Flebostan (Tablets) Instructions for Use

Marketing Authorization Holder

Inter-S Group, LLC (Russia)

Manufactured By

Adipharm, EAD (Bulgaria)

ATC Code

C05CA53 (Diosmin in combination with other drugs)

Active Substances

Diosmin (Rec.INN)

Hesperidin

Dosage Form

Flebostan

Film-coated tablets, 50 mg+450 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from yellow to yellow-green in color, oval, biconvex, pale brown on the break.

Excipients: microcrystalline cellulose – 160 mg, gelatin – 5 mg, sodium carboxymethyl starch – 15 mg, talc – 12 mg, magnesium stearate – 8 mg.

Film coating composition: Opadry 200 yellow 200F220027 – 30 mg, polyvinyl alcohol – 10.5 mg, titanium dioxide (E171) – 7.215 mg, talc – 7.164 mg, macrogol – 3.6 mg, methacrylic acid copolymer – 1.2 mg, quinoline yellow dye (E104) – 0.24 mg, iron oxide yellow dye (E172) – 0.045 mg, sodium bicarbonate – 0.036 mg.

15 pcs. – blisters (2) – cardboard packs.
15 pcs. – blisters (4) – cardboard packs.
15 pcs. – blisters (6) – cardboard packs.

Clinical-Pharmacological Group

Venotonic drug

Pharmacotherapeutic Group

Venotonic and venoprotective agent

Pharmacological Action

A combined agent with angioprotective and venotonic action, containing bioflavonoids.

It reduces venous distensibility, increases venous tone, and reduces venous stasis; it reduces capillary permeability, fragility, and increases their resistance; it improves microcirculation and lymphatic drainage.

With systematic use, it reduces the severity of clinical manifestations of chronic venous insufficiency of the lower extremities of organic and functional nature.

Indications

Symptomatic treatment of venous insufficiency of the lower extremities: sensation of heaviness and pain in the legs.

Symptomatic treatment of acute hemorrhoids.

ICD codes

Dosage Regimen

For oral administration.

For venolymphatic insufficiency, the daily dose is 900 mg of diosmin + 100 mg of hesperidin.

The frequency of administration is 2 times/day (at midday and in the evening during meals).

For acute hemorrhoids, during the first 4 days the daily dose is 2.7 g of diosmin + 300 mg of hesperidin (in 2 doses in the morning and evening), during the following 3 days the daily dose is 1.8 g of diosmin + 200 mg of hesperidin (in 2 doses in the morning and evening).

Adverse Reactions

From the digestive system: often – diarrhea, nausea, vomiting, dyspepsia; infrequently – colitis.

From the CNS rarely – dizziness, headache, general malaise.

From the skin: rarely – rash, itching, urticaria; unspecified frequency – isolated edema of the face, lips, eyelids; in exceptional cases – angioedema.

Contraindications

Lactation period (breastfeeding), hypersensitivity to diosmin and hesperidin.

Use in Pregnancy and Lactation

To date, there have been no reports of any side effects when using this combination in pregnant women.

Experimental studies have not observed teratogenic effects of the Diosmin+Hesperidin combination.

Contraindicated for use during the lactation period (breastfeeding), as it is unknown whether Diosmin and Hesperidin are excreted in breast milk.

Special Precautions

During an exacerbation of hemorrhoids, the use of this combination does not replace specific treatment for other anal disorders.

The duration of treatment should not exceed the recommended periods.

If symptoms do not disappear after short-term therapy, a proctological examination should be performed and the ongoing therapy should be reviewed.

In the presence of venous circulation disorders, the maximum treatment effect is achieved by combining it with a healthy, well-balanced lifestyle, which preferably involves avoiding prolonged sun exposure, prolonged standing, as well as reducing excess body weight, taking walks, and in some cases – wearing special stockings that improve 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.