Name:
Mig tablets p / o 400 mg in a blister. in pack. No. 10×1
Description:
Film-coated tablets of white or almost white color, oval, with a double-sided risk for division and embossed “E” and “E” on both sides of the risk on one of the sides. The main active ingredient Ibuprofen Release form Film-coated tablets of white or almost white color, oval, with a double-sided risk for dividing and embossing “E” and “E” on both sides of the risk on one of the sides. 1 tab. ibuprofen 400 mg Excipients: corn starch – 215 mg, sodium carboxymethyl starch (type A) – 26 mg, colloidal silicon dioxide – 13 mg, magnesium stearate – 5.6 mg. Shell composition: hypromellose (viscosity 6 mPa?s) – 2.946 mg, titanium dioxide (E171) – 1.918 mg, povidone K30 – 0.518 mg, macrogol 4000 – 0.56 mg. 10 pieces. – blisters (1) – packs of cardboard. 10 pieces. – blisters (2) – packs of cardboard. Special instructions If there are signs of bleeding from the gastrointestinal tract, ibuprofen should be discontinued. Ibuprofen can mask objective and subjective symptoms, so the drug should be administered with caution to patients with infectious diseases. The occurrence of bronchospasm is possible in patients suffering from bronchial asthma or allergic reactions in history or in the present. Side effects can be reduced by using the drug at the lowest effective dose. With prolonged use of analgesics, there is a risk of developing analgesic nephropathy. Patients who report visual impairment during ibuprofen therapy should stop treatment and undergo an ophthalmological examination. Ibuprofen may increase the activity of liver enzymes. During treatment, it is necessary to control the picture of peripheral blood and the functional state of the liver and kidneys. When symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a blood test to determine hemoglobin, hematocrit, and a fecal occult blood test. To prevent the development of NSAID gastropathy, ibuprofen is recommended to be combined with prostaglandin E preparations (misoprostol). If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. During the treatment period, ethanol is not recommended. Influence on the ability to drive vehicles and control mechanisms Patients should refrain from all activities that require increased attention and speed of psychomotor reactions. Pharmacological action Non-steroidal anti-inflammatory drug (NSAID). Ibuprofen is a derivative of propionic acid and has analgesic, antipyretic and anti-inflammatory effects due to non-selective blockade of COX-1 and COX-2, as well as an inhibitory effect on the synthesis of prostaglandins. The analgesic effect is most pronounced in inflammatory pain. The analgesic activity of the drug does not belong to the narcotic type. Like other NSAIDs, ibuprofen has antiplatelet activity. Pharmacokinetics Absorption After oral administration, the drug is well absorbed from the gastrointestinal tract. Cmax ibuprofen in plasma is approximately 30 mcg / ml and is reached approximately 2 hours after taking the drug at a dose of 400 mg. Distribution Plasma protein binding is about 99%. It is slowly distributed in the synovial fluid and excreted from it more slowly than from plasma. Metabolism Ibuprofen is metabolized in the liver mainly by hydroxylation and carboxylation of the isobutyl group. Metabolites are pharmacologically inactive. Excretion Characterized by a two-phase excretion kinetics. T1 / 2 from plasma is 2-3 hours. Up to 90% of the dose can be found in the urine in the form of metabolites and their conjugates. Less than 1% is excreted unchanged in the urine and to a lesser extent in the bile. Indications for use – headache; – migraine; – toothache; – neuralgia; – pain in muscles and joints; – menstrual pain, fever with colds and flu. Dosage and administration The drug is taken orally. The dosage regimen is set individually depending on the indications. For adults and children over 12 years of age, the drug is prescribed, as a rule, in the initial dose – 200 mg 3-4 times / day. To achieve a rapid therapeutic effect, the dose may be increased to 400 mg 3 times / day. Upon reaching the therapeutic effect, the daily dose is reduced to 600-800 mg. The drug should not be taken for more than 7 days or at higher doses. If it is necessary to use it for a longer time or in higher doses, a doctor’s consultation is required. In patients with impaired renal, hepatic or cardiac function, the dose should be reduced. Use during pregnancy and lactation There are no adequate and well-controlled studies on the safety of ibuprofen during pregnancy. The drug is contraindicated for use during pregnancy and lactation (breastfeeding). The use of ibuprofen may adversely affect female fertility and is not recommended for women planning a pregnancy. Precautions The drug should be used with caution in the following cases: advanced age; heart failure; arterial hypertension; cirrhosis of the liver with portal hypertension; hepatic and / or renal failure, nephrotic syndrome, hyperbilirubinemia; peptic ulcer of the stomach and duodenum (history), gastritis, enteritis, colitis; blood diseases of unknown etiology (leukopenia and anemia). Ibuprofen may increase the activity of liver enzymes. During treatment, it is necessary to control the functional state of the liver. During treatment, it is necessary to monitor the functional state of the kidneys. Interaction with other drugs It is possible to reduce the effectiveness of furosemide and thiazide diuretics due to sodium retention associated with inhibition of prostaglandin synthesis in the kidneys. Ibuprofen may enhance the effect of oral anticoagulants (simultaneous use is not recommended). With simultaneous appointment with acetylsalicylic acid, ibuprofen reduces its antiplatelet effect (it is possible to increase the incidence of acute coronary insufficiency in patients receiving low doses of acetylsalicylic acid as an antiplatelet agent). Ibuprofen may reduce the effectiveness of antihypertensive agents. Isolated cases of increased plasma concentrations of digoxin, phenytoin and lithium have been described in the literature while taking ibuprofen. Ibuprofen, like other NSAIDs, should be used with caution in combination with acetylsalicylic acid or other NSAIDs and corticosteroids, because. this increases the risk of adverse effects of the drug on the gastrointestinal tract. Ibuprofen may increase the plasma concentration of methotrexate. When combined therapy with zidovudine and ibuprofen may increase the risk of hemarthrosis and hematoma in HIV-infected patients with hemophilia. The combined use of ibuprofen and tacrolimus may increase the risk of developing nephrotoxic effects due to impaired prostaglandin synthesis in the kidneys. Ibuprofen enhances the hypoglycemic effect of oral hypoglycemic agents and insulin; dose adjustment may be necessary. Contraindications – erosive and ulcerative diseases of the organs: gastrointestinal tract (including peptic ulcer of the stomach and duodenum in the acute phase, Crohn’s disease, NUC); – “aspirin triad”; – hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis; – bleeding of various etiologies; – deficiency of glucose-6-phosphate dehydrogenase; – diseases of the optic nerve; – pregnancy; – lactation period; – children’s age up to 12 years; – hypersensitivity to the components of the drug; – Hypersensitivity to acetylsalicylic acid or other NSAIDs in history. Composition 1 tab. ibuprofen 400 mg Excipients: corn starch – 215 mg, sodium carboxymethyl starch (type A) – 26 mg, colloidal silicon dioxide – 13 mg, magnesium stearate – 5.6 mg. Shell composition: hypromellose (viscosity 6 mPa?s) – 2.946 mg, titanium dioxide (E171) – 1.918 mg, povidone K30 – 0.518 mg, macrogol 4000 – 0.56 mg. 10 pieces. – blisters (1) – packs of cardboard. 10 pieces. – blisters (2) – packs of cardboard. Overdose Symptoms: abdominal pain, nausea, vomiting, lethargy, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, decreased blood pressure, bradycardia, tachycardia, atrial fibrillation, respiratory arrest. Treatment: gastric lavage (only within an hour after ingestion), activated charcoal, alkaline drinking, forced diuresis, symptomatic therapy (correction of the acid-base state, blood pressure). Side effect On the part of the digestive system: NSAID-gastropathy – abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, constipation; rarely – ulceration of the gastrointestinal mucosa, which in some cases is complicated by perforation and bleeding; possible irritation or dryness of the oral mucosa, pain in the mouth, ulceration of the mucous membrane of the gums, aphthous stomatitis, pancreatitis, hepatitis. From the respiratory system: shortness of breath, bronchospasm. From the senses: hearing loss, ringing or tinnitus, toxic damage to the optic nerve, blurred vision or double vision, scotoma, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic genesis). From the side of the central nervous system 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). From the side of the cardiovascular system: 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 or urticarial), pruritus, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnea, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (syndrome Lyell), eosinophilia, allergic rhinitis. On the part of the hematopoietic system: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia. On the part of laboratory parameters: it is possible to increase bleeding time, decrease in serum glucose concentration, decrease in CC, decrease in hematocrit or hemoglobin, increase in serum creatinine concentration, increase in liver transaminase activity. With prolonged use of the drug in high doses, the risk of ulceration of the gastrointestinal mucosa, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (color vision impairment, scotoma, optic nerve damage) increases. Storage conditions Film-coated tablets of white or almost white color, oval, with a double-sided risk for division and embossed “E” and “E” on both sides of the risk on one side. Buy Mig tablets p / o 400 mg No. 10×1 tablets p/o 400mg No. 10x1Instruction for use for Mig tablets p/o 400mg No. 10×1
INN | IBUPROFEN |
---|---|
The code | 31 828 |
Barcode | 4 013 054 008 003 |
Dosage | 400mg |
Active substance | Ibuprofen |
Amount in a package | 20 |
Manufacturer | Berlin-Chemie AG, Germany |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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