Momendol 220mg Anti-inflammatory 24 Coated Tablets

INDICATIONS

Momendol is indicated in adults and adolescents over 16 years of age in the short-term symptomatic treatment of mild and 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 effects: each coated tablet contains 41.8 mg of lactose and 1 mmol (23mg) sodium For the full list of excipients, see section 6.1

EXCIPIENTS

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

CONTRAINDICATIONS AND SIDE EFFECTS

• Hypersensitivity to the active ingredient or to any of the excipients listed in paragraph 6.1 or to other active ingredients 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 treatments with non-steroidal anti-inflammatory drugs, active or previous recurrent hemorrhage/peptic ulcer, chronic intestinal inflammatory diseases (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, and in subjects with active bleeding and at risk of bleeding while receiving anticoagulant therapy. • Third trimester of pregnancy and breastfeeding (See section 4.6). • Contraindicated in children under 12 years.

DOSAGE

Dosage Adults and adolescents over 16 years: 1 film-coated tablet every 8-12 hours. If necessary, a better effect can be achieved 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 paragraphs 4.3 and 4.4). Pediatric population Momendol is contraindicated in children under 12 years of age (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 doctor if pain and fever persist or worsen.

CONSERVATION

Store in the original package to protect the medicine from light and moisture.

WARNINGS

Side effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks). 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 modest increase in the 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 naproxen at low doses (600 mg/day) to draw definitive conclusions on possible thrombotic risks. There is a close correlation between dosage and the appearance of severe gastrointestinal side effects. Therefore, the minimum effective dosage should always be used. Caution is required (talk to 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 should 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, the condition may worsen. Particular caution is advised in patients with a history of gastrointestinal diseases or liver failure and in patients with current or previous allergic reactions, as 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, have been reported very rarely, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis (see section 4.8). 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 inflammation has been reported in temporal connection with the use of NSAIDs (e.g. the development of necrotizing fasciitis). Gastrointestinal haemorrhage, ulceration and perforation, including fatalities, have been reported at any time during treatment with all NSAIDs, with or without warning symptoms or previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, especially if complicated by haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. For these patients, and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5), the possible concomitant use of protective agents (misoprostol or proton pump inhibitors) should be taken into consideration. Patients with a history of gastrointestinal toxicity, particularly elderly patients, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) in particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or haemorrhage, 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, treatment should be discontinued if gastrointestinal bleeding or ulceration occurs. NSAIDs should be administered with caution in 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 concomitantly with NSAIDs, including selective COX-2 inhibitors. Elderly patients, who generally have some degree of impairment of renal, hepatic and cardiac functions, are at greater risk of developing side effects related to the use of NSAIDs, especially gastrointestinal bleeding and perforations which can 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 medicines that interfere with haemostasis should be carefully monitored while taking Momendol. Caution is advised in habitual consumers of high daily doses of alcohol, as they are at risk of gastric bleeding. The use of the product should be avoided in cases of pain of gastrointestinal origin. This medicine contains: - Lactose: Patients suffering from rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine. - Sodium: This medicine contains 23 mg sodium per tablet equivalent to 1.15% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

INTERACTIONS

Associations not recommended The administration of naproxen with other NSAIDs or corticosteroids is not recommended as it increases the risk of ulcers and gastro-duodenal bleeding (see section 4.4) Acetylsalicylic acid Clinical pharmacodynamic data highlight that the concomitant use of naproxen for more than one consecutive day can inhibit the effect of acetylsalicylic acid at low doses on platelet activity and this inhibition may persist for a few days afterwards discontinuation of naproxen treatment. The clinical relevance of this interaction is unknown. Naproxen may increase the effect of anticoagulants, such as coumarin-type anticoagulants (e.g. warfarin, dicoumarol) because it prolongs the 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, closer monitoring of plasma lithium levels and dosage adjustment are recommended. Associations to be used with caution Due to the high binding of naproxen to plasma proteins, caution is advised in concomitant treatment with hydantoins or sulphonamides. Particular caution should also be taken in patients treated with ciclosporins, tacrolimus, sulfonylureas, loop diuretics, methotrexate, beta-blockers, ACE inhibitors, probenecid, thiazide diuretics and digoxin. Naproxen may alter bleeding time (which may be increased up to 4 days after discontinuation of therapy), creatinine clearance (may decrease), urea nitrogen and blood levels of creatinine and potassium (may increase), liver function tests (increased transaminases may be observed). Naproxen may induce false positives in the determination of urinary 17-ketosteroid values and may interfere with urinary acid determinations. 5-hydroxy-indoleacetic acid. Naproxen therapy should be discontinued at least 72 hours before performing adrenocortical function tests.

SIDE EFFECTS

The following side effects have been reported with NSAIDs and naproxen. The most commonly observed side 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 modest increase in the risk of arterial thrombotic events (for example, myocardial infarction or stroke) (see section 4.4). Below are the undesirable effects organized according to the system organic classification according to MedDRA. The following value scales were used: very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (> 1/10,000, < 1/1000); very rare (<1/10,000); not known (it is not possible to calculate the frequency based on the available data). Pathologies of the blood and lymphatic system - Very rare: aplastic or hemolytic anemia, thrombocytopenia, granulocytopenia. Immune system disorders - Uncommon: allergic reaction (including facial edema and angioedema). Psychiatric disorders - Uncommon: sleep disturbances, excitement. Nervous system disorders - Municipality: headache, drowsiness, dizziness. Very rare: meningitis-like reaction Eye disorders - Uncommon: visual disturbances Ear and labyrinth disorders - Uncommon: tinnitus, hearing disorders. Cardiac disorders - Very rare: Tachycardia, edema, hypertension and heart failure have been observed in association with treatment with NSAIDs. Vascular pathologies - Uncommon: contusion Respiratory, thoracic and mediastinal disorders - Very rare: dyspnea, asthma. Gastrointestinal disorders - Municipality: nausea, dyspepsia, vomiting, heartburn, gastralgia, flatulence. Uncommon: diarrhea, constipation. Rare: peptic ulcer, perforation or gastrointestinal bleeding, sometimes fatal, can occur especially in elderly subjects (see section 4.4), hematemesis, ulcerative stomatitis, aggravated colitis, aggravated Crohn's disease (see section 4.4). Very rare: colitis, stomatitis. Less frequently, gastritis was observed. Hepatobiliary disorders - Very rare: jaundice, hepatitis, reduced liver function Skin and subcutaneous tissue disorders - Uncommon: rash/itching. Very rare: photosensitivity, alopecia, bullous disorder including Stevens-Johnson syndrome and toxic epidermal necrolysis. Renal and urinary disorders - Uncommon: abnormal kidney function. Systemic disorders and conditions relating to the administration site - Uncommon: chills, edema (including peripheral edema). Diagnostic tests - 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: severe and sudden hypotension, acceleration or slowing of the 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, diarrhoea. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system at “http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetti-reazione-avversa”.

OVERDOSE

Symptoms Stupor, heartburn, diarrhea, nausea, vomiting, drowsiness, increased blood sodium levels, metabolic acidosis, convulsions may occur as signs of overdose. Management In case of accidental or voluntary ingestion/administration of overdose, the doctor must implement the usual measures required in these cases. Stomach emptying and usual supportive measures are recommended. The prompt administration of an adequate quantity of activated charcoal may reduce the absorption of the medicine.

PREGNANCY AND BREASTFEEDING

Pregnancy Inhibition of prostaglandin synthesis can negatively influence pregnancy and/or embryo/foetal development. Results of epidemiological studies report an increased risk of miscarriage and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The risk is believed to increase with the dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss, and embryo-foetal mortality. Furthermore, in animals to which prostaglandin synthesis inhibitors were administered during the organogenetic period, an increased incidence of various malformations, including cardiovascular malformations, has been reported. 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 inhibitors of prostaglandin synthesis can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligo-hydramnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, and anti-aggregating effect which can 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 breast milk, as a precautionary measure their use is contraindicated during breastfeeding (see section 4.3). Fertility There is some evidence that drugs that inhibit the synthesis of prostaglandins and cyclooxygenase could cause problems with female fertility, through an effect on ovulation. This effect is reversible upon discontinuation of treatment.

EFFECTS ON DRIVING ABILITY

As a rule, taking Momendol does not or negligibly alter the ability to drive or use machinery. However, caution is recommended for those who carry out an activity that requires vigilance if, during therapy, they notice drowsiness, dizziness, depression.