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Detralex® 60s 500 mg film-coated tablets




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, 500 mg Structure One tablet, film coated, contains active agent – the flavonoidny fraction cleaned, micronized **, consisting of diosmin of 450 mg (90%) and flavonoids, in the form of hesperidin of 50 mg (10%). excipients: microcrystalline cellulose, gelatin, sodium krakhmalglikolit, talc, magnesium stearate, water purified. film cover: a macrogoal 6000, sodium lauryl sulfate, mix the salmoncolored OY-S-8761 containing: glycerin, gipromelloza, magnesium stearate, ferrous oxide yellow (E 172), ferrous oxide red (E 172), titan dioxide (E 171). Description of the Tablet of an oval form, film coated salmoncolored color Pharmacotherapeutic group Cardiovascular system. Vazoprotektora. Kapillyarostabiliziruyushchy 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. Results of clinical trials confirm pharmacological activity of drug concerning indicators of a venous hemodynamics. Statistically reliable dose-dependent effect of the drug Detraleks® was shown 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 two tablets. Детралекс® raises a venous tone: by means of a venous occlusal pletizmografiya the reduction of time of venous depletion was shown. Patients with signs of the significant disturbance have microcirculation, after therapy the drug Detraleks® notes (statistically reliable in comparison with placebo) increase in the capillary resistance estimated by an angiostereometriya method. The therapeutic effectiveness of the drug Detraleks® at treatment of chronic diseases of veins of the lower extremities is proved and also at treatment of hemorrhoids. 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 – 2 tablets a day (for one or two receptions): in the morning, in the afternoon and/or in the evening, during meal. Duration of a course of treatment can be several months (up to 12 months). In case of repeated emergence of symptoms, according to the recommendation of the doctor, the course of treatment can be repeated. The recommended dose in acute hemorrhoids – 6 tablets a day (on 2 tablets 3 times a day) within 4 days, then on 4 tablets a day (on 2 tablets 2 times a day) during the next 3 days. The recommended dose in chronic hemorrhoids – 2 tablets a day. Side effects the Side effects of the drug Detraleks® observed during clinical trials were easy degree of manifestation. Disturbances from digestive tract (diarrhea, dyspepsia, nausea, vomiting) were mainly noted. 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). From the central nervous system: Seldom: dizziness, headache, general malaise. From digestive tract: Often: diarrhea, dyspepsia, nausea, vomiting. Infrequently: colitis. Not specified frequency: abdominal pain. From integuments: Seldom: rash, itching, urticaria. Not specified frequency: the isolated edema of face, lips, a century. In exceptional cases Quincke’s disease. Inform the doctor on emergence of any, including not mentioned in this instruction, undesirable reactions and feelings and also on changes of laboratory indicators against the background of therapy. Contraindications – 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. It was not noted medicinal interactions. It is necessary to inform the attending physician on all lekrastvenny drugs taken by you. 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. Duration of treatment should not exceed the terms specified in the section Route of Administration and Doses. 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 Pregnancy Experiments on animals did not reveal teratogenic effects. So far there were no messages about undesirable effects at drug use by pregnant women. Feeding by a breast due to the lack of data on removal of drug with breast milk, is not recommended to the feeding women administration of drug. Influence on reproductive function of the Research of reproductive toxicity was not shown by influences on reproductive function at rats of both sexes. The feature of influence of medicine on ability to run motor transport or potentially dangerous mechanisms does not influence. Overdose of Cases of overdose it is not described. At drug overdose immediately ask for medical care. The form of release and packing On 12 (for packing No. 36) or 15 (for packings No. 30 and No. 60) tablets place in blister strip packaging from a film of polivinilkhloridy and aluminum foil. On 2 or 4 (for packings No. 30 and No. 60), or on 3 (for packing No. 36) blister strip packagings together with the instruction for medical use in the state and Russian languages place in a box of cardboard. To Store storage conditions at a temperature not above 25 °C. To store out of children’s reach! 4 years not to apply a period of storage after an expiration date. Prescription status the LLC SERVYE RUS Producer, the Russian Federation the Owner of the registration certificate of Les Laboratoires Servier (Le Laboratoir of Servye), 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, the accepting claim (offer) on quality of medicines from consumers and responsible for post-registration observation of safety of medicine Is released without prescription: Servye Kazakhstan LLP 050020, Almaty, Dostyk Ave of 310 g, Business center, 3rd floor Ph.: (727) 386 76 62/63/64/70/71, Fax: (727) 386 76 67 E-mail:


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