoxifylline), a medicine used to treat leg ulcers, as it may increase gastrointestinal side effects;
• baclofen, a medicine used to relax muscles. Other medicines may also affect or be affected by treatment with Moment. Therefore, always consult your doctor or pharmacist before using Moment with other medicines.

Moment with alcohol
Do not drink alcohol during treatment with Moment, as it may increase the possible side effects.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Moment during the last 3 months of pregnancy, as it may cause serious heart, lung, and kidney problems in the fetus or cause complications during childbirth. It may affect your and your baby's tendency to bleed and delay or prolong labour more than expected. You should not take MOMENT during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor.
If treatment is needed during this period or while trying to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from the 20th week of pregnancy onwards, Moment may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios), or may cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk; therefore, do not take Moment if you are breastfeeding.
Fertility
If you have difficulty conceiving or are undergoing fertility investigations, discontinue use of Moment, as this medicine may temporarily impair fertility.
Driving and using machines
Normally, Moment does not affect the ability to drive or use machinery. However, if you perform an activity requiring alertness, be cautious if you experience drowsiness, dizziness, or depression during treatment with Moment.
This medicine contains:

• Sucrose: if your doctor has diagnosed you with an intolerance to certain sugars (such as sucrose), contact him before taking this medicine.
• Methyl 4-hydroxybenzoate: may cause allergic reactions (including delayed reactions).
• Ethanol: This medicine contains small amounts of ethanol (alcohol) less than 100 mg per dose.
• Potassium: contains 1.26 mmol of potassium per dose. This should be considered in individuals with reduced kidney function or those on a low-potassium diet.
• Sodium metabisulfite: may rarely cause severe hypersensitivity reactions and bronchospasm.
• Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to take Moment

Take this medicine exactly as stated in this leaflet or according to your doctor’s or pharmacist’s instructions. If you have any doubts, consult your doctor or pharmacist.
Consult your doctor if you have noticed any recent changes in the characteristics of your condition.
Adults and adolescents over 12 years of age: the recommended dose is 25–50 drops (25 drops = ibuprofen 200 mg), two to three times daily.
The bottle has a child-resistant cap: to open, press down on the cap while turning it counterclockwise until it opens (fig. 1).
Place the bottle upright with the opening facing downward.
Wait a few seconds until the liquid starts to flow.
If the liquid does not flow, tap the bottom of the bottle gently with a finger 3–4 times (fig. 2).
Before taking, briefly mix the contents of the glass.

Moment may be taken on an empty stomach. However, in individuals with gastric intolerance issues, it is preferable to take the medicine with food.
If there is no noticeable improvement after three days of treatment, consult your doctor.
The lowest effective dose for the shortest necessary duration should be used to relieve symptoms.
If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
Do not exceed a dose of 50 drops three times daily. If you are elderly, adhere to the lower doses indicated above.
If you suffer from kidney and/or liver or heart disease, consult your doctor, who will determine the appropriate dose for you.
If you have severe liver disease, do not take Moment.

Use in the elderly
Consult your doctor, who will determine the appropriate dose for you, possibly reducing the recommended dose, especially if you have kidney and/or liver problems.

Use in adolescents
Consult your doctor if use of the medicine is required for more than 3 days in an adolescent, or if symptoms worsen.

If you take more Moment than you should
If you have taken more Moment than prescribed, or if your child has accidentally ingested this medicine, contact a doctor or the nearest hospital immediately for advice on potential risks and necessary actions.
If you take an excessive dose (overdose) of ibuprofen, you may commonly experience the following symptoms: nausea, vomiting, stomach pain, deep drowsiness with reduced response to normal stimuli (lethargy), drowsiness, headache, dizziness, ringing in the ears (tinnitus), uncontrolled body movements (convulsions), and loss of consciousness. Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Rarely, you may experience: uncontrolled eye movements (nystagmus), lowered body temperature (hypothermia), kidney problems, gastrointestinal bleeding, deep loss of consciousness (coma), temporary cessation of breathing (apnea), diarrhea, reduced activity of the nervous system (central nervous system depression), and reduced respiratory activity (respiratory depression).
Additionally, you may also develop: disorientation, excited state, fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia).
In cases of severe poisoning, metabolic acidosis (increased acid levels in the blood) may occur.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with traces of blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, confusion, and uncontrolled eye movements. Furthermore, agitation, drowsiness, disorientation, or coma may occur. Occasionally, patients may develop seizures. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties may occur.
In addition, the prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute kidney failure and liver damage may occur. Asthma may worsen in patients with asthma. Moreover, low blood pressure and reduced respiratory function may occur.
If you have any doubts about the use of Moment, consult your doctor or pharmacist.

If you forget to take Moment
Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Moment can cause side effects, although not everyone experiences them.
The side effects of this medicine can be minimized by using the lowest dose among those recommended and by using the medicine only for the duration necessary to control your symptoms.
If you develop a stomach ulcer, bleeding of the stomach and/or intestines, or skin and/or mucous membrane lesions, you must stop treatment with Moment and consult your doctor. Usually, these side effects are more common in elderly patients.
The use of Moment may cause generally mild or moderate side effects, or more severe reactions, including allergic reactions, although rarely.
If you experience any of the following symptoms, STOP using Moment IMMEDIATELY and consult a doctor or go to the nearest hospital, where you will receive appropriate and specific treatment:

• chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome,

  • skin rashes or lesions,
  • mucous membrane lesions,
  • signs of allergic reaction, even severe (erythema, itching, urticaria, asthma, swelling of the skin and mucous membranes, anaphylactic shock),
  • skin peeling,
  • flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin desquamation, ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis),
  • widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome),
  • widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized pustular eruption).

• visual disturbances,

• liver disease (hepatic dysfunction),

• bleeding, ulcers, and perforation of the stomach and intestines, which can be fatal, particularly in the elderly. If you experience any of the allergic reactions listed above, go to hospital immediately, as immediate access to emergency equipment, medications, and trained personnel is necessary. Severe, sometimes fatal, adverse reactions have been reported following ibuprofen use, even in the absence of known allergy.

The risk of experiencing such symptoms is higher during the initial stages of treatment: in most cases, the reaction occurs within the first month of therapy.
Additionally, you may experience other side effects that have also been reported with medicines similar to Moment, listed below according to frequency:

Common (may affect up to 1 in 10 people)

• dizziness
• malaise
• fatigue

Uncommon (may affect up to 1 in 100 people)

• inflammation of the stomach (gastritis)
• insomnia, anxiety
• numbness of limbs or other body parts (paresthesia), drowsiness
• inflammation of the nasal mucosa (rhinitis)
• difficulty breathing (bronchospasm, dyspnea)
• temporary interruption of breathing (apnea)
• visual disturbances
• hearing impairment
• ringing in the ears (tinnitus)
• vertigo
• liver disorders (altered liver function)
• inflammation of the liver (hepatitis)
• yellowing of the skin and eyes (jaundice)
• kidney diseases (impaired kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome, and renal failure)
• hypersensitivity reactions such as skin rash, urticaria, itching, red spots on the skin (purpura), swelling of the skin and mucous membranes (angioedema), difficulty breathing (bronchospasm or dyspnea), asthma attacks possibly accompanied by low blood pressure
• skin reactions to light (photosensitivity)

Rare (may affect up to 1 in 1,000 people)

• reduction in blood cells: reduced white blood cells (leukopenia, neutropenia, agranulocytosis), reduced red blood cells (hemolytic anemia, aplastic anemia), reduced platelets (thrombocytopenia)
• reduced blood clotting ability, depression, confusion, hallucinations
• inflammation of the optic nerve (optic neuritis)
• inflammation of the meninges, the membranes covering the brain (aseptic meningitis, especially in patients with pre-existing autoimmune disorders, see section “Warnings and precautions”), with symptoms such as neck stiffness, headache, nausea, vomiting, fever, or disorientation
• eye disorders with visual disturbances and optic nerve pathology (toxic optic neuropathy)
• swelling due to fluid accumulation in tissues
• a disease that may affect various organs and tissues of the body (lupus erythematosus syndrome)
• worsening of inflammation caused by an existing infection (e.g., development of necrotizing fasciitis)
• high levels of nitrogen in the blood
• abnormal liver function tests (increased transaminases, increased alkaline phosphatase)
• abnormal blood tests (reduced hemoglobin, reduced hematocrit, prolonged bleeding time, decreased blood calcium, increased blood uric acid)

Very rare (may affect up to 1 in 10,000 people)

• inflammation of the pancreas, a gland involved in digestive processes (pancreatitis)
• awareness of your own heartbeat (palpitations)
• heart disease (heart failure)
• heart attack (myocardial infarction)
• presence of fluid in the lungs (acute pulmonary edema)
• liver disease (liver failure)
• hypertension
• severe allergic reactions, which may include symptoms such as severe asthma, swelling of the face, tongue, and throat making breathing difficult, rapid heartbeat, severe and rapidly developing allergic reaction that can be fatal (anaphylaxis), severe skin rash or skin exfoliation (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme)
• severe skin infections and soft tissue disorders may occur during varicella infection.

Not known (frequency cannot be estimated from available data)

• feeling of heaviness in the stomach
• nausea
• vomiting
• diarrhea
• flatulence
• constipation
• difficulty digesting
• abdominal pain
• heartburn
• blood in the stool
• blood in vomit
• mouth sores
• worsening of inflammatory bowel diseases (colitis, Crohn's disease)
• increased risk of sudden reduction in blood circulation to the brain (stroke)
• allergic reactions, anaphylaxis
• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome): a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell).
• a widespread, red, scaly rash with pustules under the skin and blisters, mainly localized on skin lesions, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using Moment if you develop these symptoms and contact your doctor immediately. See also section 2.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor. You can also report side effects directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Moment

This medicine does not require any special temperature storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Moment contains

• The active substance is ibuprofen 200 mg. The other components are sucrose, glycerol, potassium hydroxide, pyridoxine hydrochloride, anhydrous sodium sulfite, polysorbate 20, methyl 4-hydroxybenzoate, sodium citrate, sodium saccharin, sodium edetate, peppermint flavour (contains ethanol), sambuca flavour (contains ethanol), erythrosine (E127), purified water.

Description of the appearance of Moment and contents of the pack
Moment is available as oral drops.
Each pack contains a 15 ml amber glass bottle with a dropper.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Angelini Pharma S.p.A.
Viale Amelia, 70 - 00181 Rome
Manufacturer
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona

N D E S
There are several types of pain, of various origins and nature, that all of us encounter with greater or lesser frequency, such as headache and toothache, muscle and joint pain, and menstrual pain.
One of the most common types of pain is certainly headache. If you suffer from headaches, it is important to identify the factors that may trigger them and try to prevent them (irregular eating habits, specific foods, smoking, alcohol, stress, excessive physical exertion, excessive sun exposure, excessively loud noises, overly strong perfumes, etc.).
Menstrual pain, sometimes even of considerable intensity, can be treated with painkillers that work by reducing the amount of prostaglandins—substances produced by the uterus and considered primarily responsible for the discomfort.
By scanning the QR code on the carton or visiting the website http://leaflet.angelini.it/LXX, you can access the updated, multilingual package leaflet.

Package leaflet: information for the user

MOMENT 200 mg oral solution granules

ibuprofen
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

1. What Moment is and what it is used for
2. What you need to know before taking Moment
3. How to take Moment
4. Possible side effects
5. How to store Moment
6. Contents of the pack and other information

1. What Moment is and what it is used for

Moment contains ibuprofen, a medicine belonging to the class of analgesic-anti-inflammatory drugs, that is,
medicines which fight pain and inflammation.
Moment is used in adults and adolescents from the age of 12 for the treatment of pain of various
origin and nature (headache, toothache, neuralgia, osteo-articular and muscular pain, menstrual pain).
Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment.

2. What you should know before taking Moment

Do not take Moment

• If you are allergic to ibuprofen and/or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other anti-rheumatic medicines (e.g. acetylsalicylic acid, etc.), or medicines used to treat joint or muscle pain (see section “Other medicines and Moment”).
• If the patient is a child under 12 years of age.
• If you are in the last 3 months of pregnancy or are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).
• If you suffer from stomach or intestinal diseases (e.g. active or severe gastroduodenal ulcer).
• If you have previously experienced stomach or intestinal bleeding or perforation following the use of medicines.
• If you have previously had two or more separate episodes of stomach ulcer or bleeding.
• In case of severe heart disease (severe heart failure).
• In case of severe liver or kidney disease.
• If you have lost a significant amount of fluids (severe dehydration) due to vomiting, diarrhoea or insufficient fluid intake.
• If you suffer from a metabolic disorder of amino acids, which are the building blocks of proteins, called phenylketonuria.

Warnings and precautions – Take special care with Moment
What you should know before taking Moment
With ibuprofen, signs of an allergic reaction to this medicine have been reported, including breathing difficulties, swelling of the face and neck area (angioedema), and chest pain. Immediately stop treatment with Moment and contact your doctor or emergency medical service if you notice any of these signs.
Skin reactions
Serious skin reactions have been reported during treatment with ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop using Moment and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Talk to your doctor or pharmacist before taking Moment:

• If you have previously experienced episodes of breathing difficulties (bronchospasm) after taking acetylsalicylic acid (aspirin) or other anti-inflammatory medicines.
• If you suffer from asthma, runny nose (chronic rhinitis), nasal polyps (nasal polyposis), inflammation of the mucous membranes of the paranasal sinuses (sinusitis), or suffer/have suffered from allergies, as you may develop breathing difficulties (bronchospasm), skin redness with itching (urticaria), or swelling of the skin and throat (angioedema), especially if you have previously had allergic reactions after using other medicines used to treat joint or muscle pain, fever, or inflammation (NSAIDs).
• If you are taking other anti-inflammatory medicines, including selective COX-2 inhibitors (an enzyme involved in inflammatory processes), as the risk of ulcers and bleeding may increase (see section “Other medicines and Moment”).
• If you are elderly or have previously suffered from ulcers, especially if the ulcer was associated with bleeding or perforation (see section “Do not take Moment”), as the risk of bleeding, ulceration or perforation is higher, particularly with higher doses of anti-inflammatory medicines. In such cases, treatment should be started with the lowest available dose, and you may need to consult your doctor for a prescription of a medicine that protects the stomach (misoprostol or proton pump inhibitors). This possibility should also be considered if you are taking low-dose acetylsalicylic acid or other medicines that may increase the risk of stomach and/or intestinal diseases (see section “Other medicines and Moment”).
• If you have suffered or suffer from chronic intestinal diseases (ulcerative colitis, Crohn’s disease), as these may worsen (see section 4 “Possible side effects”).
• If you have had stomach or intestinal diseases related to medicine use, and particularly if you are elderly, inform your doctor of any unusual intestinal symptoms (especially bleeding), particularly during the initial stages of treatment.
• If you are taking other medicines that increase the risk of stomach or intestinal ulcer or bleeding, such as oral corticosteroids (e.g. cortisone), anticoagulants (e.g. warfarin), antidepressants (selective serotonin reuptake inhibitors), or antiplatelet agents (e.g. acetylsalicylic acid). See also section “Other medicines and Moment”. If gastrointestinal bleeding or ulceration occurs in patients taking Moment, treatment must be discontinued.
• If you have high blood pressure and your current medicines are not effectively lowering it, and/or if you have heart or circulatory diseases affecting the brain or other body areas, or if you think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol, or if you smoke).
• If you suffer from high blood pressure and/or heart diseases, as fluid retention, increased blood pressure, and swelling have been observed following treatment with NSAIDs. NSAIDs may reduce the effectiveness of medicines used to lower blood pressure (see section “Other medicines and Moment”).
• If you have lost a significant amount of fluids, or if swelling, heart problems or high blood pressure occur.
• If you have reduced kidney function, heart or liver dysfunction, or if you are elderly or taking medicines for high blood pressure, as you may be more prone to kidney problems. Furthermore, habitual concurrent use of multiple painkillers may further increase this risk.
• If you suffer from a blood clotting disorder or are taking medicines that slow blood clotting (anticoagulants) (see section “Other medicines and Moment”).
• If you suffer from a disease affecting multiple organs and tissues (systemic lupus erythematosus) or a connective tissue disease present in many parts of the body, such as bones and cartilage, as symptoms of “aseptic meningitis” have been observed in rare cases in patients treated with ibuprofen. Although this is more likely to occur in patients with systemic lupus erythematosus or related connective tissue disorders, it has also been observed in patients without concomitant chronic diseases.
• If you are taking medicines to treat pain, heart diseases or high blood pressure (see section “Other medicines and Moment”).
• If you intend to become pregnant (see section “Pregnancy, breastfeeding and fertility”).
• If you have difficulty conceiving or are undergoing fertility investigations (see section “Pregnancy, breastfeeding and fertility”).
• If you have an infection – see section “Infections” below.

Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when administered at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking Moment if you have:

• heart problems, including heart attack, angina (chest pain), or a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation to legs or feet due to narrowing or blockage of arteries), or any type of stroke (including ‘mini-stroke’ or “TIA”, transient ischemic attack);
• high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Medicines like Moment can:

• be associated with the development of kidney diseases, even severe ones (such as renal papillary necrosis, analgesic nephropathy and renal failure); therefore, your doctor will monitor your kidney function;
• cause eye disorders; therefore, periodic eye examinations are recommended during prolonged treatment. If you experience visual disturbances, stop treatment with Moment.

Infections
Moment may mask symptoms of infections such as fever and pain. Therefore, Moment could delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.

Adolescents
If an adolescent is dehydrated, there is a risk of developing kidney disease.

Other medicines and Moment
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Moment can affect or be affected by other medicines. For example:
Do not take Moment together with acetylsalicylic acid (e.g. aspirin) or other anti-inflammatory medicines (such as COX-2 inhibitors or other NSAIDs).
Consult your doctor before using Moment with other medicines, especially:

• corticosteroids (medicines used to treat inflammation, such as cortisone);
• medicines with anticoagulant effects (i.e. substances that slow blood clotting, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower high blood pressure (diuretics, ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan). Moment may reduce the effect of these medicines. If you are being treated with these medicines, are elderly, or have kidney disease, your doctor may advise you to drink adequate fluids to avoid dehydration and may ask you to have blood tests;
• selective serotonin reuptake inhibitors (medicines used to treat depression), as they may increase the risk of injury or bleeding. Your doctor may therefore prescribe a medicine to protect your stomach;
• lithium (a medicine used to treat mental illnesses) or phenytoin (a medicine used to treat epilepsy). During treatment with these medicines, your doctor may ask you to have blood tests;
• methotrexate, a medicine used to treat cancer or rheumatoid arthritis;
• moclobemide, a medicine used to treat depression;
• aminoglycosides (antibiotic medicines);
• cardiac glycosides (medicines used to treat certain heart diseases). Medicines like Moment may worsen heart conditions;
• colestyramine (a medicine used to lower blood lipids);
• cyclosporine (a medicine used after organ transplantation), as medicines like Moment may increase the risk of kidney damage;
• herbal extracts such as Ginkgo Biloba, as when taken together with medicines like Moment, they may increase the risk of gastrointestinal bleeding;
• mifepristone (a medicine used in women to induce abortion);
• quinolone antibiotics (medicines used to treat infections), as when taken together with medicines like Moment, there may be an increased risk of seizures;
• sulphonamides, medicines used to treat diabetes; if concomitant treatment is necessary, your doctor may perform blood tests;
• tacrolimus, a medicine used to prevent and treat organ transplant rejection; concomitant administration with Moment may increase the risk of kidney damage;
• zidovudine and ritonavir, medicines used to treat AIDS; if concomitant treatment is necessary, your doctor may perform blood tests;
• probenecid, a medicine used to treat gout;
• CYP2C9 inhibitors, such as voriconazole and fluconazole (medicines used to treat fungal infections);
• bisphosphonates, medicines used to treat bone diseases, as they may increase gastrointestinal side effects;
• oxpentifylline (pentoxifylline), a medicine used to treat leg ulcers, as it may increase gastrointestinal side effects;
• baclofen, a medicine used to relax muscles.

Other medicines may also affect or be affected by treatment with Moment. Therefore, always consult your doctor or pharmacist before using Moment with other medicines.

Moment and alcohol
Do not drink alcohol during treatment with Moment, as it may increase the risk of possible side effects.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take Moment during the last 3 months of pregnancy, as it may cause serious problems to the heart, lungs and kidneys of the unborn baby or cause complications during delivery. It may affect your and your baby’s tendency to bleed and delay or prolong labour more than expected. You should not take MOMENT during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor.
If treatment is needed during this period or while trying to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from the 20th week of pregnancy onwards, Moment may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios), or may cause narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment for more than a few days is necessary, your doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk; therefore, do not take Moment if you are breastfeeding.

Fertility
If you have difficulty conceiving or are undergoing fertility investigations, discontinue use of Moment, as this medicine may temporarily impair fertility.

Driving and using machines
Generally, Moment does not affect the ability to drive or use machinery. However, if you perform an activity requiring alertness, be cautious if you experience drowsiness, dizziness or depression during treatment with Moment.

This medicine contains:

• Potassium: this medicine contains 2.25 mmol of potassium per dose. This should be taken into account in individuals with reduced kidney function or those on a low-potassium diet.
• Sucrose: if your doctor has diagnosed you with an intolerance to certain sugars (such as sucrose), contact him before taking this medicine.
• Aspartame: this medicine contains 20 mg of aspartame per sachet equivalent to 20 mg/3000 mg. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.

3. How to take Moment

Take this medicine exactly as indicated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Consult your doctor if you have noticed any recent changes in the characteristics of your condition.
Adults and adolescents over 12 years of age: the recommended dose is 1–2 sachets, two to three times daily.
Dissolve the contents of one sachet in a glass of water, stirring with a teaspoon until fully dissolved, and drink the resulting solution immediately.
Moment may be taken on an empty stomach. However, in individuals experiencing gastric intolerance, it is preferable to take the medicine with food.
If there is no noticeable improvement after three days of treatment, consult your doctor.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
Do not exceed 6 sachets per day. If you are elderly, adhere to the lower doses specified above.
If you suffer from kidney and/or liver or heart disease, consult your doctor, who will determine the appropriate dose for you.
If you have severe liver disease, do not take Moment.

Use in the elderly
Consult your doctor, who will determine an appropriate dose for you, possibly reducing the recommended dose, especially if you have kidney and/or liver problems.

Use in adolescents
Consult your doctor if use of the medicine is required for more than 3 days in an adolescent, or if symptoms worsen.

If you take more Moment than you should
If you have taken more Moment than recommended, or if your child has accidentally ingested this medicine, contact a doctor or the nearest hospital immediately for advice on potential risks and necessary actions.
If you take an excessive dose (overdose) of ibuprofen, you may commonly experience the following symptoms: nausea, vomiting, stomach pain, deep drowsiness with reduced response to normal stimuli (lethargy), drowsiness, headache, dizziness, ringing in the ears (tinnitus), uncontrolled body movements (convulsions), and loss of consciousness. Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Rarely, you may experience: uncontrolled eye movements (nystagmus), lowered body temperature (hypothermia), kidney-related effects, gastrointestinal bleeding, deep unconsciousness (coma), temporary interruption of breathing (apnea), diarrhoea, reduced activity of the nervous system (central nervous system depression), and reduced respiratory activity (respiratory depression).
Additionally, you may experience: disorientation, excited state, fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia).
In cases of severe poisoning, metabolic acidosis (increased acid levels in the blood) may occur.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with traces of blood), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, ringing in the ears, confusion, and uncontrolled eye movements. Furthermore, agitation, drowsiness, disorientation, or coma may occur. Occasionally, patients may develop convulsions. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (especially in children), weakness, dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties may be reported.
In addition, the prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute kidney failure and liver damage may occur. Asthma may worsen in patients with asthma. Moreover, low blood pressure and reduced respiratory function may occur.

If you have any doubts about how to use Moment, consult your doctor or pharmacist.

If you forget to take Moment
Do not take a double dose to make up for the missed sachet.

4. Possible side effects

Like all medicines, Moment can cause side effects, although not everyone experiences them.
The side effects of the medicine can be minimized by using the lowest dose among those recommended and by using the medicine only for the period necessary to control your symptoms.
If you develop a stomach ulcer, bleeding of the stomach and/or intestines, or skin and/or mucosal lesions, you must stop treatment with Moment and consult your doctor. These side effects are usually more frequent in elderly patients.
The use of Moment may cause generally mild or moderate side effects or, more rarely, more serious reactions, including allergic ones.
If you experience any of the following symptoms, STOP using Moment IMMEDIATELY and contact your doctor or go immediately to the nearest hospital, where you will be given appropriate and specific treatment:

• chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome,
• skin rashes or lesions,
• mucosal lesions,
• signs of allergic reaction, even severe (erythema, itching, urticaria, asthma, swelling of the skin and mucous membranes, anaphylactic shock),
• skin peeling,
• flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin desquamation, ulcers of the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis),
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome),
• widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute exanthematous pustulosis),
• visual disturbances,
• liver disease (hepatic dysfunction),
• bleeding, ulceration, and perforation of the stomach and intestines, which can be fatal, particularly in elderly patients. In case of any of the above-mentioned allergic reactions, go to hospital immediately, as immediate access to emergency treatment equipment, medications, and trained personnel is required, since serious, sometimes fatal, adverse reactions have been reported following ibuprofen use, even in the absence of known allergy.

The risk of experiencing such symptoms is higher during the initial stages of therapy: in most cases, the reaction occurs within the first month of treatment.
Additionally, you may experience other side effects that have also been reported with other medicines similar to Moment, listed below by frequency:
Common (may affect up to 1 in 10 people)

• dizziness
• malaise
• fatigue

Uncommon (may affect up to 1 in 100 people)

• inflammation of the stomach (gastritis)
• insomnia, anxiety
• numbness of limbs or other body parts (paresthesia), drowsiness
• inflammation of the nasal mucosa (rhinitis)
• breathing difficulties (bronchospasm, dyspnea)
• temporary interruption of breathing (apnea)
• visual disturbances
• hearing impairment
• ringing in the ears (tinnitus)
• vertigo
• liver disorders (altered liver function)
• inflammation of the liver (hepatitis)
• yellowing of the skin and eyes (jaundice)
• kidney diseases (impaired kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome, and renal failure)
• hypersensitivity reactions such as skin rash, urticaria, itching, red spots on the skin (purpura), swelling of the skin and mucous membranes (angioedema), breathing difficulties (bronchospasm or dyspnea), asthma attacks possibly accompanied by low blood pressure
• skin reactions to light (photosensitivity)

Rare (may affect up to 1 in 1,000 people)

• reduction in blood cell counts: reduction in white blood cells (leukopenia, neutropenia, agranulocytosis), red blood cells (hemolytic anemia, aplastic anemia), platelets (thrombocytopenia)
• reduced blood clotting ability
• depression, confusion, hallucinations
• inflammation of the optic nerve (optic neuritis)
• inflammation of the meninges, the membranes covering the brain (aseptic meningitis, especially in patients with pre-existing autoimmune disorders, see section “Warnings and precautions”), with symptoms such as neck stiffness, headache, nausea, vomiting, fever, or disorientation
• eye disorders with visual disturbances and optic nerve pathology (toxic optic neuropathy)
• swelling due to fluid accumulation in tissues
• a disease that may affect various organs and tissues of the body (lupus erythematosus syndrome)
• worsening of inflammation caused by an existing infection (e.g., development of necrotizing fasciitis)
• high levels of nitrogen in the blood
• abnormal liver function tests (increased transaminases, increased alkaline phosphatase)
• abnormal blood tests (reduced hemoglobin, reduced hematocrit, prolonged bleeding time, decreased blood calcium, increased blood uric acid)

Very rare (may affect up to 1 in 10,000 people)

• inflammation of the pancreas, a gland involved in digestive processes (pancreatitis)
• awareness of your own heartbeat (palpitations)
• heart disease (heart failure)
• heart attack (myocardial infarction)
• accumulation of fluid in the lungs (acute pulmonary edema)
• liver disease (liver failure)
• hypertension
• severe allergic reactions, which may include symptoms such as severe asthma, swelling of the face, tongue, and throat making breathing difficult, rapid heartbeat, severe and rapidly developing allergic reaction that can be fatal (anaphylaxis), severe skin rash or skin exfoliation (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme)
• severe skin infections and soft tissue disorders may occur during varicella infection

Not known (frequency cannot be estimated from available data)

• feeling of heaviness in the stomach
• nausea
• vomiting
• diarrhea
• flatulence
• constipation
• difficulty digesting
• abdominal pain
• heartburn
• blood in stools
• blood in vomit
• lesions inside the mouth
• worsening of inflammatory bowel diseases (colitis, Crohn's disease)
• increased risk of sudden reduction in blood circulation to the brain (stroke)
• allergic reactions, anaphylaxis
• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome): a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell)
• a widespread, red, scaly rash with pustules under the skin and blisters, mainly localized on skin lesions, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute exanthematous pustulosis). Stop using Moment if you develop these symptoms and contact your doctor immediately. See also section 2.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You can also report side effects directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Moment

This medicine does not require any special storage temperature.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Moment contains

• The active substance is ibuprofen 200 mg (as sodium salt dihydrate 256 mg).
• The other ingredients are sucrose, potassium bicarbonate, orange flavour, acesulfame potassium, aspartame (E 951).

Description of the appearance of Moment and contents of the pack
Moment is presented as sachets of oral granules.
Each pack contains 12 sachets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Angelini Pharma S.p.A.
Viale Amelia, 70 - 00181 Rome
Manufacturer
E-Pharma Trento S.p.A., Frazione Ravina - Via Provina, 2 - 38123 Trento (TN) (Italy)

N D E S
There are several types of pain, of different origin and nature, which all of us encounter with varying frequency, particularly headache and toothache, muscular and joint pain, and menstrual pain.
One of the most common types of pain is certainly headache. If you suffer from headaches, it is important to identify the factors that may trigger them and try to prevent them (irregular eating habits, certain foods, smoking, alcohol, stress, excessive physical exertion, excessive sun exposure, loud noises, overly strong perfumes, etc.).
Menstrual pain, sometimes very intense, can be relieved with analgesics that work by reducing the amount of prostaglandins—substances produced by the uterus and considered primarily responsible for the discomfort.
By scanning the QR code on the carton or visiting the address http://leaflet.angelini.it/L02, it is possible to read the updated, multilingual package leaflet.

Instructions for the user: package leaflet

MOMENT 200 mg oral suspension sachets

Ibuprofen
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

1. What Moment is and what it is used for
2. What you need to know before taking Moment
3. How to take Moment
4. Possible side effects
5. How to store Moment
6. Contents of the pack and other information

1. What Moment is and what it is used for

Moment contains ibuprofen, a medicine belonging to the class of analgesic-anti-inflammatory drugs, i.e. medicines that fight pain and inflammation.
Moment is used in adults and adolescents aged 12 years and older for:

• Treating pain of various origins and types (headache, toothache, neuralgia, osteoarticular and muscular pain, menstrual pain);
• Reducing symptoms of fever and flu-like conditions.
  Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment.

2. What you should know before taking Moment

Do not take Moment

• If you are allergic to ibuprofen and/or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other anti-rheumatic medicines (e.g. acetylsalicylic acid, etc.), or medicines used to treat joint or muscle pain (see section “Other medicines and Moment”).
• If the patient is a child under 12 years of age.
• If you are in the last 3 months of pregnancy or are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).
• If you suffer from stomach or intestinal diseases (e.g. active or severe gastroduodenal ulcer).
• If you have previously experienced stomach or intestinal bleeding or perforation following the use of medicines.
• If you have previously had two or more separate episodes of stomach ulcer or bleeding.
• If you have severe heart disease (severe heart failure).
• If you have severe liver or kidney disease.
• If you have lost a significant amount of fluids (severe dehydration) due to vomiting, diarrhoea, or insufficient fluid intake.

Warnings and precautions – Take special care with Moment
What you should know before taking Moment
Signs of an allergic reaction to this medicine, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported with ibuprofen.
Stop taking Moment immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
Skin reactions
Serious skin reactions have been reported with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop using Moment and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.

Consult your doctor or pharmacist before taking Moment:

• If you have experienced episodes of breathing difficulties (bronchospasm) after taking acetylsalicylic acid (aspirin) or other anti-inflammatory medicines.

• If you suffer from asthma, runny nose (chronic rhinitis), nasal polyps (nasal polyposis), inflammation of the mucous membranes of the paranasal sinuses (sinusitis), or have allergies, as you may develop breathing difficulties (bronchospasm), skin redness with itching (urticaria), or swelling of the skin and throat (angioedema), especially if you have previously had allergic reactions after using other medicines for joint or muscle pain, fever, or inflammation (NSAIDs).

• If you are taking other anti-inflammatory medicines, including selective COX-2 inhibitors (an enzyme involved in inflammatory processes), as the risk of ulcers and bleeding may increase (see section “Other medicines and Moment”).

• If you are elderly or have had a history of ulcers, especially if the ulcer was associated with bleeding or perforation (see section “Do not take Moment”), as the risk of bleeding, ulceration, or perforation is higher, particularly with higher doses of anti-inflammatory medicines. In such cases, treatment should be started with the lowest available dose, and you may need to consult your doctor for a medicine that protects the stomach (misoprostol or proton pump inhibitors). This should also be considered if you are taking low-dose acetylsalicylic acid or other medicines that may increase the risk of stomach and/or intestinal diseases (see section “Other medicines and Moment”).

• If you have had or currently suffer from chronic intestinal diseases (ulcerative colitis, Crohn’s disease), as these may worsen (see section 4 “Possible side effects”).

• If you have had stomach or intestinal diseases related to medicine use, and especially if you are elderly, inform your doctor of any unusual intestinal symptoms (especially bleeding), particularly during the initial stages of treatment.

• If you are taking other medicines that increase the risk of stomach or intestinal ulcer or bleeding, such as oral corticosteroids (e.g. cortisone), anticoagulants (e.g. warfarin), antidepressants (selective serotonin reuptake inhibitors), or antiplatelet agents (e.g. acetylsalicylic acid). See also section “Other medicines and Moment”. If gastrointestinal bleeding or ulceration occurs in patients taking Moment, treatment must be discontinued.

• If you have high blood pressure and your medicines are not effectively lowering it, or if you have heart or circulatory diseases affecting the brain or other areas, or think you may be at risk for such diseases (e.g. if you have high blood pressure, diabetes, high cholesterol, or smoke).

• If you suffer from high blood pressure and/or heart disease, as fluid retention, increased blood pressure, and swelling have been observed with NSAID treatment. NSAIDs may reduce the effectiveness of medicines used to lower blood pressure (see section “Other medicines and Moment”).

• If you have lost a significant amount of fluids, or if swelling, heart problems, or high blood pressure develop.

• If you have reduced kidney function, heart or liver dysfunction, or are elderly or taking medicines for high blood pressure, as you may be more prone to kidney problems. Additionally, habitual concurrent use of multiple painkillers may further increase this risk.

• If you suffer from a blood clotting disorder or are taking medicines that slow blood clotting (anticoagulants) (see section “Other medicines and Moment”).

• If you suffer from a disease affecting multiple organs and tissues (systemic lupus erythematosus) or a connective tissue disease present in many parts of the body, such as bones and cartilage, as symptoms of aseptic meningitis have been observed in rare cases in patients treated with ibuprofen. Although this is more likely to occur in patients with systemic lupus erythematosus and related connective tissue disorders, it has also been observed in patients without concomitant chronic diseases.

• If you are taking medicines to treat pain, heart conditions, or high blood pressure (see section “Other medicines and Moment”).

• If you are planning to become pregnant (see section “Pregnancy, breastfeeding and fertility”).

• If you have difficulty conceiving or are undergoing fertility investigations (see section “Pregnancy, breastfeeding and fertility”). If you have an infection – see section “Infections” below. Anti-inflammatory/painkillers such as ibuprofen may be associated with a modest increase in the risk of heart attack or stroke, especially when administered at high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss treatment with your doctor or pharmacist before taking Moment if you have:

• Heart problems, including heart attack, angina (chest pain), history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation to legs or feet due to narrowed or blocked arteries), or any type of stroke (including ‘mini-stroke’ or “TIA”, transient ischemic attack);
• High blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker. Medicines like Moment can:
• Be associated with the development of kidney diseases, even severe ones (such as renal papillary necrosis, analgesic nephropathy, and renal failure); therefore, your doctor will monitor your kidney function;
• Cause eye disorders; therefore, periodic eye examinations are recommended during prolonged treatment. If you experience visual disturbances, discontinue treatment with Moment.
  Infections
  Moment may mask symptoms of infections such as fever and pain. Therefore, Moment could delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and the infection symptoms persist or worsen, contact your doctor immediately.

Adolescents
If an adolescent is dehydrated, there is a risk of developing kidney disease.
Other medicines and Moment
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Moment can affect or be affected by other medicines. For example:
Do not take Moment together with acetylsalicylic acid (e.g. aspirin) or other anti-inflammatory medicines (such as COX-2 inhibitors or other NSAIDs).
Consult your doctor before using Moment with other medicines, especially:

• Corticosteroids (medicines used to treat inflammation, such as cortisone);
• Medicines that have an anticoagulant effect (i.e. substances that slow blood clotting, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine, heparin);
• Medicines that reduce high blood pressure (diuretics, ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan). Moment may reduce the effect of these medicines. If you are taking these medicines, are elderly, or have kidney disease, your doctor may advise you to drink adequate fluids to avoid dehydration and may ask you to have blood tests;
• Selective serotonin reuptake inhibitors (medicines used to treat depression), as they may increase the risk of injury or bleeding. Your doctor may therefore prescribe a medicine to protect your stomach;
• Lithium (a medicine used to treat mental illnesses) or phenytoin (a medicine used to treat epilepsy). During treatment with these medicines, your doctor may ask you to have blood tests;
• Methotrexate, a medicine used to treat cancer or rheumatoid arthritis;
• Moclobemide, a medicine used to treat depression;
• Aminoglycosides (antibiotic medicines);
• Cardiac glycosides (medicines used to treat certain heart conditions). Medicines like Moment may worsen heart disease;
• Colestipol (a medicine used to lower blood lipids);
• Cyclosporine (a medicine used if you have had an organ transplant), as medicines like Moment may increase the risk of kidney damage;
• Herbal extracts such as Ginkgo biloba, as when taken together with medicines like Moment, they may increase the risk of gastrointestinal bleeding;
• Mifepristone (a medicine used in women to induce abortion);
• Quinolone antibiotics (medicines used to treat infections), as when taken together with medicines like Moment, there may be an increased risk of seizures;
• Sulfonylureas, medicines used to treat diabetes; if concurrent treatment is necessary, your doctor may order blood tests;
• Tacrolimus, a medicine used to prevent and treat organ transplant rejection; concomitant administration with Moment may increase the risk of kidney damage;
• Zidovudine and ritonavir, medicines used to treat AIDS; if concurrent treatment is necessary, your doctor may order blood tests;
• Probenecid, a medicine used to treat gout;
• CYP2C9 inhibitors, such as voriconazole and fluconazole (medicines used to treat fungal infections);
• Bisphosphonates, medicines used to treat bone diseases, as they may increase gastrointestinal side effects;
• Oxypentifylline (pentoxifylline), a medicine used to treat leg ulcers, as it may increase gastrointestinal side effects;
• Baclofen, a medicine used to relax muscles.
  Other medicines may also affect or be affected by treatment with Moment.
  Therefore, always consult your doctor or pharmacist before using Moment with other medicines.

Moment with alcohol
Do not drink alcohol during treatment with Moment, as it may increase the risk of adverse effects.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Moment during the last 3 months of pregnancy, as it may cause serious problems to the baby’s heart, lungs, and kidneys, or cause complications during delivery. It may affect your and your baby’s tendency to bleed and delay or prolong labour more than expected. You should not take MOMENT during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor.
If treatment is needed during this period or while trying to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from the 20th week of pregnancy onwards, Moment may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios), or may cause narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk; therefore, do not take Moment if you are breastfeeding.
Fertility
If you have difficulty conceiving or are undergoing fertility investigations, discontinue use of Moment, as this medicine may temporarily impair fertility.
Driving and using machines
Generally, Moment does not affect the ability to drive or use machinery. However, if you perform an activity requiring alertness, be cautious if you experience drowsiness, dizziness, or depression during treatment with Moment.
This medicine contains:

• Sucrose: if your doctor has diagnosed you with an intolerance to certain sugars (such as sucrose), contact them before taking this medicine.
• Propyl and methyl parahydroxybenzoate: may cause allergic reactions (including delayed reactions).
• Sodium (disodium edetate dihydrate): this medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium-free”.

3. How to take Moment

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Consult your doctor if you have noticed any recent changes in the nature of your condition.
Adults and adolescents aged 12 years and older: the recommended dose is 1–2 sachets, two to three times a day.
Instructions for use:

Before use, gently press the sachet between your fingers to homogenize the contents.

Once opened, take the product by pouring it directly into the mouth without water, gently squeezing from the bottom to ensure complete emptying.
Moment may be taken on an empty stomach. In patients with gastric intolerance, it is preferable to take the medicine with food.
If there is no noticeable improvement after three days of treatment, consult your doctor.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, contact your doctor immediately if symptoms (e.g., fever and pain) persist or worsen (see section 2).
Do not exceed 6 single-dose sachets per day. If you are elderly, follow the lower recommended dosages.
If you suffer from kidney and/or liver or heart disease, consult your doctor, who will determine the appropriate dose for you.
If you have severe liver disease, do not take Moment.
Use in the elderly
Consult your doctor, who will determine the appropriate dose for you by reducing the recommended dose, especially if you have kidney and/or liver disorders.
Use in adolescents
Consult your doctor if use of the medicine is required for more than 3 days in an adolescent, or if symptoms worsen.
If you take more Moment than you should
If you have taken more Moment than you should, or if your child has accidentally ingested this medicine, contact a doctor or the nearest hospital immediately for advice on the risk and actions to take.
If you take an excessive dose (overdose) of ibuprofen, you may commonly experience the following symptoms: nausea, vomiting, stomach pain, deep drowsiness with reduced response to normal stimuli (lethargy), drowsiness, headache, dizziness, ringing in the ears (tinnitus), uncontrolled body movements (convulsions), and loss of consciousness. Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Rarely, you may experience: uncontrolled eye movements (nystagmus), lowered body temperature (hypothermia), kidney effects, gastrointestinal bleeding, deep loss of consciousness (coma), temporary interruption of breathing (apnea), diarrhea, reduced activity of the nervous system (central nervous system depression), and reduced respiratory activity (respiratory depression).
Additionally, you may also experience: disorientation, excited state, fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia).
In cases of severe poisoning, metabolic acidosis (increased acid levels in the blood) may occur. Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with traces of blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, confusion, and uncontrolled eye movements. Agitation, drowsiness, disorientation, or coma may also occur. Occasionally, patients may develop convulsions. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (especially in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties may be reported.
In addition, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute kidney failure and liver damage may occur. Asthma may worsen in patients with asthma. Moreover, low blood pressure and reduced respiratory function may occur.
If you have any doubts about how to use Moment, consult your doctor or pharmacist.
If you forget to take Moment
Do not take a double dose to make up for the forgotten dose.

4. Possible side effects

Like all medicines, Moment can cause side effects, although not everyone will experience them.
The side effects of this medicine can be minimized by using the lowest dose among those recommended and only for the duration needed to control your symptoms.

If you develop a stomach ulcer, gastrointestinal bleeding and/or intestinal lesions, or skin and/or mucosal lesions, you must stop treatment with Moment and contact your doctor immediately.
These side effects usually occur more frequently in elderly patients.

The use of Moment may cause generally mild or moderate side effects, or more severe reactions—including allergic reactions—although these are rare.

If you experience any of the following symptoms, STOP using Moment IMMEDIATELY and seek immediate medical attention at your doctor’s office or the nearest hospital, where you will receive appropriate and specific treatment:

• chest pain, which may be a sign of a potentially serious allergic reaction known as Kounis syndrome,
  • skin eruptions or lesions,
  • mucosal lesions,
  • signs of allergic reaction, even severe (erythema, itching, urticaria, asthma, swelling of the skin and mucous membranes, anaphylactic shock),
  • skin peeling,
  • flat, non-elevated reddish spots, target-shaped or circular, on the trunk, often with central blisters, skin desquamation, mouth, throat, nose, genital, or eye ulcers. These serious skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis),
  • widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome),
• widespread, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized pustular eruption),
• vision disturbances,
• liver disease (hepatic dysfunction),
• bleeding, ulceration, and perforation of the stomach and intestines, which may be fatal, particularly in elderly patients.

If you experience any of the allergic reactions listed above, go to hospital immediately, as immediate access to emergency equipment, medications, and trained personnel is necessary. Severe adverse reactions, sometimes fatal, have been reported following ibuprofen use, even in the absence of known allergies.

The risk of experiencing such symptoms is higher during the early stages of treatment: in most cases, the reaction occurs within the first month of treatment.

In addition, you may experience other side effects that have also been reported with other medicines similar to Moment, listed below by frequency:

Common (may affect up to 1 in 10 people)

• dizziness
• malaise
• fatigue

Uncommon (may affect up to 1 in 100 people)

• inflammation of the stomach (gastritis)
• insomnia, anxiety
• numbness of limbs or other body parts (paresthesia), drowsiness
• inflammation of the nasal mucosa (rhinitis)
• breathing difficulties (bronchospasm, dyspnea)
• temporary interruption of breathing (apnea)
• vision disturbances
• hearing impairment
• ringing in the ears (tinnitus)
• vertigo
• liver disorders (altered liver function)
• inflammation of the liver (hepatitis)
• yellowing of the skin and eyes (jaundice)
• kidney disorders (impaired kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome, and renal failure)
• hypersensitivity reactions such as skin rash, urticaria, itching, red spots on the skin (purpura), swelling of the skin and mucous membranes (angioedema), asthma, breathing difficulties (bronchospasm or dyspnea), asthma attacks possibly with low blood pressure
• skin reactions to light (photosensitivity)
• allergic skin rash (erythema)

Rare (may affect up to 1 in 1,000 people)

• reduction in blood cell counts: reduced white blood cells (leukopenia, neutropenia, agranulocytosis), reduced red blood cells (hemolytic anemia, aplastic anemia), reduced platelets (thrombocytopenia)
• reduced blood clotting ability
• depression, confusion, hallucinations
• inflammation of the optic nerve (optic neuritis)
• inflammation of the meninges, the membranes covering the brain (aseptic meningitis, especially in patients with pre-existing autoimmune disorders; see section “Warnings and precautions”), with symptoms such as neck stiffness, headache, nausea, vomiting, fever, or disorientation
• eye disorders with vision disturbances and optic nerve pathology (toxic optic neuropathy)
• swelling due to fluid accumulation in tissues
• a disease that may affect various organs and tissues of the body (lupus erythematosus syndrome)
• worsening of inflammation caused by an existing infection (e.g., development of necrotizing fasciitis)
• high levels of nitrogen in the blood
• abnormal liver function tests (increased transaminases, increased alkaline phosphatase)
• abnormal blood tests (reduced hemoglobin, reduced hematocrit, prolonged bleeding time, decreased blood calcium, increased blood uric acid)

Very rare (may affect up to 1 in 10,000 people)

• inflammation of the pancreas, a gland involved in digestive processes (pancreatitis)
• awareness of your own heartbeat (palpitations)
• heart disease (heart failure)
• heart attack (myocardial infarction)
• accumulation of fluid in the lungs (acute pulmonary edema)
• liver disease (liver failure)
• hypertension
• severe allergic reactions, which may include symptoms such as severe asthma, facial, tongue, and throat swelling making breathing difficult, rapid heartbeat, severe and rapidly developing allergic reaction that can be fatal (anaphylaxis), severe skin rash or skin exfoliation (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme)
• severe skin infections and soft tissue disorders may occur during varicella infection
• Skin infection and soft tissue disorder

Not known (frequency cannot be estimated from available data)

• Peptic ulcer, gastrointestinal hemorrhage.
• stomach fullness or heaviness
• nausea
• vomiting
• diarrhea
• flatulence
• constipation
• difficulty digesting
• abdominal pain
• heartburn
• blood in stools
• blood in vomit
• mouth lesions
• worsening of inflammatory bowel diseases (colitis, Crohn's disease)
• increased risk of sudden reduction in blood flow to the brain (stroke)
• allergic reactions, anaphylaxis
• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome): a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell).
• a widespread, red, scaly rash, with pustules under the skin and blisters, mainly localized in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized exanthematous pustulosis). Stop using Moment if you develop these symptoms and contact your doctor immediately. See also section 2.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Moment

This medicine does not require any special storage temperature.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Moment contains

• The active substance is ibuprofen 200 mg.
• The other components are cetyl alcohol, sucrose, xanthan gum, sucrose monopalmitate, anhydrous colloidal silica, citric acid monohydrate, disodium edetate dihydrate,

methyl parahydroxybenzoate, simethicone emulsion, propyl parahydroxybenzoate, red orange flavor,
purified water

Description of the appearance of Moment and the contents of the pack
Moment 200 mg comes as single-dose sachets
containing a fluid, homogeneous suspension, white to slightly yellow in color.
Each pack contains 6, 8, 10, 12, 16, 18, 20, 24 or 30 single-dose sachets of 5 ml.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Angelini Pharma S.p.A.
Viale Amelia, 70 - 00181 Rome, Italy
Manufacturer
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona, Italy

N D E S
There are several types of pain, of various origins and nature, which all of us encounter with greater or lesser frequency, particularly headache and toothache, muscular and joint pain, and menstrual pain.
One of the most common types of pain is certainly headache. If you suffer from headaches, it is important to identify the factors that may trigger them and try to prevent them (irregular eating habits, specific foods, smoking, alcohol, stress, excessive physical exertion, excessive sun exposure, excessively loud noises, overly strong perfumes, etc.).
Menstrual pain, sometimes even of considerable intensity, can be treated with painkillers that work by reducing the amount of prostaglandins—substances produced by the uterus and considered primarily responsible for this condition.