Description
Release form
Tablets 500 mg or 1000 mg.
10 tablets per blister pack of PVC film and varnished printed aluminum foil.
3 or 6 blister packs along with instructions for use are placed in a pack of cardboard.
Pharmacological action
Pharmacotherapeutic group: Venotonic and venoprotective agent.
Code APC: C05CA53
Pharmacological properties of
Pharmacodynamics
The combination of diosmin + hesperidin 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 in relation to venous hemodynamics. A statistically significant dose-dependent effect of the drug was demonstrated for the following venous plethysmographic parameters: venous capacity, venous extensibility, time of venous emptying. The optimal dose-response ratio is observed when taking 1000 mg per day.
The combination of diosmin + hesperidin increases venous tone: using venous occlusal plethysmography, a decrease in venous emptying time was shown. In patients with signs of severe microcirculatory disturbance, an increase in capillary resistance assessed by angiostereometry was observed (statistically significant compared with placebo) after drug therapy.
The therapeutic efficacy of the combination of diosmin + hesperidin has been proven in the treatment of chronic lower limb vein diseases, as well as in the treatment of hemorrhoids.
Pharmacokinetics
The main excretion of the drug occurs with feces. With urine, on average, about 14% of the accepted amount of the drug is excreted. The half-life is 11 hours.
The drug undergoes an active metabolism, which is confirmed by the presence of phenolic acids in the urine.
Indications
Venolife Duo is indicated for the treatment of symptoms of chronic venous diseases (elimination and relief of symptoms).
Therapy for symptoms of venous-lymphatic insufficiency:
– pain
– cramps of the lower extremities
– feeling of heaviness and fullness in the legs
– tired legs.
Therapy for manifestations of venous-lymphatic insufficiency:
– edema of the lower extremities
– trophic changes in the skin and subcutaneous tissue
– venous trophic ulcers.
Symptomatic therapy of acute and chronic hemorrhoids.
Contraindications
Hypersensitivity to the active substance or to excipients that make up the drug.
Not recommended for lactating women.
Pregnancy and lactation
Pregnancy
Animal experiments have not revealed teratogenic effects.
To date, there have been no reports of adverse effects when using the drug in pregnant women.
Breastfeeding
Due to the lack of data regarding the excretion of the drug with breast milk, lactating women are not recommended to take the drug.
Impact on reproductive function
Reproductive toxicity studies have not shown an effect on reproductive function in rats of both sexes.
Special instructions
Before you start taking Venolife Duo, it is recommended that you consult a doctor.
In case of exacerbation of hemorrhoids, the administration of Venolife Duo does not replace the specific treatment of other anal disorders. The duration of treatment should not exceed the time specified in the Method of application and dose. In the event that the symptoms do not disappear after the recommended course of therapy, you should undergo an examination by the proctologist who will select further therapy.
In the presence of impaired venous circulation, the maximum treatment effect is ensured by a combination of therapy with a healthy (balanced) lifestyle: it is advisable to avoid a long stay in the sun, prolonged standing on the legs, and
is recommended to reduce excess body weight. Hiking and, in some cases, wearing special stockings help to improve blood circulation.
Get medical attention immediately if during the treatment your condition worsened or no improvement came.
Influence on the ability to drive vehicles, mechanisms
Clinical studies to study the effects of the combination of diosmin + hesperidin ability to drive a car and perform work requiring a high speed of mental and physical reactions were not conducted. However, based on the available safety data, we can conclude that diosmin + hesperidin does not (have no significant effect) on these processes.
Composition
One tablet contains:
active ingredient:
Purified micronized flavonoid fraction (in terms of anhydrous substance) containing diosmin (90%) and other flavonoids (10%) – 500 mg or 1000 mg.
excipients:
gelatin,
magnesium stearate,
microcrystalline cellulose,
sodium carboxymethyl starch,
talc.
Film coating:
ready-made mixture of Vivacout [macrogol 6000, titanium dioxide, glycerol, magnesium stearate, hypromellose, dye iron oxide red, dye iron oxide yellow],
sodium lauryl sulfate.
Dosage and Administration
Inside.
The recommended dose for venous-lymphatic insufficiency is 1000 mg per day, preferably in the morning during meals. Tablets should be swallowed with water.
Risk on tablet is intended solely for dividing in order to facilitate swallowing.
The duration of treatment can be several months (up to 12 months). In case of recurrence of symptoms, as recommended by a physician, the course of treatment may be repeated.
The recommended dose for acute hemorrhoids is 3000 mg per day (1000 mg in the morning, afternoon and evening) for 4 days, then 2000 mg per day (1000 mg in the morning and evening) for the next 3 days.
The recommended dose for chronic hemorrhoids is 1000 mg per day.
Side effects
Side effects of the combination diosmin + hesperidin, observed in clinical trials were mild. Mostly, gastrointestinal disturbances were noted (diarrhea, dyspepsia, nausea, vomiting).
While taking the combination of diosmin + hesperidin, the following side effects were reported 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, <1/1 000) extremely rarely (<1/10 000), unspecified frequency (the frequency cannot be calculated from the available data). From the central nervous system: Rarely: dizziness, headache, general malaise. From the gastrointestinal tract: Often: diarrhea, dyspepsia, nausea, vomiting. Infrequently: pricks. Unspecified frequency: abdominal pain. From the skin: Rarely: skin rash, pruritus, urticaria. Unspecified frequency: isolated swelling of the face, lips, eyelids. In exceptional cases, angioedema. Inform your doctor about your appearance of any adverse reactions, including those not mentioned in this manual, as well as changes in laboratory parameters during therapy. Drug interaction Clinical studies on the interactions of the combination of diosmin + hesperidins with other drugs have not been conducted. To date, no reported cases of drug interaction have been reported. Overdose Cases of overdose are not described. If you overdose, seek medical attention immediately. Storage Conditions At a temperature not exceeding 25 ° C. Keep out of the reach and sight of children. Expiration 2 years. Conditions of release from drugstores Without prescription The dosage form of tablet
