Moment Influenza and cold

Package leaflet: information for the patient

Moment Influenza e Raffreddore 200 mg/30 mg film-coated tablets

Ibuprofen/Pseudoephedrine hydrochloride
For adults and adolescents aged 15 years and older
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, consult your doctor or pharmacist. See section 4.
• Consult your doctor if symptoms worsen or if you need to take this medicine for more than 4 days (adults) or 3 days (adolescents).

Contents of this leaflet:

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

1. What Moment Influenza e Raffreddore is and what it is used for

Moment Influenza e Raffreddore contains two active substances: ibuprofen and pseudoephedrine hydrochloride.
Ibuprofen belongs to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by reducing pain and lowering fever.
Pseudoephedrine hydrochloride belongs to a class of active substances called vasoconstrictors, which act on the blood vessels in the nose to relieve nasal congestion.
Moment Influenza e Raffreddore is indicated for the symptomatic treatment of nasal congestion associated with headache and/or fever in colds, in adults and adolescents aged 15 years and older.
You should take this combination of active substances only if you have both a blocked nose and headache or fever. If you experience only one of these symptoms, consult your pharmacist or doctor about using ibuprofen or pseudoephedrine alone.
Consult your doctor if your symptoms worsen or if you need to take this medicine for more than 4 days (adults) or 3 days (adolescents).

2. What you need to know before taking Moment Influenza and Cold

Do not take Moment Influenza and Cold if:

• you are allergic to ibuprofen or to hydrochloride pseudoephedrine or to any of the other ingredients of this
  medicine (listed in section 6)
• you are under 15 years of age
• you are in the third trimester of pregnancy (pregnant for at least 7 months)
• you are breastfeeding
• in the past you have had an allergic reaction or shortness of breath, asthma, skin rash, runny and itchy nose, or swelling of the face after taking acetylsalicylic acid or other NSAIDs
• you have previously suffered from or currently suffer from gastrointestinal bleeding or recurrent gastric/duodenal ulcers (peptic ulcers) (at least two distinct episodes of ulcers or bleeding confirmed)
• you have a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs
• you have very high blood pressure (severe hypertension) or uncontrolled hypertension due to medication
• you suffer from severe acute (sudden) or chronic (long-term) kidney disease or renal failure
• you suffer from severe liver or kidney failure
• you suffer from severe heart failure
• you suffer from serious heart or circulatory problems (heart disease, high blood pressure, angina, increased heart rate), overactivity of the thyroid gland, diabetes, or phaeochromocytoma (a tumour of the adrenal gland)
• you have a history of heart attack (myocardial infarction)
• you have previously had a stroke or have been told you are at risk of stroke
• you have a history of seizures (convulsions)
• you suffer from blood cell production disorders of unknown origin
• you experience increased eye pressure (closed-angle glaucoma)
• you have difficulty urinating due to prostate problems
• you have been diagnosed with systemic lupus erythematosus (SLE), a disease affecting the immune system causing joint pain, skin changes, and other problems
• you are taking:
  • other oral or nasal decongestants (vasoconstrictors) (e.g. phenylpropanolamine, phenylephrine, ephedrine, xylometazoline or oxymetazoline)
  • methylphenidate, a medicine used to treat attention deficit hyperactivity disorder (ADHD)
  • medicines for depression, such as non-selective monoamine oxidase inhibitors (known as MAOIs, e.g. iproniazide), or have taken them in the last 14 days.

Warnings and precautions – Take special care with Moment Influenza and Cold
What you need to know before taking Moment Influenza and Cold
Allergic reactions to this medicine, including breathing problems, swelling of the face and neck (angioedema), and chest pain, have been reported with ibuprofen. Stop taking Moment Influenza and Cold immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
Consult your doctor or pharmacist before taking Moment Influenza and Cold if:

• you suffer from asthma; use of this medicine may trigger an asthma attack
• you have a history of gastrointestinal disorders (such as hiatal hernia, gastrointestinal bleeding, peptic or duodenal ulcer)
• you currently suffer from or have previously suffered from gastrointestinal diseases (ulcerative colitis or Crohn’s disease)
• you suffer from high blood pressure
• you have liver or kidney problems
• you suffer from diabetes, due to the potential development of diabetic nephropathy
• you suffer from overactive thyroid (hyperthyroidism) or psychosis
• you suffer from a blood clotting disorder
• you have an infection – see section “Infections” below.

Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration. Elderly patients are at greater risk of adverse effects.
Concomitant use of NSAIDs, including selective cyclooxygenase (COX-2) inhibitors, increases the risk of adverse reactions (see section “Other medicines and Moment Influenza and Cold” below) and should be avoided.
Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a slight increased risk of heart attack or stroke, particularly when taken at high doses. Do not exceed the recommended treatment duration or dose.
Consult your doctor or pharmacist before taking Moment Influenza and Cold if:

• you suffer from heart problems, including heart failure and angina (chest pain), or have previously had a heart attack, 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 transient ischemic attack “TIA”);
• you suffer from high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or smoke. The following conditions are contraindicated due to the presence of pseudoephedrine (see previous section “Do not take Moment Influenza and Cold if”): serious heart or circulatory problems (heart disease, high blood pressure, angina, increased heart rate), overactivity of the thyroid gland, diabetes, phaeochromocytoma (a tumour of the adrenal gland), history of heart attack (myocardial infarction), history of stroke or presence of risk factors for stroke.

Prolonged use of any type of painkiller for headache may worsen it.
If this situation occurs or is suspected, medical advice must be sought and treatment discontinued. Medication-overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite (or because of) regular use of headache medications.
Cases of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following the use of medicines containing pseudoephedrine. PRES and RCVS are rare conditions that may lead to reduced blood flow to the brain. Stop using Moment Influenza and Cold immediately and seek immediate medical assistance if you develop symptoms that could indicate PRES or RCVS (see section 4 “Possible side effects” for symptoms).
Sudden abdominal pain or rectal bleeding may occur with Moment Influenza and Cold due to inflammation of the colon (ischemic colitis). If you develop these gastrointestinal symptoms, stop taking Moment Influenza and Cold and contact your doctor or seek immediate medical help. See section 4.
Moment Influenza and Cold may reduce blood flow to the optic nerve. If sudden vision loss occurs, stop taking Moment Influenza and Cold and consult your doctor or a healthcare facility immediately. See section 4.
Skin reactions
Serious skin reactions have been reported with Moment Influenza and Cold, 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 Influenza and Cold and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.
If you develop a generalized feverish rash with pustules, stop taking Moment Influenza and Cold and contact your doctor or seek immediate medical assistance. See section 4.
Interference with blood test results
Pseudoephedrine may interfere with certain blood diagnostic tests. If you need to undergo blood tests, inform your doctor that you are taking this medicine.
Infections
Moment Influenza and Cold may mask symptoms of infections such as fever and pain. Therefore, Moment Influenza and Cold 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 symptoms persist or worsen, consult your doctor immediately.
Children and adolescents
Moment Influenza and Cold must not be administered to children and adolescents under 15 years of age.
Dehydrated adolescents are at risk of kidney failure.
Athletes
For those engaged in sports: using the medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Other medicines and Moment Influenza and Cold
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Moment Influenza and Cold may affect or be affected by various other medicines. For example:

• anticoagulants (medicines that thin the blood and prevent clots, such as acetylsalicylic acid, warfarin, ticlopidine)
• medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II antagonists such as losartan).

Other medicines may also affect or be affected by treatment with Moment Influenza and Cold. Always consult a doctor before using Moment Influenza and Cold with other medicines.
Moment Influenza and Cold must not be taken in combination with:

• other vasoconstrictors used as nasal decongestants, administered orally or nasally (e.g. phenylpropanolamine, phenylephrine, and ephedrine)
• a medicine for the treatment of attention deficit hyperactivity disorder (ADHD) called methylphenidate
• medicines for depression, such as non-selective monoamine oxidase inhibitors (MAOIs, such as iproniazide). Do not use this medicine even if you have taken these drugs within the last 14 days.

In particular, inform your doctor or pharmacist if you are taking:

• other non-steroidal anti-inflammatory drugs (NSAIDs), including high-dose acetylsalicylic acid and selective COX-2 inhibitors
• medicines for cardiac arrhythmias (cardiac glycosides, e.g. digoxin)
• medicines for epilepsy (e.g. phenytoin)
• glucocorticoids, used for various conditions such as pain, swelling, allergies, asthma, rheumatism, and skin problems
• injectable heparin
• certain medicines for depression (e.g. lithium, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase A inhibitors (MAO-A))
• medicines to temporarily suppress the immune system, e.g. methotrexate (for treatment of osteoarthritis, psoriasis, and some tumours), cyclosporine or tacrolimus (administered after transplants)
• antidiabetic medicines (sulfonylureas)
• medicines used to treat infections (e.g. quinolone antibiotics, trimethoprim)
• medicines that promote urination (diuretics, e.g. potassium-sparing diuretics)
• medicines for gout (e.g. probenecid and sulfinpyrazone)
• any anti-migraine medicine (including ergot alkaloid derivatives)
• a medicine for HIV/AIDS (zidovudine)
• preparations containing ginkgo biloba.

Administration of pseudoephedrine may cause a sudden increase in blood pressure during surgery. If you are scheduled for surgery, discontinue taking Moment Influenza and Cold several days in advance and inform your anaesthetist.
Moment Influenza and Cold and alcohol
You should avoid alcohol consumption during treatment.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Moment Influenza and Cold during the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. This may cause kidney or heart problems in the fetus. It may affect your and your baby’s tendency to bleed and may cause delayed or prolonged labour.
Do not take Moment Influenza and Cold 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 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 Influenza and Cold may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or 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
Do not take this medicine if you are breastfeeding, as it may harm the baby.
Fertility
Ibuprofen belongs to a class of medicines (NSAIDs) that may impair fertility in women. This effect is reversible upon discontinuation of treatment.
Driving and using machines
Moment Influenza and Cold may cause dizziness, hallucinations, unusual headache, and disturbances in vision or hearing, thus temporarily impairing your ability to drive or operate machinery. If you experience any of these symptoms, avoid driving or operating machinery.
Moment Influenza and Cold contains:

• Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take Moment Influenza and Cold

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.
Duration of treatment
This medicine should only be used for short-term treatment. You should take the lowest dose necessary to relieve your symptoms for the shortest possible time.
Contact your doctor if your symptoms worsen or if you need to take this medicine for more than
4 days (adults) or 3 days (adolescents).
Dosage
The recommended dose for adults and adolescents aged 15 years and over is:
1 tablet every 6 hours, as needed. In case of more severe symptoms, take 2 tablets every 6 hours, as needed.
The lowest effective dose should be used 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).
Never exceed the maximum daily dose of 6 tablets per day (equivalent to 1200 mg of ibuprofen and
180 mg of pseudoephedrine hydrochloride).
Method of administration
The tablets are for oral use. They must be swallowed whole and not chewed, with a glass of water,
preferably during meals.
Use in children and adolescents
Moment Influenza and Cold must not be given to children and adolescents under 15 years of age.
If you take more Moment Influenza and Cold than you should
If you have taken more Moment Influenza and Cold than recommended, or if your child has taken this
medicine by mistake, always contact a doctor or the nearest hospital for advice on the risk and guidance on actions to take.
Stop treatment and consult a doctor immediately, even if you feel well.
In cases of severe poisoning, metabolic acidosis may occur.
Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, tinnitus, confusion and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness and dizziness, blood in the urine, low blood potassium levels, feeling cold and breathing difficulties may occur.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking Moment Influenza and Cold and consult a doctor immediately if you experience:

• signs of intestinal bleeding, such as bright red stools (faeces), black tarry stools, vomiting blood or dark particles resembling coffee grounds
• signs of a severe allergic reaction, such as severe skin rashes, skin peeling, desquamation or blistering, facial swelling, unexplained wheezing, shortness of breath, or easy bruising
• flat, red, target-shaped or circular rashes 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 occur early in treatment (generalized pustular eruption). Stop treatment with Moment Influenza and Cold immediately and seek urgent medical advice if you develop symptoms that could indicate reversible posterior encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS). These include:
  • sudden, severe headache
  • nausea
  • vomiting
  • confusion
  • seizures
  • changes in vision

Inform your doctor if you experience any of the following side effects, if they worsen, or if you notice any side effect not listed here.
Common (may affect up to 1 in 10 people)

• indigestion, stomach discomfort or pain, nausea, vomiting, flatulence, diarrhoea, constipation, mild gastrointestinal bleeding which in rare cases may lead to anaemia

Uncommon (may affect up to 1 in 100 people)

• hypersensitivity reactions with urticaria, itching, asthma attacks (with drop in blood pressure)
• disorders of the central nervous system, such as headache, dizziness, difficulty sleeping, agitation, irritability or fatigue
• visual disturbances
• gastric or intestinal ulcers, sometimes associated with bleeding or perforation, gastritis, inflammation of the mouth lining with ulceration (ulcerative stomatitis), worsening of colitis and Crohn’s disease
• various skin rashes

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

• tinnitus (ringing in the ears)
• insomnia, nervousness, anxiety, restlessness, tremors, hallucinations
• worsening of asthma or hypersensitivity reaction with shortness of breath
• kidney tissue damage (papillary necrosis), increased blood uric acid levels

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

• worsening of infectious inflammation (e.g. necrotizing fasciitis), aseptic meningitis (neck stiffness, headache, nausea, vomiting, fever or confusion) in patients with pre-existing autoimmune diseases (systemic lupus erythematosus (SLE), mixed connective tissue disease)
• problems with blood cell production (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis), which may lead to increased tendency to bruise or increased susceptibility to infections
• severe allergic reactions
• psychotic reactions and depression
• high blood pressure, palpitations, heart failure, heart attack
• inflammation of the oesophagus (oesophagitis) and pancreas (pancreatitis), diaphragm-like intestinal stricture
• liver dysfunction, liver damage (particularly with prolonged therapy), liver failure, acute liver inflammation (hepatitis)
• severe skin reactions, including rashes with redness and blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell’s syndrome), hair loss (alopecia), severe skin infections and soft tissue complications in varicella infection (varicella-zoster virus infection), increased serum creatinine, oedema (particularly in patients with hypertension or renal failure), nephritic syndrome, interstitial nephritis, acute renal failure

Not known (frequency cannot be estimated from available data)

• reduced blood flow to the optic nerve (ischaemic optic neuropathy)
• behavioural abnormalities
• stroke, seizures, headache
• palpitations, tachycardia, chest pain, arrhythmia
• high blood pressure
• dry mouth, thirst, nausea, vomiting
• rash, urticaria, itching, excessive sweating
• difficulty urinating
• a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells)
• a widespread, red, scaly rash with pustules 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 Influenza and Cold 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
• inflammation of the colon due to inadequate blood supply (ischaemic colitis)
• serious conditions affecting cerebral blood vessels known as reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)

Stop using Moment Influenza and Cold if you develop these symptoms and contact your doctor or seek immediate medical assistance.
Medicines such as Moment Influenza and Cold may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or stroke.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can 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 Influenza and Cold

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after EXP. The
expiry date refers to the last day of the month.
Do not store above 30°C.
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 Influenza e Raffreddore contains

• The active substances are ibuprofen and pseudoephedrine hydrochloride. Each film-coated tablet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride.
• The other components are: Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, corn starch, colloidal anhydrous silica, magnesium stearate.
  Tablet coating: hypromellose, macrogol 400, talc, titanium dioxide (E171), yellow iron oxide (E172).

Description of the appearance of Moment Influenza e Raffreddore and pack sizes
Moment Influenza e Raffreddore are yellow, round, film-coated tablets.
Pack sizes: 10, 12, 20 or 24 film-coated tablets.
Not all pack sizes may be marketed.

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

Manufacturer
Dragenopharm Apotheker Püschl GmbH
Göllstraße 1, 84529 Tittmoning, Germany
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona, Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Moment Influenza e Raffreddore 200 mg/30 mg film-coated tablets

The updated multilingual package leaflet can be accessed by scanning the QR code on the carton or visiting the website http://leaflet.angelini.it/L13