MOMENXSIN 200 MG/30 MG FILM-COATED TABLETS 12 TABLETS IN PVC/PVDC/AL BLISTER

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


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

Ibuprofen belongs to a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by relieving 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 case 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, headache, or fever. If you experience only one of these symptoms, talk to your pharmacist or doctor about using ibuprofen or pseudoephedrine alone.

Talk to 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:
• are allergic to ibuprofen or pseudoephedrine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• is under 15 years old;
• is in the third trimester of pregnancy (at least 7 months pregnant);
• is breastfeeding;
• have had an allergic reaction or shortness of breath, asthma, rash, runny or itchy nose or swelling of the face in the past following the use of acetylsalicylic acid or other NSAIDs;
• have had or currently have recurrent gastric/duodenal bleeding or ulcers (peptic ulcers) (at least two distinct episodes of confirmed ulcers or bleeding);
• has a history of gastrointestinal bleeding or perforation related to previous NSAID treatment;
• if you have very high blood pressure (severe hypertension) or hypertension not controlled by drugs;
• if you suffer from severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• has severe liver or kidney failure;
• suffers from severe heart failure;
• have serious heart or circulatory problems (heart disease, high blood pressure, angina, rapid heart rate), overactive thyroid, diabetes, pheochromocytoma (a tumor of the adrenal gland);
• have a history of heart attack (myocardial infarction);
• have had a stroke in the past or have been told that you are at risk of stroke;
• has a history of seizures (convulsions);
• suffers from blood cell production disorders of unknown origin;
• experience increased pressure in the eye (closed-angle glaucoma);
• has difficulty urinating related to prostate problems;
• you have been diagnosed with systemic lupus erythematosus (SLE), a disease that affects the immune system and causes joint pain, skin changes, and other problems;
• is taking:
- other nasal decongestants (vasoconstrictor drugs) administered orally or nasally (e.g. phenylpropanolamine, phenylephrine, ephedrine, xylometazoline, or oxymetazoline);
- methylphenidate, a medicine to treat attention-deficit/hyperactivity disorder (ADHD);
- medicines to treat 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 ibuprofen have been reported, including breathing problems, swelling of the face and neck (angioedema), and chest pain. Stop taking Momenxsin immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Talk to your doctor or pharmacist before taking Momenxsin if:
• you have asthma; using this medicine may cause an asthma attack;
• has a history of gastrointestinal disorders (such as hiatal hernia, gastrointestinal bleeding, peptic or duodenal ulcer);
• suffers or has suffered in the past from gastrointestinal diseases (ulcerative colitis or Crohn's disease);
• has high blood pressure;
• have liver or kidney problems;
• suffers from diabetes, due to the potential development of diabetic nephropathy;
• has an overactive thyroid (hyperthyroidism) or psychosis;
• has a blood clotting disorder;
• have an infection – see section “Infections” below.

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

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

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

Talk to your doctor or pharmacist before taking Momenxsin if:
- have 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 the arteries), or any type of stroke (including a "ministroke" or transient ischemic attack "TIA");
- has high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or smokes.
The following conditions are contraindicated due to the presence of pseudoephedrine (see the previous section "Do not take Momenxsin if"): severe heart or circulatory problems (heart disease, high blood pressure, angina, rapid 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 pain reliever for headaches can cause them to worsen.
If this condition is observed 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) the regular use of headache medications.

Cases of posterior reversible 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 can lead to reduced blood flow to the brain. Stop using Momenxsin immediately and seek immediate medical attention if you develop symptoms that could be signs of PRES or RCVS (see section 4 "Possible side effects" for symptoms).

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.

Momenxsin may cause reduced blood flow to the optic nerve. If you experience sudden vision loss, stop taking Momenxsin and contact your doctor or healthcare provider 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), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with Momenxin treatment. Stop using Momenxin 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 generalized feverish rash associated with pustules, stop taking Momenxsin and contact your doctor or seek medical help immediately. See section 4.

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

Infections
Momenxsin may mask the symptoms of infections, such as fever and pain. Therefore, Momenxsin may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms persist or worsen, contact 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 who participate in sports: the use of the drug without therapeutic need constitutes doping and may still result in a positive anti-doping test.


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

Stop taking Momenxsin and see a doctor immediately if you experience:
• signs of intestinal bleeding such as bright red stools (faeces), black tarry stools, vomit containing blood or dark particles resembling coffee grounds;
• signs of a serious allergic reaction such as severe skin rash, peeling, flaking or blistering of the skin, facial swelling, wheezing of unknown origin, shortness of breath, easy bruising;
• flat, target-shaped or circular reddish spots on the trunk, often with central blisters, peeling skin, and ulcers of the mouth, throat, nose, genitals, and eyes. These severe 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 start of treatment (acute generalized exanthematous pustulosis).

Stop taking Momenxsin immediately and contact your doctor urgently if you develop symptoms that could be signs of posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS). These include:
• severe headache with sudden onset;
• nausea;
• vomit;
• confusion;
• convulsions;
• changes in vision.

Tell your doctor if you experience any of the following side effects, if they get worse, 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, diarrhea, constipation, mild gastrointestinal bleeding which in rare cases leads to anemia.

Uncommon (may affect up to 1 in 100 people)
• hypersensitivity reactions with hives, itching and asthma attacks (with drop in blood pressure);
• central nervous system disorders, such as headache, dizziness, difficulty sleeping, agitation, irritability or tiredness;
• vision disorders;
• 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 concentrations of uric acid in the blood.

Very rare (may affect up to 1 in 10,000 people)
• worsening of infectious inflammation (e.g. necrotizing fasciitis), aseptic meningitis (stiff neck, 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 (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis) which may 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 narrowing of the intestine;
• liver dysfunction, liver damage, particularly with prolonged therapy, liver failure, acute liver inflammation (hepatitis);
• serious skin reactions, including red, blistering rashes (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia), serious skin infections and soft tissue complications of chickenpox infection (varicella-zoster virus infection);
• increased serum creatinine, edema (particularly in patients with arterial hypertension or renal insufficiency), nephritic syndrome, interstitial nephritis, acute renal failure.

Not known (frequency cannot be estimated from the available data)
• reduction of blood flow to the optic nerve (ischemic optic neuropathy);
• behavioral anomalies;
• stroke, seizures, headache;
• palpitations, tachycardia, chest pain, arrhythmia;
• high blood pressure;
• dry mouth, thirst, nausea, vomiting;
• skin rash, hives, itching, excessive sweating;
• difficulty urinating;
• a serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes, and an increase in eosinophils (a type of white blood cell);
• a widespread, red, scaly rash with pustules under the skin and blisters, mainly in the skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized 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);
• serious conditions affecting the blood vessels in the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

Stop using Momenxsin if you develop these symptoms and contact your doctor or seek medical help immediately.

Medicines such as Momenxsin may be associated with a small increased risk of heart attack ('myocardial infarction') or stroke.

Reporting of side effects
If you experience 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.