Composition, form of production and packaging
? The tablets covered with a film cover, orange-pink color, oval; at the break - from pale yellow to yellow, a heterogeneous structure.
1 tab.
purified micronized flavonoid fraction 500 mg,
in t.ch. diosmin (90%) 450 mg
flavonoids in terms of hesperidin (10%) 50 mg
Excipients: gelatin - 31 mg, magnesium stearate - 4 mg, microcrystalline cellulose - 62 mg, sodium carboxymethyl starch - 27 mg, talc - 6 mg, purified water - 20 mg.
The composition of the film shell: macrogol 6000 - 0.710 mg, sodium lauryl sulfate - 0.033 mg, premix for the film coat of orange-pink color (glycerol 0.415 mg, magnesium stearate 0.415 mg, hypromellose 6.886 mg, iron oxide oxide yellow 0.161 mg, dye iron oxide red - 0.054 mg, titanium dioxide - 1.326 mg).
14 pcs. - blisters (2) - packs of cardboard.
14 pcs. - blisters (4) - packs of cardboard.
15 pcs. - blisters (2) - packs of cardboard.
15 pcs. - blisters (4) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
PHARMACHOLOGIC EFFECT
Detralex В® 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 Detralex В® 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 В® increases the venous tone: venous occlusion plethysmography has been shown to decrease the time of venous emptying. In patients with signs of severe disturbance of microcirculation, after treatment with Detralex В®, there is a (statistically significant, compared to placebo) increase in capillary resistance, estimated by angiostereiometry.
The therapeutic effectiveness of Detralex В® in the treatment of chronic diseases of the veins of the lower extremities, as well as in the treatment of hemorrhoids, is proved.
PHARMACOKINETICS
Metabolism
The drug is subject to active metabolism, which is confirmed by the presence of phenolic acids in the urine.
Excretion
It is excreted from the body mainly with feces. With urine, an average of about 14% of the drug intake is taken. T 1/2 is 11 hours.
INDICATIONS
Detralex В® 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;
- Feeling of heaviness and raspiraniya in the legs;
- "fatigue" of the feet.
Therapy of manifestations of venous-lymphatic insufficiency:
swelling of the lower extremities;
- trophic changes in the skin and subcutaneous tissue;
venous trophic ulcers.
Symptomatic therapy of acute and chronic hemorrhoids.
DOSING MODE
The drug is prescribed inside.
The recommended dose for venous-lymphatic insufficiency is 2 tab. / Day (for 1 or 2 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 / day: 3 tablets. in the morning and 3 tab. in the evening for 4 days, then - 4 tab. / day: 2 tab. in the morning and 2 tab. in the evening for the next 3 days.
The recommended dose for chronic hemorrhoids is 2 tablets / day with a meal.
SIDE EFFECT
Side effects of Detralex В® , observed in clinical trials, were mild. Most noted violations of the digestive tract (diarrhea, dyspepsia, nausea, vomiting).
During the reception of Detralex В® , the following side effects were reported as the following gradation: very often (> 1/10), often (> 1/100, <1/10), moderately (> 1/1000, <1/100) , rarely (> 1/10 000, <1/1000), very rarely (<10 000), unspecified frequency (frequency can not be calculated from available data).
From the side of the central nervous system: rarely - dizziness, headache, general malaise.
From the gastrointestinal tract: often - diarrhea, indigestion, nausea, vomiting; infrequently - colitis; Unspecified frequency - abdominal pain.
From the skin: rarely - rash, itching, urticaria; unspecified frequency - isolated edema of the face, lips, eyelids; in exceptional cases - angioedema.
The patient should be informed that if any of the patients appear on the background of therapy, incl. not mentioned in the manual, adverse reactions and sensations, as well as changes in laboratory indicators, should be reported to the doctor.
CONTRAINDICATIONS
- Hypersensitivity to the active components or excipients included in the preparation.
It is not recommended to take the drug for lactating women.
PREGNANCY AND LACTATION
Pregnancy
In experimental studies on animals teratogenic effects of Detralex В® were not observed.
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 isolation of the drug with breast milk, lactating women are not recommended taking the drug.
Influence on reproductive function
Reproductive toxicity studies showed no effect on reproductive function in rats of both sexes.
SPECIAL INSTRUCTIONS
Before starting Detralex В®, the patient is advised to consult a doctor.
With exacerbation of hemorrhoids, the purpose of Detralex В® does not replace the specific treatment of other anal disorders. Duration of treatment should not exceed the recommended time, indicated in the section "Dosage regimen." In the event that the symptoms do not disappear after the recommended course of therapy, you should conduct a survey with a proctologist who will choose further therapy.
In the presence of violations of venous circulation, the maximum effect of treatment is provided by combining 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.
The patient should immediately consult a doctor if the condition worsens or there is no improvement during treatment.
Impact on the ability to drive vehicles and manage mechanisms
The drug does not affect the ability to drive vehicles and perform work that requires a high rate of mental and physical reactions.
OVERDOSE
Cases of overdose are not described.
In case of an overdose, the patient should immediately seek medical help.
DRUG INTERACTION
Drug interaction of Detralex В® was not noted.
It is necessary to inform the attending physician of all medications taken by the patient.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children. Special storage conditions are not required. Shelf life - 4 years.
Do not use after the expiration date stated on the package.
