MOMENDOL * 12CPR RIV 220MG

MOMENDOL * 12CPR RIV 220MG

Therapeutic indications

Momendol is indicated in adults and adolescents over 16 years for 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.

Dosage and method of use

DosageAdults and adolescents over 16 years: 1 film-coated tablet every 8-12 hours. If necessary, a better effect can 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 insufficiency Elderly patients and patients with mild or moderate renal insufficiency should not exceed 2 film-coated tablets in 24 hours. (See sections 4.3 and 4.4). Pediatric population Momendol is contraindicated in children below 12 years (See section 4.3).Method of administrationMomendol should preferably be taken after a meal. Swallow the tablets whole with water. Do not use for more than 7 days for pain and more than 3 days for fever. Patients should be advised to consult a physician if pain and fever persist or worsen.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 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, non-steroidal anti-inflammatory drugs (NSAIDs) and / or antirheumatics, due to the possible cross sensitivity. • Naproxen is contraindicated in patients with gastrointestinal bleeding or perforation related to previous treatment with non-steroidal anti-inflammatory drugs, active or previous recurrent peptic ulcer / haemorrhage, chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease), severe insufficiency liver, severe heart failure, severe renal failure (creatinine clearance). • Contraindicated in children under 12 years.

Side effects

The following side effects have been reported with NSAIDs and naproxen. The most commonly observed undesirable 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 treatment) may be associated with a modest increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke ) (see section 4.4) The undesirable effects are listed below, organized according to MedDRA system organ class. The following scales of values were used: very common (> 1/10); common (> 1/100, 1/1000, 1 / 10,000, Blood and lymphatic system disorders -Very rare:aplastic or haemolytic anemia, thrombocytopenia, granulocytopenia.Immune system disorders - Uncommon:allergic reaction (including face edema and angioedema).Psychiatric Disorders - Uncommon: sleep disturbances, arousal.Nervous system disorders - Common:headache, somnolence, dizziness.Very rare: meningitis-like reactionEye disorders - Uncommon:visual disturbancesEar and labyrinth disorders - Uncommon:tinnitus, hearing disorders.Cardiac disorders - Very rare:tachycardia, edema, hypertension and heart failure have been observed in association with NSAID treatment.Vascular disorders - Uncommon:bruiseRespiratory, thoracic and mediastinal disorders - Very rare:dyspnoea, asthma.Gastrointestinal disorders - Common:nausea, dyspepsia, vomiting, heartburn, gastralgia, flatulence.Uncommon: diarrhea, constipation.Rare: peptic ulcer, gastrointestinal perforation or bleeding, sometimes fatal, may occur mainly in elderly subjects (see section 4.4), haematemesis, ulcerative stomatitis, aggravated colitis, aggravated Crohn's disease (see section 4.4).Very rare: colitis, stomatitis. Gastritis was observed less frequently.Hepatobiliary disorders - Very rare:jaundice, hepatitis, impaired liver functionSkin 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.General disorders and administration site conditions - 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 prior exposure to drugs belonging to this class. The characteristic symptoms of an anaphylactic reaction are: severe and sudden hypotension, rapid or slow heart rate, unusual tiredness or weakness, anxiety, agitation, loss of consciousness, difficulty in breathing or swallowing, itching, hives with or without angioedema, redness of the skin, nausea, vomiting, crampy abdominal pain, diarrhea.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. 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”.

Special warnings

Gli effetti indesiderati possono essere minimizzati con l'uso della dose minima efficace per la durata di trattamento la più breve possibile necessaria a controllare i sintomi (vedere i paragrafi sottostanti sui rischi gastrointestinali e cardiovascolari). Studi clinici e dati epidemiologici suggeriscono che l’uso dei coxib e di alcuni FANS (specialmente ad alti dosaggi e per trattamenti di lunga durata) può essere associato ad un modesto aumento del rischio di eventi trombotici arteriosi (p.es. infarto del miocardio o ictus). Sebbene alcuni dati suggeriscono che l’uso di naprossene (1000 mg/die) può essere associato ad un rischio più basso, alcuni rischi non possono essere esclusi. Non ci sono dati sufficienti sugli effetti di naprossene a bassi dosaggi (600 mg/die) per trarre conclusioni definitive sui possibili rischi trombotici. Esiste una stretta correlazione tra dosaggio e comparsa di severi effetti indesiderati a livello gastrointestinale. Pertanto, dovrebbe essere sempre usato il dosaggio minimo efficace. È richiesta cautela (parlarne con il proprio medico o farmacista) prima di iniziare il trattamento nei pazienti con anamnesi positiva per ipertensione e/o insufficienza cardiaca poiché in associazione al trattamento con i FANS sono stati riscontrati ritenzione di liquidi, ipertensione ed edema. La diuresi e la funzionalità renale devono essere attentamente monitorate, in particolare negli anziani, nei pazienti con insufficienza cardiaca congestizia cronica o con insufficienza renale cronica, nei pazienti in trattamento con diuretici, o in seguito ad interventi chirurgici maggiori che comportano ipovolemia. Nei pazienti con grave insufficienza cardiaca, può intervenire un peggioramento delle condizioni. Si consiglia particolare cautela nei pazienti con precedenti di malattie gastrointestinali o insufficienza epatica e nei pazienti con manifestazioni allergiche in atto o pregresse, in quanto in questi soggetti il prodotto può determinare broncospasmo, asma, o altri fenomeni allergici. Se insorgono disturbi visivi il trattamento con Momendol deve essere sospeso. In associazione con l'uso dei FANS, sono state riportate molto raramente gravi reazioni cutanee, alcune delle quali fatali, quali la dermatite esfoliativa, sindrome di Stevens-Johnson e necrolisi epidermica tossica (vedere paragrafo 4.8). Nelle prime fasi della terapia i pazienti sembrano essere a più alto rischio: l'insorgenza della reazione si verifica nella maggior parte dei casi entro il primo mese di trattamento. Momendol deve essere interrotto alla prima comparsa di rash cutaneo, lesioni della mucosa o qualsiasi altro segno di ipersensibilità. Il naprossene, come ogni altro FANS, può mascherare i sintomi di malattie infettive concomitanti. In casi isolati, è stata riportata una esacerbazione di infiammazioni su base infettiva in connessione temporale con l’uso di FANS (es. lo sviluppo di fasciti necrotizzanti). Emorragia gastrointestinale, ulcerazione e perforazione, anche fatali, sono state riportate in qualsiasi momento del trattamento con tutti i FANS, con o senza sintomi premonitori o precedente storia di gravi eventi gastrointestinali. Negli anziani e in pazienti con storia di ulcera, soprattutto se complicata da emorragia o perforazione (vedere paragrafo 4.3), il rischio di emorragia gastrointestinale, ulcerazione o perforazione è più alto con dosi aumentate di FANS. Questi pazienti devono iniziare il trattamento con la più bassa dose disponibile. Per questi pazienti, e anche per pazienti che assumono basse dosi di aspirina o altri farmaci che possono aumentare il rischio di eventi gastrointestinali (vedere sotto e paragrafo 4.5), deve essere presa in considerazione l'eventuale uso concomitante di agenti protettori (misoprostolo o inibitori di pompa protonica). I pazienti con storia di tossicità gastrointestinale, in particolare quelli anziani, devono riferire qualsiasi sintomo gastrointestinale inusuale (soprattutto emorragia gastrointestinale) in particolare nelle fasi iniziali del trattamento. Deve essere prestata attenzione ai pazienti che assumono farmaci concomitanti che potrebbero aumentare il rischio di ulcerazione o emorragia, come corticosteroidi orali, anticoagulanti come warfarin, inibitori selettivi del reuptake della serotonina o agenti antiaggreganti come l'aspirina (vedere paragrafo 4.5). Nei pazienti che assumono Momendol, il trattamento deve essere sospeso se si verifica emorragia o ulcerazione gastrointestinale.I FANS devono essere somministrati con cautela nei pazienti con una storia di malattia gastrointestinale (colite ulcerosa, morbo di Crohn) poiché tali condizioni potrebbero aggravarsi (vedere paragrafo 4.8). L'uso di Momendol deve essere evitato in concomitanza di FANS, inclusi gli inibitori selettivi della COX-2. I pazienti anziani, che generalmente presentano qualche grado di compromissione delle funzioni renali, epatiche e cardiache, sono maggiormente esposti al rischio di insorgenza di effetti indesiderati correlati all’impiego di FANS, specialmente emorragie e perforazioni gastrointestinali che possono essere fatali. L’uso prolungato di FANS nell’anziano è sconsigliato. Il naprossene inibisce l’aggregazione piastrinica e può prolungare il tempo di sanguinamento. I pazienti con alterazioni della coagulazione o in terapia con medicinali che interferiscono con l’emostasi devono essere attentamente monitorati durante l’assunzione di Momendol. Si consiglia cautela nei consumatori abituali di alte dosi giornaliere di alcool, in quanto a rischio di sanguinamento gastrico.L’uso del prodotto deve essere evitato nei casi di dolore di origine gastrointestinale. Questo medicinale contiene: - 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 of sodium per tablet equivalent to 1.15% of the WHO recommended maximum daily intake of 2 g of sodium for an adult.

Pregnancy and breastfeeding

PregnancyInhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal 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 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 cause 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 trimester of pregnancy, naproxen should not be administered except in strictly necessary cases. 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 can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, and antiplatelet 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).Feeding timeAs NSAIDs are excreted in breast milk, their use is contraindicated during lactation as a precautionary measure (see section 4.3).FertilityThere is some evidence that drugs that inhibit prostaglandin and cyclo-oxygenase synthesis could cause problems with female fertility, through an effect on ovulation. This effect is reversible upon discontinuation of treatment.

Expiration and retention

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

Interactions with other drugs

Combinations not recommendedAdministration of naproxen with other NSAIDs or corticosteroids is not recommended as it increases the risk of gastro-duodenal ulcers and bleeding (see section 4.4) Acetylsalicylic acid Clinical pharmacodynamic data show that concomitant use of naproxen for more than one consecutive day may inhibit the effect of low dose acetylsalicylic acid on platelet activity and this inhibition may persist for a few days after 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, dicumarol) 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 advised.Associations to be used with cautionDue to the high plasma protein binding of naproxen, caution is advised in concomitant treatment with hydantoin or sulfonamides. Particular caution should also be exercised in patients receiving cyclosporine, tacrolimus, sulfonylureas, loop diuretics, methotrexate, beta-blockers, ACE inhibitors, probenecid, thiazide diuretics and digoxin. Naproxen can alter bleeding time (which may be increased up to 4 days after discontinuation of therapy), creatinine clearance (may decrease), blood urea and blood levels of creatinine and potassium (may increase), liver function test (increased transaminases may be observed) Naproxen may induce false positives in urinary 17-ketosteroid determination and may interfere with urinary 5-hydroxy-indolacetic acid determinations. Naproxen therapy should be discontinued at least 72 hours prior to performing adrenal cortical function tests.

Overdose

SymptomsDrowsiness, heartburn, diarrhea, nausea, vomiting, somnolence, increased blood sodium levels, metabolic acidosis, convulsions may occur as signs of overdose.ManagementIn case of accidental or deliberate ingestion / administration of overdose, the physician should take the usual measures required in these cases. Stomach emptying and routine supportive measures are recommended. Prompt administration of an adequate amount of activated charcoal may reduce the absorption of the medicinal product.

Active principles

Naproxen 200 mg (corresponding to naproxen sodium 220 mg). Excipient with known effect: each coated tablet contains 41.8 mg oflactoseand 1 mmol (23mg) sodium For a full list of excipients, see section 6.1

Excipients

Core of the tablet: Lactose monohydrate, Maize starch, Microcrystalline cellulose, Povidone (K25), Sodium carboxymethyl starch, Silica, colloidal anhydrous, Magnesium stearate.Film-coating: Hypromellose, Macrogol 400, Titanium dioxide (E 171), Talc.