MOMENXSIN*12TAB 200MG+30MG

Momenxsin 200 mg/30 mg film-coated tablets
Ibuprofen/Pseudoephedrine hydrochloride

What it is and what it is used for
Momenxsin contains two active ingredients: ibuprofen and pseudoephedrine hydrochloride.

Ibuprofen belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by alleviating pain and reducing fever.
Pseudoephedrine hydrochloride belongs to a class of active ingredients called vasoconstrictors, which act on the blood vessels in the nose to relieve nasal congestion.

Momenxsin is indicated for the symptomatic treatment of nasal congestion in cases of cold associated with headache and/or fever, in adults and adolescents aged 15 years and over.

You should only take this combination of active ingredients if you have both a stuffy nose and a headache or fever. If you only experience one of these symptoms, talk to 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).

What you need to know before taking the medicine
Do not take Momenxsin if:
• you are allergic to ibuprofen or pseudoephedrine hydrochloride or 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 (at least 7 months pregnant)
• you are breastfeeding
• you have a history of allergic reaction or shortness of breath, asthma, rash, runny and itchy nose, or swelling of the face after taking acetylsalicylic acid or other NSAIDs
• you have a history of or currently suffer from recurrent stomach/duodenal bleeding or ulcers (peptic ulcers) (at least two distinct episodes of confirmed ulcers or bleeding)
• you have a history of gastrointestinal bleeding or perforation related to previous NSAID treatment
• you suffer from severe liver or kidney failure
• you suffer from severe heart failure
• you suffer from severe heart or circulatory problems (heart disease, high blood pressure, angina, accelerated heart rate), overactive thyroid, diabetes, pheochromocytoma (a tumor of the adrenal gland)
• you have a history of heart attack (myocardial infarction)
• you have had a stroke in the past 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 (angle-closure glaucoma)
• you have difficulty urinating related to prostate problems
• you have been diagnosed with systemic lupus erythematosus (SLE), a condition affecting the immune system and causing joint pain, skin changes, and other problems
• you are taking:
- other nasal decongestants (vasoconstrictor drugs) orally or nasally (e.g., phenylpropanolamine, phenylephrine, ephedrine, xylometazoline or oxymetazoline)
- methylphenidate, a medicine for the treatment of attention deficit/hyperactivity disorder (ADHD)
- medicines for the treatment of depression, such as non-selective monoamine oxidase inhibitors (known as MAOIs, e.g., iproniazid) or have taken them in the last 14 days.

Warnings and precautions
What you need to know before taking Momenxsin
Signs of an allergic reaction to this medicine have been reported with ibuprofen, including breathing problems, swelling of the face and neck (angioedema) and chest pain. Stop Momenxsin immediately and contact a doctor or emergency medical service immediately if you notice any of these signs.

Talk to your doctor or pharmacist before taking Momenxsin if:
• you suffer from asthma; the use of this medicine can cause an asthma attack
• you have a history of gastrointestinal disorders (such as hiatal hernia, gastrointestinal bleeding, peptic or duodenal ulcer)
• you suffer from or have suffered from gastrointestinal diseases (ulcerative colitis or Crohn's disease) in the past
• 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 an overactive thyroid (hyperthyroidism) or psychosis
• you suffer from a blood clotting disorder
• you have an infection - see Infections section below.

Side effects can be minimized by using the lowest effective dose for the shortest possible time. Elderly people are at greater risk of side effects.

Concomitant use of NSAIDs, including specific cyclo-oxygenase (COX-2) inhibitors, increases the risk of adverse reactions (see Other medicines and Momenxsin section below) and should be avoided.

Anti-inflammatory/painkillers such as ibuprofen may be associated with a slight increase in the risk of heart attack or stroke, particularly if taken in high doses. Do not exceed the duration of treatment or the recommended dose.

Talk to your doctor or pharmacist before taking Momenxsin if:
- you suffer from heart problems, including heart failure and angina (chest pain), or have had a heart attack, 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 transient ischemic attack TIA) in the past;
- 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 Momenxsin if): severe heart or circulatory problems (heart disease, high blood pressure, angina, accelerated heart rate), overactive thyroid, diabetes, pheochromocytoma (a tumor 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 can worsen it.
Where this situation is found or suspected, medical advice should be sought and treatment discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite (or because of) regular use of headache medications.

Sudden abdominal pain or rectal bleeding may occur with Momenxsin, due to inflammation of the colon (ischemic colitis). If you develop these gastrointestinal symptoms, stop taking Momenxsin and contact your doctor or seek immediate medical attention. See section 4.

A reduction in blood flow to the optic nerve may occur with Momenxsin. If you experience sudden vision loss, stop taking Momenxsin and consult your doctor or a healthcare facility immediately. See section 4.

Skin reactions
Serious skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with Momenxsin treatment. Stop using Momenxsin and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

If you develop a widespread feverish rash associated with pustules, stop taking Momenxsin and contact your doctor or seek immediate medical attention. See section 4.

Interference with blood test results
Pseudoephedrine can interfere with some diagnostic blood tests. If you need to have blood tests, tell your doctor that you are taking this medicine.

Infections
Momenxsin can mask the symptoms of infections such as fever and pain. It is therefore possible that Momenxsin may delay appropriate treatment of the infection, which could increase the risk of complications.
This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, consult your doctor immediately.

Children and adolescents
Momenxsin should not be given to children and adolescents under 15 years of age.
Dehydrated adolescents are at risk of kidney failure.

Athletes
For those involved in sports: the use of the drug without therapeutic necessity constitutes doping and can in any case lead to positive anti-doping tests.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Momenxsin and consult a doctor immediately if you experience:
• signs of intestinal bleeding such as bright red stools (faeces), black tarry stools, vomiting containing blood or dark particles resembling coffee grounds
• signs of a severe allergic reaction such as severe rashes, peeling, flaking or blistering of the skin, facial swelling, wheezing of unknown origin, shortness of breath, easy bruising
• reddish non-raised, target-shaped or circular patches on the trunk, often with central blisters, peeling of the skin, ulcers of 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 enlarged lymph nodes (DRESS syndrome)
• widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis).

Tell your doctor if you experience any of the following side effects, if they worsen or if you experience any side effects not listed.

Common (may affect up to 1 in 10 people)
• indigestion, abdominal discomfort or pain, nausea, vomiting, flatulence, diarrhoea, constipation, mild gastrointestinal bleeding which in rare cases leads to anaemia

Uncommon (may affect up to 1 in 100 people)
• hypersensitivity reactions with urticaria, itching and asthma attacks (with a drop in blood pressure)
• central nervous system disorders, such as headache, dizziness, difficulty sleeping, agitation, irritability or fatigue
• visual disturbances
• stomach or intestinal ulcers, in some cases associated with bleeding or perforation, gastritis, inflammation of the lining of the mouth 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
• damage to kidney tissue (papillary necrosis), increased uric acid concentrations in the blood

Very rare (may affect up to 1 in 10,000 people)
• worsening of infectious inflammations (e.g., necrotizing fasciitis), aseptic meningitis (neck stiffness, headache, nausea, vomiting, fever or disorientation) in patients with pre-existing autoimmune diseases (systemic lupus erythematosus (SLE), mixed connective tissue disease)
• problems in the production of blood cells (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis) which could cause a greater tendency to bruise or make you more vulnerable to infections
• severe allergic reactions
• psychotic reactions and depression
• high blood pressure, palpitations, heart failure, heart attack
• inflammation of the esophagus (esophagitis) and pancreas (pancreatitis), diaphragm-like intestinal narrowing
• liver dysfunction, liver damage, particularly with prolonged therapy, liver failure, acute hepatitis (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 a chickenpox infection (varicella-zoster virus infection)
• increased serum creatinine, oedema (particularly in patients with high blood pressure or kidney failure), nephritic syndrome, interstitial nephritis, acute kidney failure

Not known (frequency cannot be estimated from the available data)
• reduced blood flow to the optic nerve (ischemic 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, swelling of lymph nodes and increased eosinophils (a type of white blood cell).
• A widespread, red and scaly rash, with pustules forming under the skin and blisters located mainly on the skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). Stop using Momenxsin 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 insufficient blood supply (ischemic colitis).
Stop using Momenxsin if you develop these symptoms and contact your doctor or seek immediate medical attention.

Medicines such as Momenxsin may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke.

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