Composition, form of production and packaging
? The tablets covered with a cover from light pink to pink color, round, biconcave; On the cross-section, two layers are visible: a white core and a shell from light pink to pink.
ibuprofen 200 mg
Auxiliary substances: potato starch 38 mg, magnesium stearate 2 mg, silicon dioxide colloid (aerosil) 3.35 mg, vanillin 1.5 Ојg, beeswax 20 Ојg, gelatin food 320 Ојg, dye azorubin 8.5 Ојg, magnesium hydroxycarbonate 39.57 mg, wheat flour 17.37 mg , povidone low molecular weight 1.5 mg, sucrose 144.96 mg, titanium dioxide 2.9 mg.
10 pieces. - Cellular outline packaging.
10 pieces. - packings cellular planimetric (2) - packs cardboard.
10 pieces. - packings cellular planimetric (5) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
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 prostaglandins - mediators of pain, inflammation and hyperthermia.
Absorption is high, quickly and almost completely absorbed from the digestive tract. C max ibuprofen in plasma is achieved 1-2 hours after taking the drug. The connection with plasma proteins is more than 90%, T 1/2 - 2 hours. Slowly penetrates into the joint cavity, is retained in synovial tissue, creating in it greater concentrations than in plasma. After absorption, about 60% of the 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.
- inflammatory diseases of the joints and spine (including rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, gouty arthritis);
- moderate pain syndrome of various etiologies (including headache, migraine, toothache, neuralgia, myalgia, postoperative pain, post traumatic pain, primary algodismenorea);
- febrile syndrome with "colds" and infectious diseases;
- is intended for symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.
Ibuprofen is prescribed for adults and children over 12 years inside, in tablets of 200 mg 3-4 times per day. To achieve a rapid therapeutic effect, the dose can be increased to 400 mg (2 tablets) 3 times per day. When the therapeutic effect is achieved, the daily dose of the drug is reduced to 600-800 mg. Take the morning dose before meals, drinking with a sufficient amount of water (for a faster absorption of the drug). The remaining doses are taken throughout the day after meals.
The maximum daily dose is 1200 mg (do not take more than 6 tablets in 24 hours). Repeated dose should not be taken more than 4 hours. The duration of the drug use without consulting a doctor is no more than 5 days.
Do not use in children younger than 12 years old without consulting a doctor.
Children from 6 to 12 years: 1 tablet no more than 4 times a day; the drug can be used only in the case of a child's body weight of more than 20 kg. The interval between taking the tablets is not less than 6 hours (the daily dose is not more than 30 mg / kg).
Gastrointestinal tract (GIT): NSAIDs-gastropathy (abdominal pain, nausea, vomiting, heartburn, decreased appetite, diarrhea, flatulence, constipation, rarely - ulceration of the gastrointestinal mucosa, which in some cases is complicated by perforation and bleeding); irritation or dryness of the oral mucosa, pain in the mouth, ulceration of the gingival mucosa, aphthous stomatitis, pancreatitis.
Hepatobiliary system: hepatitis.
Respiratory system: shortness of breath, bronchospasm.
Organs of the senses: hearing impairment: hearing loss, ringing or tingling in the ears; visual impairment: toxic damage to the optic nerve, blurred vision or double vision, scotoma, dryness and irritation of the eyes, edema of the conjunctiva and eyelids (allergic genesis).
Central and peripheral nervous system: headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations, rarely - aseptic meningitis (more often in patients with autoimmune diseases).
Cardiovascular system: heart failure, tachycardia, increased blood pressure.
Urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis.
Allergic reactions: skin rash (usually erythematous or urticaria), skin itch, Quincke's edema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnea, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome) , eosinophilia, allergic rhinitis.
Organs of hematopoiesis: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, and leukopenia.
Other: increased sweating.
The risk of ulceration of the mucous membrane of the gastrointestinal tract, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (color vision, scotoma, amblyopia) increases with prolonged use in large doses.
bleeding time (may increase);
- the concentration of glucose in the serum (may decrease);
- clearance of creatinine (may decrease);
- hematocrit or hemoglobin (may decrease);
- serum creatinine concentration (may increase);
- Activity of "liver" transaminases (may increase).
If side effects occur, stop taking the medication and consult a doctor.
- hypersensitivity to any of the ingredients that make up the drug. Hypersensitivity to acetylsalicylic acid or other NSAIDs, incl. anamnestic data on an attack of bronchial obstruction, rhinitis, hives after taking acetylsalicylic acid or other NSAIDs; complete or incomplete syndrome of acetylsalicylic acid intolerance (rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma);
- erosive and ulcerative diseases of the organs of the gastrointestinal tract in the stage of exacerbation (including peptic ulcer of the stomach and duodenum, Crohn's disease, ulcerative colitis);
- Inflammatory bowel disease;
- hemophilia and other disorders of blood clotting (including hypocoagulation), hemorrhagic diathesis;
- period after aortocoronary shunting;
- gastrointestinal bleeding and intracranial hemorrhage;
- severe hepatic impairment or active liver disease;
progressive kidney disease;
- marked renal failure with creatinine clearance less than 30 ml / min, confirmed hyperkalemia;
- Children under 6 years.
Carefully. Elderly, heart failure, arterial hypertension, coronary heart disease, cerebrovascular disease, dyslipidemia, diabetes mellitus, peripheral arterial disease, smoking, frequent alcohol use, liver cirrhosis with portal hypertension, hepatic and / or renal failure with creatinine clearance less than 60 mL / min, nephrotic syndrome, hyperbilirubinemia, gastric ulcer and duodenal ulcer (in the anamnesis), presence of H. pylori infection, gastritis, enteritis, colitis, blood diseases are unclear (lakopenia and anemia), lactation, long-term use of NSAIDs, severe somatic diseases, simultaneous administration of oral GCS (including Prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline).
PREGNANCY AND LACTATION
Contraindicated in pregnancy. Apply with caution in the lactation period.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated with progressive kidney disease, severe renal failure with creatinine clearance less than 30 ml / min.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in severe hepatic insufficiency or active liver disease.
APPLICATION FOR CHILDREN
Contraindicated in children under 6 years. Do not use in children younger than 12 years old without consulting a doctor.
APPLICATION IN ELDERLY PATIENTS
With caution: the elderly.
The drug should be treated at the lowest effective dose, the minimum possible short course. 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, ethanol is not recommended.
Symptoms: abdominal pain, nausea, vomiting, retardation, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, lowering of blood pressure, bradycardia, tachycardia, atrial fibrillation, respiratory arrest.
Treatment: gastric lavage (only for 1 hour after intake), activated charcoal, alkaline drink, forced diuresis, symptomatic therapy.
It is not recommended simultaneous reception of ibuprofen with acetylsalicylic acid and other NSAIDs. With simultaneous administration of ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (possibly increasing the incidence of acute coronary insufficiency in patients receiving low doses of acetylsalicylic acid as antiplatelet agent after the onset of ibuprofen). When administered with anticoagulant and thrombolytic drugs (alteplase, streptokinase, urokinase), the risk of bleeding increases at the same time. Simultaneous reception with serotonin reuptake inhibitors (citalopram, fluoxetine, paroxetine, sertraline) increases the risk of developing serious gastrointestinal bleeding.
Cefamandol, cefaperazone, cefotetan, valproic acid, plikamycin, increase the frequency of hypoprothrombinemia. Cyclosporine and gold preparations increase the effect of ibuprofen on the synthesis of prostaglandins 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 and diuretic activity in furosemide and hydrochlorothiazide. Reduces the effectiveness of uricosuric drugs, increases the effect of indirect anticoagulants, antiaggregants, fibrinolytics (increased risk of hemorrhagic disorders), enhances ulcerogenic effects with bleeding mineralocorticosteroids, glucocorticosteroids, colchicine, estrogens, ethanol. Strengthens the effect of oral hypoglycemic drugs and insulin derivatives of sulfonylurea. Antacids and colestyramine reduce absorption. Increases the concentration in the blood of digoxin, lithium preparations, methotrexate. Caffeine increases the analgesic effect.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
In a dry place, at a temperature of no higher than 25 В° C. Keep out of the reach of children!
Shelf life - 3 years. Do not use after the expiry date printed on the package.