Index of drugs

Pains of various origins of weak to moderate intensity: toothache, conditions after dental procedures; headaches; febrile states of various origins (including influenza, colds or other infectious diseases); primary dysmenorrhea.

1 tabl powl. contains 400 mg of Ibuprofen in the form of a salt with arginine. The drug contains sucrose and sodium (82.7 mg / 1 tablet).

A drug from the group of non-steroidal anti-inflammatory drugs. It has anti-inflammatory, analgesic and antipyretic effects by inhibiting prostaglandin cyclooxygenase. The maximum plasma concentration of ibuprofen (approximately 40 μg / ml) occurred approximately 35 minutes after administration of the drug. Co-administration with food did not affect the extent of absorption, but delayed absorption by about 1 hour, resulting in a reduction in C_max (about 50%). Ibuprofen binds to plasma proteins in approximately 99%. Slowly diffuses into the synovial space and is excreted slower from these spaces than from blood plasma. It is metabolised in the liver mainly by hydroxylation and carboxylation of the isobutyl group. It is not known if the metabolites are pharmacologically active. T_0,5 drug in the plasma is 1-2 hours. Over 90% of the dose can be found in the urine in the form of metabolites and conjugated compounds. Less than 1% is excreted in urine in unchanged form.

Hypersensitivity to ibuprofen or any of the excipients of the drug. Hypersensitivity to Acetylsalicylic acid or other NSAIDs (eg bronchial spasticity, asthma, rhinitis or urticaria). Previous episodes of gastrointestinal bleeding, perforation of the gastrointestinal tract, associated with NSAIDs. Active or in history of peptic ulcer and / or duodenal ulcer, perforation or bleeding (two or more separate episodes). Other active bleeding, such as central nervous system bleeding and bleeding in ulcerative colitis. Severe renal failure, severe liver failure, severe heart failure. Hemorrhagic diathesis. Third trimester of pregnancy. Do not use ibuprofen together with acetylsalicylic acid and other NSAIDs, including COX-2 inhibitors.

Caution should be exercised in elderly patients with peptic ulcer and / or duodenal ulcer (especially if complications such as haemorrhage or perforation), due to the increased risk of gastrointestinal side effects. In these patients and patients receiving concomitant low-dose acetylsalicylic acid or other medications that may increase the risk of gastrointestinal disorders, consideration should be given to treatment with barrier medicines (e.g., proton pump inhibitors or misoprostol). In addition, caution should be exercised in patients taking concomitant medications that may increase the risk of gastrointestinal ulceration or bleeding (oral corticosteroids, anticoagulants - Warfarin, selective serotonin reuptake inhibitors or antiplatelet agents, e.g. acetylsalicylic acid). The drug should be discontinued if bleeding or ulceration of the gastrointestinal tract occurs and if the first symptoms of skin rash, mucosal damage or other signs of hypersensitivity occur. Caution should be exercised in patients with gastrointestinal disorders, particularly ulcerative colitis or Crohn's disease (risk of worsening disease symptoms); with hypertension or mild to moderate congestive heart failure (risk of fluid retention and edema); with coagulation disorders; with impaired renal and / or liver function; with diagnosed bronchial asthma, other bronchial spastic states or a prevalence of allergic reactions (increased risk of bronchospasm); with systemic lupus erythematosus and mixed connective tissue disease. Ibuprofen may mask the symptoms of infection. The drug is not indicated for use in children under 12 years (a dose greater than the recommended dose in this age group).The drug contains sucrose - do not use in patients with rare hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency. In addition, the drug contains sodium (82.7 mg / 1 tablet), which should be taken into account in patients with reduced salt intake in the diet.

The drug should not be used in the first and second trimester of pregnancy, unless in the doctor's opinion the benefit for the mother outweighs the potential threat to the fetus. Data from epidemiological studies indicate an increased risk of fetal abortion or malformation after the use of a prostaglandin synthesis inhibitor in early pregnancy. This risk is greater after long-term use of high-dose drugs. Animal studies have shown toxic effects of ibuprofen on reproduction and fetal development. In women planning pregnancy, or in the first or second trimester of pregnancy, if in the doctor's opinion it is necessary, the lowest dose of the drug should be used and used for the shortest possible period. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to toxic effects on the heart and lungs (premature closure of the Botalla cord, pulmonary hypertension) and on renal dysfunction; and expose mother and fetus to prolonged bleeding time, suppressed uterine contractions, and prolonged labor. Therefore, the use of ibuprofen in the third trimester of pregnancy is contraindicated. Ibuprofen and its decomposition products pass into very low concentrations in breast milk. In general, it is not necessary to discontinue breast-feeding during short-term treatment at the recommended dose in the treatment of pain and fever. The use of ibuprofen may lead to impaired fertility in women, so it is not recommended in women planning pregnancy.

Very common: indigestion, diarrhea. Common: abdominal pain, nausea, headache, dizziness, skin changes and rash. Uncommon: gastric and / or duodenal ulceration, gastrointestinal bleeding, allergic reactions, asthma, exacerbation of asthma, bronchospasm, shortness of breath. Rare: constipation, impaired hearing, thrombocytopenia, agranulocytosis, aplastic anemia, hematuria, liver dysfunction, anaphylactic reactions, angioneurotic edema. Very rare: bullous dermatoses, such as erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic vasculitis, interstitial nephritis, renal papillary necrosis, renal failure. Not known: anorexia, edema, heart failure, hypertension, pruritus, urticaria, purpura. Patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are at increased risk of developing aseptic meningitis when using NSAIDs. Clinical trials and epidemiological data suggest that intake of Ibuprofen, especially long-term at high doses (2,400 mg / day) may be associated with a small increase in the risk of arterial blockages (eg, myocardial infarction or stroke).

Orally. Adults and children> 12 years: 1 tabl., If necessary 1 tabl. every 6 hours; the maximum dose is 3 tablets (1200 mg) daily. If it is necessary to use the drug for more than 3 days or if the patient's condition worsens, he or she should contact a doctor. In patients with gastrointestinal disorders, it is recommended to take the medicine with food. In patients with impaired renal, hepatic or circulatory function, doses should be individualized.