The instruction for medical use of Detraleks medicine the Trade name of Detraleks the International unlicensed name Is not present the Dosage form of the Tablet, film coated, 1000 mg Structure One tablet, film coated, contains active agent - the flavonoidny fraction cleaned, micronized **, consisting from (diosmin of 900 mg (90%) and flavonoids, in the form of hesperidin of 100 mg (10%), excipients: microcrystalline cellulose, gelatin, sodium carboxymethylstarch (type A), talc, magnesium stearate, water purified structure of a film cover: sodium lauryl sulfate, mix the salmoncolored OY-S-8761 containing: glycerin, gipromelloza, macrogoal 6000, magnesium stearate, ferrous oxide red (E 172), titan dioxide (E 171), ferrous oxide yellow (E 172). filler for polish of tablets - a macrogoal 6000. The description of the Tablet of oblong shape, film coated salmoncolored color, with risky for a break on both parties of a tablet. A tablet kernel after a break – from pale yellow till yellow color with non-uniform structure. Pharmacotherapeutic group Cardiovascular system. Vazoprotektora. Kapillyarostabiliruyushchy means. Bioflavonoids. Diosmin, combinations. The ATX C05CA53 code Pharmacological action Pharmacokinetics the Main discharge of drug takes place with a stake. With urine, on average, about 14% of the accepted amount of drug are removed. Elimination half-life makes 11 hours. Drug is exposed to active metabolism that is confirmed by presence of phenolic acids at urine. The pharmacodynamics of Detraleks® has venotoniziruyushchy and angioprotektivny properties. Drug reduces extensibility of veins and venous stagnation, reduces permeability of capillaries and increases their resistance. The dose-dependent effect of the drug Detraleks® was revealed for the following venous plethysmographic parameters: venous capacity, venous extensibility, time of venous depletion. The optimum ratio ²doza-effect ² is observed at reception of 1000 mg a day. Детралекс® raises a venous tone. Patients with signs of the significant disturbance have microcirculation, after therapy the drug Detraleks® notes) increase in the capillary resistance estimated by an angiostereometriya method. · At systematic use of Detraleksa® the reduction of expressiveness of clinical symptoms of chronic venous insufficiency of the lower extremities of the organic and functional nature and also a hemorrhoidal disease is noted. Indications - symptomatic treatment of venous and lymphatic insufficiency (weight in legs, pain, swell also spasms) - the functional symptoms connected with bad attacks of hemorrhoids the Route of administration and doses the Recommended dose at venous and lymphatic insufficiency – 1 tablet a day, is preferable in the morning during meal. Risk on a tablet it is intended only for division for the purpose of ingestion simplification. The recommended dose in acute hemorrhoids – 3 tablets a day (on 1 tablet in the morning, in the afternoon and in the evening) within 4 days, then on 2 tablets a day (on 1 tablet in the morning and in the evening) during the next 3 days. Duration of a course of treatment is defined by the attending physician. The average duration of treatment is 2–3 months. Side effects during administration of drug of Detraleks® it was reported about the following side effects, in the form of the following gradation: very often (≥1/10), it is frequent (≥1/100, & lt, 1/10), infrequently (≥1/1,000, & lt, 1/100), is rare (≥1/10,000, & lt, 1/1,000), is extremely rare (& lt, 1/10,000), not specified frequency (frequency cannot be counted according to available data). Often - diarrhea, dyspepsia, nausea, vomiting Infrequently - colitis Seldom - dizziness, a headache, a general malaise - rash, an itching, urticaria of not specified frequency - an abdominal pain - the isolated edema of face, lips, a century In exceptional cases - a Quincke's disease Inform the doctor on emergence of any, including not mentioned in this instruction, undesirable reactions and feelings and also about changes of laboratory indicators against the background of therapy. The contraindication - hypersensitivity to active components or to the excipients which are a part of drug - in the period of a lactation - children's age up to 18 years Medicinal interactions At the moment was not reported about clinically significant medicinal interactions in the post-registration period. Special instructions Before beginning to take the drug Detraleks®, it is recommended to consult with the doctor. At exacerbation of hemorrhoids the prescribing of the drug Detraleks® does not replace specific treatment of other anal disturbances. In case symptoms do not disappear after the recommended therapy course, it is necessary to have examination at the proctologist who will pick up further therapy. In the presence of disturbances of venous blood circulation the maximum effect of treatment is provided with a therapy combination to the healthy (balanced) lifestyle: it is desirable to avoid long stay in the sun, long stay standing and also, decrease in excess body weight is recommended. Foot walks and, in certain cases, wearing special stockings promote blood circulation improvement. Immediately see a doctor if in the course of treatment your state worsened or improvement did not occur. Use at pregnancy and during breastfeeding the Data on use of the micronized cleaned flavonoidny fraction for pregnant women are limited or are absent. For precaution it is undesirable to accept Detralex during pregnancy. Breastfeeding Is unknown whether active ingredient or its metabolites gets into breast milk. It is impossible to exclude risk for newborns and babies. The decision on stopping breastfeeding or to stop / not to begin therapy with Detralex, it is necessary to accept proceeding from advantage of breastfeeding for the child and advantage of therapy for the woman. Features of influence of medicine on ability to run vehicles or potentially dangerous mechanisms the Overdose Symptoms does not influence Data on overdose of Detralex are limited. At overdose the undesirable phenomena from digestive tract (diarrhea, nausea, an abdominal pain) were most often observed and integuments (itching, rash). Treatment At overdose is carried out symptomatic treatment. A form of release and packing On 9 or 10 tablets in blister strip packaging from a film of polyvinylchloride and aluminum foil. On 2 (9 tablets) and on 3 (10 tablets) planimetric packings together with the instruction for medical use in the state and Russian languages put in a pack from cardboard. To Store storage conditions at a temperature not above 30 °C. To store out of children's reach. 4 years not to apply a period of storage after an expiration date. Prescription status Without prescription LLC SERVYE RUS Producer, the Russian Federation 108828, Moscow, the settlement of Krasnopakhorskoye, p. 1. The holder of the registration certificate of Servye Laboratory, France the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan accepting claims (offer) on quality of medicines from consumers and responsible for post-registration observation of safety of medicine of Servye Kazakhstan LLP 050020, Almaty, Dostyk Ave of 310 g, Business center, the 3rd floor Ph.: (727) 386 76 62/63/64/70/71, Fax: (727) 386 76 67 E-mail: kazadinfo@servier.com
Related Products
