Moment orosoluble: detailed information

Package leaflet: Information for the user

Moment Orosolubile 200 mg oral powder

Ibuprofen
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

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

Contents of this leaflet

What Moment Orosolubile is and what it is used for
What you need to know before taking Moment Orosolubile
How to take Moment Orosolubile
Possible side effects
How to store Moment Orosolubile
Contents of the pack and other information

1. What Moment Orosolubile is and what it is used for

Moment Orosolubile contains ibuprofen, a medicine belonging to the class of non-steroidal anti-inflammatory drugs (NSAIDs), which are medicines that fight pain and inflammation.
Moment Orosolubile is used in adults and adolescents from the age of 12 years onwards to treat:

pains of various origin and nature (headache, toothache, neuralgia, bone and joint pain, muscle pain, menstrual pain);
and to help reduce symptoms of fever and flu-like conditions.

Consult your doctor if you do not feel better or if you feel worse:

after 3 days in adolescents;
after 3 days of treatment for fever or after 4 days of treatment for pain in adults.

2. What you should know before taking Moment Orosolubile

Do not take Moment Orosolubile:

if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6)
if in the past you have experienced bronchospasm, asthma attacks, nasal mucosa swelling, angioedema or skin reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)
if you have unspecified blood disorders
if you have recurrent or current gastric/duodenal ulcers (peptic ulcers) or gastrointestinal bleeding (at least two distinct episodes of confirmed ulceration or bleeding)
if you have previously experienced gastrointestinal haemorrhage or perforation related to prior NSAID therapy
if you have cerebrovascular haemorrhage or any other active bleeding
if you suffer from severe impairment of liver or kidney function
if you have severe heart failure
if you are severely dehydrated (caused by vomiting, diarrhoea or insufficient fluid intake)
during the last 3 months of pregnancy (see section 2, Pregnancy, breastfeeding and fertility)

Warnings and precautions – Take special care with Moment Orosolubile
What you should know before taking Moment Orosolubile
Allergic reactions to this medicine, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported with ibuprofen. Immediately stop taking Moment Orosolubile and contact your doctor or emergency medical services if you notice any of these symptoms.

Consult your doctor or pharmacist before taking Moment Orosolubile:

if you have had or developed a stomach or duodenal ulcer, gastrointestinal bleeding or perforation, which may present as severe or persistent abdominal pain and/or black stools, or may occur without warning signs. The risk is higher with prolonged treatment and high doses, in patients with a history of peptic ulcer disease, and in elderly patients. In such cases, your doctor may consider prescribing a gastroprotective agent;
if you suffer from kidney or liver disease;
if you are dehydrated;
if you have chickenpox;
if you suffer from oedema (fluid retention);
if you have asthma or other respiratory disorders;
if you have recently undergone major surgery;
if you have an infection – see the section “Infections” below;
if you have heart disease, kidney or liver disease, are over 60 years old, and need to take the medicine for long periods (more than 1-2 weeks), your doctor may need to perform regular check-ups. Your doctor will inform you about the frequency of these checks;
if you have systemic lupus erythematosus (SLE) or mixed connective tissue disease;
if you have congenital disorders of porphyrin metabolism (e.g. acute intermittent porphyria);
if you have urticaria;
if you have coagulation disorders.

Inform your doctor:

if you are taking medications that affect blood coagulation, such as oral anticoagulants or antiplatelet agents (medicines like Aspirin).

Additionally, inform your doctor if you are taking other medicines that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs);

if you have Crohn’s disease or ulcerative colitis, as this medicine may worsen these conditions;
if you have previously experienced gastrointestinal toxicity, especially if you are elderly, report any unusual abdominal symptoms (particularly gastrointestinal bleeding) especially during the initial stages of treatment. Discontinue treatment if patients treated with Moment Orosolubile 200 mg oral powder report gastrointestinal bleeding or ulceration.

Cardiovascular precautions
Anti-inflammatory medicines such as ibuprofen may be associated with a slight increase in the risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended duration of treatment or dosage. Discuss treatment with your doctor or pharmacist before taking Moment Orosolubile if:

you have heart problems, including heart failure, angina (chest pain), or a 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-strokes" or TIA, transient ischaemic attack);
you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

Renal effects:
Due to its effect on renal perfusion, ibuprofen may cause sodium, potassium and fluid retention in patients who have not previously suffered from kidney disorders. This may lead to oedema (fluid retention) or even heart failure or hypertension in predisposed patients. Cases of acute interstitial nephritis and renal toxicity have been reported. Patients at higher risk include those with impaired renal function, heart failure, impaired liver function, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID treatment is generally followed by a return to pre-treatment conditions.

Allergic reactions
Very rare cases of severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. Treatment must be discontinued at the first sign of a hypersensitivity reaction after taking/supposing ibuprofen. Depending on symptoms, trained personnel must initiate appropriate medical procedures.

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 Orosolubile and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.
Patients appear to be at higher risk for these reactions during the early stages of therapy: the reaction usually occurs within the first month of treatment.

Infections
Moment Orosolubile may mask symptoms of infections such as fever and pain. Therefore, Moment Orosolubile 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.

Other medicines and Moment Orosolubile
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The following medicines may affect or be affected by treatment with ibuprofen; therefore, they should not be taken together without first consulting your doctor:

other non-steroidal anti-inflammatory drugs (NSAIDs), which may increase the risk of adverse effects;
medicines with anticoagulant effects (i.e. substances that thin the blood and prevent clot formation, e.g. Aspirin/acetylsalicylic acid, warfarin, ticlopidine);
lithium (a medicine used to treat depression), which may increase lithium blood levels and the risk of adverse effects. If you need to take ibuprofen and lithium, your doctor may need to adjust your lithium dose;
digoxin: ibuprofen may increase digoxin blood levels;
methotrexate: if taken together with ibuprofen (within a 24-hour interval), ibuprofen may increase methotrexate blood levels and the risk of toxicity. Your doctor may advise against taking ibuprofen if you are undergoing high-dose methotrexate therapy;
hydantoins such as phenytoin (for epilepsy treatment);
aminoglycosides: as their toxic effects may be potentiated;
medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-based medicines, angiotensin II receptor antagonists such as losartan).

Other interactions requiring caution:

corticosteroids such as cortisone and prednisolone, diuretics (including potassium-sparing diuretics), fluconazole, pentoxifylline, probenecid, quinolones (such as norfloxacin), sulfinpyrazone, sulfonylureas (such as tolbutamide), tacrolimus, cyclosporine, zidovudine may increase the risk of ulceration and bleeding;
selective serotonin reuptake inhibitors (SSRIs) may also increase the risk of gastrointestinal bleeding;
herbal extracts such as Ginkgo biloba: may increase the risk of bleeding;
mifepristone: ibuprofen may reduce its effectiveness;
colestyramine (used to lower cholesterol): prolongs and reduces (by 25%) ibuprofen absorption. These medicines should be administered at least two hours apart.

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

Moment Orosolubile with food and drinks
For patients with stomach problems, or if gastrointestinal issues occur during treatment, it is recommended to take the product with food.
Alcohol consumption should be avoided during treatment with ibuprofen.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Inform your doctor if you become pregnant while using ibuprofen.
Do not take Moment Orosolubile during the last 3 months of pregnancy, as it may harm the unborn baby or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and may delay or prolong labour beyond expected duration. You should not take Moment Orosolubile during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or when trying to conceive, the lowest effective dose for the shortest possible time should be used.
From week 20 of pregnancy, Moment Orosolubile may cause kidney problems in the fetus if taken for more than a few days, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing 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
Although drug levels in breast milk are negligible, it is recommended to consult your doctor if long-term treatment with high doses is needed during breastfeeding.

Fertility
Patients of reproductive age should be aware that this medicine has been associated with reduced fertility.

Driving and using machines
Since undesirable effects such as fatigue, dizziness and visual disturbances may occur during ibuprofen use, the ability to react and maintain active vigilance while driving or operating machinery may be impaired in isolated cases. These effects may be further enhanced if alcohol is consumed concurrently.

Moment Orosolubile contains isomalt
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Moment Orosolubile

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.

Dosage

Adults and adolescents over 12 years of age: the recommended dose is 1-2 sachets, 2-3 times daily as needed.

The interval between doses should be determined based on symptoms and the maximum daily dose. The interval must not be less than 6 hours.

Do not exceed the recommended maximum daily dose (1200 mg – 6 sachets).

For short-term treatment only.

If an adolescent needs to take this medicine for more than 3 days, or if symptoms worsen, a doctor must be consulted.

If an adult needs to take this medicine for more than 3 days to treat fever, or more than 4 days to treat pain, or if symptoms worsen, a doctor must be consulted.

Method of administration

For oral use.

Empty the oral powder onto the tongue, wait for it to dissolve, then swallow; water is not required.

This formulation can be used in situations where liquids are not available.

Moment Orosolubile may be taken on an empty stomach.

Patients with stomach disorders should take this medicine during or after meals.

Use the lowest effective dose for the shortest duration necessary 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).

You can minimize adverse reactions by using the lowest effective dose for the shortest possible duration needed to control symptoms.

Special patient groups

Elderly

Due to the possible adverse effect profile (see section 2), consult your doctor before using Moment Orosolubile. In elderly patients, adverse reactions to NSAIDs are more frequent, especially gastrointestinal bleeding and perforation, which may be fatal.

Renal impairment

If you have renal impairment, consult your doctor before using Moment Orosolubile.

Hepatic impairment

If you have hepatic impairment, consult your doctor before using Moment Orosolubile.

If you take more Moment Orosolubile than you should

Seek immediate medical attention in case of overdose or accidental ingestion of the sachets.

If you have taken more Moment Orosolubile than you should, or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital for advice on the risk and what actions to take.

Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, ringing in the ears, confusion, and uncontrolled eye movements. 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 problems may occur.

Additionally, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors.

Symptoms following acute ibuprofen overdose are generally limited to abdominal pain, nausea, vomiting, and diarrhoea. Tinnitus, headache, dizziness, vertigo, and gastrointestinal bleeding may also occur. Severe poisoning may lead to drowsiness, excitement, disorientation, coma, seizures, myoclonic spasms in children, blurred vision and eye disorders, low blood pressure, respiratory depression, bluish skin discoloration, metabolic acidosis, increased tendency to bleed, acute kidney failure, and liver damage. Asthmatic patients may experience worsening of asthma.

If you forget to take Moment Orosolubile

Do not take a double dose to make up for the missed dose.

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

4. Possible side effects

Like all medicines, Moment Orosolubile can cause side effects, although not everyone will experience them.
The following list of side effects includes all known adverse reactions associated with ibuprofen treatment, including those reported in patients with rheumatic conditions undergoing long-term, high-dose therapy.
Frequency data, except for very rare reports, are based on short-term administration of the drug, with maximum daily doses of 1200 mg of ibuprofen for oral formulations and maximum doses of 1800 mg for suppositories.
It should be noted that the following adverse effects are predominantly dose-dependent and may vary from patient to patient.
The most commonly observed side effects involve the gastrointestinal system.
Gastric/duodenal ulcers (peptic ulcers), gastrointestinal perforation or bleeding, sometimes fatal, may occur, particularly in elderly patients (see section 2). The following effects have been reported with the use of ibuprofen: nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, black tarry stools, blood in vomit, inflammation of the mouth lining with ulceration (ulcerative stomatitis), and worsening of colitis and Crohn’s disease (see section 2). Gastric mucosal inflammation (gastritis) has been observed less frequently; in particular, the risk of gastrointestinal bleeding depends on the dose and duration of treatment.
Edema, high blood pressure, and heart failure have been reported in association with NSAID therapy.
Drugs such as ibuprofen may be associated with a slight increase in the risk of heart attacks ("myocardial infarction") or stroke. A serious 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 cells).
The risk of side effects can be minimized by using the lowest effective dose for the shortest duration necessary to relieve symptoms.
STOP TAKING this medicine and seek immediate medical attention if you experience:

signs of intestinal bleeding such as: relatively severe abdominal pain, black tarry stools, blood in the stool, blood or dark particles resembling coffee grounds in vomit;
signs of serious adverse reactions such as worsening asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, drop in blood pressure leading to shock. These effects may occur even with the first use of this medicine;
severe skin reactions that may affect the entire body; skin peeling, blistering, or skin sloughing;
flat, non-elevated reddish spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe 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).

Frequencies are defined as follows: very common (affects more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people), rare (affects up to 1 in 1,000 people), very rare (affects up to 1 in 10,000 people), and not known (frequency cannot be estimated from available data).
Other side effects
Common (may affect up to 1 in 10 people)

heartburn, abdominal pain, nausea, vomiting, flatulence (passing gas), diarrhoea, constipation, and minor gastrointestinal blood loss which may exceptionally lead to anaemia.

Uncommon (may affect up to 1 in 100 people)

headache, dizziness, insomnia, restlessness, irritability, or fatigue;
visual disturbances. In this case, inform your doctor immediately and discontinue treatment with ibuprofen;
inflammation of the stomach lining (gastritis);
gastrointestinal ulcers, potentially with bleeding and perforation. Ulcerative stomatitis, exacerbation of colitis and Crohn’s disease, gastritis;
various skin rashes;
hypersensitivity reactions, with skin rash and itching, or asthma attacks (possibly with low blood pressure). In this case, inform your doctor immediately and discontinue treatment with Moment Orosolubile.

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

sensation of ringing in the ears (tinnitus);
kidney tissue damage (papillary necrosis), particularly with long-term therapy, and increased blood levels of uric acid.

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

palpitations, heart failure, myocardial infarction (heart attack);
blood disorders: anaemia, leucopenia (reduced white blood cell count), thrombocytopenia (low platelet count), pancytopenia (reduction in all blood cell types), agranulocytosis (severe reduction in a type of white blood cells). Initial signs may include fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe weakness, nosebleeds, and skin bleeding. In such cases, you must stop taking the medicine immediately, avoid self-medication with analgesics or antipyretics, and consult a doctor;
inflammation of the oesophagus (oesophagitis), pancreas (pancreatitis), or development of diaphragm-like intestinal strictures (a rare colon disorder);
reduced urine output and development of oedema, particularly in patients with hypertension (high blood pressure) or renal impairment, inflammatory kidney disease (interstitial nephritis), nephrotic syndrome with protein loss and fluid accumulation in the body. Decreased urine production, fluid retention (oedema), and general malaise may be signs of kidney disease and even renal failure. If any of the symptoms listed above occur or worsen, you must stop taking Moment Orosolubile and contact your doctor immediately;
severe skin reactions, such as skin rash with redness and blistering (e.g., Stevens-Johnson syndrome) and toxic epidermal necrolysis (Lyell’s syndrome), alopecia. In isolated cases, severe skin infections with soft tissue complications may occur during chickenpox infections;
worsening of infection-related inflammation (e.g., development of necrotizing fasciitis, a serious bacterial infection). If signs of infection (e.g., redness, swelling, high temperature, pain, fever) appear or worsen during ibuprofen use, consult a doctor immediately;
symptoms of aseptic meningitis, including neck stiffness, headache, nausea, vomiting, fever, or altered consciousness, have been observed during ibuprofen treatment. Patients with autoimmune disorders (SLE, mixed connective tissue disease) appear to be more susceptible;
high blood pressure;
severe generalized hypersensitivity reactions. These may present as facial swelling, tongue swelling, internal laryngeal swelling leading to airway constriction, breathing difficulty, rapid heartbeat, and drop in blood pressure up to life-threatening shock. If any of these symptoms occur, even with the first use of the medicine, seek immediate medical help;
liver dysfunction, liver damage, particularly with prolonged therapy, liver failure, acute hepatitis (liver inflammation);
psychotic reactions, depression. Not known
Skin becomes sensitive to light.
A widespread, red, scaly rash, with pustule formation under the skin and blisters, mainly affecting skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using Moment orosolubile if you develop these symptoms and contact your doctor immediately. See also section 2.
Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

If any of the symptoms listed above occur or worsen, you must stop taking ibuprofen and contact your doctor immediately.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. 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 Orosoluble

Keep this medicine out of the sight and reach of children.
Do not store above 30 ºC. Store in the original packaging.
Do not use this medicine after the expiry date stated on the outer carton 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 Orosolubile contains

The active substance is ibuprofen. Each sachet contains 200 mg of ibuprofen.
The other components (excipients) are: isomalt (see section “Moment Orosolubile contains isomalt”), anhydrous citric acid, potassium acesulfame (E950), glycerol distearate (type I), and lemon flavour.

Description of the appearance of Moment Orosolubile and contents of the package
Moment Orosolubile 200 mg is a white or almost white oral powder, free from foreign particles, with a lemon flavour, packaged in sachets made of coated paper, extruded polyethylene, aluminium foil, and extruded polyethylene.
Pack sizes: 10, 12 or 20 units.
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

Manufacturers
BIOFABRI, S.L.
A Relva, s/n, O Porriño,
36400 Pontevedra - SPAIN
FARMALIDER S.A.
c/ Aragoneses 2
28108 Alcobendas- Madrid - SPAIN
EDEFARM, S.L.
Polígono Industrial Enchilagar del Rullo, 117, Villamarchante
46191 Valencia - SPAIN

This medicinal product is authorised in the EEA Member States under the following names:
Italy: Moment Orosolubile 200 mg oral powder

N E S
All of us have experienced different types of pain, of various origins and natures, with greater or lesser frequency, particularly: headache, 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, certain foods, smoking, alcohol, stress, excessive physical exertion, excessive exposure to sunlight, loud noises, strong perfumes, etc.).
Menstrual pain, which can sometimes be quite 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.

Package leaflet: information for the user

Moment Orosolubile 400 mg effervescent powder

Ibuprofen
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you would like 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 4 days of treatment for pain, or after 3 days when treating fever in adolescents.

Contents of this leaflet

What Moment Orosolubile is and what it is used for
What you need to know before taking Moment Orosolubile
How to take Moment Orosolubile
Possible side effects
How to store Moment Orosolubile
Contents of the pack and other information

1. What is Moment Orosolubile and what is it used for

Moment Orosolubile contains ibuprofen, a medicine that belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs), which are medicines that fight pain and inflammation.
Moment Orosolubile is used in adults and adolescents from the age of 12 years onwards, to treat:

pains of various origin and nature (headache, toothache, neuralgia, bone and joint pain, muscle pain, menstrual pain);
to help reduce symptoms of fever and flu-like conditions.

Consult a doctor if you do not feel better or if you feel worse

after 3 days in adolescents;
after 3 days of treatment for fever or after 4 days of treatment for pain in adults.

2. What you should know before taking Moment Orosoluble

Do not take Moment Orosoluble:

if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6)
if in the past you have experienced bronchospasm, asthma attacks, nasal mucosal swelling, angioedema, or skin reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)
if you have unspecified blood disorders
if you have recurrent gastric/duodenal ulcers (peptic ulcers) or current or previous gastrointestinal bleeding (at least two distinct episodes of confirmed ulceration or bleeding)
if you have previously had gastrointestinal hemorrhage or perforation associated with prior NSAID therapy
if you have cerebrovascular hemorrhage or any other active bleeding
if you suffer from severe impairment of liver or kidney function
if you suffer from severe heart failure
if you are severely dehydrated (caused by vomiting, diarrhea, or insufficient fluid intake)
during the last 3 months of pregnancy (see section 2, Pregnancy, breastfeeding and fertility)

Warnings and precautions – Take special care with Moment Orosoluble
What you should know before taking Moment Orosoluble
Allergic reactions to this medicine, including respiratory problems, swelling of the face and neck (angioedema), and chest pain, have been reported with ibuprofen. Immediately stop taking Moment Orosoluble and contact your doctor or emergency medical services if you notice any of these symptoms.

Consult your doctor or pharmacist before taking Moment Orosoluble:

if you have had or develop a stomach or duodenal ulcer, gastrointestinal bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even occur without warning signs. The risk is higher with prolonged treatment and high doses, especially in elderly patients or those with a history of peptic ulcer disease. In such cases, your doctor may consider prescribing a gastroprotective agent;
if you suffer from kidney or liver disease;
if you are dehydrated;
if you have chickenpox;
if you suffer from edema (fluid retention);
if you have asthma or other respiratory disorders;
if you have recently undergone major surgery;
if you have an infection – see section "Infections" below;
if you have heart disease, kidney or liver disease, are over 60 years old, and need to take the medicine for long periods (more than 1–2 weeks), your doctor may need to perform regular check-ups. Your doctor will inform you about the frequency of these checks;
if you suffer from systemic lupus erythematosus (SLE) or mixed connective tissue disease;
if you have congenital disorders of porphyrin metabolism (e.g., acute intermittent porphyria);
if you suffer from urticaria;
if you have coagulation disorders.

Inform your doctor:

if you are taking medications that affect blood coagulation, such as oral anticoagulants or antiplatelet agents (medicines like aspirin).

Additionally, inform your doctor if you are taking other medicines that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs);

if you suffer from Crohn’s disease or ulcerative colitis, as this medicine may worsen these conditions;
if you have previously experienced gastrointestinal toxicity, especially if you are elderly, report any unusual abdominal symptoms (particularly gastrointestinal bleeding) promptly, especially during the initial stages of treatment. Discontinue treatment if patients taking Moment Orosoluble 400 mg oral powder report gastrointestinal bleeding or ulceration.

Cardiovascular precautions
Anti-inflammatory medicines such as ibuprofen may be associated with a slight increase in the risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended treatment duration or dose. Discuss treatment with your doctor or pharmacist before taking Moment Orosoluble if:

you have heart problems, including heart failure, 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-strokes" or TIA – transient ischemic attack);
you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Renal effects:
Due to its effect on renal perfusion, ibuprofen may cause sodium, potassium, and fluid retention in patients who have not previously had kidney problems. This may lead to edema (fluid retention), heart failure, or hypertension in predisposed patients. Cases of acute interstitial nephritis and renal toxicity have been reported. Patients at greatest risk include those with impaired renal function, heart failure, liver dysfunction, those taking diuretics or ACE inhibitors, and the elderly. Discontinuation of NSAID treatment usually leads to a return to pre-treatment conditions.

Allergic reactions
Very rare cases of severe acute hypersensitivity reactions (e.g., anaphylactic shock) have been observed. Treatment must be discontinued at the first signs of hypersensitivity following ibuprofen administration. Based on symptoms, trained personnel should initiate appropriate medical procedures.

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 Orosoluble and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.
Patients appear to be at higher risk for these reactions early in treatment: onset typically occurs within the first month of treatment.

Infections
Moment Orosoluble may mask symptoms of infections such as fever and pain. Therefore, it may 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, seek immediate medical advice.

Other medicines and Moment Orosoluble
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
The following medicines may interact with or be affected by ibuprofen treatment; therefore, they should not be taken together without first consulting your doctor:

other non-steroidal anti-inflammatory drugs (NSAIDs), which may increase the risk of adverse effects;
medicines with anticoagulant effects (i.e., substances that thin the blood and prevent clotting, e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine);
lithium (a medicine used to treat depression), which may lead to increased lithium levels in the blood and a higher risk of adverse effects. If you need to take ibuprofen with lithium, your doctor may need to adjust your lithium dose;
digoxin: ibuprofen may increase digoxin blood levels;
methotrexate: if taken concurrently with ibuprofen (within 24 hours), ibuprofen may increase methotrexate blood levels and the risk of toxicity. Your doctor may advise against taking ibuprofen if you are undergoing high-dose methotrexate therapy;
hydantoins such as phenytoin (used to treat epilepsy);
aminoglycosides: due to potential enhancement of their toxic effects;
medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan). Other interactions requiring caution:
corticosteroids such as cortisone and prednisolone, diuretics (including potassium-sparing diuretics), fluconazole, pentoxifylline, probenecid, quinolones (e.g., norfloxacin), sulfinpyrazone, sulfonylureas (e.g., tolbutamide), tacrolimus, cyclosporine, zidovudine may increase the risk of ulceration and bleeding;
selective serotonin reuptake inhibitors (SSRIs) may also increase the risk of gastrointestinal bleeding;
herbal extracts such as Ginkgo biloba: may increase the risk of bleeding;
mifepristone: ibuprofen may reduce its effectiveness;
colestyramine (used to lower cholesterol): delays and reduces (by 25%) ibuprofen absorption. These medicines should be administered at least two hours apart. Other medicines may also interact with or be affected by Moment Orosoluble. Therefore, always consult your doctor or pharmacist before using Moment Orosoluble with other medicines.

Moment Orosoluble with food and drinks
For patients with stomach disorders or if gastrointestinal problems occur during treatment, it is recommended to take the product with food.
Alcohol consumption should be avoided during treatment with ibuprofen.

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

Pregnancy
Inform your doctor if you become pregnant while using ibuprofen.
Do not take Moment Orosoluble during the last 3 months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby’s tendency to bleed and delay or prolong labor beyond normal. You should not take Moment Orosoluble during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is needed during this period or while trying to conceive, the lowest effective dose for the shortest possible time should be used.
From week 20 of pregnancy, Moment Orosoluble may cause kidney problems in the fetus if taken for more than a few days, leading to reduced levels of amniotic fluid surrounding the baby (oligohydramnios) or 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
Although drug levels in breast milk are negligible, long-term treatment with high doses during breastfeeding should be discussed with your doctor.

Fertility
Patients of reproductive age should be aware that this medicine has been associated with reduced fertility.

Driving and using machines
Since undesirable effects such as fatigue, dizziness, and visual disturbances may occur during ibuprofen use, reaction ability and active vigilance while driving and operating machinery may be impaired in isolated cases. These effects may be further enhanced if alcohol is consumed concurrently.

Moment Orosoluble contains isomalt
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Moment Orosolubile

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.

Dosage

Adults and adolescents over 12 years of age: the recommended dose is 1 sachet, 1–3 times daily as needed.

The interval between doses should be determined based on symptoms and the maximum daily dose. The interval must not be less than 6 hours.

Do not exceed the recommended maximum daily dose (1200 mg – 3 sachets).

For short-term treatment only.

If an adolescent needs to take this medicine for more than 3 days or if symptoms worsen, a doctor must be consulted.

If an adult needs to take this medicine for more than 3 days to treat fever, or for more than 4 days to treat pain, or if symptoms worsen, a doctor must be consulted.

Method of administration

For oral use.

Pour the oral powder onto the tongue, wait for it to dissolve, then swallow; no water is needed.

This formulation can be used in situations where liquids are not available.

Moment Orosolubile may be taken on an empty stomach.

Patients with stomach disorders should take this medicine during or after meals.

Use the lowest effective dose for the shortest duration necessary to relieve symptoms.

If you have an infection, consult your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).

You can minimize adverse reactions by using the lowest effective dose for the shortest possible duration needed to control symptoms.

Special patient groups

Elderly

Due to the possible adverse effect profile (see section 2), consult your doctor before using Moment Orosolubile. In elderly patients, adverse reactions to NSAIDs increase in frequency, especially gastrointestinal bleeding and perforation, which may be fatal.

Renal impairment

If you have renal impairment, consult your doctor before using Moment Orosolubile.

Hepatic impairment

If you have hepatic impairment, consult your doctor before using Moment Orosolubile.

If you take more Moment Orosolubile than you should

Seek immediate medical help in case of overdose or accidental ingestion of the sachets.

If you have taken more Moment Orosolubile than you should, or if your child has accidentally taken this medicine, always contact a doctor or the nearest hospital for advice on the risk and guidance on actions to take.

In addition, prothrombin time/INR may be prolonged, probably due to interference with circulating coagulation factors.

Symptoms following acute ibuprofen overdose are generally limited to abdominal pain, nausea, vomiting, and diarrhoea. Tinnitus, headache, dizziness, vertigo, and gastrointestinal bleeding may also occur. Severe poisoning may lead to drowsiness, excitement, disorientation, coma, convulsions, myoclonic spasms in children, blurred vision and eye disorders, low blood pressure, respiratory depression, bluish discoloration of the skin, metabolic acidosis, increased tendency to bleeding, acute renal failure, and liver damage. Asthmatic patients may experience worsening of asthma.

If you forget to take Moment Orosolubile

Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, Moment Orosolubile can cause side effects, although
not everyone experiences them.
The following list of side effects includes all known adverse reactions
associated with ibuprofen treatment, including those reported in patients
with rheumatic conditions undergoing long-term treatment with high doses.
Frequency data, except for very rare reports, are based on short-term administration of the drug with maximum daily doses of 1200 mg
of ibuprofen for oral formulations and maximum doses of 1800 mg for suppositories.
Regarding the following adverse reactions, it should be noted that they are primarily dose-dependent and may vary from patient to patient.
The most commonly observed side effects involve the gastrointestinal system.
Gastric/duodenal ulcers (peptic ulcers), gastrointestinal perforation or
bleeding, sometimes fatal, may occur, particularly in elderly patients (see
paragraph 2). The following effects have been reported following the use of ibuprofen:
nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, tarry stools, blood in vomit, inflammation of the mouth lining
with ulceration (ulcerative stomatitis), and worsening of colitis and Crohn's disease
(see paragraph 2). Gastric mucosal inflammation (gastritis) has been observed less frequently; in particular, the risk of gastrointestinal
bleeding depends on dose and duration of treatment.
Oedema, high blood pressure, and heart failure have been reported in association with NSAID therapy.
Drugs such as ibuprofen may be associated with slight increases in the risk of heart attacks ("myocardial infarction") or stroke.
A serious 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 cells).
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to relieve symptoms.
STOP TAKING THIS MEDICINE AND SEEK IMMEDIATE MEDICAL ADVICE IF YOU EXPERIENCE:

signs of intestinal bleeding such as: relatively severe abdominal pain, black tarry stools, blood in stools, presence of blood or dark particles resembling coffee grounds in vomit;
signs of severe adverse reactions such as worsening asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, drop in blood pressure causing shock. These effects may occur even with the first use of this medicine;
severe skin reactions that may affect the entire body; skin peeling, blistering or desquamation;
flat, reddish spots on the trunk, often target-shaped or circular, sometimes with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];
widespread skin 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).

Frequencies are defined as follows: very common (affects more than 1
in 10 people), common (may affect up to 1 in 10 people), uncommon (may
affect up to 1 in 100 people), rare (affects up to 1 in 1,000 people), very
rare (affects up to 1 in 10,000 people), and not known (frequency cannot be
estimated from the available data).
Other side effects
Common (may affect up to 1 in 10 people)

heartburn, abdominal pain, nausea, vomiting, flatulence (passing gas), diarrhoea, constipation, and minor gastrointestinal blood loss which may exceptionally lead to anaemia.

Uncommon (may affect up to 1 in 100 people)

headache, dizziness, insomnia, agitation, irritability or fatigue;
visual disturbances. In this case, inform your doctor immediately and stop treatment with ibuprofen;
inflammation of the stomach lining (gastritis);
gastrointestinal ulcers, potentially with bleeding and perforation. Ulcerative stomatitis, exacerbation of colitis and Crohn's disease, gastritis;
various skin rashes;
hypersensitivity reactions, with skin rash and itching, or asthma attacks (possibly with drop in blood pressure). In this case, inform your doctor immediately and stop treatment with Moment Orosolubile.

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

sensation of ringing in the ears (tinnitus);
kidney tissue damage (papillary necrosis), particularly with long-term therapy, and increased blood uric acid levels.

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

palpitations, heart failure, myocardial infarction (heart attack);
blood disorders: anaemia, leucopenia (reduced white blood cell count), thrombocytopenia (low platelet count), pancytopenia (reduction in all blood cell types), agranulocytosis (severe reduction in a type of white blood cells). Initial signs may include fever, sore throat, mouth ulcers, flu-like symptoms, severe weakness, nosebleeds, and skin bleeding. In such cases, stop taking the medicine immediately, avoid self-medication with analgesics or antipyretics, and consult a doctor;
inflammation of the oesophagus (oesophagitis), pancreas (pancreatitis), formation of diaphragm-like intestinal strictures (a rare colon disorder);
reduced urine output and oedema formation, particularly in patients with hypertension (high blood pressure) or renal impairment, inflammatory kidney disease (interstitial nephritis), nephrotic syndrome with protein loss and fluid accumulation in the body. Reduced urine production, fluid accumulation in the body (oedema), and general malaise may be
signs of kidney disease and even renal failure. If any of the
above symptoms occur or worsen, you must stop taking
Moment Orosolubile and contact your doctor immediately;
severe skin reactions such as skin rash with redness and blistering (e.g. Stevens-Johnson syndrome) and toxic epidermal necrolysis (Lyell's syndrome), alopecia. In isolated cases, severe skin infections with complications involving soft tissues may occur during varicella infection;
worsening of infection-related inflammation (e.g. development of necrotising fasciitis, a serious bacterial infection). If signs of infection (e.g. redness, swelling, high temperature, pain, fever) appear or worsen during ibuprofen use, immediate medical advice must be sought;
symptoms of aseptic meningitis, including neck stiffness, headache, nausea, vomiting, fever or altered consciousness, have been observed during ibuprofen treatment. Patients with autoimmune disorders (SLE, mixed connective tissue disease) appear to be predisposed;
high blood pressure;
severe generalized hypersensitivity reactions. These may present as facial oedema, tongue swelling, internal laryngeal swelling leading to airway obstruction, breathing difficulties, rapid heartbeat, drop in blood pressure leading to life-threatening shock. If any of these symptoms occur, even with first use of the medicine, seek immediate medical help;
liver dysfunction, liver damage, particularly with prolonged therapy, liver failure, acute hepatitis (liver inflammation);
psychotic reactions, depression.

Not known

Skin becomes sensitive to light.
A widespread, red, scaly rash, with pustules forming under the skin and blisters, mainly affecting skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using Moment Orosolubile if you develop
these symptoms and contact your doctor immediately. See also paragraph 2.
Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

If any of the symptoms listed above occur or worsen, you must
stop taking ibuprofen and contact your doctor immediately.
Reporting of side effects
If you experience any side effect, including those not listed in this
leaflet, consult your doctor or pharmacist. 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 Orosoluble

Keep this medicine out of the sight and reach of children.
Do not store above 30 °C. Keep it in the original packaging.
Do not use this medicine after the expiry date stated on the outer carton 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Moment Orosolubile contains

The active substance is ibuprofen. Each sachet contains 400 mg of ibuprofen.
The other components (excipients) are: isomalt (see section “Moment Orosolubile contains isomalt”), anhydrous citric acid, potassium acesulfame (E950), glycerol distearate (type I), and lemon flavour.

Description of the appearance of Moment Orosolubile and contents of the pack
Moment Orosolubile 400 mg is a white or almost white oral powder, free from foreign particles, with a lemon flavour, packaged in sachets made of coated paper, extruded polyethylene, aluminium foil and extruded polyethylene.
Pack sizes: 10, 12 or 20 units.
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

Manufacturers
BIOFABRI, S.L.
A Relva, s/n, O Porriño,
36400 Pontevedra - SPAIN
FARMALIDER S.A.
C/ Aragoneses 2
28108 Alcobendas - Madrid - SPAIN
EDEFARM, S.L.
Polígono Industrial Enchilagar del Rullo, 117, Villamarchante
46191 Valencia - SPAIN

This medicinal product is authorised in the EEA Member States under the following names:
Italy: Moment Orosolubile 400 mg oral powder

N E S
All of us have experienced different types of pain, of various origins and nature, with greater or lesser frequency, particularly: headache, 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, 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.