Venolife Duo (Tablets) Instructions for Use

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

ATC Code

C05CA53 (Diosmin in combination with other drugs)

Active Substance

Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin)

Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin) (Grouping name)

Dosage Forms

	Venolife Duo	Film-coated tablets, 500 mg: 30 or 60 pcs.
		Film-coated tablets, 1000 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets orange-pink in color, oval, biconvex; on the break – from light yellow to gray-yellow in color, of heterogeneous structure; marbling is allowed.

Excipients: gelatin, magnesium stearate, microcrystalline cellulose, sodium carboxymethyl starch, talc.

Film coating composition ready-made mixture “Vivacoat” [macrogol 6000, titanium dioxide, glycerol, magnesium stearate, hypromellose, iron oxide red dye, iron oxide yellow dye], sodium lauryl sulfate.

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.

Film-coated tablets orange-pink in color, oval, biconvex, with a score on both sides; on the break – from light yellow to gray-yellow in color, of heterogeneous structure; marbling is allowed.

Excipients: gelatin, magnesium stearate, microcrystalline cellulose, sodium carboxymethyl starch, talc.

Film coating composition ready-made mixture “Vivacoat” [macrogol 6000, titanium dioxide, glycerol, magnesium stearate, hypromellose, iron oxide red dye, iron oxide yellow dye], sodium lauryl sulfate.

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.

Clinical-Pharmacological Group

Venotonic and venoprotective drug

Pharmacotherapeutic Group

Venotonic and venoprotective agent

Pharmacological Action

Venotonic agent, also has angioprotective properties. Reduces venous distensibility and venous congestion, decreases capillary permeability and increases their resistance. Results of clinical studies confirm the pharmacological activity of drugs containing this active substance in relation to venous hemodynamics parameters.

Increases venous tone: venous occlusion plethysmography showed a decrease in venous emptying time. In patients with signs of severe microcirculation impairment after therapy with drugs containing this active substance, a (statistically significant, compared to placebo) increase in capillary resistance, assessed by the angiosterometry method, is noted.

Therapeutic efficacy in the treatment of chronic venous diseases of the lower extremities, as well as in the treatment of hemorrhoids, has been proven.

Pharmacokinetics

After oral administration, it undergoes active metabolism, which is confirmed by the presence of phenolic acids in the urine. It is excreted from the body mainly with feces. On average, about 14% of the administered dose is excreted in the urine. T_1/2 is 11 h.

Indications

Therapy of symptoms of venous-lymphatic insufficiency: pain; cramps of the lower extremities; sensation of heaviness and fullness in the legs; “tired” legs.

Therapy of manifestations of venous-lymphatic insufficiency: swelling of the lower extremities; trophic changes of the skin and subcutaneous tissue; venous trophic ulcers.

Symptomatic therapy of acute and chronic hemorrhoids.

ICD codes

Dosage Regimen

Take orally with a meal.

For chronic venous and lymphatic insufficiency, take one 1000 mg tablet or two 500 mg tablets daily. Administer the total daily dose as a single intake during lunch.

For acute hemorrhoids, take three 1000 mg tablets or six 500 mg tablets daily for the first four days. Then reduce the dose to two 1000 mg tablets or four 500 mg tablets daily for the next three days.

For chronic hemorrhoids, take two 1000 mg tablets or four 500 mg tablets daily. Divide this daily dose into two separate intakes, taken with morning and evening meals.

The recommended treatment duration for venous-lymphatic insufficiency is typically 1 to 3 months. For hemorrhoidal symptoms, the usual course is 1 to 2 weeks.

Do not exceed the recommended daily dose. If symptoms persist after the full course of treatment, consult a physician for further evaluation.

Adverse Reactions

Nervous system disorders rarely – dizziness, headache.

Gastrointestinal disorders often – diarrhea, dyspepsia, nausea, vomiting; infrequently – colitis; frequency not specified – abdominal pain.

Skin and subcutaneous tissue disorders: rarely – rash, itching, urticaria; frequency not specified – isolated edema of the face, lips, eyelids; in exceptional cases – angioedema.

General disorders rarely – general malaise.

Contraindications

Hypersensitivity to the active substance.

Use in Pregnancy and Lactation

To date, there have been no reports of adverse effects when used in pregnant women.

Use during breastfeeding is not recommended.

Special Precautions

In case of exacerbation of hemorrhoids, the use of this medicinal product does not replace specific treatment of other anal disorders.

If symptoms do not disappear after the recommended course of therapy, an examination by a proctologist should be performed.

In the presence of venous circulation disorders, the maximum treatment effect is achieved by combining therapy with a healthy (balanced) lifestyle: it is advisable to avoid prolonged exposure to the sun, prolonged standing, and weight reduction is recommended in case of excess body weight. Walking and, in some cases, wearing special stockings promote better blood circulation.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.