Maprofen 10s 100 mg film-coated tablets

The instruction for medical use of MAPROFEN® medicine Trade name МАПРОФЕН® the International unlicensed name Flurbiprofen Lekarstvennaya the Tablet form, film coated, 100 mg Structure One tablet contains active agent – flurbiprofen 100 mg, excipients: ludipress (LCE), cellulose microcrystalline PH 102, sodium of a kroskarmelloz, silicon dioxide colloidal (Aerosil 200), magnesium stearate, structure of a cover of Opadry II Blue 85F20578: makrogol / polyethyleneglycol 3350, titan dioxide (E 171), FD&C blue 2 / Aluminium pigment, gland (III) oxide yellow (E172), talc, polyvinyl alcohol. The description of the Tablet, film coated blue color, oblong shape, biconvex and with risky on one party. Pharmacotherapeutic group Non-steroidal anti-inflammatory drugs. Propionic acid derivatives. Flurbiprofen. ATX M01AE09 code Pharmacological Pharmacokinetics Absorption properties: after intake flurbiprofen it is quickly soaked up from the digestive tract (DT) and reaches the maximum concentration in plasma in 1.5 h. Meal does not affect bioavailability of drug. Elimination half-life averages 6 h. Distribution, metabolism and removal: flurbiprofen it is almost completely metabolized and removed generally with urine in the form of free and connected medicine (20%) and hydroxylated metabolites (50%). Flurbiprofen contacts proteins of plasma more than for 99%. A pharmacodynamics of Maprofen® – the non-steroidal anti-inflammatory drug (NPVS) derivative of fenilpropionovy acid possessing analgeziruyushchy and anti-inflammatory action. The mechanism of action is connected with oppression of synthesis of prostaglandins due to enzyme blocking – cyclooxygenase (TsOG-1 and TsOG-2) and prevention of fabric sensitivity from peripheral mediators of pain. Frequency of development of side effect low. The majority of by-effects are easy and temporary. Data about undesirable impact on a liver, kidneys and the haematogenic system are not available. Indications - a headache, a toothache, neuralgia - symptomatic therapy in a pseudorheumatism, an osteoarthritis, an ankylosing spondylitis, acute gouty arthritis, arthralgias, arthroses, a lumbago, acute sciatica - relief of symptoms of pain and inflammation at states after surgical intervention and injuries of soft tissues (bursitis, tendinites), in otolaryngology, stomatology the Route of administration and doses the Recommended doses for adult 100 mg 1-3 times a day depending on sharpness of symptoms. Duration of a course of therapy is determined by the attending physician. Maximum single dose of 100 mg. Maximum daily dose of 300 mg. Side effects - dyspepsia, heartburn, nausea, vomiting, diarrhea, constipations - NPVS-gastropathies, abdominal pains, change of body weight, an abnormal liver function - an ulceration of a mucous membrane of digestive tract, bleeding (gastrointestinal, hemorrhoidal, from gums), cholestatic jaundice (at prolonged use in high doses) - a headache, dizziness, sonitus, drowsiness or insomnia, an asthenia, a depression, amnesia, a tremor, excitement - a hamaturia, tubulointerstitsialny nephrite, an edematous syndrome, a renal failure - increase in the ABP, tachycardia, heart failure - skin rash, an itching, a small tortoiseshell, a bronchospasm, a photosensitization, a Quincke's edema, an acute anaphylaxis - a visual disturbance, rhinitis - decrease in hearing - strengthening of sweating Is rare - anemia (iron deficiency, hemolytic, aplastic), an agranulocytosis, a leukopenia, thrombocytopenia - an ataxy, paresthesias, disturbance of consciousness In isolated cases - a renal failure of the Contraindication - hypersensitivity to a flurbiprofen - patients in the anamnesis with reactions of hypersensitivity (bronchial asthma, rhinitis, a small tortoiseshell) in response to reception of a flurbiprofen, aspirin or other NPVS - digestive tract erosive cankers - arterial hypertension, heart failure - chronic kidney disease - children's and teenage age up to 18 years - pregnancy and the period of a lactation Medicinal interactions decrease in diuretic effect when using Maprofen® with diuretic drugs of type of furosemide is possible. Like other NPVS Maprofen® with care appoint to patients who accept anticoagulants, in connection with possible risk of developing bleeding. At combined use with corticosteroids the risk of gastrointestinal bleedings increases. At a concomitant use of Maprofen® and aspirin the decrease in concentration of a flurbiprofen was noted. Therefore, it is not necessary to combine these two drugs. When sharing the effect of hypotensive drugs decreases. When sharing the toxicity of cardiac glycosides can increase. Removal of lithium, a methotrexate can decrease. At combined use of Maprofen® with cyclosporine the nephrotoxicity of the last can amplify. Inductors of microsomal oxidation in a liver (Phenytoinum, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase products of hydroxylated active metabolites. At simultaneous use of Maprofen® reduces efficiency of uricosuric drugs, strengthens effect of anticoagulants (increases risk of bleedings), antiagregant, fibrinolitik, side effects of mineralokortikoid, estrogen, enhances hypoglycemic effect of derivatives of sulphonylurea. Ranitidine – reduces concentration of drug in plasma. Antacids and Colestyraminum reduce absorption of a flurbiprofen. Special instructions Patients, it is long the accepting NPVS, have to be attentively surveyed to avoid by-effects from digestive system Like other NPVS Maprofen® with care appoint to patients with diseases of a liver, kidneys and a GIT Because of risk of developing hypostases and a delay of Maprofen® liquid with care appointed to patients with heart failure, an arterial hypertension and other diseases of Maprofen® can prolong a bleeding time therefore with care appoint to patients with risk of pathological bleeding of Feature of influence of medicine on ability to run motor transport or potentially dangerous mechanisms It is necessary to be careful during the driving of the car and occupations other potentially dangerous types of activity requiring special attention and speed of psychomotor reactions. The overdose of Specific antidote against a flurbiprofen does not exist. Symptoms: breath disturbance, nausea, pain in epigastric area, a headache, dizziness. Treatment: gastric lavage and symptomatic treatment. The form of release and packing On 5 tablets place in blister strip packaging from a film of transparent PVH/PE/PVDH/and printing aluminum foil. On 2, 3, 4 or 6 planimetric packs together with the instruction for medical use in the state and Russian languages place in a pack cardboard with the hologram of firm – producer. To Store storage conditions at a temperature not over 25 ºС, in the dry, protected from light place. To store out of children's reach! The period of storage Drug should not be used 3 years after the term noted on packing. Prescription status According to the prescription Republic of Kazakhstan JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Producer, Almaty, Shevchenko St. 162 E. The owner of the registration certificate of JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika the Republic of Kazakhstan the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Republic of Kazakhstan, Almaty, Shevchenko St. 162 E. Phone number: (+7 727) 399-50-50 Fax number: (+7 727) 399-60-60