Composition
One film-coated tablet contains: Â
Active ingredient: Â
Purified, micronized flavonoid fraction, in terms of dry matter,1000.00 mg, consisting of: diosmin 900 mg (90%), flavonoids in terms of hesperidin 100 mg (10%).
Auxiliary substances:
Purified water 40.00 mg,
gelatin 62.00 mg,
magnesium stearate 8.00 mg,
microcrystalline cellulose 124.00 mg,
sodium carboxymethyl starch type A 54.00 mg,
talc 12.00 mg.
Tablet core weight: 1340 mg 1).
Film shell: Â
Sodium lauryl sulfate 0.130 mg,
premix for orange-pink film coating OY-S-8761, consisting of:
glycerol 1.628 mg,
hypromellose 27.039 mg,
macrogol 6000 0.651 mg,
magnesium stearate 1.628 mg,
iron oxide red dye 0.211 mg,
titanium dioxide 5.205 mg,
iron oxide yellow dye 0.633 mg.
Tablet polishing aid:
macrogol 6000 1,300 mg.
The weight of the film-coated tablet is 1378.425 mg
.1) Taking into account the average humidity of the purified, micronized flavonoid fraction-4%, (or 40 mg per tablet), the amount of substance per tablet – 1040.00 mg
Pharmacological action
Detralex® has venotonizing and angioprotective properties. The drug reduces the dilatability 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 in relation to venous hemodynamic parameters. A statistically significant dose-dependent effect of Detralex® was demonstrated for the following venous plethysmographic parameters:
- venous capacity,
- venous extensibility,
- and venous emptying time.
The optimal dose-effect ratio is observed when taking 1000 mg per day. Detralex ® increases venous tone: venous occlusal plethysmography has been shown to reduce the time of venous emptying.
In patients with signs of severe microcirculation disorders, after therapy with Detralex®, an increase in capillary resistance (statistically significant compared to placebo), estimated by angiostereometry, is noted.
The therapeutic efficacy of Detralex® in the treatment of chronic venous diseases of the lower extremities, as well as in the treatment of hemorrhoids, has been proven.
Indications
Detralex® is indicated for the treatment of symptoms of chronic venous diseases (elimination and relief of symptoms).
Treatment of symptoms of venous-lymphatic insufficiency:
- pain;
- cramps of the lower extremities;
- feeling of heaviness and bursting in the legs;
- ” fatigue ” of the legs.
Treatment of venous-lymphatic insufficiency manifestations:
- edema of the lower extremities;
- trophic changes in the skin and subcutaneous tissue;Â
- venous trophic ulcers.
Symptomatic treatment of acute and chronic hemorrhoids.
Contraindications
- hypersensitivity to the active ingredients or excipients that make up the drug.
- due to the lack of data on the excretion of the drug in breast milk, lactating women are not recommended to take the drug.
Side effects
From the gastrointestinal tract, nausea and a feeling of discomfort in the stomach, vomiting and diarrhea may occur.
From the central nervous system, headache and dizziness may occur.
Very rarely, the skin may have such allergic manifestations as rash, itching, urticaria. Urticaria is an acute allergic reaction characterized by rapid blistering. Accompanied by itching.
If you experience any side effects, you should consult your doctor about the need to adjust the treatment.
How to take, course of use and dosage
The drug is prescribed inside.
The recommended dose for venous-lymphatic insufficiency is 1 tablet/day, preferably in the morning, with meals.
The label on the tablet is intended solely for division in order to facilitate ingestion.
The duration of the course of treatment can be several months (up to 12 months). In case of recurrent symptoms, the course of treatment may be repeated on the doctor’s recommendation.
The recommended dose for acute hemorrhoids is 3 tablets/day (1 tablet each). morning, afternoon and evening) for 4 days, then-2 tablets/day (1 tablet each). morning and evening) for the next 3 days.
The recommended dose for chronic hemorrhoids is 1 tablet/day.
Overdose
Cases of overdose are not described.
If you overdose, seek immediate medical attention.
Special instructions
Before using Detralex®, the patient is recommended to consult a doctor.
In case of acute hemorrhoids, the use of Detralex® does not replace the specific treatment of other anal disorders. The duration of treatment should not exceed the time specified in the section “Dosage regimen”. In the event that the symptoms do not disappear after the recommended course of therapy, you should conduct an examination with a proctologist, who will select further therapy.
In the presence of venous circulatory disorders, the maximum effect of treatment is provided by combining therapy with a healthy (balanced) lifestyle: it is advisable to avoid long exposure to the sun, long stay on your feet, and it is also recommended to reduce excess body weight. Walking and, in some cases, wearing special stockings helps to improve blood circulation.
The patient should immediately consult a doctor if the condition worsens or does not improve during treatment.
The drug does not affect the ability to drive vehicles and perform work that requires a high rate of mental and physical reactions.
Form of production
Oval tablets, film-coated, orange-pink in color.
Type of tablet on the break: from pale yellow to yellow color of heterogeneous structure.
Active ingredient
Hesperidin, Diosmin
Dosage form
Tablets
Description
For adults as prescribed by a doctor, for pregnant women as prescribed by a doctor
Indications
Varicose veins, Trophic ulcers, Hemorrhoids
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