Active ingredients

Naproxen 200 mg (corresponding to naproxen sodium 220 mg). Excipients: 41.8 mg of lactose per film-coated tablet. For a 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.

Therapeutic indications

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 to treat fever.

Contraindications/Side effects

Hypersensitivity to the active substance or to any of the excipients, or to other closely related substances. Naproxen is contraindicated in patients with allergic reactions, 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 treatment or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding), active gastric or duodenal ulcer, 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, 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.

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 patients and patients with mild or moderate renal impairment should not exceed 2 film-coated tablets in 24 hours. (See 4.3, “Contraindications” and 4.4, “Special warnings and special precautions for use”). Momendol should preferably be taken after a meal. 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.

Conservation

Store in the original packaging to protect from light and moisture.

Warnings

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see sections below on gastrointestinal and cardiovascular risks). 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 (e.g., 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 draw firm conclusions about possible thrombotic risks. There is a close correlation between dosage and the occurrence of severe gastrointestinal adverse effects. Therefore, the lowest effective dosage should always be used. Caution is advised (discuss with your doctor or pharmacist) before initiating treatment in patients with a history of hypertension and/or heart failure, as fluid retention, hypertension, and edema have been reported in association with NSAID treatment. Urine output and renal function should be closely monitored, particularly in the elderly, patients with chronic congestive heart failure or chronic renal failure, patients receiving diuretics, or following major surgery resulting in 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 reactions, as the product may cause bronchospasm, asthma, or other allergic reactions in these patients. 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 4.8). Patients appear to be at highest risk early in therapy, with the onset of the reaction occurring 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, exacerbation of infectious inflammation (e.g., development of necrotizing fasciitis) has been reported in temporal connection with the use of NSAIDs. Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can 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. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in the elderly and in patients with a history of ulcers, particularly if complicated with haemorrhage or perforation (see section 4.3). 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-dose aspirin or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5). Patients with a history of gastrointestinal toxicity, 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 antiplatelet agents such as aspirin (see section 4.5). If 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 (see section 4.8 - Undesirable effects). The use of Momendol should be avoided in combination with NSAIDs that are selective COX-2 inhibitors. Elderly patients, who generally have some degree of renal, hepatic, and cardiac function, 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 taking medications that interfere with hemostasis should be carefully monitored while taking Momendol. Caution is advised in those who regularly consume high doses of alcohol, due to the risk of gastric bleeding. Use of the product should be avoided in cases of gastrointestinal pain. This medicinal product contains lactose: patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine. Regarding combinations with other medicinal products that require caution, see section 4.5 "Interaction with other medicinal products and other forms of interaction".

Interactions

Combinations not recommended: The administration of naproxen with other nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids is not recommended as it increases the risk of ulcers and gastrointestinal bleeding (see section 4.4). Naproxen may increase the effect of anticoagulants, such as coumarin-type anticoagulants (e.g., warfarin, dicoumarol), because it prolongs prothrombin time and reduces platelet aggregation, increasing the risk of gastrointestinal bleeding (see section 4.4). The combination of naproxen and lithium should be avoided; when necessary, close monitoring of plasma lithium levels and dosage adjustment are recommended. Combinations to be used with caution: Due to the high plasma protein binding of naproxen, caution is advised in concomitant treatment with hydantoins or sulfonamides. Particular caution should also be exercised in patients being treated with ciclosporin, tacrolimus, sulfonylureas, loop diuretics, methotrexate, beta-blockers, ACE inhibitors, probenecid, thiazide diuretics, and digoxin. Naproxen may alter bleeding time (which may increase up to 4 days after discontinuation of therapy), creatinine clearance (may decrease), blood urea nitrogen (BUN), creatinine and potassium levels (may increase), and liver function tests (increased transaminases may occur). Naproxen may induce false-positive urinary 17-ketosteroid values ​​and may interfere with urinary 5-hydroxyindoleacetic acid measurements. Naproxen therapy should be discontinued at least 72 hours before performing adrenal function tests.

Side effects

Like other NSAIDs, naproxen may induce the following adverse effects. The most commonly observed adverse 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 (e.g. myocardial infarction or stroke) (see Section 4.4). 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). Gastrointestinal disorders: Common: nausea, dyspepsia, vomiting, heartburn, gastralgia, flatulence. Uncommon: diarrhoea, constipation. Rare: peptic ulcer, perforation or gastrointestinal bleeding, sometimes fatal, especially in the elderly, may occur (see section 4.4), haematemesis, ulcerative stomatitis, worsening of colitis and Crohn's disease (see section 4.4). Very rare: colitis, stomatitis. Less frequently, gastritis has been observed. Nervous system disorders: Common: headache, drowsiness, dizziness. Very rare: meningitis-like symptoms. Auditory and vestibular disorders: Uncommon: tinnitus, hearing impairment. Eye disorders: Uncommon: visual disturbances. General disorders and administration site conditions: Uncommon: chills, oedema (including peripheral oedema). Immune system disorders: Uncommon: allergic reactions (including facial swelling and angioedema). Psychiatric disorders: Uncommon: sleep disturbances, excitation. Renal and urinary tract disorders: Uncommon: decreased renal function. Skin and subcutaneous tissue disorders: Uncommon: rash/pruritus. Very rare: photosensitivity, alopecia, vesicular rash, 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 cardiac failure have been observed in association with treatment with NSAIDs. Hepatobiliary system disorders: Very rare: jaundice, hepatitis, impaired liver function. Diagnostic tests: Very rare: increased blood pressure. Respiratory, thoracic, and mediastinal disorders: Very rare: dyspnea, asthma. As with other NSAIDs, anaphylactic or anaphylactoid allergic reactions may occur in patients with or without previous exposure to drugs in this 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, and diarrhea.

Overdose

Signs of overdose may include lethargy, heartburn, diarrhea, nausea, vomiting, drowsiness, increased blood sodium levels, metabolic acidosis, and convulsions. If a large amount of the product is ingested/administered, whether accidentally or intentionally, the physician should implement the usual measures required in these cases. Emptying the stomach and administering usual supportive measures are recommended. Prompt administration of an adequate amount of activated charcoal may reduce drug absorption.

Pregnancy and breastfeeding

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 is reversible if treatment is stopped. Pregnancy: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonic/fetal development. Results of epidemiological studies suggest an increased risk of miscarriage, 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. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimesters 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 trimesters 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 newborn, at the end of pregnancy, to: possible prolongation of bleeding time, and an antiplatelet effect that may occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, naproxen is contraindicated during the third trimester of pregnancy. Breastfeeding: Since NSAIDs are excreted in breast milk, their use should be avoided during breastfeeding as a precautionary measure.