Active substanceIbuprofenIbuprofen
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  • Dosage form: & nbspCapsules
    Composition:Contents of the capsule:
    active ingredient - ibuprofen 200 mg,
    auxiliary components : the contents of the capsule - macrogol 600. purified water, potassium hydroxide solid; the composition of the capsule shell is gelatin, anhydrisorb 85/70 (sorbitol, sorbitan.mannitol, higher polyols); dye patented blue. (B 131).
    Description:Oval soft gelatin capsule of blue color; contents of capsule - clear oily liquid
    Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID).
    ATX: & nbsp

    M.01.A.E.01   Ibuprofen

    Pharmacodynamics:The drug belongs to non-steroidal anti-inflammatory drugs (NSAIDs). Has analgesic, antipyretic and anti-inflammatory effect. Non-selectively blocks COX1 and COX2. The mechanism of action of ibuprofen is due to inhibition of the synthesis of prostaglaidins - mediators of pain, inflammation and hyperthermia.
    Pharmacokinetics:Absorption is high, rapidly absorbed from the digestive tract. The maximum concentration is reached in 40-60 minutes. T1 / 2 (the period of semi-excretion) is 2h, the connection with plasma proteins is 90%. Slowly penetrates into the joint cavity, lingers in the synovial tissue, creating in it greater concentrations than in the plasma. After absorption about 60% of pharmacologically inactive R- form is slowly transformed into an active S-form. Exposed to metabolism. It is excreted by the kidneys (in an unchanged form not more than 1%) and.to a lesser extent, with bile.
    Indications:Headache and toothache, migraine, painful menstruation, neuralgia, pain. in the back, muscular and rheumatic pains: feverish conditions with influenza and colds.
    Contraindications:
    - hypersensitivity to the active substance or ancillary components;
    - complete or incomplete combination of bronchial asthma, recurrent sex and posture of nose or paranasal sinuses and intolerance of acetylsalicylic acid and other NSAIDs (including in history);
    - erosive and ulcerative changes in the gastric mucosa or duodenum, active gastrointestinal bleeding; cerebrovascular or other bleeding;
    - inflammatory bowel disease (Crohn's disease, ulcerative colitis) during the exacerbation phase;
    - hemophilia and other bleeding disorders;
    - Decompensated heart failure;
    - hepatic insufficiency or active liver disease;
    - marked renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease, confirmed gilercalemia:
    - period after aortocoronary shunting;
    - pregnancy (III trimester):
    - children under 12 years.
    Carefully:

    Ischemic heart disease, cerebrovascular diseases, arterial hypertension, chronic heart failure, dyslipidemia / hyperlipidemia, diabetes mellitus, portal hypertension, peripheral arterial disease, smoking, creatinine clearance less than 60 ml / min.

    Anamnestic data on the development of gastrointestinal ulceration, gastritis, enteritis, colitis, hyperbilirubinemia. the presence of Helicobacter pylori infection, old age, prolonged use of NSAIDs. frequent alcohol consumption, nephritic syndrome, severe somatic diseases, blood diseases of unclear etiology (leukopenia, anemia), concomitant therapy with the following drugs:

    - anticoagulants (for example, warfarin)

    - antiaggregants (eg, acetylsalicylic acid, clopidogrel)

    - oral glucocorticosteroids (for example, prednisolone)

    - selective serotonin reuptake inhibitors (eg, cyhalopram, fluoxetine, paroxetine, sertraline).

    - Pregnancy I-II trimester, the period of breastfeeding (should be refused from feeding).

    Pregnancy and lactation:I-II trimester - with caution, III trimester - is contraindicated.
    The period of breastfeeding - you should stop feeding during the treatment.
    Dosing and Administration:
    Children older than 12 years inside the I capsule, adults 1-2 capsules. Capsule should be washed down with water. If necessary, take 1 capsule every 4 hours.
    Do not take more than 6 capsules within 24 hours. The maximum daily dose is 1200 mg. The maximum daily dose for children from 12-17 years is 1000 mg. If the drug persists for 2-3 days, the symptoms persist, it is necessary to stop treatment and consult a doctor.
    Side effects:

    When used within 2-3 days, side effects are rare. In the case of prolonged use, the risk of side effects increases:

    From the digestive system: NSAIDs-gastropathy (nausea, vomiting, abdominal pain, heartburn, decreased appetite, diarrhea, flatulence, pain and discomfort in the epigastric region), ulceration of the gastrointestinal mucosa (in some cases complicated by perforation and bleeding); irritation, dryness of the oral mucosa or pain in the mouth, ulceration of the gingival mucosa, aphthous stomatitis, pancreatitis, constipation, hepatitis.

    From the respiratory system: shortness of breath, bronchospasm.

    From the sense organs: hearing loss, ringing or noise in the ears, reversible toxic optic neuritis, blurred vision or diplopia, dryness and irritation of the eyes, conjunctival edema and eyelids (allergic genesis), scotoma.

    From the nervous system: headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depressions, confusion, hallucinations, rarely - aseptic meningitis (more often in patients with autoimmune diseases).

    From the cardiovascular system: development or aggravation of heart failure, tachycardia, increased blood pressure.

    From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis.

    Allergic reactions: skin rash (usually erythematous urticaria), itchy skin, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm, fever. multiforme exudative erythema (including Stevens-Johnson syndrome). toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis.

    From the hematopoiesis: anemia (including haemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.

    Other: increased sweating.

    Overdose:
    Symptoms: abdominal pain, nausea, vomiting, retardation, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, lowering blood pressure, bradycardia, tachycardia, atrial fibrillation, respiratory arrest.
    Treatment: gastric lavage (only for an hour after ingestion), Activated carbon, alkaline casting, forced diuresis, symptomatic therapy.

    Interaction:

    It is not recommended simultaneous reception with acetylsalicylic acid and other NSAIDs. With simultaneous appointment ibuprofen reduces inflammatory and antiplatelet effect of acetylsalicylic acid (may increase the incidence of acute coronary insufficiency in patients receiving as antiplatelet agents acetylsalicylic acid, low dose, after initiation of ibuprofen). When administered with anticoagulant and thrombolytic drugs (alteplase,streptokinase, urokinase) simultaneously increases the risk of bleeding. Cefamandol, cefapperazone, cefotetan, valproic acid, plikamycin, increase the frequency of hypoprothrombinemia. Cyclosporin and gold preparations increase the effect of ibuprofen on the synthesis of prostaglandin in the kidneys, which is manifested by increased nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of its hepatotoxic effects. Drugs that block tubular secretion, reduce excretion and increase the plasma concentration of ibuprofen. Inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin. phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe intoxication. Inhibitors of microsomal oxidation - reduce the risk of hepatotoxic effects. Reduces the hypotensive activity of vasodilators. natriuretic in furosemide and hydrochlorothiazide. Reduces the effectiveness of uricosuric drugs, enhances the effect of indirect anticoagulants. antiaggregants, fibrinolytics.Increases the side effects of mineralocorticoids. glycocorticoids, estrogens, ethanol. Strengthens the effect of oral gypoglycemic drugs and insulin derivatives of sulfonylurea. Antacids and colestramine. reduce absorption. Increases the concentration in the blood of digoxin, lithium preparations, methotrexate. Caffeine strengthens the analgesic effect. Myelotoxic drugs increase the manifestation of hepatotoxicity of the drug.

    Special instructions:

    During long-term treatment, control of the peripheral blood picture and the functional state of the liver and kidneys is necessary. When symptoms of gastropathy appear, careful monitoring including esophagogastroduodenoscopy, a general blood test (determination of hemoglobin), and analysis of feces for latent blood are shown. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test. Patients should refrain from all activities requiring increased attention, rapid mental and motor reaction. During the period of treatment it is not recommended to take alcohol onPweaving.

    When signs of liver damage (skin itch.yellowing of the skin, nausea, vomiting, abdominal pain, darkening of the urine, increasing the level of "liver" transaminases) should stop taking the drug and consult a doctor. Do not use the drug simultaneously with other NSAIDs. The drug can change the properties of platelets, but does not replace the preventive effect of acetylsalicylic acid in cardiovascular diseases.

    The use of the drug may adversely affect female fertility and is not recommended for women planning pregnancy.

    After 2 weeks of using the drug, it is necessary to monitor the performance of the function liver ("transaminase").

    Effect on the ability to drive transp. cf. and fur:Patients should refrain from all activities requiring increased attention, rapid mental and motor reaction.
    Form release / dosage:Capsules 200 mg.
    Packaging:For 6, 10 or 12 capsules in a blister of PVC / PVDC / Al. By 1. 2 or 3 blisters and in a cardboard pack with instructions for use.
    Storage conditions:Store at temperatures from 15 to 25 ° C out of the reach of children!
    Shelf life:
    2 years.
    Do not use after the date shown on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-006591/09
    Date of registration:18.08.2009
    The owner of the registration certificate:Aktavis Ltd.Aktavis Ltd. Iceland
    Manufacturer: & nbsp
    Representation: & nbspACTAVIS GROUP AO ACTAVIS GROUP AO Iceland
    Information update date: & nbsp26.02.2014
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