Momendol 200mg Anti-inflammatory 12 Coated Tablets

Momendol Tablets is a naproxen-based over-the-counter drug which is used in the short-term symptomatic treatment of mild and moderate pain and in the treatment of fever .

Momendol is an anti-inflammatory useful for treating muscle and joint pain, headaches, toothaches and menstrual pain . Momendol's Naproxen 200mg Anti-inflammatory 12 Tablets also has an antipyretic action , useful for controlling the temperature and treating flu symptoms .

Posology and method of use of Momendol 200mg Anti-inflammatory 12 Coated Tablets

How to take Momendol 200mg Coated Tablets?

Momendol 200mg tablets should be taken according to the following doses and methods.

Adults and adolescents over 16 years : 1 Momendol tablet every 8-12 hours. If necessary, a better effect can be obtained by starting on the first day with 2 Momendol tablets followed by 1 film-coated tablet after 8-12 hours.

Momendol should preferably be taken after a meal.

Do not exceed 3 film-coated tablets in 24 hours. Elderly patients and patients with mild to moderate renal impairment should not exceed 2 film-coated tablets in 24 hours.

Active Ingredients and Excipients Momendol 200mg Anti-inflammatory 12 Coated Tablets

One Momendol tablet contains:

Active ingredient: Naproxen 200 mg (corresponding to naproxen sodium 220 mg).

Excipients: Tablet core: Lactose monohydrate, Maize starch, Microcrystalline cellulose, Povidone (K25), Carboxymethyl starch sodium, Colloidal anhydrous silica, Magnesium stearate. Film-coating: Hypromellose, Macrogol 400, Titanium dioxide (E 171), Talc

Contraindications Momendol 200mg Anti-inflammatory 12 Coated Tablets

Momendol 200mg Anti-inflammatory 12 Coated Tablets is contraindicated in case of:

• Hypersensitivity to the active substance or to any of the excipients or to other closely related substances from a chemical point of view.
• Naproxen is contraindicated in patients with allergic manifestations, such as asthma, urticaria, rhinitis, nasal polyps, angioedema, and anaphylactic or anaphylactoid reactions induced by acetylsalicylic acid, analgesics, non-steroidal anti-inflammatory drugs (NSAIDs) and/or antirheumatics, due to the possible cross-sensitivity
• Naproxen is contraindicated in patients with gastrointestinal bleeding or perforation related to previous non-steroidal anti-inflammatory drug treatments, active treatments or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding), stomach ulcer and active duodenum, inflammatory bowel disease (ulcerative colitis, Crohn's disease), severe hepatic insufficiency, severe cardiac insufficiency, severe renal insufficiency (creatinine clearance < 30 ml/min), angioedema, during intensive therapy with diuretics , in subjects with bleeding in progress and at risk of bleeding during therapy with anticoagulants
• Third trimester of pregnancy and breastfeeding
• Contraindicated in children under 12 years.

Side effects Momendol 200mg Anti-inflammatory 12 Coated Tablets

Like other NSAIDs, Momendol 200mg tablets naproxen can induce the following undesirable effects. The most commonly observed undesirable effects are gastrointestinal in nature Clinical studies and epidemiological data suggest that the use of coxibs and some NSAIDs (especially at high doses and for long-term treatments) may be associated with a small increased risk of thrombotic events arterial disease (e.g. myocardial infarction or stroke). ).

• Gastrointestinal disorders: Common: nausea, dyspepsia, vomiting, heartburn, gastralgia, flatulence. Uncommon: diarrhoea, constipation. Rare: peptic ulcer, perforation or gastrointestinal bleeding, sometimes fatal, especially in elderly subjects, haematemesis, ulcerative stomatitis, worsening of colitis and Crohn's disease may occur. Very rare: colitis, stomatitis. Less frequently gastritis has been observed.
• Nervous system disorders: Common: headache, somnolence, dizziness. Very rare: meningitis-like symptoms
• Auditory and vestibular disorders: Uncommon: tinnitus, hearing impaired. Eye disorders. Uncommon: visual disturbances. General disorders and administration site alteration. Uncommon: chills, edema (including peripheral oedema).
• Immune system disorders: Uncommon: allergic reactions (including face edema and angioedema)
• Psychiatric disorders: Uncommon: sleep disturbances, excitation
• Renal and urinary disorders: Uncommon: decreased renal function
• Skin and subcutaneous tissue disorders: Uncommon: rash/pruritus. Very rare: photosensitivity, alopecia, vesicular eruption, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
• Vascular system disorders: Uncommon: ecchymosis.
• Blood and lymphatic system disorders. Very rare: aplastic or haemolytic anaemia, thrombocytopenia, granulocytopenia
• Cardiac disorders: Very rare: Tachycardia, edema, hypertension and heart failure have been observed in conjunction with NSAID treatment.
• Hepatobiliary system disorders: Very rare: jaundice, hepatitis, impaired liver function
• Investigations: Very rare: Increased blood pressure.
• Respiratory, thoracic and mediastinal disorders: Very rare: dyspnoea, asthma.

As with other NSAIDs, allergic anaphylactic or anaphylactoid-type reactions may occur in patients with or without previous exposure to drugs belonging to this class. The characteristic symptoms of an anaphylactic reaction are: sudden severe low blood pressure, fast or slow heart rate, unusual tiredness or weakness, anxiety, agitation, loss of consciousness, difficulty breathing or swallowing, itching, hives with or without angioedema, flushing skin, nausea, vomiting, cramping abdominal pain, diarrhea.

Overdose Momendol 200mg Tablets

As signs of overdose, lethargy, heartburn, diarrhea, nausea, vomiting, drowsiness, increased blood sodium levels, metabolic acidosis, convulsions may occur. In case of accidental or voluntary ingestion/administration of a large quantity of the product, the doctor should implement the normal measures required in these cases. Stomach emptying and usual supportive measures are recommended. Prompt administration of an adequate amount of activated charcoal may reduce drug absorption.

Warnings Momendol 200mg Anti-inflammatory 12 Coated Tablets

Undesirable effects may be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see sections on gastrointestinal and cardiovascular risks below). Clinical trial and epidemiological data suggest that the use of coxibs and some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (eg myocardial infarction or stroke). Although some data suggest that the use of naproxen (1000 mg/day) may be associated with a lower risk, some risks cannot be excluded. There are insufficient data on the effects of low-dose naproxen (600 mg/day) to arrive at precise conclusions on possible thrombotic risks. There is a close correlation between dosage and the appearance of severe gastrointestinal side effects. Therefore the lowest effective dosage should always be used.

Caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a history of hypertension and/or heart failure since fluid retention, hypertension and edema have been reported in association with NSAID treatment. Diuresis and renal function should be closely monitored, particularly in the elderly, in patients with chronic congestive heart failure or chronic renal insufficiency, in patients treated with diuretics, or following major surgery involving hypovolemia. In patients with severe heart failure, conditions may worsen. Particular caution is advised in patients with a history of gastrointestinal disease or hepatic insufficiency and in patients with current or previous allergic reactions, as in these subjects the product can cause bronchospasm, asthma, or other allergic phenomena. If visual disturbances occur, treatment with Momendol should be discontinued. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Momendol should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Naproxen, like any other NSAID, can mask the symptoms of concomitant infectious diseases. In isolated cases, an exacerbation of infectious inflammations (e.g. the development of necrotizing fasciitis) has been reported in temporal connection with the use of NSAIDs. Gastrointestinal haemorrhage, ulceration and perforation Gastrointestinal haemorrhage, ulceration and perforation, which can be fatal, have been reported at any time during treatment with all NSAIDs, with or without warning symptoms or a previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, especially if complicated with haemorrhage or perforation, the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment on the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events. Patients with a history of GI toxicity, particularly the elderly, should report any unusual GI symptoms (especially GI bleeding) particularly in the initial stages of treatment. Caution should be exercised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin. When gastrointestinal bleeding or ulceration occurs in patients taking Momendol, the treatment should be discontinued.

NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated. The use of Momendol should be avoided in conjunction with COX-2 selective inhibitor NSAIDs. Elderly patients, who generally have some degree of impairment of renal, hepatic and cardiac functions, are at increased risk of developing undesirable effects related to the use of NSAIDs, especially gastrointestinal bleeding and perforation which can be fatal. Prolonged use of NSAIDs in the elderly is not recommended. Naproxen inhibits platelet aggregation and can prolong bleeding time. Patients with coagulation disorders or in therapy with medicines that interfere with haemostasis must be closely monitored while taking Momendol. Caution is advised in habitual consumers of high doses of alcohol, due to the risk of gastric bleeding. The use of the product should be avoided in cases of pain of gastrointestinal origin. This medicine contains lactose: patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Pregnancy and breastfeeding Momendol 200mg Anti-inflammatory 12 Coated Tablets

Can I take Momendol 200mg Anti-inflammatory Tablets when pregnant or breastfeeding?

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The risk was considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, naproxen should not be administered unless strictly necessary. If naproxen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose:

• the fetus a : cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which can progress to renal failure with oligohydramnios;
• the mother and the newborn, at the end of pregnancy, to: possible prolongation of bleeding time, and antiplatelet effect which may occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labour

Consequently, naproxen and Momendol 200mg tablets are contraindicated during the third trimester of pregnancy.

Since NSAIDs are excreted in breast milk, naproxen and Momendol 200mg tablets are contraindicated during breastfeeding as a precautionary measure.

Expiration and conservation of Momendol 200mg Anti-inflammatory 12 Coated Tablets

How to store Momendol 200mg Anti-inflammatory Tablets?

Check the expiry date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Store in the original package in order to protect from light and moisture.

Warning: do not use the medicine after the expiry date indicated on the package.