Momendol 220mg 12 soft capsules

INDICATIONS

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

Each soft capsule contains: Active ingredient: Naproxen sodium 220 mg (equal to naproxen 200 mg) Excipients with known effects: sorbitol and sodium. For the complete list of excipients see section 6.1

EXCIPIENTS

Capsule contents: Macrogol 600, Lactic acid, Purified water. Capsule lining: Gelatin, Sorbitol/Special Glycerol (50:50), Brilliant Blue (E133), Lecithin, Medium Chain Triglycerides.

CONTRAINDICATIONS AND SIDE EFFECTS

• Hypersensitivity to the active ingredient or to any of the excipients listed in paragraph 6.1 or to other substances closely related 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 sensitivity cruciate, • patients with gastrointestinal or other haemorrhage, for example cerebrovascular, • patients with gastrointestinal bleeding or perforation related to previous treatments with non-steroidal anti-inflammatory drugs, current treatments with potentially gastro-harmful drugs or history of recurrent peptic haemorrhage/ulcer (two or more distinct episodes of demonstrated ulceration or bleeding), • active stomach and duodenal ulcer, • congestive gastropathy, atrophic gastritis, • chronic inflammatory diseases intestinal disorders (ulcerative colitis, Crohn's disease), • severe hepatic insufficiency, • severe heart failure, • severe renal insufficiency (creatinine clearance < 30 ml/min), • during treatment at full dosage with diuretics, • in subjects with active bleeding and at risk of bleeding during therapy with anticoagulants, • pregnancy and breastfeeding (See section 4.6). • children and adolescents under 16 years of age.

DOSAGE

Dosage Adults and adolescents over 16 years 1 soft capsule every 8-12 hours. If necessary, a better effect can be achieved 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 softgels in 24 hours. (See paragraph 4.3, and paragraph 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.

CONSERVATION

Do not store above 25°C. Store in the original container to protect the product from 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 regarding the effects of naproxen doses from 220 to 660 mg per day to reach precise conclusions on possible thrombotic risks. There is a close correlation between dosage and the appearance of serious side effects at the gastrointestinal level. Therefore, the minimum effective dosage should always be used. 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. 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 positive history of hypertension and/or non-severe heart failure since fluid retention, hypertension and edema have been found in association with treatment with NSAIDs. Diuresis and renal function should be well monitored, particularly in the elderly, in patients treated with diuretics, or following major surgery involving hypovolemia. Particular caution is advised in patients with a history of non-serious gastrointestinal diseases or hepatic insufficiency, especially the elderly. The use of the medicine 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-serious gastrointestinal diseases and for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5). Caution is advised in the treatment of habitual consumers of high doses of alcohol, as they are at risk of gastric bleeding. The use of Momendol should be avoided concomitantly with NSAIDs including selective COX-2 inhibitors. During treatment with Momendol If visual disturbances occur, treatment with Momendol must be suspended. 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). 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 (e.g. the development of necrotizing fasciitis) has been reported in temporal connection with the use of NSAIDs. DDuring treatment with all NSAIDs, gastrointestinal bleeding, ulceration and perforation, which may be fatal, have been reported at any time, with or without warning symptoms or previous history of serious gastrointestinal events. Patients with gastric tolerability problems, particularly elderly people, should report any unusual gastrointestinal symptoms (especially gastrointestinal haemorrhage) 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 antiplatelet agents such as aspirin (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Momendol, treatment should be discontinued. Naproxen inhibits platelet aggregation and may prolong bleeding time. Patients with coagulation disorders or on therapy with drugs that interfere with haemostasis must be carefully monitored while taking Momendol. Regarding associations with other drugs requiring caution, see section 4.5 “Interaction with other medicinal products and other forms of interaction”. Momendol soft capsules contains: • Sorbitol: sorbitol is a source of fructose. If your doctor has told you that you (or your child) is intolerant to some sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients are unable to process fructose, talk to your doctor before you (or your child) take this medicine.• Sodium: This medicinal product contains less than 1 mmol (23 mg) sodium per capsule, i.e. essentially 'sodium-free'.

INTERACTIONS

Contraindicated associations Anticoagulants 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 sections 4.3 and 4.4). Associations not recommended Non-steroidal anti-inflammatories (NSAIDs) or corticosteroids The administration of naproxen with other non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids is not recommended as it increases the risk of gastroduodenal ulcers and bleeding (see section 4.4). Lithium The combination of naproxen and lithium should be avoided; when necessary, close monitoring of plasma lithium levels and dosage adjustment are recommended. Increased lithium levels may induce nausea, polydipsia, polyuria, tremors and confusion. Antiplatelet drugs and selective serotonin reuptake inhibitors (SSRIs) The concomitant use of antiplatelets and selective serotonin reuptake inhibitors (SSRIs) increases the risk of gastrointestinal bleeding (see section 4.4). Acetylsalicylic acid Clinical pharmacodynamic data highlight that concomitant use of naproxen for more than one consecutive day can inhibit the effect of low-dose acetylsalicylic acid on platelet activity and this inhibition can persist for a few days after discontinuation of treatment with naproxen. The clinical relevance of this interaction is unknown. Cyclosporine Inhibitors of prostaglandin synthesis such as naproxen, due to their effect on renal prostaglandins, may cause an increase in the nephrotoxicity of ciclosporin. Tacrolimus The simultaneous use of non-steroidal anti-inflammatory drugs and tacrolimus can cause acute renal failure. Methotrexate A severe increase in methotrexate toxicity has also been observed in case of combined therapy with naproxen. The mechanism of this interaction, which may be due to reduced renal clearance of methotrexate, is unclear. Associations to be used with caution Hydantoin and sulphonamide derivatives Due to the high binding of naproxen to plasma proteins, caution is advised in concomitant treatment with hydantoin or sulphonamide derivatives. Sulfonylureas It is important to take into account the possibility of an accentuation of the effects of the bonds of sulfonylureas (oral antidiabetics) due to the inhibition of plasma proteins. Furosemide and loop diuretics Concomitant use with furosemide may lead to a reduction in the natriuretic effect of the diuretic.Beta blockers The association of Momendol with beta-blockers may reduce their antihypertensive effect. Probenecid Concomitant intake of probenecid increases plasma levels of naproxen and significantly extends plasma half-life. Thiazide diuretics, ACE inhibitors and Angiotensin II antagonists NSAIDs may reduce the effect of thiazide diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy, especially in elderly patients. Digoxin Concomitant intake of Momendol with digoxin may alter the serum levels of the latter. Laboratory tests 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

Like other NSAIDs, naproxen can induce the following side effects. 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 (e.g. myocardial infarction or stroke) (see section 4.4). Peptic ulcers, perforation or gastrointestinal haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4). After administration of Momendol the following have been reported: nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4). Less frequently, gastritis has been observed. Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rarely). Edema, hypertension and heart failure have been reported in association with treatment with NSAIDs. 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. The following table lists the side effects, using the following frequency value scales: 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 (frequency cannot be estimated from the available data).

Blood and lymphatic system disorders - Frequency category: Very rare: aplastic or hemolytic anemia, eosinophilia, thrombocytopenia, leukopenia, granulocytopenia such as agranulocytosis.

Immune system disorders - Frequency category: Uncommon: allergic reactions (including facial edema and angioedema).

Psychiatric disorders - Frequency category: Uncommon: sleep disorder, excitement.

Psychiatric disorders - Frequency category: Very rare: depression, difficulty concentrating.

Metabolism and nutrition disorders - Frequency category: Rare: hyperglycemia, hypoglycemia.

Nervous system disorders - Frequency category: Common: headache, drowsiness, dizziness, dizziness.

Nervous system disorders - Frequency category: Uncommon: drowsiness, insomnia.

Nervous system disorders - Frequency category: Very rare: meningitis-like reaction aseptic meningitis in patients with autoimmune diseases, cognitive disorders, convulsions.

Eye disorders - Frequency category: Uncommon: visual disturbances.

Eye disorders - Frequency category: Very rare: corneal opacity, papillitis, retrobulbar optic neuritis, papilledema.

Ear and labyrinth disorders - Frequency category: Uncommon: tinnitus, hearing disorders.

Ear and labyrinth disorders - Frequency category: Very rare: hearing loss.

Cardiac disorders - Frequency category: Very rare: tachycardia, edema, hypertension and heart failure have been observed in conjunction with treatment with NSAIDs.

Vascular disorders - Frequency category: Uncommon: ecchymosis.

Vascular disorders - Frequency category: Very rare: vasculitis.

Respiratory, thoracic and mediastinal disorders - Frequency category: Very rare: dyspnoea, asthma, eosinophilic pneumonia, alveolitis.

Gastrointestinal disorders - Frequency category: Common: nausea, dyspepsia, vomiting, heartburn, gastralgia, flatulence.

Gastrointestinal disorders - Frequency category: Uncommon: diarrhoea, constipation.

Gastrointestinal disorders - Frequency category: 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 (see section 4.4).

Gastrointestinal disorders - Frequency category: Very rare: colitis, stomatitis, pancreatitis, aphthous ulcers, esophagitis. It has been observed less frequently.

Gastrointestinal disorders - Frequency category: Not known: gastritis.

Hepatobiliary disorders - Frequency category: Very rare: jaundice, hepatitis (including fatal cases), reduced liver function.

Skin and subcutaneous tissue disorders - Frequency category: Uncommon: rash/itching.

Skin and subcutaneous tissue disorders - Frequency category: Very rare: photosensitivity including porphyria cutanea tardi (“pseudoporphyria”) or epidermolysis bullosa, alopecia, vesicular eczema, including Stevens-Johnson syndrome and toxic epidermal necrolysis, erythema multiforme, erythema nodosa, fixed erythema, lichen planus, pustules, lupus erythematosus systemic, purpura, sweating.

Musculoskeletal system and connective tissue disorders - Frequency category: Rare: myalgia, muscle weakness.

Renal and urinary disorders - Frequency category: Uncommon: reduced renal function.

Renal and urinary disorders - Frequency category: Rare: glomerulonephritis.

Renal and urinary disorders - Frequency category: Very rare: interstitial nephritis, papillary necrosis, nephrotic syndrome, nephritic syndrome, renal failure, nephropathy, haematuria, proteinuria.

General disorders and administration site conditions - Frequency category: Uncommon: chills, edema (including peripheral edema).

Systemic disorders and conditions relating to the administration site - Frequency category: Rare: pyrexia.

Systemic disorders and conditions relating to the administration site - Frequency category: Very rare: thirst, malaise.

Diagnostic tests - Frequency category: Very rare: increased blood pressure, increased serum creatinine, abnormal liver function tests, hyperkalemia.

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 reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

As signs of overdose may occur drowsiness, heartburn, diarrhea, nausea, vomiting, abdominal pain, dizziness, disorientation, gastric hemorrhage, drowsiness, increased blood sodium levels, metabolic acidosis, convulsions, changes in liver function, hypoprothrombinemia, renal dysfunction, apnea. In case of ingestion/administration of a large quantity of product, accidental or voluntary, the doctor must 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 the absorption of the medicine.

PREGNANCY AND BREASTFEEDING

Pregnancy Inhibition of prostaglandin synthesis can negatively affect pregnancy and/or embryo/foetal development. Results of epidemiological studies suggest 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 absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was thought 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, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals to which prostaglandin synthesis inhibitors were administered during the organogenetic period. 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 occur even at very low doses; • inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, Momendol is contraindicated during pregnancy (see section 4.3). Breastfeeding Since NSAIDs are excreted in breast milk, the medicine 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 is reversible if you stop treatment. The use of Momendol, like any drug that inhibits the synthesis of prostaglandins and cyclooxygenase, is not recommended in women who intend to become pregnant. The administration of Momendol should be suspended in women who have fertility problems or who are undergoing fertility investigations.

EFFECTS ON DRIVING ABILITY

Due to the possible onset of drowsiness, dizziness, dizziness or insomnia Momendol may impair the ability to drive and use machinery. In this case, avoid these activities or others that require particular vigilance.