Index of drugs

Pain of mild to moderate intensity such as headache including migraine headache, toothache. Primary painful menstruation. Fever.

1 tabl powl. contains 200 or 400 mg of ibuprofen.

A non-steroidal anti-inflammatory drug, a propionic acid derivative. Anti-inflammatory, analgesic and antipyretic. The mechanism of action is based on inhibition of prostaglandin synthesis. Ibuprofen also has the ability to reversibly inhibit platelet aggregation. It inhibits the synthesis of prostaglandins in the uterus, thereby reducing resting and exercise intrauterine pressure, periodic uterine contraction and the amount of prostaglandins released into the circulation. It is presumed that these changes relieve menstrual pain. 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 is metabolized in the liver (hydroxylation, carboxylation) to inactive metabolites, excreted mainly by the kidneys (90%), and also bile. T_0,5 it is about 2.5 hours.

Hypersensitivity to ibuprofen or any of the excipients. In patients with a history of hypersensitivity reactions (eg asthma, runny nose, urticaria or angioneurotic edema) as a response to the use of Acetylsalicylic acid or other NSAIDs. Gastrointestinal bleeding or history of perforation associated with previous NSAID treatment. Active or recurrent peptic ulceration or gastrointestinal bleeding (two or more severe, confirmed episodes of ulceration or bleeding). Severe liver, kidney or heart failure. Coronary artery disease. Third trimester of pregnancy. Significant dehydration (caused by vomiting, diarrhea or insufficient hydration). Bleeding from cerebral vessels or other active bleeding. Dyshemopoeza of unknown origin. Children under 6 years.

In patients with systemic lupus erythematosus and other autoimmune diseases (increased risk of developing sterile meningitis) and congenital disorders of porphyrin metabolism (eg acute diarrhea porphyria), the drug should only be administered after careful benefit-risk assessment. Exercise caution in cases of: diseases of the gastrointestinal tract, including chronic intestinal inflammation (ulcerative colitis, Crohn's disease, exacerbation of the disease may occur); heart failure and hypertension; impaired renal function, liver; disorders of blood coagulation and hematopoiesis disorders; allergic diseases, hay fever, chronic mucosal edema, COPD or bronchial asthma; directly after extensive surgery; fluid retention and edema associated with NSAIDs. In addition, caution should be exercised in patients with active or past bronchial asthma, chronic rhinitis, sinusitis, palatine tonsils, nasal polyps and allergic diseases (risk of bronchospasm, urticaria or angioneurotic edema), as well as in elderly patients ( increased risk of side effects, treatment should start with the lowest possible doses). 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; Headaches may also occur, which should not be treated with increased doses of medicines. 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. The intake of ibuprofen especially at high doses (2,400 mg / day) over a long period of time may be associated with a small increase in the risk of arterial blockages (e.g., myocardial infarction or stroke). Long-term treatment requires periodic monitoring of liver and kidney function as well as blood counts, especially in high-risk patients. Avoid alcohol while taking the drug.

Do not administer ibuprofen in the first and second trimester of pregnancy unless it is absolutely necessary (increased risk of miscarriage and heart defects). If the drug is to be given to a woman planning to become pregnant or a woman in the first or second trimester of pregnancy, the lowest possible effective dose and the shortest possible duration of the treatment should be used. The preparation is contraindicated in the third trimester of pregnancy (in the fetus there may be: toxic effects on the heart and lungs, including premature closure of the ductus arteriosus and pulmonary hypertension, renal dysfunction, which may lead to renal failure with oligohydramnios, in the mother may inhibit uterine contraction causing delay or prolongation of delivery, in the mother and in the newborn it is possible to prolong the bleeding time and the anti-aggregation effect). Discontinuation of breastfeeding is not necessary during short-term treatment with ibuprofen at doses used to treat pain and fever. Ibuprofen may affect fertility in women by affecting ovulation; this effect is transient and disappears after discontinuation of the preparation.

Very common: stomach and bowel problems (heartburn, indigestion, abdominal pain and nausea, vomiting, bloating, diarrhea, constipation). Common: headache, drowsiness, dizziness, fatigue, anxiety, insomnia and irritability, gastrointestinal ulceration, sometimes with bleeding and perforation, latent bleeding (possibly leading to anemia), tarry stools, vomiting with blood, ulcerative oral mucositis , colitis, exacerbation of inflammatory disease of the colon, complications of diverticular disease (perforation, fistula). Uncommon: visual disturbances, rhinitis, bronchospasm, gastritis, edema (especially in patients with hypertension or renal failure), nephrotic syndrome (may be associated with renal failure), photosensitivity, hypersensitivity reactions (urticaria, pruritus, erythema and rash as well as asthma attacks sometimes with hypotension). Rare: elevation of urea nitrogen, serum transaminases or alkaline phosphatase, decrease in hemoglobin and hematocrit, inhibition of platelet aggregation, prolonged bleeding time, decrease in serum Calcium, increased serum uric acid, amblyopic amblyopia, systemic lupus erythematosus, depression , confusion, hallucinations. Very rare: palpitations, heart failure, myocardial infarction, acute pulmonary edema, edema, hematopoiesis disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis), sterile meningitis, tinnitus, oesophagitis, pancreatitis, stenosis of the intestine, renal wart wart (especially during long-term use), severe forms of skin reactions of various types (ie erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, alopecia, necrotizing fasciitis), hypertension, severe hypersensitivity reactions (swelling of the face, swelling of the tongue, laryngeal edema with airway closure, indigestion, tachycardia, drop in blood pressure, up to life-threatening shock), liver dysfunction, liver damage, especially with long-term use, liver failure,acute hepatitis, jaundice.

Orally.Mild to moderate pain and fever. Adults and adolescents over 12 years (body weight ≥ 40 kg): single dose 200-400 mg or 3-4 times daily every 4-6 h. 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 aged 6-9 years (20-29 kg m.c.): 200 mg, 1- 3 times a day if necessary at intervals of 4-6 hours. The maximum daily dose should not exceed 600 mg. Children aged 10-12 years (30-40 kg m.c.): 200 mg, 1-4 times a day if necessary at intervals of 4-6 hours. The maximum daily dose should not exceed 800 mg.Painful menstruation. Adults and adolescents over 12 years of age: 200-400 mg, 1-3 times daily if necessary at intervals of 4-6 h; the maximum daily dose should not exceed 1200 mg. In elderly patients, patients with mild to moderate renal or hepatic impairment should use the lowest dose for the shortest possible time. Table. swallow whole with water, during or after a meal.