Momentact 400mg Ibuprofen Analgesic 12 Coated Tablets

"MOMENTACT Tablets" is used in cases of pain of various kinds such as headaches, toothaches and osteoarticular pains.
Composition
Active ingredient: ibuprofen 400 mg
Excipients: Pregelatinised starch, sodium carboxymethyl starch, sodium carmellose, povidone, microcrystalline cellulose, precipitated silica, talc, sodium lauryl sulfate, lactose monohydrate, hypromellose, titanium dioxide, Macrogol 4000

Indications
Pain of various origins and nature (headache, toothache, neuralgia, osteo-joint and muscle pain, menstrual pain); adjuvant in the symptomatic treatment of fever and flu.

Contraindications
Do not administer under the age of 12; pregnancy and breastfeeding; hypersensitivity to the active substance, to other antirheumatics (acetylsalicylic acid, etc.) or to any of the excipients; active or severe gastroduodenal ulcer or other gastropathies; history of gastrointestinal haemorrhage or perforation related to previous active treatments or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding); severe hepatic or renal insufficiency; severe heart failure.

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

Warnings
In asthmatic patients the product should be used with caution. The use of the product is not recommended for women intending to become pregnant. The administration of the drug should be suspended in women who have fertility problems 'or who are undergoing investigation of fertility'. The use of the drug should be avoided concomitantly with NSAIDs, including selective COX-2 inhibitors. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. Cardiovascular and cerebrovascular effects: 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 increased risk of arterial thrombotic events. In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. <= 1200 mg / day) are associated with an increased risk of myocardial infarction. In dehydrated adolescents there is a risk of impaired renal function. Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs. 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 and also for patients taking low dose aspirin or other drugs that may increase the risk of gastrointestinal events. Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Carefully monitor patients who are 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 aspirin. When gastrointestinal bleeding or ulceration occurs in patients taking the medicinal product, discontinue treatment. 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. Caution is required before starting treatment in patients with a history of hypertension and / or heart failure as fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs. 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. 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. The product should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity '. The drug contains lactose.

Interactions
Any interactions with coumarin-type anticoagulants should be kept in mind: patients undergoing treatment with such drugs must consult their doctor before taking the product. It is also advisable to seek medical advice in case of any concomitant therapy before administering the product. Corticosteroids: increased risk of gastrointestinal ulceration or bleeding. Anticoagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. Diuretics, ACE inhibitors and Angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, usually reversible. These interactions should be considered in patients taking the drug 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. Experimental data indicate that ibuprofen can inhibit the effects of low dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. However, the limited data and the uncertainties relating to their application to the clinical situation do not allow definitive conclusions to be drawn for the continued use of ibuprofen; there appears to be no clinically relevant effect from the occasional use of ibuprofen.

Side effects
Skin Effects: Sometimes allergic skin rashes (erythema, itching, urticaria) may occur. Bullous reactions including: Stevens-Johnson syndrome and toxic epidermal necrolysis (very rarely). Gastrointestinal Effects: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, may occur, particularly in the elderly. After administration of the drug the following have been reported: feeling of stomach weight, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease. Gastritis has been observed less frequently. Cardiovascular Effects: Edema, hypertension and heart failure have been reported in association with NSAID treatment. Clinical studies and epidemiological data suggest that the use of ibuprofen (especially at high doses of 2400 mg / day) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (eg. myocardium or stroke). These phenomena quickly regress with the suspension of the treatment.

Pregnancy
Inhibition of prostaglandin synthesis can negatively affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The risk was believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in 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 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 occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor.