Detralex, 1000 mg 18 pcs.

Pharmacodynamics

Detralex® has venotonic and angioprotective properties. The drug reduces venous distensibility and venous stasis, reduces capillary permeability 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® has been shown for the following venous plethysmographic parameters:

• venous capacity,
• venous distensibility,
• time of venous emptying.

The optimal ″dose-effect ratio″ is observed when taking 1000 mg daily. Detralex® increases venous tone: venous occlusion plethysmography has shown a decrease in venous emptying time. In patients with signs of severe microcirculatory disorders, after therapy with Detralex® an increase in capillary resistance evaluated by angiostereometry (statistically significant compared to placebo) has been observed. The therapeutic efficacy of Detralex® has been proven in treatment of chronic diseases of lower limb veins and hemorrhoids.

Pharmacokinetics

The main excretion of the drug is in the feces. With the urine, on average, about 14% of the taken amount of the drug is excreted. The elimination half-life is 11 hours. The drug undergoes 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 vein disease (elimination and relief of symptoms).

The therapy of symptoms of venous and lymphatic insufficiency:

Therapy for manifestations of venous-lymphatic insufficiency:

Symptomatic therapy of acute and chronic hemorrhoids.

Active ingredient

Composition

One film-coated tablet contains:

Active substance:

1000 mg of purified micronized flavonoid fraction, consisting of diosmin 900 mg (90%) and flavonoids, in terms of hesperidin 100 mg (10%).

Excipients:

Purified water, gelatin, magnesium stearate, microcrystalline cellulose, sodium carboxymethyl starch type A, talc.

Shell film:

Sodium lauryl sulfate, macrogol 6000, orange-pink film jacket premix consisting of: glycerol, magnesium stearate, hypromellose, macrogol 6000, magnesium stearate, red iron oxide dye, titanium dioxide, yellow iron oxide dye.

Polishing tablet excipient:

Macrogol 6000 1,300 mg. The weight of the film-coated tablet is 1378.425 mg. 1) Considering the average moisture content of the purified, micronized flavonoid fraction – 4%, (or 40 mg per tablet), the amount of substance per tablet is 1,040.00 mg.

How to take, the dosage

Ingestion.

Recommended dose in veno-lymphatic insufficiency

1 tablet daily, preferably in the morning, with a meal. The tablets should be swallowed with water. The rickey on the tablet is intended solely to be divided to make it easier to swallow. The duration of treatment may be several months (up to 12 months). If symptoms recur, the course of treatment may be repeated on the doctor’s recommendation.

Recommended dose in acute hemorrhoids

3 tablets daily (1 tablet in the morning, afternoon and evening) for 4 days, then 2 tablets daily (1 tablet in the morning and evening) for the next 3 days.

Recommended dose for chronic hemorrhoids

1 tablet daily.

Interaction

Clinical studies on the study of interaction of the drug Detralex® with other medicinal products have not been conducted. To date, no cases of drug interactions have been reported.

Please tell your doctor about all the medicines you are taking.

Special Instructions

Consultation with a physician is recommended before taking Detralex®.
In the treatment of hemorrhoids, the prescription of Detralex® does not replace the specific treatment of other diseases of the rectum and anal canal. When using the drug independently, do not exceed the maximum terms and recommended doses stated in the section “Method of administration and doses”. If the symptoms of hemorrhoids persist after the recommended course of therapy, it is necessary to be examined by a proctologist, who will determine the further therapy.

In the presence of venous circulation disorders the maximum effect of therapy is achieved by a combination of therapy with additional preventive measures/healthy (balanced) way of life: it is advisable to avoid long periods of exposure to the sun, prolonged standing on feet and it is also recommended to decrease excessive body weight. Walking and, in some cases, wearing special stockings can improve blood circulation.
Contact your doctor immediately if your condition worsens or if there is no reduction in symptoms during treatment.

Impact on the ability to drive and perform work requiring high mental and physical speed:

There have been no clinical studies to study the effect of the drug Detralex® on the ability to drive and perform work requiring high speed mental and physical reactions. However, based on the available safety data it can be concluded that Detralex® has no effect (no significant effect) on these processes.

Synopsis

Contraindications

Hypersensitivity to the active ingredients or excipients in the drug.

Pregnancy and breastfeeding (limited or no experience of use).

Children under 18 years of age (no experience of use).

Side effects

The side effects of the drug Detralex® observed during clinical trials were mild in severity. Gastrointestinal disorders (diarrhea, dyspepsia, nausea, vomiting) were mostly observed. During the use of Detralex® medicine the following side effects have been reported, in the following grading: very common (≥1/10); common (≥1/100, < 1/10); infrequent (≥1/1 000, < 1/100); rare (≥1/10 000, < 1/1 000); extremely rare ( < 1/10 000), unspecified frequency (frequency cannot be estimated using available data).

From the central nervous system:

Rarely: dizziness, headache, general malaise.

Gastrointestinal tract:

Often: diarrhea, dyspepsia, nausea, vomiting.

Infrequent: colitis. Unspecified frequency: abdominal pain.

Skin and subcutaneous tissue: Rarely: skin rash, skin itching, urticaria. Unspecified frequency: isolated swelling of the face, lips, eyelids. In exceptional cases, angioedema.

TELL your physician about any unwanted reactions or sensations, including those not mentioned in this leaflet, and about changes in laboratory values during therapy.

Overdose

Symptoms

The data on cases of overdose of the drug Detralex® are limited. The most common adverse reactions in cases of overdose were gastrointestinal disorders (diarrhea, nausea, abdominal pain) and skin reactions (itching, rash).

Treatment

The treatment of overdose should be the management of clinical symptoms.

In case of an overdose of the drug, seek immediate medical attention.

Pregnancy use

Pregnancy:

There are no or limited data on the use of purified micronized flavonoid fraction in pregnant women.

Animal studies have shown no reproductive toxicity.

As a precautionary measure, it is preferable not to use Detralex® during pregnancy.

Breastfeeding period:

It is not known whether the purified micronized flavonoid fraction (metabolites) penetrates human breast milk.

There is a risk to newborns and infants. A decision should be made either to stop breastfeeding or to discontinue therapy with Detralex®, taking into account the benefit of breastfeeding for the baby and the benefit of therapy for the woman.

Effects on reproduction:

Reproductive toxicity studies have shown no effect on reproduction in rats of either sex.

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