Momentact 400mg 30 Tablets

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

Momentact 30 Tablets 400mg is an over-the-counter drug based on ibuprofen, an active ingredient belonging to the class of NSAIDs (non-steroidal anti-inflammatory drugs), indicated for symptomatic treatment of pain and fever. Its highly concentrated formulation (400 mg per tablet) allows for faster and more intense action than other over-the-counter painkillers, ensuring effective relief in a short time.

Thanks to its high bioavailability and coated tablet technology, Momentact 400mg tablets is able to act already within 10-15 minutes of taking it, thus becoming an ideal choice for those who need a quick and powerful pain reliever. The pack of 30 tablets represents a comfortable and convenient solution for repeated treatments or for those suffering from recurring pain.

Momentact is indicated for adults and adolescents over 12 years of age, and is used in the treatment of various types of acute pain of mild to moderate intensity, including:

• Headache and tension headaches
• Menstrual pain
• Muscle pain and joints
• Toothache
• Flu symptoms with fever and widespread pain

Ibuprofen works by blocking the production of prostaglandins, chemical mediators of inflammation and pain, thus allowing you to rapidly reduce inflammation, body temperature and perceived pain.

The format in 30 tablets of 400mg it is ideal for both occasional and continuous use (on medical indication), guaranteeing effective coverage for several days of treatment. The coated tablets are easy to swallow and well tolerated, even by those with a sensitive stomach, as long as they are taken during or after meals.

INDICATIONS

Why is Momentact 400mg 30 Tablets used? What is it for?

Momentact is indicated in adults and adolescents over 12 years of age. Pain of various origins and nature (headache, toothache, neuralgia, osteo-articular and muscular pain, menstrual pain). Adjuvant in the symptomatic treatment of fever and flu.

ACTIVE INGREDIENTS AND EXCIPIENTS

What is the composition of Momentact 400mg 30 Tablets?

Each film-coated tablet contains; active ingredient: ibuprofen 400 mg. Excipients with known effects: lactose, sodium. For the complete list of excipients see section 6.1.

Pregelatinized starch, sodium carboxymethyl starch, sodium carmellose, povidone, microcrystalline cellulose, precipitated silica, talc, sodium lauryl sulfate, lactose monohydrate, hypromellose, titanium dioxide, macrogol 4000.

DOSAGE

How to take Momentact 400mg 30 Tablets?

Dosage. Adults and adolescents over 12 years: 1 tablet 2-3 times a day. Do not exceed the dose of 3 tablets per day. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see section 4.4). If the use of the medicine is necessary for more than 3 days in adolescents, or in the case of worsening of symptoms, the doctor should be consulted. Do not exceed the recommended doses: elderly patients in particular must stick to the minimum dosages indicated above. Elderly: NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events and are at increased risk of potentially fatal gastrointestinal haemorrhage, ulceration or perforation (see section 4.4). If treatment is considered necessary, the lowest dose for the shortest duration necessary to control symptoms should be used (see section 4.4). Renal insufficiency: In patients with mild or moderate reduction in renal function, the dosage should be kept as low as possible for the shortest duration necessary to control symptoms and renal function should be monitored. Hepatic impairment: In patients with mild or moderate reduction in liver function, the dosage should be kept as low as possible for the shortest duration necessary to control symptoms and liver function should be monitored. Momentact is contraindicated in patients with severe hepatic impairment (see section 4.3). Pediatric population: Momentact is contraindicated in children under 12 years of age (see section 4.3). Method of administration: Momentact can be taken on an empty stomach. In subjects with gastric tolerability problems, it is preferable to take the medicine on a full stomach.

CONTRAINDICATIONS AND SIDE EFFECTS

When should Momentact 400mg 30 Tablets not be used and what side effects can it cause?

Hypersensitivity to the active ingredient, to other antirheumatic drugs (acetylsalicylic acid, etc.) or to any of the excipients listed in paragraph 6.1; do not administer to children under 12 years of age; ibuprofen is contraindicated during the third trimester of pregnancy and during breastfeeding (see section 4.6); active or severe gastroduodenal ulcer or other gastropathies; history of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic hemorrhage/ulcer (two or more distinct episodes of demonstrated ulceration or bleeding); severe liver or kidney failure; severe heart failure (NYHA class IV); severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake).

The side effects observed with ibuprofen are generally common to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs and are reported below using the following convention: 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). The most commonly observed adverse events are gastrointestinal in nature. Clinical studies and epidemiological data suggest that the use of ibuprofen (especially at high doses 2400 mg/day) 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). Gastrointestinal disorders: Peptic ulcers, perforation or gastrointestinal haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4). Gastrointestinal perforation with ibuprofen use has been observed rarely. After administration of ibuprofen the following have been reported: feeling of heaviness in the stomach, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4). Uncommon: gastritis; very rare: pancreatitis. Immune system disorders. The following side effects have been reported following treatment with NSAIDs: non-specific allergic reaction and anaphylaxis; uncommon: hypersensitivity reactions such as skin rash of various types, urticaria, itching, purpura, angioedema, exanthema, reactions affecting the respiratory tract including asthma, even severe, bronchospasm or dyspnea asthmatic attack (sometimes with hypotension); rare: lupus erythematosus syndrome; very rare: serious hypersensitivity reactions. Symptoms may include: facial edema, tongue edema, laryngeal edema, airway edema with constriction, dyspnoea, tachycardia, anaphylaxis, exfoliative and bullous dermatitis (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme). Cardiac and vascular disorders: edema, fatigue, hypertension and heart failure have been reported in association with treatment with NSAIDs. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/day) may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Very rare: palpitations, heart failure, myocardial infarction, acute pulmonary edema, edema, hypertension. These phenomena generally tend to regress upon suspension of treatment. Other adverse events reported less frequently and for which causality has not necessarily been established include. Pathologies of the blood and lymphatic system. Rare: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia and haemolytic anemia. Psychiatric disorders. Uncommon: insomnia, anxiety; rare: depression, confusional state, hallucinations. Nervous system disorders. Common: dizziness; uncommon: paraesthesia, drowsiness; rare: optic neuritis. Infections and infestations. Uncommon: rhinitis; rare: aseptic meningitis. Rhinitis and aseptic meningitis (especially in patients with pre-existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of neck stiffness, headache, nausea, vomiting, fever or disorientation (see section 4.4). exacerbation of infection-related inflammation has been described (e.g. development of necrotizing fasciitis). Thoracic and mediastinal respiratory disorders. Uncommon: bronchospasm, dyspnea, apnea. Eye pathologies. Uncommon: visual disturbances; rare: ocular alteration resulting in visual disturbances, toxic optic neuropathy. Ear and labyrinth disorders. Uncommon: impaired hearing, tinnitus, vertigo. Hepatobiliary disorders. Uncommon: abnormal liver function, hepatitis and jaundice; very rare: liver failure. Pathologies of the skin and subcutaneous tissue. Sometimes allergic skin rashes may occur (erythema, itching, urticaria). Uncommon: photosensitivity reactions; very rare: bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. In exceptional cases, serious skin infections and soft tissue disorders may occur during chickenpox infection (see ""infections and infestations""). Not known: drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (PEAG). Renal and urinary disorders. Uncommon: impaired renal function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure. Systemic pathologies and conditions relating to the administration site. Common: malaise, fatigue; rare: edema. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. 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.

INTERACTIONS

Which medicines or foods can change the effect of Momentact 400mg 30 Tablets?

It is advisable to seek medical advice in case of any concomitant therapy before administering the product. Ibuprofen (like other NSAIDs) should be taken with caution in combination with the substances listed below. Corticosteroids: increased risk of gastrointestinal ulceration or haemorrhage (see section 4.4). Anticoagulants: NSAIDs may increase the effects of anticoagulants, such as warfarin or heparin (see section 4.4). In case of concomitant treatment, monitoring of coagulation status is recommended. Cyclooxygenase-2 (COX-2) inhibitors and other NSAIDs: these substances may increase the risk of adverse reactions affecting the gastrointestinal tract (see section 4.4). It is advisable not to combine ibuprofen with other NSAIDs, including selective COX-2 inhibitors, due to potential additive effects (see section 4.4). Acetylsalicylic acid: Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects. Experimental data suggest that ibuprofen may competitively inhibit low-dose acetylsalicylic acid on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotectiveness of acetylsalicylic acid at low doses cannot be excluded. No relevant clinical effects are considered likely following occasional use of ibuprofen (see section 5.1). Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal haemorrhage (see section 4.4). Diuretics, ACE inhibitors (such as captopril), beta blockers and angiotensin II antagonists: NSAIDs may reduce diuretics and other antihypertensive drugs. Diuretics may also increase the risk of NSAID-associated neurotoxicity. 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 cyclooxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking Momentact concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy and thereafter. Phenytoin and lithium: concomitant administration of ibuprofen and phenytoin or lithium preparations may result in reduced elimination of these medicines with consequent increase in their plasma levels with the possibility of reaching the toxic threshold. If this association is deemed necessary, monitoring of plasma levels of phenytoin and lithium is recommended in order to adapt the appropriate dosage during simultaneous treatment with ibuprofen. Methotrexate: NSAIDs may inhibit the tubular secretion of methotrexate and some metabolic interactions may occur resulting in reduced clearance of methotrexate and resulting in an increased risk of toxicity. Moclobemide: increases ibuprofen. Aminoglycosides: NSAIDs can decrease the excretion of aminoglycosides, increasing toxicity. Cardiac glycosides: NSAIDs can exacerbate heart failure, reduce the glomerular filtration rate and increase levels plasma of cardiac glycosides. Monitoring of serum glycoside levels is recommended. Cholestyramine: Concomitant administration of ibuprofen and cholestyramine may reduce the absorption of ibuprofen from the gastrointestinal tract. However, the clinical relevance of this interaction is unknown. Ciclosporins: the concomitant administration of ciclosporin and some NSAIDs causes an increased risk of renal damage. This effect cannot be excluded for the combination of ciclosporin and ibuprofen. Plant extracts: Ginkgo Biloba may increase the risk of bleeding in association with NSAIDs. Mifepristone: Due to the anti-prostaglandin properties of NSAIDs, their use after mifepristone administration may result in mifepristone reduction. Limited evidence suggests that co-administration of NSAIDs and prostaglandins on the same day does not adversely affect the effects of mifepristone or prostaglandin on cervical ripening or uterine contractility and does not reduce the clinical efficacy of the medicinal product on pregnancy termination. Quinolone antibiotics: Patients taking NSAIDs and quinolones may have an increased risk of developing seizures. Sulfonylureas: NSAIDs may increase hypoglycemic sulfonylureas. In the case of simultaneous treatment, monitoring of blood glucose levels is recommended. Tacrolimus: co-administration of NSAIDs and tacrolimus may lead to an increased risk of nephrotoxicity. Zidovudine: there is evidence of an increased risk of haemarthrosis and hematoma in HIV-positive haemophiliac patients in simultaneous treatment with Zidovudine and other NSAIDs. A haematological examination is recommended 1-2 weeks after starting treatment. Ritonavir: may cause an increase in plasma concentrations of NSAIDs. Probenecid: slows the excretion of ibuprofen, with possible increase in their plasma concentrations. CYP2C9 inhibitors: Concomitant administration of ibuprofen and CYP2C9 inhibitors may slow the elimination of ibuprofen (CYP2C9 substrate) resulting in increased ibuprofen exposure. In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased exposure to S(+)-ibuprofen by approximately 80% to 100% was observed. Reduction of the ibuprofen dose should be considered in cases of co-administration with strong CYP2C9 inhibitors, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole. Alcohol, bisphosphonates and oxypentifylline (pentoxifylline): can potentiate gastrointestinal side effects and the risk of bleeding and ulcers. Baclofen: high toxicity of baclofen.

PREGNANCY AND BREASTFEEDING

Can Momentact 400mg 30 Tablets be used during 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 early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk has been thought to increase with 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. From the twentieth week of pregnancy onwards, the use of Momentact may cause oligohydramnios resulting from fetal renal dysfunction. This may occur shortly after starting treatment and is usually reversible upon discontinuation. Additionally, cases of ductus arteriosus constriction have been reported following treatment in the second trimester, most of which resolved after treatment discontinuation. Therefore, during the first and second trimester of pregnancy, Momentact should not be administered unless strictly necessary. If Momentact is used by a woman trying to conceive or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. Following exposure to Moment Act for several days of gestational week 20 onwards, prenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered. Momentact should be discontinued if oligohydramnios or constriction of the ductus arteriosus is experienced. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: cardiopulmonary toxicity (premature constriction/closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction (see above); at the end of pregnancy, all inhibitors of prostaglandin synthesis can expose the mother and newborn 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, Momentact is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3). Breastfeeding: Ibuprofen is excreted in breast milk, but at therapeutic doses during short-term treatment, the risk of influencing the newborn appears unlikely. If, however, the treatment is longer term, early weaning should be considered. NSAIDs should be avoided during breastfeeding. Fertility: The use of Ibuprofen may compromise female fertility and is not recommended in women attempting to conceive. This effect is reversible upon discontinuation of treatment. In women who have difficulty conceiving or who are under investigation for infertility, discontinuation of ibuprofen treatment should be considered.

WARNINGS

What are the warnings of Momentact 400mg 30 Tablets?

The use of Moment Act, like any drug that inhibits the synthesis of prostaglandins and cyclooxygenase, is not recommended in women who intend to become pregnant. The administration of Moment Act should be suspended in women who have fertility problems or who are undergoing fertility investigations. Side effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks). Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2). Cardiovascular and cerebrovascular effects: caution is required before starting treatment in patients with a positive history of hypertension and/or heart failure since fluid retention, hypertension and edema have been found in association with treatment with NSAIDs. NSAIDs can reduce diuretics and other antihypertensive drugs (see section 4.5). Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/day), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. <= 1200 mg/day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and high doses (2400 mg/day) should be avoided. Careful consideration must also be exercised before starting patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit) on long-term treatment, especially if high doses (2400 mg/day) of ibuprofen are necessary. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration. Similar considerations must be made before starting long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking). Gastrointestinal haemorrhage, ulceration and perforation: the use of Momentact should be avoided concomitantly with NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors due to an increased risk of ulceration or bleeding (see section 4.5). In particular, gastrointestinal bleeding, ulceration and perforation, which may be fatal, have been reported during treatment with all NSAIDs at any time, 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. The concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of acetylsalicylic acid 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 older adults, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Carefully monitor patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Momentact, 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). Severe skin reactions: Severe skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with ibuprofen-containing medicinal products. Ibuprofen should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other sign of hypersensitivity as well as if visual disturbances or persistent signs of liver dysfunction occur. Renal effects: When initiating treatment with ibuprofen, caution should be exercised in patients with considerable dehydration. Ibuprofen may cause water and sodium, potassium retention in patients who have never suffered from kidney disease due to its effects on renal perfusion. This may cause edema or heart failure or hypertension in predisposed patients. Long-term use of ibuprofen, as with other NSAIDs, has led to renal papillary necrosis and other renal pathological changes. In general, the habitual use of analgesics, especially combinations of different analgesic active ingredients, can lead to permanent kidney damage, with the risk of onset of renal failure (analgesic nephropathy). Renal toxicity has been reported in patients in whom renal prostaglandins have a compensatory role in maintaining renal perfusion. The administration of NSAIDs in these patients can lead to a dose-dependent reduction in the formation of prostaglandins and, as a secondary effect, in renal blood flow which can quickly lead to renal decompensation.

CONSERVATION

How is Momentact 400mg 30 Tablets stored?

This medicine does not require any particular storage temperature.

FORMAT

What is the format of Momentact 400mg 30 Tablets?

30 Tablets

DRUG LEGAL TEXT

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