Detralex® (Detralex®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspfilm coated tablets
Composition:

One tablet, film-coated, contains:

Active substances: 500 mg purified micronized flavonoid fraction consisting of diosmin 450 mg (90 %) and flavonoids, in terms of hesperidin 50 mg (10 %).

Excipients: gelatin 31.00 mg, magnesium stearate 4.00 mg, microcrystalline cellulose 62.00 mg, sodium carboxymethyl starch 27.00 mg, talc 6.00 mg, purified water 20.00 mg.

Film sheath: macrogol 6000 0,710 mg, sodium lauryl sulfate 0.033 mg, premix for orange-pink color film shell, consisting of: glycerol 0.415 mg, magnesium stearate 0.415 mg, hypromellose 6.866 mg, iron oxide dye yellow 0.161 mg, iron oxide red dye 0.054 mg, titanium dioxide 1.326 mg.

Description:

Oval tablets covered with a film membrane, orange-pink color.

Type of tablet on the break: from pale yellow to yellow color of the heterogeneous structure.

Pharmacotherapeutic group:Venotonizing and venoprotective agent
ATX: & nbsp
  • Diosmin in combination with other drugs
    • Pharmacodynamics:

    Detralex® has venotonic and angioprotective properties.

    The drug reduces the extensibility of veins and venous congestion, reduces the permeability of capillaries and increases their resistance.The results of clinical studies confirm the pharmacological activity of the drug with respect to the indices of venous hemodynamics. Statistically significant dose-dependent effect of the drug Detralex® was demonstrated for the following venous plethysmographic parameters: venous capacity, venous dilatability, venous emptying time. The optimal "dose-effect" ratio is observed when taking 2 tablets.

    Detralex® increases the venous tone: a decrease in the time of venous emptying has been shown with venous occlusion plethysmography. In patients with signs of severe disturbance of microcirculation, after treatment with Detralex®, there is a (statistically significant, compared to placebo) increase in capillary resistance estimated by angiostereiometry.

    The therapeutic effectiveness of Detralex ® in the treatment of chronic diseases of the veins of the lower extremities, as well as in the treatment of hemorrhoids, is proved.

    Pharmacokinetics:

    The main release of the drug occurs with feces. With urine, an average of about 14% of the drug intake is taken.

    The half-life is 11 hours.

    The drug is subject to active metabolism, which is confirmed by the presence of phenolic acids in the urine.

    Indications:

    Detralex® is indicated for the treatment of symptoms of chronic venous diseases (elimination and alleviation of symptoms).

    Therapy of symptoms of venous-lymphatic insufficiency:

    - pain;

    - convulsions of the lower limbs;

    - a feeling of heaviness and protrusions in the legs;

    - "fatigue" of the feet.

    Therapy of manifestations of venous-lymphatic insufficiency:

    swelling of the lower extremities;

    - trophic skin changes and subcutaneous tissue;

    venous trophic ulcers.

    Symptomatic therapy of acute and chronic hemorrhoids.

    Contraindications:

    Hypersensitivity to the active ingredients or to the excipients included in the preparation.

    It is not recommended to take the drug for lactating women.

    Pregnancy and lactation:

    Pregnancy

    Experiments on animals did not reveal teratogenic effects.

    To date, there have been no reports of undesirable effects in the use of the drug by pregnant women.

    Lactation

    Due to the lack of data on the excretion of the drug with breast milk, lactating women are not recommended taking the drug.

    Influence on reproductive function

    Studies of reproductive toxicity have not shown an effect on reproductive function in rats of both sexes.

    Dosing and Administration:

    Inside.

    The recommended dose for venous-lymphatic insufficiency is 2 tablets per day (for one or two doses): morning, afternoon and / or evening, during meals.

    The duration of treatment can be several months (up to 12 months). In case of recurrence of symptoms, on the recommendation of a doctor, the course of treatment can be repeated.

    The recommended dose for acute hemorrhoids is 6 tablets per day: 3 tablets in the morning and 3 tablets in the evening for 4 days, then 4 tablets per day: 2 tablets in the morning and 2 tablets in the evening for the next 3 days. The recommended dose for chronic hemorrhoids is 2 tablets per day with meals.

    Side effects:

    The side effects of Detralex®, observed during clinical trials, were mild.

    Most noted violations of the gastrointestinal tract (diarrhea, dyspepsia, nausea, vomiting).

    During the reception of Detralex®, the following side effects were reported as the following gradation: very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10 000, <1/1000); extremely rare (<1/10 000),frequency (frequency can not be calculated from available data).

    From the central nervous system:

    Rarely: dizziness, headache. general malaise.

    From the gastrointestinal tract:

    Often: diarrhea, dyspepsia, nausea, vomiting.

    Infrequently: colitis.

    Unspecified frequency: abdominal pain.

    From the skin:

    Rarely: rash, itching, hives.

    Unspecified frequency: isolated edema of the face, lips, eyelids.

    In exceptional cases angioedema.

    PROMOTE THE DOCTOR ON THE APPEARANCE OF YOU ANYONE, INCLUDING NOT UNDERSTANDING IN THESE INSTRUCTIONS, ADVERSE REACTIONS AND FEELINGS, AND ALSO ABOUT CHANGING LABORATORY INDICES AT THE BACKGROUND OF THERAPY.

    Overdose:

    Cases of overdose are not described.

    If an overdose occurs, seek medical help immediately.
    Interaction:

    Not noted.

    SHOULD INFORM THE TREATMENT OF THE DOCTOR ON ALL OF THE MEDICINES YOU HAVE TAKEN.

    Special instructions:

    - Before taking Detralex®, it is recommended that you consult a doctor.

    - With an exacerbation of hemorrhoids, the purpose of Detralex® does not replace the specific treatment of other anal disorders.Duration of treatment should not exceed the time specified in the section "Method of administration and dose". In the event that the symptoms do not disappear after the recommended course of therapy, you should undergo an examination with a proctologist who will choose further therapy.

    - In the presence of violations of venous circulation, the maximum effect of treatment is provided combination of therapy with a healthy (balanced) way of life: it is advisable to avoid long exposure to the sun, prolonged stay on legs, and it is also recommended to reduce excess body weight. Hiking and, in some cases, wearing special stockings, helps improve blood circulation. Do not hesitate to contact a doctor immediately if in the process of treatment Your condition has worsened or no improvement has occurred.

    Effect on the ability to drive transp. cf. and fur:Does not affect.
    Form release / dosage:

    Tablets, film-coated, 500 mg.

    Packaging:

    In the manufacture of the Servier Laboratory Industry, France

    By 15 or 14 tablets in the blister (PVC / Al). For 2 or 4 blisters with instructions on the medical application in a pack of cardboard.

    When packaging (packaging) at a Russian enterprise LLC "Serdiks"

    For 15 tablets per blister (PVC / Al).For 2 or 4 blisters with instructions for medical use in a pack of cardboard.

    When manufacturing at a Russian enterprise OOO "Serdiks"

    To 15 or 14 pills in a blister (PVC / Al). For 2 or 4 blisters with instructions on the medical application in a pack of cardboard.

    Storage conditions:

    Special storage conditions are not required.

    Keep out of the reach of children.

    Shelf life:

    4 years.

    Do not use after the expiration date stated on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N011469 / 01
    Date of registration:26.06.2009 / 23.09.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Servier LaboratoriesServier Laboratories France
    Manufacturer: & nbsp
    Representation: & nbspServier Laboratories Servier Laboratories France
    Information update date: & nbsp25.03.2017
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