Short-term symptomatic treatment of mild to moderate pain and fever. A suspension of 20 mg / ml is used in children weighing 5-29 kg (6 months-9 years). The 40 mg / ml suspension is used in children with a body weight of 10 kg (1 year old), in adolescents and adults. Table. powl. is used in adults, adolescents and children weighing 20 kg (from 6 years of age).
Composition:
1 tabl powl. contains 400 mg of ibuprofen. 1 ml of MIG for children contains 20 mg ibuprofen; the product contains liquid maltitol and sodium (3.7 mg / ml). 1 ml Mig suspension for children forte strawberry flavor contains 40 mg ibuprofen; the product contains liquid maltitol and sodium (5.32 mg / ml).
Action:
A non-steroidal anti-inflammatory drug that inhibits prostaglandin synthesis. It has antipyretic effects, reduces pain and edema associated with inflammation, inhibits platelet aggregation induced by ADP and collagen. After oral administration Ibuprofen is partially absorbed in the stomach, the remaining part in the small intestine. Maximum plasma concentration is reached after 1-2 h. Plasma protein binding is approximately 99%. After metabolism in the liver (hydroxylation, carboxylation), inactive metabolites are completely excreted, mainly by the kidneys (90%), partly by the bile. T0,5 in healthy people and in patients with kidney and liver diseases is 1.8-3.5 hours.
Contraindications:
Hypersensitivity to the active substance or other ingredients of the preparations. Bronchospasm, asthma, rhinitis, angioneurotic edema or urticaria after taking Acetylsalicylic acid or other NSAIDs. hemopoetic disorder with unexplained etiology. Active or recurrent gastric and / or duodenal ulcers or gastrointestinal haemorrhages (two or more separate episodes of confirmed ulceration or bleeding). Gastrointestinal bleeding or perforation following NSAID use. Bleeding from cerebral vessels or other active bleeding. Severe renal or hepatic failure. Severe heart failure. Severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake). Third trimester of pregnancy. The tablets should not be used in children weighing less than 20 kg (6 years) due to too high content of active substance for this age group. Mig migrated for children should not be used in children with ischemic heart disease.
Precautions:
It should be used after careful consideration of the benefit / risk balance in systemic lupus erythematosus, in mixed connective tissue disease, and in patients with congenital porphyrin metabolism disorder (eg acute diarrhea porphyria). Particularly caution should be used in patients who have: gastrointestinal symptoms or if the patient has a history of chronic intestinal inflammatory disorders (ulcerative colitis, Crohn's disease), renal or liver dysfunction, hypertension or heart failure, dehydration , right after major surgery; in patients who have hay fever, nasal polyps or chronic obstructive pulmonary disease, because these patients have a higher risk of allergic reactions, including asthma attacks (called analgesia), Quincke's edema or urticaria; in patients who have had allergic reactions to other substances due to the increased risk of hypersensitivity reactions; in the elderly. In such patients, treatment should be started with the lowest effective doses and co-administration with drugs that have a protective effect on the gastric mucosa (eg misoprostol or proton pump inhibitors) should be considered. Caution should be exercised in patients receiving concomitant medications that may increase the risk of stomach ulcers and / or duodenal ulcers or bleeding such as oral corticosteroids, anticoagulants (warfarin), selective serotonin reuptake inhibitors or antiplatelet drugs (acetylsalicylic acid). The concomitant use of the preparation with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.Caution should be exercised in patients already taking other analgesics or antipyretics or antibiotics. In the event of the first signs of skin rash, changes in mucous membranes or other symptoms of hypersensitivity, in case of bleeding from the gastrointestinal tract or gastric ulcer and / or duodenal ulcer should be immediately discontinued. Ibuprofen may temporarily inhibit platelet function, therefore patients with bleeding disorders should be closely monitored during treatment. If a headache gets worse after prolonged use of a painkiller, the patient should consult a doctor and discontinue the treatment. The habitual use of analgesics (especially several at the same time) can lead to permanent kidney damage and may involve the risk of renal failure (analgesic nephropathy). Avoid administration of the product in the case of chickenpox (risk of deterioration of infection). NSAIDs may mask the symptoms of infection and fever. Due to the content of maltitol, the suspension should not be used in patients with fructose intolerance. The suspension contains sodium - this should be taken into account in patients who control the sodium content of the diet.
Pregnancy and lactation:
In the I and II trimester of pregnancy, the preparation should not be administered if it is not absolutely necessary. In the third trimester, the use of ibuprofen is contraindicated due to the inhibition of uterine contractions, prolonged bleeding time, antiaggregation (even at low doses) in women and fetus and premature closure of the ductus arteriosus, pulmonary hypertension and renal dysfunction in the fetus. Ibuprofen and its metabolites are excreted in breast milk in small amounts. No reports of harmful effects of the preparation on infants, discontinuation of breastfeeding is not necessarily short-term treatment with ibuprofen. Ibuprofen may reduce fertility in women by affecting ovulation. This effect is transient and disappears after treatment.
Side effects:
Common: heartburn, abdominal pain, nausea, vomiting, bloating, diarrhea, constipation and minor gastrointestinal bleeding, which in individual cases may lead to anemia. Uncommon: pain and dizziness, insomnia, excessive agitation, irritability or fatigue, visual disturbances, gastric and / or duodenal ulcer, sometimes with bleeding and perforation, ulcerative oral mucositis, exacerbation of colitis and Crohn's disease, gastritis, hypersensitivity reactions with skin rashes and pruritus, asthma attacks (with possible accompanying sudden decrease in blood pressure), skin rashes. Rare: tinnitus, damaged kidney tissue (renal wart), and increased levels of uric acid in the blood. Very rare: palpitations, heart failure, myocardial infarction (anemia, leukopenia, thrombocytopenia, aplastic anemia, agranulocytosis), esophagitis, pancreatitis, formation of membranes in the gut, reduction of urine output, formation of edema, especially in patients with hypertension or kidney failure, nephrotic syndrome, transient nephritis, which may be accompanied by acute renal failure, follicular alveolar changes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, alopecia, exacerbation of inflammation caused by infection (eg, development of necrotizing fasciitis ) in a temporal relation with systemic use of NSAIDs, signs of aseptic meningitis with stiff neck, headache, nausea, vomiting, fever and consciousness disorders, hypertension, severe general hypersensitivity reactions ( swelling of the face, swelling of the tongue, laryngeal edema with narrowing of the airways, respiratory distress syndrome, rapid heartbeat, sudden decrease in blood pressure up to life-threatening shock), liver dysfunction, liver damage, especially during long-term treatment, liver failure, acute inflammation liver, psychotic reactions, depression, asthma, bronchospasm, shortness of breath, wheezing. In isolated cases, during infection with the virusvaricella severe skin infections and complications of connective tissue may occur.
Dosage:
Orally.tablets: adults and adolescents over 12 years (body weight ≥ 40 kg): a single dose is 200-400 mg, the maximum daily dose is 1200 mg; children 10-12 years (mc.30-39 kg): single dose is 200 mg, maximum daily dose 800 mg; children 6-9 years (20-29 kg): a single dose is 200 mg, the maximum daily dose is 600 mg.Mig suspension for children (20 mg / ml): children 7-9 years (body weight: 21-29 kg): a single dose is 200 mg, the maximum daily dose is 600 mg; children 4-6 years (16-20 kg): single dose is 150 mg, maximum daily dose 450 mg; children 1-3 years (10-15 kg): a single dose is 100 mg, the maximum daily dose is 300 mg; children 9-12 months (7-9 kg): a single dose is 50 mg, the maximum daily dose is 200 mg; children 6-8 months (5-6 kg): a single dose is 50 mg, the maximum daily dose is 150 mg.Mig suspension for children forte (40 mg / ml): adults and adolescents from 12 years (body weight ≥ 40 kg): a single dose is 200-400 mg, the maximum daily dose is 1200 mg; children 10-11 years (30-39 kg): a single dose is 200 mg, the maximum daily dose is 800 mg; children 6-9 years (20-29 kg): a single dose is 200 mg, the maximum daily dose is 600 mg; children 4-5 years (16-19 kg): single dose is 150 mg, maximum daily dose 450 mg; children 1-3 years (10-15 kg): a single dose is 100 mg, the maximum daily dose is 300 mg. In children and adolescents, the single dose should be 7-10 mg / kg and the maximum daily dose 30 mg / kg. The interval between successive doses should depend on the symptoms and the maximum daily dose used; however, it should not be less than 6 hours. If children need to be given more than 3 days or if the symptoms worsen, a doctor should be consulted. If it is necessary for adolescents or adults to be given more than 3 days for fever or for more than 4 days for the treatment of pain or if the symptoms worsen, a doctor should be consulted. Patients with a sensitive digestive tract are recommended to take the preparation during meals. The tablets should be swallowed whole with plenty of liquid, during or after a meal.