Sandoz Ibuprofen 200mg Pain Reliever 24 Coated Tablets

NAME
IBUPROFENE SANDOZ 200 MG TABLETS COATED WITH FILM

PHARMACOTHERAPEUTIC CATEGORY
Non-steroidal anti-inflammatory and antirheumatic drugs.

ACTIVE PRINCIPLES
One tablet contains: ibuprofen 200 mg.

EXCIPIENTS
Colloidal hydrated silica; talc; sodium carboxymethyl starch; polyvinylpyrrolidone; microcrystalline cellulose; cornstarch; erythrosine lacquer; polyethylene glycol 400; titanium dioxide; hydroxypropylmethylcellulose.

INDICATIONS
Pain of various origins and nature (menstrual pain, headache, bad teeth, neuralgia, osteoarticular and muscle pain).

CONTRAINDICATIONS / SECONDARY EFFECT
Children under 12 years old. Pregnancy and breastfeeding. Hypersensitivity to the active ingredient, to any of the excipients or to other non-steroidal anti-inflammatory drugs (acetylsalicylic acid, etc.). History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Other gastropathies. Severe hepatic or renal insufficiency. Severe heart failure.

DOSAGE
Adults and children over 12 years: 1-2 tablets 2-3 times a day. Do not exceed the dose of 6 tablets per day. Do not exceed the recommended dose; in particular elderly patients should follow the minimum dosages indicated above. Take the product on a full stomach. After 3 days of treatment without noticeable results, consult your doctor.

STORAGE
No special storage precautions.

WARNINGS
In asthmatic patients the product should be used with caution consulting your doctor before taking the product. The use of the drug is not recommended in women who intend to become pregnant. Administration should be discontinued in women who have fertility problems or who are undergoing investigation of fertility. The use of the drug should be avoided in conjunction with selective COX-2 inhibitor NSAIDs. 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. 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 at any time during treatment with all NSAIDs, 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 doses of 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. Caution should be exercised in patients taking 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 aspirin. When gastrointestinal bleeding or ulceration occurs in patients taking the medicinal product, 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. Caution is required (discuss with your doctor or pharmacist) 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 drug should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity '.

INTERACTIONS
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, 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 failure. acute renal, usually reversible. These interactions should be considered in patients taking Cibalgina Due Fast 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. Patients undergoing drug treatment should consult their doctor before taking the product. 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
Sometimes allergic skin rashes (erythema, itching, urticaria) can occur. Gastrointestinal: the most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, may occur, particularly in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported after administration of the drug. Gastritis was observed less frequently. Edema, hypertension and heart failure have been reported in association with iNSAID treatment. Bullous reactions including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (very rarely). These phenomena quickly regress with the suspension of the treatment. 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 (e.g. heart attack). myocardium or stroke).

PREGNANCY AND BREASTFEEDING
Its use is contraindicated during pregnancy and lactation. 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 absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. 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 given prostaglandin synthesis inhibitors during the periodoorganogenetic 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.