Index of drugs

Pains of various origins of weak to moderate severity: headaches (including migraines), toothaches, muscular, joint and bone pain, post-trauma pains, neuralgia, pain associated with colds and flu. Painful menstruation. Febrile states of various origins (inter alia in the course of influenza, colds or other infectious diseases). Symptomatic treatment of osteoarthritis and rheumatoid arthritis (including juvenile rheumatoid arthritis).

One capsule contains 200 mg of ibuprofen. The drug contains sorbitol (59.8 mg).

A non-steroidal anti-inflammatory drug from the phenylpropionic arylcarboxylic acid group. Anti-inflammatory, analgesic and antipyretic. The mechanism of action consists in inhibiting the activity of cyclooxygenase. Ibuprofen also has the ability to reversibly inhibit platelet aggregation. It is well absorbed from the gastrointestinal tract, C_max is achieved within 1-2 h after administration. It binds to plasma proteins in about 99%. It penetrates into the synovial fluid. It is metabolised in the liver to two major inactive metabolites, which in free form or as conjugates are excreted by the kidneys together with ibuprofen unchanged. Renal excretion is rapid and complete. T_0,5 is about 2 hours.

Hypersensitivity to Ibuprofen, other NSAIDs, or any of the excipients .. the past with hypersensitivity reactions, such as attack of asthma, rhinitis or urticaria induced by salicylates (including aspirin) and other NSAIDs. Perforation or bleeding from the gastrointestinal tract associated with previous NSAID treatment. Active or recurrent peptic ulcer of the stomach and / or duodenum or gastrointestinal bleeding (severe bleeding or more than one episode of ulceration or bleeding). Hemorrhagic diathesis. Bleeding, cerebrovascular or other active bleeding. Dyshemopoeza of unknown origin. Severe hepatic failure. Severe renal failure. Severe heart failure or coronary artery disease. Significant dehydration (caused by vomiting, diarrhea or insufficient hydration). Children <6 years of age. <20 kg. Third trimester of pregnancy.

The drug should be given only after careful evaluation of the benefit-risk for the following: systemic lupus erythematosus, and mixed connective tissue disease (may be at increased risk of developing aseptic meningitis), and inborn errors of metabolism porphyrins (eg. acute intermittent porphyria). Particular care should be taken when using ibuprofen in the following cases: gastrointestinal disease and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease, exacerbation of the disease); hypertension and / or mild to moderate congestive heart failure; fluid retention and edema associated with NSAIDs; impaired renal function (there is a risk of further deterioration of renal function); liver dysfunction; disturbed hematopoiesis; blood coagulation disorders; immediately after a major surgery. In addition, caution should be exercised in patients with active, or a history of bronchial asthma, chronic rhinitis, sinusitis, tonsillitis, nasal polyps and allergic diseases (risk of bronchospasm, urticaria or angioedema), as well as patients in the elderly ( increased risk of side effects). In case of bleeding or ulceration of the gastrointestinal tract and the first symptoms of skin rash, mucosal damage or other symptoms of hypersensitivity, ibuprofen should be discontinued. Caution should be used in patients taking other medicines at the same time, which may increase the risk of stomach and bowel disorders or bleeding.Caution should be exercised in patients with uncontrolled hypertension, congestive heart failure, ischemic heart disease, peripheral artery disease or cerebrovascular disease, and prior to the initiation of long-term treatment of patients with risk factors for cardiovascular disease (eg hypertension, hyperlipidemia, diabetes, smoking) . Long-term intake of ibuprofen, especially in combination with other analgesics, may cause permanent kidney damage and risk of renal failure, particularly in patients at greatest risk - patients with renal impairment, heart failure, liver problems, diuretics and ACE inhibitors, and patients Elderly. Ibuprofen may mask the signs or symptoms of infection. Ibuprofen may temporarily inhibit platelet aggregation and prolong bleeding time - patients with blood coagulation disorders or those taking anticoagulants should be observed. Due to the sorbitol content, the drug should not be used in patients with rare hereditary fructose intolerance.

Ibuprofen should not be used during the first and second trimester of pregnancy, unless it is absolutely necessary (risk of miscarriage and the occurrence of congenital heart defects and gastroschisis due to prostaglandin synthesis inhibitor in early pregnancy, total risk of cardiovascular malformations increases from less than 1% up to about 1.5%, the risk increases with the dose and duration of treatment). If ibuprofen is to be used in women planning pregnancy or in the first or second trimester of pregnancy, the lowest possible dose should be used for the shortest possible time. In the third trimester, the use of ibuprofen is contraindicated. Ibuprofen used in the third trimester of pregnancy may cause pulmonary hypertension, premature closure of the ductus arteriosus and renal dysfunction, which may be converted into renal failure with oligohydramnios; in the mother - suppress the uterine contractile function; in the mother and in the fetus an anti-aggregation effect may be manifested by the prolongation of coagulation time. Ibuprofen and its metabolites can penetrate into human milk in very small amounts (0.0008% of the applied dose). In the case of short-term intake of ibuprofen in doses used to treat pain and fever, adverse effects on the infant are unlikely. If longer treatment is recommended, discontinuation of breast-feeding should be considered. The use of ibuprofen may reduce fertility in women and it is not recommended for women who are planning pregnancy. For women who have difficulty conceiving or who are being tested for infertility, discontinuation should be considered.

The list of the following side effects includes all the side effects seen during treatment with ibuprofen, including those after long-term high-dose therapy, used in patients with rheumatic disease. Common: heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, minor gastrointestinal bleeding (which may lead to anemia in exceptional cases). Uncommon: headache, drowsiness, dizziness, insomnia, agitation, irritability or fatigue; visual disturbances, gastrointestinal ulceration (potentially with bleeding and perforation), ulceration of the oral mucosa, exacerbation of ulcerative colitis and Crohn's disease, gastritis, hypersensitivity reactions with skin rash and pruritus, as well as dyspnoea (possible occurrence in combined with hypotension). Rare: tinnitus, damage to kidney tissue (wart necrosis) and increase in uric acid in the blood. Very rare: palpitations, heart failure, myocardial infarction, hematological disorders - anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis (first symptoms are fever, sore throat, superficial ulceration of the oral mucosa, flu-like symptoms, fatigue, bleeding, e.g. bruises, ecchymosis, purpura, nosebleeds); oesophagitis, pancreatitis, formation of diaphragmatic stenosis, edema (especially in patients with hypertension or renal failure), nephrotic syndrome, interstitial nephritis (which is accompanied by acute renal failure), Stevens-Johnson syndrome,toxic necrotic decay of the epidermis, hypertension, severe, generalized hypersensitivity reactions (swelling of the face, tongue, laryngeal internal swelling with impaired airway obstruction, respiratory failure, tachycardia, hypotension, to life-threatening shock), liver dysfunction, liver damage (especially with long-term use), hepatic failure, acute hepatitis, psychotic reactions, depression, infections associated with conditions causing the use of NSAIDs (eg, necrotizing fasciitis). Symptoms of aseptic meningitis have also been observed. In exceptional cases, severe infections of the skin and complications of soft tissues may occur during infection with chickenpox. N edtions, hypertension, and heart failure have been reported with 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 thrombosis (eg myocardial infarction or stroke).

Orally.Mild to moderate pain and fever. Adults and adolescents> 12 years (≥40 kg): initial dose 200-400 mg, then 200-400 mg every 4 mg (for a 200 mg dose) to 6 hours (for a 400 mg dose); the maximum daily dose should not exceed 1200 mg. Migraine headaches: 400 mg as a single dose, then if necessary 400 mg administered in intervals of 4-6 h; the maximum daily dose should not exceed 1200 mg.Children 10-12 years old (body weight 30-39 kg): initial dose 200 mg, then 200 mg every 6 hours if necessary; the maximum daily dose is 800 mg.Children 6-9 years old (20-9 kg): the daily dose is usually 20 mg / kg. in divided doses, an initial dose of 200 mg, then, if necessary, 200 mg every 8 hours; the maximum daily dose is 600 mg.Painful menstruation. Adults and adolescents> 12 years: 200-400 mg, 1-3 times a day if necessary at intervals of 4-6 h; the maximum daily dose should not exceed 1200 mg.Symptomatic treatment of osteoarthritis and rheumatoid arthritis (including juvenile rheumatoid arthritis). Adults and adolescents> 12 years: the usual dose is 400-600 mg 3 times a day, maintenance dose 600-1200 mg; during the exacerbation of the disease, the dose may be increased to a maximum dose of 2400 mg per day in 3-4 divided doses, after a clinical improvement the dose should be reduced.Children 6-12 years oldThe recommended dose is 20-40 mg / kg. daily, in 3-4 divided doses, after the improvement, the dose should be reduced.Special groups of patients. In the elderly, use the lowest effective dose and for the shortest possible time, observe the patient for gastrointestinal bleeding. In patients with mild to moderate renal impairment, use the lowest effective dose and for the shortest possible time and monitor renal function. In patients with mild to moderate hepatic impairment, use the lowest effective dose and for the shortest possible time and monitor liver function.Way of giving. The drug is used during or after a meal.