MOMENDOL 24CPR RIV 220MG

MOMENDOL 220 MG COMPRESENT RIVES WITH FILM

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 (23mg) of sodium For the full list of excipients, see paragraph 6.1

Excellent

Compressed core: Lactose monohydrate, Corn starch, Cellulose microcrystalline, Povidone (K25), Carbossimetilamido sodium, Silice colloidal anidra, Magnesium stearate. Film-coating: Ipromellose, Macrogol 400, Titanium dioxide (E 171), Talco.

Therapeutic indications

Momendol is indicated in adults and adolescents over 16 years in the short-term symptomatic treatment of mild and moderate pains such as muscle and joint pain, headaches, toothache and menstrual pain. Momendol can also be used in the treatment of fever.

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1 or to other active ingredients closely related to chemical naproxane. • Naprossene is contraindicated in patients with allergic manifestations, such as asthma, hives, rhinitis, nasal polyps, angioedema, and anaphylactic or anaphylactoid reactions induced by acetylsalicylic acid, analgesic, nonsteroidal anti-inflammatory drugs (FANS) and/or anti-rheumatic, due to the possible crused sensitivity. • Naprossene is contraindicated in patients with bleeding or gastro-intestinal perforation related to previous treatments with non-steroidal anti-inflammatory drugs, hemorrhage/peptic ulcer recurring in active or previous phase, chronic intestinal inflammatory diseases ( ulcerative colitis, Crohn's disease), severe liver failure, severe heart failure, severe kidney failure (creainine clearance). • Contraindicated in children under 12 years.

Population

Population Adults and teenagers over 16 years: 1 tablet coated with film every 8-12 hours. If necessary, a better effect can be obtained by starting, on the first day, with 2 tablets coated with movies followed by 1 tablet coated with film after 8-12 hours. Do not exceed 3 tablets coated with movies in 24 hours. Senior patients and patients with mild or moderate kidney failure should not exceed 2 tablets coated with movies in 24 hours. (See paragraph 4.3 and 4.4). Pediatric population Momendol is contraindicated in children under 12 years old (See paragraph 4.3) Method of administration Momendol should be taken preferably after a meal. Swallow whole tablets with water. Do not use for more than 7 days for pain and for more than 3 days for fever. Patients should be informed to consult a doctor if pain and fever persist or worsen.

Conservation

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

Warnings

Undesirable effects can be minimized with the use of the minimal effective dose for the shortest possible duration of treatment needed to control symptoms (see below paragraphs on gastrointestinal and cardiovascular risks). Clinical studies and epidemiological data suggest that the use of coxib and some NSAIDs (especially high doses and long-term treatments) may be associated with a modest increase in the risk of arterial thrombotic events (p.es. infarction of myocardial or stroke). Although some data suggest that the use of naprossene (1000 mg/die) may be associated with a lower risk, some risks may not be excluded. There is no sufficient data on the effects of low dose nanoproxins (600 mg/die) to draw definitive conclusions on possible trombotic risks. There is a close correlation between dose and appearance of severe unwanted gastrointestinal effects. Therefore, the effective minimum dosage should always be used. Caution is required (talk with your physician or pharmacist) before you begin treatment in patients with positive anamnesis for hypertension and/or heart failure because in association with the treatment with the NSAIDs fluid retention, hypertension and edema were found. Diuresis and kidney function must be carefully monitored, especially in the elderly, in patients with chronic congestive heart failure or chronic kidney failure, in patients treated with diuretics, or as a result of major surgery that involve hypovolemia. In patients with severe heart failure, conditions can deteriorate. Particular caution is recommended in patients with previous gastrointestinal diseases or liver failure and in patients with allergic manifestations in place or in advance, as in these subjects the product may determine bronchospasm, asthma, or other allergic phenomena. If visual disturbances arise treatment with Momendol must be suspended. In association with the use of NSAIDs, severe skin reactions have been reported very rarely, some of which are fatal, such as exfoliatory dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis (see paragraph 4.8). In the early stages of therapy patients seem to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Momendol must be stopped at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Naprossene, like any other NSAID, can mask the symptoms of concomitant infectious diseases. In isolated cases, there was an exacerbation of inflammations on an infectious basis in time connection with the use of NSAIDs (e.g. the development of necrotizer bundles). Gastrointestinal hemorrhage, ulceration and perforation, even fatal, were reported at any time of treatment with all NSAIDs, with or without premonitory symptoms or previous history of serious gastrointestinal events. In the elderly and in patients with history of ulcer, especially if complicated by hemorrhage or perforation (see paragraph 4.3), the risk of gastrointestinal hemorrhage, ulceration or perforation is higher with increased doses of NSAID. These patients must begin treatment with the lowest dose available. 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 4.5), it must be taken into account the possible concomitant use of protective agents (misoprostol or protonic pump inhibitors). Patients with history of gastrointestinal toxicity, especially older ones, must report any unusual gastrointestinal symptoms (especially gastrointestinal hemorrhage) in particular in the early stages of treatment. It should be paid attention to patients taking concomitant drugs that could increase the risk of ulceration or hemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-aggregating agents such as aspirin (see paragraph 4.5). In patients taking Momendol, treatment should be suspended if bleeding or gastrointestinal ulcer occurs. I NSAIDs should be administered with caution in patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease) since these conditions may aggravate (see paragraph 4.8). The use of Momendol must be avoided in conjunction with FANS, including selective COX-2 inhibitors. Senior patients, who generally have some degree of impairment of kidney, liver and heart functions, are most exposed to the risk of undesirable effects related to the use of NSAIDs, especially hemorrhages and gastrointestinal perforations that may be fatal. Prolonged use of NSAIDs in the elderly is not recommended. Naprossene inhibits piastrinic aggregation and can prolong bleeding time. Patients with clotting alterations or medications that interfere with hemostasis should be carefully monitored while taking Momendol. It is recommended caution in regular consumers of high daily doses of alcohol, as at risk of gastric bleeding. The use of the product must be avoided in cases of gastrointestinal pain. This medicine contains: - Lactose: patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose mal absorption, should not take this medicine. - Sodium: This medicine contains 23 mg of sodium per tablet equivalent to 1,15% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult.

Interactions

Unrecommended associations The administration of naprossene with other NSAIDs or corticosteroids is not recommended as it increases the risk of gastro-duodenal ulcers and bleeding (see paragraph 4.4) Acetylsalicylic acid Clinical pharmacodymanic data show that the concomitant use of naprossene for more than one consecutive day may inhibit the effect of acetylylylethylene acid at low doses on pyasternic activity and this inhibition may persist for a few days after the interruption of treatment with naproxins. The clinical relevance of this interaction is not known. Naprossene can increase the effect of anticoagulants, such as cumarinic anticoagulants (e.g. warfarin, dicumarol) because it extends protrombine time and reduces pyastrinic aggregation, increasing the risk of gastrointestinal hemorrhage (see paragraph 4.4). The combination of naprossene and lithium should be avoided; when necessary, we recommend a closer monitoring of the plasma levels of lithium and a adjustment of the dosage. Associations to be used with precaution Due to the high bond of naprossene with plasma proteins, caution is recommended in the treatment of idantoinics or sulfamidics. Special caution must be taken also in patients in treatment with cyclosporins, tacrolimo, sulfaniluree, ansa diuretics, metotressate, beta-blockers, ACE-inhibitionrs, probenecid, thiazide diuretics and digoxin. Naproxins can alter bleeding time (which can be increased up to 4 days after the therapy break), creatinine clearance (can decrease), atathemia and blood levels of creatinine and potassium (can increase), liver function tests (can be observed increased transamines). Naproxins can induce false positives in the determination of the urinary values of 17-chetosteroid and can interfere with the urinary determinations of 5-hydroxy-hyndolacetic acid. Naprossene therapy should be interrupted at least 72 hours prior to the execution of cortico-surrenalic function tests.

Effects

The following side effects were reported with the NSAIDs and naproxins. The most commonly observed side effects are gastrointestinal. Clinical studies and epidemiological data suggest that the use of coxib and some NSAIDs (especially high doses and long-term treatment) may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial or stroke infarction) (see paragraph 4.4). Below are the side effects organized according to the organic systemic classification according to MedDRA. The following values scales have been used: very common (>1/10); common (>1/100, 1/1000, 1/10.000, Emolinfopoietic system pathologies - Very rare: aplastic anemia or hemolytics, thrombocytopenia, granulocytopenia. Immune system disorders - Not common: allergic reaction (including facial edema and angioedema). Psychiatric disorders - Not common: sleeping disorders, excitement. Diseases of the nervous system - City: headache, drowsiness, dizziness. Very rare: simil-mening reaction Eye pathologies - Not common: visual disorders Ear and labyrinth pathologies - Not common: tinnitus, hearing disorders. Heart disease - Very rare: in association with the treatment with the NSAIDs were observed tachycardia, edema, hypertension and heart failure. Vascular pathologies - Not common: contuition Respiratory, chest and mediastinic pathologies - Very rare: dispnea, asthma. Gastrointestinal pathologies - City: nausea, dyspepsia, vomiting, pyrosis, gastralgia, flatulence. Not common: diarrhea, constipation. Rare: peptic ulcer, perforation or gastrointestinal bleeding, sometimes fatal, can be manifested above all in the elderly (see paragraph 4.4), hematitis, ulcerative stomatitis, aggravated colitis, Cruhn's disease aggravated (see paragraph 4.4). Very rare: colitis, stomatitis. Less frequently gastritis was observed. Hepatobile pathologies - Very rare: jaundice, hepatitis, reduced liver function Pathologies of skin and subcutaneous tissue - Not common: rash/hardened. Very rare: photosensitivity, alopecia, bollous disorder including Stevens-Johnson syndrome and toxic epidermal necrolysis. Kidney and urinary pathologies - Not common: abnormal kidney function. Systemic pathologies and conditions for administration - Not common: bruises, edema (including peripheral edema). Diagnostic examinations - Very rare: increased blood pressure. As with other NSAIDs, allergic reactions of anaphylactic or anaphylactic type may occur in patients with or without a 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, tiredness or unusual weakness, anxiety, agitation, loss of knowledge, difficulty in breathing or swallowing, itching, hive with or without angioedema, redness of the skin, nausea, vomiting, abdominal cramps, diarrhea. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address “http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa”.

Overdosing

Synonyms As signs of overdose may occur a state of numbness, heartburn, diarrhea, nausea, vomiting, drowsiness, increased blood levels of sodium, metabolic acidosis, seizures. Management In case of accidental or voluntary overdose ingestion/administration, the doctor must implement the usual measures required in these cases. It is recommended to empty the stomach and the usual support measures. The prompt administration of an adequate amount of activated carbon can reduce the absorption of the medicinal product.

Pregnancy Inhibition of prostaglandin synthesis can negatively affect pregnancy and/or embryo/fetal development. Epidemiological studies report an increased risk of abortion and heart disease and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. It is believed that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has shown to cause an increase in pre- and post-plant loss, and embryo-fetal mortality. In addition, in animals with synthetic inhibitors of prostaglandins during the organogenic period, an increase in the incidence of various malformations was reported, including cardiovascular disease. During the first and second quarter of pregnancy, naprossene should not be administered if not in strictly necessary cases. If naprossene is used by a woman waiting for conception, or during the first and second trimester of pregnancy, the dose and duration of treatment must be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress in kidney failure with oligo-idroamnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, and anti-aggregating effect that can also appear at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. Therefore, naprossene is contraindicated during the third trimester of pregnancy (see paragraph 4.3). Food Since NSAIDs are excreted in breast milk, as a precautionary measure their use is contraindicated during breastfeeding (see paragraph 4.3).

Fertility

There are some evidence that drugs that inhibit the synthesis of prostaglandins and cyclo-oxygenases could cause female fertility problems, through an effect on ovulation. This effect is reversible with the interruption of treatment.

Source: Farmadati