Expiration date: 02/2025

Form of production, composition and packaging

Suspension for oral administration is homogeneous, light yellow, with a characteristic smell.

1 sachet (10 ml) contains:

purified micronized flavonoid fraction 1000 mg,

 including diosmin 900 mg (90%)

 flavonoids in terms of hesperidin 100 mg (10%)

Excipients: citric acid-12.5 mg, orange flavor-15 mg, maltol-1800 mg, sodium benzoate-15 mg, xanthan gum-50 mg, water purified q.s. - up to 10 ml.

A 10 ml sachet of the multilayer (15) - packs of cardboard.

A 10 ml sachet of the multilayer (30) - packs of cardboard.

Clinico-pharmacological group: Venotonic and venoprotektornym drug

Pharmaco-therapeutic group: Venotonic and venoprotektornym tool

Pharmacological action

Detralex® has venotonic and angioprotective properties. The drug reduces the extensibility of veins and venous stagnation, reduces the permeability of capillaries and increases their resistance. The results of clinical studies confirm the pharmacological activity of the drug in relation to the indicators of venous hemodynamics.

Statistically significant dose-dependent effect of the drug Detralex® has been demonstrated for venous pletizmographic the following parameters: venous capacitance, venous distensibility, venous emptying time. The optimal ratio of "dose-effect" is observed when taking 1000 mg/day.

Detralex® increases venous tone: using venous occlusion plethysmography has been shown time decrease venous emptying. In patients with signs of pronounced disorders of microcirculation after treatment with the drug Detralex® marked (statistically significant compared with placebo) increase in capillary resistance, assessed by the method of angioleiomyoma.

Therapeutic efficacy of Detralex ® in the treatment of chronic diseases of the lower extremities veins, as well as in the treatment of hemorrhoids.

Detralex ® reduces undesirable side effects of invasive treatment of chronic venous diseases (reduces the frequency of undesirable side effects in surgical and endovascular treatment of varicose veins: significantly reduces the intensity of postoperative pain, swelling and severity of hemorrhages after endovascular and surgical treatment).

Pharmacokinetics

The main excretion of the drug occurs with feces. With urine, on average, about 14% of the taken amount of the drug is excreted. T1/2 is 11 h.

The drug is subjected 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 relief of symptoms).

Treatment of symptoms of venous lymphatic insufficiency:

• pain;
  
• spasms of the lower extremities;
  
• feeling of heaviness and sprains in the legs;
  
• tired legs.
  

Therapy of manifestations of venous-lymphatic insufficiency:

• swelling of the lower limbs;
  
• trophic changes of skin and subcutaneous tissue;
  
• venous trophic ulcers.
  

Symptomatic therapy of acute and chronic hemorrhoids.

Dosage regimen

The drug is taken orally.

The recommended dose for venous-lymphatic insufficiency-1000 mg (contents 1 sachet) / day, preferably in the morning, during meals.

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

The recommended dose for acute hemorrhoids-3000 mg / day (1000 mg (contents of 1 sachet) in the morning, afternoon and evening) for 4 days, then - 2000 mg/day (1000 mg (contents of 1 sachet) in the morning and evening) for the next 3 days.

The recommended dose for chronic hemorrhoids is 1000 mg (content of 1 sachet)/day at any convenient time of the day with meals.

Side effect

Side effects of Detralex®, observed in clinical studies,were mild. Mostly there were violations of the gastrointestinal tract (diarrhea, dyspepsia, nausea, vomiting).

At the time of taking Detralex® reported the following side effects in the form of 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), unspecified 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.

On the part of the skin: rarely - skin rash, skin itching, urticaria; unspecified frequency-isolated swelling of the face, lips, eyelids; in exceptional cases - angioedema.

The patient should inform the doctor about the appearance of any, including not mentioned in the instructions, adverse reactions and sensations, as well as changes in laboratory parameters during therapy.

Contraindications to use

• hypersensitivity to the active substance or to auxiliary substances included in the preparation;
  
• fructose intolerance.
  

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

Use during pregnancy and breast-feeding

Pregnancy

No teratogenic effects were found in experimental studies on animals.

To date no reports of adverse effects when using the drug pregnant women.

Breastfeeding period

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

Impact on reproductive function

Reproductive toxicity studies have shown no effect on reproductive function in rats of both sexes.

Special instruction

Before using Detralex®, the patient is recommended to consult a doctor.

In acute hemorrhoids appointment drug Detralex® does not replace the specific treatment of other anal disorders. The duration of treatment should not exceed the time specified in the "dosing regimen". In that case, if the symptoms do not disappear after the recommended course of therapy, you should be examined by a proctologist who will choose further therapy.

In the presence of venous circulation disorders, the maximum effect of treatment is provided by a combination of therapy with a healthy (balanced) lifestyle; it is desirable to avoid a long stay in the sun, a long stay on the legs, and it is recommended to reduce excess body weight. Walking and, in some cases, wearing special stockings (compression knitwear) helps to improve blood circulation.

The patient should immediately consult a doctor if the condition worsens or if there is no improvement in the treatment process.

Impact on the ability to drive and operate machinery

The drug does not affect the ability to drive and perform work that requires a high rate of mental and physical reactions.

Overdose

Cases of overdose are not described.

In case of overdose of the drug, the patient should immediately seek medical help.

Drug interaction

Drug interactions drug Detralex® were noted.

The patient should inform the attending physician about all medications taken.

Storage conditions and terms

The drug should be stored out of reach of children at a temperature not exceeding 30°C. shelf life - 3 years. Do not use after the expiration date specified on the package.