Momentact 400mg - pain relief medicament 30 tablets

Product Description

Treatment that combats pain of various origins and nature (headache, toothache, neuralgia, osteo-articular and muscular pain, menstrual pain). This pain treatment should be taken on a full stomach.

Indications

MomentACT 400mg is a medicine useful in adults and adolescents over 12 years of age, to combat pain of various origins and nature (headache, toothache, neuralgia, osteo-articular and muscular pain, menstrual pain) and as an adjuvant in the symptomatic treatment of fever and flu.

Composition

Active ingredients

Ibuprofen 400 mg.

Excipients

Starch pregelatinized, sodium starch glycolate, sodium carmellose, povidone, microcrystalline cellulose, precipitated silica, talc, sodium lauryl sulfate, lactose monohydrate, hypromellose, titanium dioxide, Macrogol 4000.

Directions for use and Dosage

• Adults and adolescents over 12 years: 1 tablet 2-3 times a day;
• Do not exceed the dose of 3 tablets a day;
• If the use of the medicine is necessary for more than one month, consult a doctor. 3 days in adolescents, or in case of worsening of symptoms, a doctor should be consulted;
• Do not exceed the recommended doses: elderly patients in particular should stick to the minimum dosages indicated above;
• Take the product on a full stomach.

Warnings

The use of Momentact, as with any drug that inhibits the synthesis of prostaglandins and cyclooxygenase, is not recommended in women intending to become pregnant. Administration of Momentact should be suspended in women who have fertility problems or who are undergoing investigation of fertility. Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. Caution is advised before initiating treatment in patients with a history of hypertension and/or heart failure, as fluid retention, hypertension, and edema have been reported in association with NSAID therapy. NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.

Clinical studies suggest that use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a small increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low-dose ibuprofen (e.g., <1200 mg/day) is 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 should also be exercised before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g., hypertension, hyperlipidemia, diabetes mellitus, smoking), especially if high doses (2400 mg/day) of ibuprofen are required. 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 consideration should be made before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).

The use of Momentact should be avoided with concomitant 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 can be fatal, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3). These patients should start treatment on the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients taking low-dose aspirin or other drugs likely to increase the risk of gastrointestinal events.

Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the initial stages of treatment. Patients receiving concomitant medications that could 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, should be closely monitored.

If gastrointestinal bleeding or ulceration occurs in patients receiving Momentact, the 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.

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. Patients appear to be at highest risk early in the course of therapy, with the onset of the reaction occurring in the majority of cases within the first month of treatment. Momentact should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity, as well as if visual disturbances or persistent signs of liver dysfunction occur.

When initiating treatment with ibuprofen, caution should be exercised in patients with significant dehydration. Ibuprofen may increase the risk of serious side effects. Ibuprofen may cause fluid, sodium, and potassium retention in patients who have never had renal disorders due to its effects on renal perfusion. This may cause edema or cardiac failure or hypertension in predisposed patients. Long-term use of ibuprofen, as with other NSAIDs, has led to renal papillary necrosis and other pathological renal changes. In general, the habitual use of analgesics, especially combinations of different analgesic active ingredients, can lead to permanent renal damage, with the risk of developing renal failure (analgesic nephropathy). Renal toxicity has been observed in patients in whom renal prostaglandins have a compensatory role in maintaining renal perfusion. The administration of NSAIDs in these patients may lead to a dose-dependent reduction in prostaglandin formation and, as a secondary effect, renal blood flow, which can quickly lead to renal failure. Patients with renal failure may be at increased risk of renal failure. Those at risk of these reactions include those with reduced renal function, heart failure, liver dysfunction, the elderly, and all patients taking diuretics and ACE inhibitors. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state. In dehydrated adolescents, there is a risk of impaired renal function. With prolonged use, monitor renal function, particularly in cases of diffuse lupus erythematosus.

Momentact should be prescribed with caution in patients with bronchial asthma, chronic rhinitis, nasal polyps, sinusitis, or current or previous allergic diseases, as bronchospasm, urticaria, and angioedema may occur. The same applies to those who have experienced bronchospasm after using acetylsalicylic acid or other NSAIDs.

Analgesics, antipyretics, and NSAIDs can cause potentially serious hypersensitivity reactions (anaphylactoid reactions), even in subjects not previously exposed to these types of drugs. The risk of hypersensitivity reactions after taking ibuprofen is greater in subjects who have experienced such reactions after using other analgesics, antipyretics, and NSAIDs, and in subjects with bronchial hyperreactivity (asthma), hay fever, nasal polyps, or chronic obstructive respiratory disease, or previous episodes of angioedema. Hypersensitivity reactions may present as asthma attacks (so-called analgesic asthma), Quincke's edema, or urticaria. Serious hypersensitivity reactions (e.g., anaphylactic shock) have been observed rarely. Treatment should be discontinued at the first signs of a hypersensitivity reaction after administration of ibuprofen. Medically assisted measures must be initiated by specialized medical personnel, in line with the symptoms.

Particular caution should be exercised when treating patients with reduced cardiac, hepatic, or renal function, as the use of NSAIDs may lead to deterioration of renal function. The habitual concomitant use of several painkillers may further increase this risk. In patients with reduced cardiac, hepatic, or renal function, it is advisable to use the lowest effective dose for the shortest duration of treatment and to periodically monitor clinical and laboratory parameters, especially in case of prolonged treatment.

Ibuprofen, like other NSAIDs, can inhibit platelet aggregation and has been shown to prolong bleeding time in healthy subjects. Therefore, patients with coagulation defects or on anticoagulant therapy should be carefully observed.

On rare occasions, symptoms of aseptic meningitis have been observed in patients treated with ibuprofen. Although this is more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has also been observed in patients without concomitant chronic diseases. Since ocular changes have been observed in animal studies with NSAIDs, periodic ophthalmological checks are recommended in case of prolonged treatment. Alcohol consumption should be avoided as it can intensify the side effects of NSAIDs, especially those affecting the gastrointestinal tract or the central nervous system. Ibuprofen may mask the signs or symptoms of infection (fever, pain and swelling).

Momentact contains lactose: patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Contraindications

Hypersensitivity to the active substance, to other antirheumatics or to any of the excipients. Do not administer to children under 12 years of age. Ibuprofen is contraindicated during the third trimester of pregnancy and during breastfeeding. Active or severe gastroduodenal ulcer or other gastropathies. History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic haemorrhage/ulcer. Severe hepatic or renal insufficiency. Severe heart failure (NYHA class IV). Severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).

Pregnancy and breastfeeding

During the first and second trimester of pregnancy, the drug should not be administered unless clearly necessary. If the drug 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 may expose the fetus. Consequently, the drug is contraindicated during the third trimester of pregnancy. Ibuprofen is excreted in breast milk, but at therapeutic doses during short-term treatment, the risk of influence on the newborn appears unlikely. If, however, treatment is longer-term, early weaning should be considered. NSAIDs should be avoided during breastfeeding. The use of ibuprofen may increase the risk of fetal harm. compromise female fertility and is not recommended in women attempting to conceive. This effect is reversible upon discontinuation of treatment. In women who have difficulties conceiving or who are being investigated for infertility, discontinuation of treatment should be considered.

Interactions

Ibuprofen should be used with caution in combination with the substances listed below.

• Corticosteroids;
• Anticoagulants;
• Cyclooxygenase-2 (COX-2) inhibitors;
• Acetylsalicylic acid;
• Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs);
• Phenytoin and lithium;
• Methotrexate;
• Aminoglycosides;
• Cardiac glycosides;
• Cholestyramine;
• Cyclosporins;
• Extracts plants;
• Mifepristone;
• Quinolone antibiotics;
• Tacrolimus;
• Ritonavir;
• Probenecid;
• Alcohol, bisphosphonates and oxypentifylline (pentoxifylline);
• Baclofen.

Storage

Check the expiry date indicated on the package. The expiry date indicated on the package refers to the product in its intact package, stored correctly. This medicine does not require any special temperature storage conditions.

Warning: do not use the medicine after the expiry date indicated on the package.

Format

Pack of 30 coated tablets.