Ibufen Forte oral suspension 200mg/5ml 100ml №1

Name Ibufen forte. Release formSuspension for oral administration. Dosage 200 mg / 5 ml 100 ml. Qty per package: 1 pc. ProducerMedana pharma s.a. INNIBuprofen. FTGNpvp. 5 ml suspension contains: active ingredient: ibuprofen 200 mg excipients: macrogol glyceryl hydroxystearate, xanthan gum, glycerol, sodium benzoate, sodium phosphate dodecahydrate (or dihydrate), citric acid monohydrate, sodium saccharinate, liquid maltitol, Cola flavor, purified water . Pharmacotherapeutic groupNon-steroidal anti-inflammatory and antirheumatic drugs. Derivatives of propionic acid. ATC code: M01AE01 Pharmacological properties Ibuprofen is a derivative of propionic acid. It has analgesic, antipyretic and anti-inflammatory effects. The mechanism of action of ibuprofen is primarily due to the suppression of prostaglandin biosynthesis by reducing the activity of cyclooxygenase (COX), an enzyme that regulates the conversion of arachidonic acid into prostaglandins, prostacyclin and thromboxane. At the same time, as a result of irreversible inhibition of the cyclooxygenase pathway of arachidonic acid metabolism, the formation of prostaglandins decreases. A decrease in the concentration of prostaglandins at the site of inflammation is accompanied by a decrease in the formation of bradykinin, endogenous pyrogens, other biologically active substances, oxygen radicals and nitric oxide (II). All this leads to a decrease in the activity of the inflammatory process (anti-inflammatory effect of ibuprofen) and is accompanied by a decrease in pain reception (analgesic effect). A decrease in the concentration of prostaglandins in the cerebrospinal fluid leads to the normalization of body temperature (antipyretic effect). After oral administration, more than 80% of ibuprofen is absorbed from the digestive tract. 90% of the drug binds to plasma proteins (mainly albumin). The period of reaching the maximum concentration in the blood plasma when taken on an empty stomach – 45 minutes, when taken after a meal – 1.5-2.5 hours; in the synovial fluid – 2-3 hours, where higher concentrations are created than in the blood plasma. The drug does not accumulate in the body. Ibuprofen is metabolized mainly in the liver. It undergoes presystemic and postsystemic metabolism. After absorption, about 60% of the pharmacologically inactive form of ibuprofen is slowly transformed into the active form. 60-90% of the drug is excreted by the kidneys in the form of metabolites and products of their combination with glucuronic acid, to a lesser extent, with bile and no more than 1% is excreted unchanged. After taking a single dose, the drug is completely eliminated within 24 hours. Indications for use Ibufen® Forte has an antipyretic, analgesic, anti-inflammatory effect. Reduces the manifestation of symptoms such as fever, pain and swelling, by acting at the site of their occurrence. The drug does not contain sugar, so it can be used in people with diabetes. Ibufen® Forte is intended for use in the following cases: Elevated body temperature of various origins in case of: colds, acute respiratory viral infections, influenza, tonsillitis (pharyngitis), childhood infections, accompanied by fever, post-vaccination reactions. Pain syndrome of various origins of mild to moderate intensity with: ear pain with inflammation of the middle ear toothache, painful teething headache, migraine painful menstruation neuralgia rheumatic pain pain in the muscles, joints injuries of the musculoskeletal system. Contraindications The drug Ibufen® Forte should not be used in case of: individual hypersensitivity to any component of the drug, as well as to other non-steroidal anti-inflammatory drugs; manifestations of ever earlier symptoms of allergy in the form of a runny nose, skin rashes or bronchospastic reactions after the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs; peptic ulcer of the stomach and duodenum in the acute phase; the expressed insufficiency of function of a liver, kidneys; severe heart failure (class IV according to the NYHA classification); blood diseases: hemophilia, hypocoagulation, hemorrhagic diathesis; in the third trimester of pregnancy. Interaction with other drugs Ibuprofen (as well as other drugs of the group of non-steroidal anti-inflammatory drugs) should not be used simultaneously with the following drugs: acetylsalicylic acid; Simultaneous therapy with ibuprofen and acetylsalicylic acid is not recommended due to the possible aggravation of undesirable effects. when used together, it increases the hypoglycemic effect of oral antidiabetic agents (sulfonylurea derivatives) and insulin; enhances the side effects of mineralocorticoids, corticosteroids, estrogens, ethanol; while taking antacids and cholestyramine reduce the absorption of ibuprofen; when used together, ibuprofen increases the blood concentration of digoxin, lithium preparations, methotrexate; ibuprofen increases the plasma concentration of cyclosporine and the likelihood of developing its hepatotoxic effects; when used together, microsomal oxidation inducers (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of developing severe intoxications; inhibitors of microsomal oxidation reduce the risk of developing hepatotoxic effects of ibuprofen; when used together, ibuprofen reduces the hypotensive activity of vasodilators, the natriuretic effect of furosemide and hydrochlorothiazide; when combined, cyclosporine and gold preparations increase the effect of ibuprofen on the synthesis of prostaglandin in the kidneys, which leads to an increase in the nephrotoxic effect; with simultaneous use with anticoagulants and thrombolytic drugs (alteplase, streptokinase, urokinase), the risk of bleeding increases; when used together with ibuprofen, cefamandol, cefoperazine, cefotetan, valproic acid, plicamycin increase the incidence of hypoprothrombinemia; ibuprofen reduces the effectiveness of uricosuric drugs, enhances the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics; drugs that block tubular secretion, with simultaneous use, reduce excretion and increase the plasma concentration of ibuprofen; caffeine enhances the analgesic effect of ibuprofen. Before taking the drug Ibufen® Forte, you should consult with your doctor if you have previously been confirmed: bronchial asthma, urticaria, liver and kidney disease, a history of gastric and duodenal ulcer, arterial hypertension. The drug does not contain dyes and can be used in children prone to allergic reactions to dyes at recommended dosages. Taking the drug for as short a period as possible to relieve symptoms reduces the risk of side effects. Anti-inflammatory/pain medications such as ibuprofen may be associated with a slightly increased risk of heart attack or stroke, especially when taken at high doses. Do not exceed recommended doses and duration of treatment. You should discuss your treatment with your doctor or pharmacist before taking Ibufen® Forte if you: have heart problems, including heart failure, angina pectoris (chest pain), and if you have previously had a heart attack, coronary artery surgery blood vessels, any type of stroke (including a “mini-stroke” or transient ischemic attack “TIA”), or you have peripheral arterial disease (poor circulation in the feet due to narrowing or blockage of the arteries); have high blood pressure, diabetes, high blood cholesterol, heart disease or stroke in family members, or if you smoke. Severe skin reactions, some of them fatal, including scaling dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of drugs from the NSAID group. The highest risk of these severe reactions is observed at the beginning of therapy, in most cases – in the first month of using the drug. It is necessary to stop using the drug after the first symptoms appear: skin rash, changes in the oral mucosa or other symptoms of hypersensitivity. Children and adolescents with dehydration are at risk of kidney failure. When using ibuprofen, isolated cases of toxic amblyopia (weakening of visual acuity) were noted, so all visual impairment should be reported to the doctor. This drug belongs to a group of drugs (non-steroidal anti-inflammatory drugs) that can adversely affect the fertility of women. This is a transient effect, and it passes after the end of therapy. Pregnancy and lactation The use of ibuprofen in the first 6 months of pregnancy requires caution and is permitted only on prescription, after assessing the expected benefits and possible risks. Do not use ibuprofen during the last trimester of pregnancy. Ibuprofen can be excreted in small amounts in breast milk. There are no known cases of side effects in infants, but it is recommended to stop breastfeeding during treatment with ibuprofen. Influence on the ability to drive vehicles and maintain mechanical equipment There is no information on contraindications to driving vehicles and maintaining mechanisms after the drug Ibufen® Forte. Method of administration and doses For oral administration. 5 ml suspension contains 200 mg ibuprofen. Shake before use until a homogeneous suspension is obtained. The drug is taken after a meal with a liquid. The measuring cup attached to the package with a scale allows you to accurately dose the drug. The dose is set depending on age and body weight. A single dose of Ibufen® Forte is 5-10 mg/kg of the child’s body weight 3-4 times a day. The maximum daily dose of the suspension is 20-30 mg/kg of body weight. The drug is prescribed in single doses according to the scheme below: Children from 1 to 2 years old (10-12 kg): a single dose of 2.5 ml (corresponding to 100 mg of ibuprofen). The maximum daily dose is 7.5 ml (300 mg ibuprofen). Children from 3 to 5 years (13-19 kg): 2.5 ml single dose (corresponding to 100 mg of ibuprofen). The maximum daily dose is 10 ml (400 mg ibuprofen). Children 6 to 9 years old (20-29 kg): 5.0 ml single dose (corresponding to 200 mg ibuprofen). The maximum daily dose is 15 ml (600 mg ibuprofen). Children 10 to 12 years old (30-39 kg): 5.0 ml single dose (corresponding to 200 mg ibuprofen). The maximum daily dose is 20 ml (800 mg ibuprofen). Children from 12 years old and adults (over 40 kg): a single dose of 5.0-10.0 ml (corresponding to 200-400 mg of ibuprofen). The maximum daily dose is 30 ml (1200 mg ibuprofen). The minimum interval between successive doses is 4-6 hours. Children under 1 year old can use the drug only after consulting a doctor in accordance with his recommendations. The drug should not be used for more than 3 days without medical supervision. Undesirable effects can be minimized by using the drug for the shortest amount of time necessary at the lowest effective dose to control symptoms. Overdose In case of taking a higher dose of the drug than recommended, you should immediately contact your doctor or pharmacist. Overdose symptoms: abdominal pain, vomiting, lethargy, headache, tinnitus, depression, drowsiness, metabolic acidosis, coma, hemorrhagic diathesis, lowering blood pressure, convulsions, acute renal failure, liver dysfunction, increased or decreased heart rate. High doses of ibuprofen are usually well tolerated provided no other drugs are used concomitantly. Overdose measures: gastric lavage (only within an hour after taking the drug), activated charcoal, alkaline drinking, symptomatic therapy (correction of the acid-base state, blood pressure). Side effects Side effects are classified by frequency of occurrence using the following definitions: Very common: ≥ 1/10 Common: ≥ 1/100 to < 1/10 Uncommon: ≥ 1/1000 to < 1/100 Rare: ≥ 1/10,000 to < 1/1000 very rarely: < 1/10 000 When using Ibufen® Forte for 2-3 days, side effects are practically not observed. In case of prolonged use, the following side effects may occur: From the gastrointestinal tract: Infrequently: nausea, heartburn, diarrhea, abdominal pain. Rare: vomiting, flatulence, constipation, inflammation of the gastrointestinal tract. Very rare: ulceration of the mucous membrane of the gastrointestinal tract, bleeding, impaired liver function. From the nervous system: Infrequently: headache. Rarely: dizziness, agitation, insomnia, drowsiness. In isolated cases, described: hearing loss, tinnitus, depression. From the urinary system: Rarely: edematous syndrome. Very rare: acute renal failure, allergic nephritis, polyuria, cystitis. On the part of the hematopoietic organs: Very rarely: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia. Allergic reactions: Infrequently: skin rash, itching, urticaria. Very rare: Quincke's edema, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm, fever, erythema multiforme exudative, toxic epidermal necrolysis, eosinophilia, allergic rhinitis. Since the cardiovascular system: In the treatment of NSAIDs may appear: heart failure, increased blood pressure, tachycardia. The appearance of all side (unusual) effects, including those not listed in the package insert, must be reported to the attending physician. Shelf life 2 years Opened bottle must be used within 6 months. Do not use after the expiry date stated on the package. Release from pharmacies Without a prescription. Storage conditions Store in the original packaging to protect from light, at temperatures below 25°C. The drug should be kept out of the reach of children. Packing 100 ml in plastic bottles with a screw cap with a guarantee ring and a measuring cup. Each vial, together with the leaflet, is placed in individual cardboard boxes. Buy Ibufen Forte oral suspension 200mg/5ml 100ml No. 1 /5ml 100ml №1