MOMENDOL "220 MG FILM-COATED TABLETS"12 COATED TABLETS"

Name
MOMENDOL 220 mg film-coated tablets
Naproxen sodium


What is it and what is it for?
Momendol belongs to the class of nonsteroidal analgesic-anti-inflammatory-antirheumatic drugs, that is, medicines that combat pain, inflammation, fever and are useful in the symptomatic treatment of rheumatic diseases.
Momendol is used for the short-term symptomatic treatment of mild to moderate pain, such as muscle and joint pain (e.g., back pain, stiff neck), headache, toothache, and menstrual pain.
Momendol can also be used to treat fever.
Contact your doctor if you do not feel better or if you feel worse after 7 days of treatment for pain, and after 3 days of treatment for fever.


What you need to know before taking the medicine
Do not take MOMENDOL:
• if you are allergic to naproxen sodium or any of the other ingredients of this medicine (listed in section 6), or to other chemically related substances;
• if you suffer from allergic reactions, such as asthma, urticaria, rhinitis, nasal polyps, angioedema and allergic reactions induced by acetylsalicylic acid, analgesics, anti-inflammatory and/or antirheumatic drugs;
• if you have had a history of gastrointestinal bleeding or perforation, active or previous recurrent peptic ulcer, chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease), severe liver failure, severe heart failure, severe renal failure (creatinine clearance <30 ml/min), angioedema, during intensive therapy with diuretics, in subjects with active haemorrhage and at risk of haemorrhage during therapy with anticoagulants (See "Other medicines and MOMENDOL" and "Warnings and precautions");
• during pregnancy, starting from the third trimester and during breastfeeding (See "Pregnancy, breastfeeding and fertility");
• the medicine cannot be administered to children under 12 years of age.


Warnings and precautions
Talk to your doctor or pharmacist before taking Momendol:
• since there is a close correlation between dosage and the onset of severe gastrointestinal side effects. Therefore, the minimum effective dosage should always be used;
• Medicines such as MOMENDOL may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment (7 days for pain and 3 days for fever);
• when MOMENDOL is used in hypertensive patients and/or in patients with reduced cardiac and/or renal function. During treatment with MOMENDOL, diuresis and renal function should be carefully monitored, particularly in the elderly, in patients with cardiac or chronic renal failure, and in patients treated with diuretics following major surgery involving significant blood loss;
• if you have heart problems, or a history of stroke, or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes or high cholesterol, or if you smoke), you should discuss your treatment with your doctor or pharmacist;
• when MOMENDOL is used in patients with severe heart failure, worsening of the condition may occur;
• when MOMENDOL is used in patients with a history of gastrointestinal diseases or liver failure and in patients with current or previous allergic reactions, as the product may cause bronchospasm, asthma, or other allergic reactions in these subjects. In these cases, particular caution is recommended;
• MOMENDOL must be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of allergy and/or hypersensitivity;
• if visual disturbances occur, treatment with MOMENDOL must be discontinued;
• since naproxen, like any other anti-inflammatory drug, can mask the concomitant symptoms of infectious diseases;
• since in isolated cases, in temporal connection with the use of anti-inflammatory drugs, an aggravation of inflammation on an infectious basis has been reported;
• if used in elderly patients, who generally have some degree of impaired renal, hepatic, and cardiac function, since this group of patients is more at risk of developing side effects related to the use of anti-inflammatory drugs. Prolonged use of anti-inflammatory drugs in the elderly is not recommended;
• since naproxen inhibits platelet aggregation and may prolong bleeding time. Patients with coagulation disorders or taking drugs that interfere with coagulation should be carefully monitored while taking MOMENDOL;
• when MOMENDOL is used by habitual consumers of high daily doses of alcohol there is a high risk of stomach bleeding;
• Use of the product should be avoided in cases of gastrointestinal pain. It is known that stomach or intestinal bleeding may occur in patients taking anti-inflammatory drugs;
• in asthmatic patients, the product is generally contraindicated;
• when MOMENDOL is used in combination with other drugs that require caution, see "Other medicines and MOMENDOL";
• Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Momendol. If you notice any of the symptoms of these serious skin reactions, described in section 4, stop taking Momendol and contact your doctor immediately.

Children and adolescents
Anyone under 16 years of age is advised to contact their doctor.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly observed side effects are gastrointestinal in nature.
The following adverse effects have been reported with NSAIDs and naproxen:

Common (may affect up to 1 in 10 people):
- Headache, drowsiness, dizziness;
- Nausea, dyspepsia, vomiting, heartburn, gastralgia, flatulence.

Uncommon (may affect up to 1 in 100 people):
- Allergic reaction (including facial swelling and angioedema);
- Sleep disturbances, excitement;
- Vision disturbances;
- Tinnitus, hearing disorders;
- Contusion;
- Diarrhea, constipation;
- Rash/itching;
- Abnormal kidney function;
- Chills, edema (including peripheral edema).

Rare (may affect up to 1 in 1,000 people):
- Peptic ulcer, perforation or gastrointestinal bleeding, sometimes fatal, may occur especially in the elderly, haematemesis, ulcerative stomatitis, aggravated colitis and aggravated Crohn's disease.

Very rare (may affect up to 1 in 10,000 people):
- Hemolytic or aplastic anemia, thrombocytopenia, granulocytopenia;
- Meningitis-like reaction;
- Tachycardia, edema, hypertension and cardiac failure have been observed in association with treatment with NSAIDs;
- Dyspnea, asthma;
- Colitis, stomatitis. Gastritis has been observed less frequently;
- Jaundice, hepatitis, reduced liver function;
- Photosensitivity, alopecia, bullous disorder including Stevens-Johnson syndrome and toxic epidermal necrolysis;
- Increased blood pressure.

Stop taking Momendol and contact your doctor immediately if you notice any of the following side effects:

Not known: frequency cannot be estimated from the available data
- Extensive skin rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS). See also section 2;
- A distinctive allergic skin reaction known as a fixed drug eruption, which usually recurs at the same site or sites with re-exposure to the medicine and may appear as round or oval patches with redness and swelling of the skin, a rash with blisters (hives), and an itching sensation.

As with other anti-inflammatory drugs, anaphylactic or anaphylactoid allergic reactions may occur in patients with or without previous exposure to drugs of the same class.

The characteristic symptoms of an anaphylactic reaction are: sudden, severe hypotension, rapid or slow heartbeat, unusual tiredness or weakness, anxiety, agitation, loss of consciousness, difficulty breathing or swallowing, itching, hives with or without angioedema, redness of the skin, nausea, vomiting, crampy abdominal pain, diarrhea.
Medicines like MOMENDOL 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.