Short-term symptomatic treatment of mild to moderate pain such as muscle and joint pain, headache, toothache and menstrual pain. Momendol can also be used in the treatment of fever.
Active Ingredients
Each soft capsule contains: Active ingredient: Naproxen sodium 220 mg (equivalent to naproxen 200 mg) Excipients with known effect: sorbitol and sodium. For a full list of excipients, see section 6.1
Excipients
Capsule content : Macrogol 600, Lactic acid, Purified water. Capsule coating : Gelatin, Sorbitol/Glycerol special (50:50), Brilliant blue (E133), Lecithin, Medium chain triglycerides.
Dosage
Dosage Adults and adolescents over 16 years 1 soft capsule every 8-12 hours. If necessary, a better effect can be obtained by starting, on the first day, with 2 soft capsules followed by 1 soft capsule after 8-12 hours. Do not exceed 3 soft capsules in 24 hours. Elderly and patients with renal insufficiency Elderly patients and patients with mild or moderate renal impairment should not exceed 2 soft capsules in 24 hours. (See section 4.3, and section 4.4). Do not use for more than 7 days for pain and for more than 3 days for fever. Patients should be advised to consult a doctor if pain and fever persist or worsen. Method of administration Momendol should be taken with a glass of water preferably after a meal.
Warnings
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see gastrointestinal and cardiovascular risks below). Clinical trial and epidemiological data suggest that 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 (for example myocardial infarction or stroke). Although some data suggest that 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 naproxen doses of 220 to 660 mg/day to draw firm conclusions on possible thrombotic risks. There is a close correlation between dosage and the occurrence of serious gastrointestinal undesirable effects. Therefore, the lowest effective dosage should always be used. Elderly patients, who generally have some degree of renal, hepatic and cardiac function impairment, are at increased risk of developing adverse effects related to the use of NSAIDs, especially gastrointestinal bleeding and perforation which may be fatal. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients. Prolonged use of NSAIDs in the elderly is not recommended. Before starting treatment with Momendol Caution is required before starting treatment in patients with a history of hypertension and/or non-severe heart failure since fluid retention, hypertension and edema have been reported in association with NSAID treatment. Diuresis and renal function should be well monitored, particularly in the elderly, in patients treated with diuretics, or following major surgery involving hypovolaemia. Particular caution is advised in patients with a history of gastrointestinal disease or non-severe hepatic insufficiency, especially in the elderly. The use of the medicinal product should be avoided in cases of pain of gastrointestinal origin. The concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered in elderly patients, in patients with non-severe gastrointestinal disease and for patients taking low dose aspirin or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5). Caution is advised when treating habitual consumers of high doses of alcohol, as they are at risk of gastric bleeding. The use of Momendol should be avoided in conjunction with NSAIDs including selective COX-2 inhibitors. During treatment with Momendol 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 (see section 4.8). Patients appear to be at highest risk in the early stages of therapy: 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, may mask the symptoms of concomitant infectious diseases. In isolated cases, an exacerbation of infectious-based inflammation (e.g. development of necrotizing fasciitis) has been reported in temporal connection with the use of NSAIDs. Gastrointestinal bleeding, ulceration and perforation, which may be fatal, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. Patients with gastric tolerance problems, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal 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 anti-platelet agents such as aspirin (see section 4.5). If gastrointestinal bleeding or ulceration occurs in patients receiving Momendol, the treatment should be withdrawn. Naproxen inhibits platelet aggregation and may prolong bleeding time. Patients with coagulation disorders or on therapy with medicinal products that interfere with haemostasis should be carefully monitored while taking Momendol. Regarding combinations with other medicinal products requiring caution, see section 4.5 “Interaction with other medicinal products and other forms of interaction” . Momendol soft capsules contain: • Sorbitol: sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot break down fructose, talk to your doctor before you (or your child) take this medicine.• Sodium: This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'.
Conservation
Do not store above 25°C. Store in the original container to protect from moisture.
Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1 or to other closely related substances from a chemical point of view, • 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 possible cross-sensitivity, • patients with gastrointestinal or other bleeding, e.g. cerebrovascular, • patients with gastrointestinal bleeding or perforation related to previous treatment with non-steroidal anti-inflammatory drugs, ongoing treatment with potentially gastro-injurious drugs or history of recurrent peptic haemorrhage/ulcer (two or more distinct episodes of proven ulceration or bleeding), • active stomach and duodenal ulcer, • congestive gastropathy, atrophic gastritis, • chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease), • severe hepatic insufficiency, • severe cardiac insufficiency, • severe renal insufficiency (creatinine clearance < 30 ml/min), • during full-dose treatment with diuretics, • in subjects with active bleeding and at risk of bleeding during anticoagulant therapy, • pregnancy and breastfeeding (See section 4.6 ) . • children and adolescents under 16 years of age.
Side effects
Like other NSAIDs, naproxen may induce the following undesirable effects. The most commonly observed undesirable effects are gastrointestinal in nature. Clinical trial and epidemiological data suggest that 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 (for example myocardial infarction or stroke) (see section 4.4). Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported after administration of Momendol (see section 4.4). Less frequently, gastritis has been observed. Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare). Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. As with other NSAIDs, allergic reactions of anaphylactic or anaphylactoid type may occur in patients with or without previous exposure to drugs belonging to this class. 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, urticaria with or without angioedema, redness of the skin, nausea, vomiting, crampy abdominal pain, diarrhoea. The following table lists the undesirable effects using the following frequency scales: very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (> 1/10,000, < 1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).
