Momendol is indicated in adults and adolescents over 16 years of age for the 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
Naproxen 200 mg (corresponding to naproxen sodium 220 mg). Excipient with known effect: each coated tablet contains 41.8 mg of lactose and 1 mmol (23 mg) of sodium. For the full list of excipients, see section 6.1.
Excipients
Tablet core : Lactose monohydrate, Maize starch, Microcrystalline cellulose, Povidone (K25), Sodium starch glycolate, Colloidal anhydrous silica, Magnesium stearate. Film-coating : Hypromellose, Macrogol 400, Titanium dioxide (E 171), Talc.
Dosage
Dosage Adults and adolescents over 16 years: 1 film-coated tablet every 8-12 hours. If necessary, a better effect may be obtained by starting on the first day with 2 film-coated tablets followed by 1 film-coated tablet after 8-12 hours. Do not exceed 3 film-coated tablets in 24 hours. Elderly/Renal impairment Elderly patients and patients with mild or moderate renal impairment should not exceed 2 film-coated tablets in 24 hours. (See sections 4.3 and 4.4). Paediatric population Momendol is contraindicated in children under 12 years (See section 4.3) Method of administration Momendol should preferably be taken after a meal. Swallow the tablets whole with water. 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 physician if pain and fever persist or worsen.
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 at low doses (600 mg/day) to draw definitive conclusions on possible thrombotic risks. There is a close correlation between dosage and the occurrence of severe gastrointestinal undesirable 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 treatment with NSAIDs. Diuresis and renal function must be carefully monitored, particularly in the elderly, in patients with chronic congestive heart failure or chronic renal failure, in patients treated with diuretics, or following major surgery involving hypovolemia. In patients with severe heart failure, worsening of conditions may occur. Particular caution is advised in patients with a history of gastrointestinal disease or liver failure and in patients with current or previous allergic manifestations, since in these subjects the product may cause bronchospasm, asthma, or other allergic phenomena. If visual disturbances occur, treatment with Momendol must be suspended. In association with the use of NSAIDs, serious skin reactions, some of them fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely (see section 4.8). Patients appear to be at highest risk early in the course of therapy: the onset of the reaction occurring in the majority of 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 other NSAIDs, may mask the symptoms of concomitant infectious diseases. In isolated cases, exacerbation of infectious-based inflammation has been reported in temporal connection with the use of NSAIDs (e.g. development of necrotising fasciitis). Gastrointestinal bleeding, ulceration and perforation, which may 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. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3). These patients should start treatment on the lowest dose available. The possible concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients taking low dose aspirin or other drugs likely to increase gastrointestinal risk (see below and section 4.5). Patients with a history of GI toxicity, particularly when elderly, should report any unusual GI symptoms (especially GI bleeding) particularly in the initial stages of treatment. Caution should be advised 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). In patients taking Momendol, the treatment should be discontinued if gastrointestinal bleeding or ulceration occurs. NSAIDs should be given with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be aggravated (see section 4.8). The use of Momendol should be avoided with concomitant NSAIDs, including selective COX-2 inhibitors. Elderly patients, who generally have some degree of renal, hepatic and cardiac function impairment, are more at risk of developing adverse effects related to the use of NSAIDs, especially gastrointestinal bleeding and perforation which may be fatal. Prolonged use of NSAIDs in the elderly is not recommended. 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. Caution is advised in habitual consumers of high daily doses of alcohol, as there is a risk of gastric bleeding. The use of the product should be avoided in cases of pain of gastrointestinal origin. This medicinal product contains: - Lactose : patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. - Sodium : this medicinal product contains 23 mg sodium per tablet equivalent to 1.15% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Conservation
Store in the original package in order to protect from light and moisture.
Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1 or to other active substances closely related to naproxen 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, nonsteroidal anti-inflammatory drugs (NSAIDs) and/or antirheumatics, due to possible cross-sensitivity. • Naproxen is contraindicated in patients with gastrointestinal bleeding or perforation related to previous treatment with nonsteroidal anti-inflammatory drugs, active or previous recurrent peptic ulcer/haemorrhage, chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease), severe hepatic insufficiency, severe heart failure, severe renal insufficiency (creatinine clearance < 30 ml/min), angioedema, during intensive therapy with diuretics, and in subjects with active haemorrhage and at risk of haemorrhage during anticoagulant therapy. • Third trimester of pregnancy and breastfeeding (See section 4.6 ) . • Contraindicated in children under 12 years.
Side effects
The following undesirable effects have been reported with NSAIDs and naproxen. 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). The following undesirable effects are listed below by MedDRA system organ class. The following rating scales have been used: very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data). Pathologies of the haemolymphopoietic system - Very rare: aplastic or haemolytic anaemia, thrombocytopenia, granulocytopenia. Immune system disorders - Uncommon: allergic reaction (including facial oedema and angioedema). Psychiatric disorders - Uncommon : sleep disturbances, excitation. Nervous system disorders - Common: headache, somnolence, dizziness. Very rare : meningitis-like reaction Eye disorders - Uncommon: visual disturbances Ear and labyrinth disorders - Uncommon: tinnitus, hearing impairment. Cardiac disorders - Very rare: Tachycardia, edema, hypertension and cardiac failure have been observed in association with treatment with NSAIDs. Vascular disorders - Uncommon: contusion Respiratory, thoracic and mediastinal disorders - Very rare: dyspnoea, asthma. Gastrointestinal disorders - Common: nausea, dyspepsia, vomiting, heartburn, gastralgia, flatulence. Uncommon : diarrhoea, constipation. Rare : peptic ulcer, perforation or gastrointestinal bleeding, sometimes fatal, may occur especially in the elderly (see section 4.4), haematemesis, ulcerative stomatitis, aggravated colitis, aggravated Crohn's disease (see section 4.4). Very rare : colitis, stomatitis. Less frequently, gastritis has been observed. Hepatobiliary disorders - Very rare: jaundice, hepatitis, decreased liver function Skin and subcutaneous tissue disorders - Uncommon: rash/pruritus. Very rare: photosensitivity, alopecia, bullous disorder including Stevens-Johnson syndrome and toxic epidermal necrolysis. Renal and urinary disorders - Uncommon: Abnormal renal function. General disorders and administration site conditions - Uncommon : chills, oedema (including peripheral oedema). Investigations - Very rare: increased blood pressure. As with other NSAIDs, allergic reactions of the anaphylactic or anaphylactoid type 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 hypotension, acceleration or slowing of the 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. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at “http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa”.
Overdose
Symptoms Signs of overdose may include lethargy, heartburn, diarrhea, nausea, vomiting, drowsiness, increased blood sodium levels, metabolic acidosis, convulsions. Management In case of accidental or voluntary ingestion/administration of overdose, the physician should implement the usual measures required in these cases. Emptying of the stomach and usual supportive measures are recommended. Prompt administration of an adequate amount of activated charcoal may reduce the absorption of the drug.
Pregnancy
Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/fetal development. Results of epidemiological studies report an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The risk is believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss, and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has 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 clearly 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 to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; the mother and the neonate, at the end of pregnancy, to: - possible prolongation of bleeding time, and anti-aggregating effect which may appear even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Therefore, naproxen is contraindicated during the third trimester of pregnancy (see section 4.3). Breastfeeding Since NSAIDs are excreted in human milk, as a precautionary measure their use is contraindicated during breastfeeding (see section 4.3). Fertility There is some evidence that drugs that inhibit prostaglandin synthesis and cyclooxygenase may cause problems with female fertility, through an effect on ovulation. This effect is reversible upon discontinuation of treatment.
