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Flebaven® (Tablets) Instructions for Use

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)

Clinical-Pharmacological Group

Venotonic drug

Pharmacotherapeutic Group

Venotonic and venoprotective agent

Pharmacological Action

Venotonic agent, also possesses angioprotective properties. It reduces venous distensibility and venous stasis, decreases capillary permeability and increases their resistance. The results of clinical studies confirm the pharmacological activity of drugs containing this active substance in relation to venous hemodynamic parameters.

It increases venous tone: a decrease in venous emptying time was demonstrated using venous occlusion plethysmography. In patients with signs of severe microcirculation impairment, therapy with drugs containing this active substance leads to a (statistically significant, compared to placebo) increase in capillary resistance, assessed by angiostereometry.

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

Pharmacokinetics

After oral administration, it undergoes active metabolism, which is confirmed by the presence of phenolic acids in the urine. It is eliminated from the body mainly with feces. On average, about 14% of the administered dose is excreted in the urine. T1/2 is 11 hours.

Indications

Treatment of symptoms of venous-lymphatic insufficiency: pain; cramps in the lower limbs; sensation of heaviness and distension in the legs; “tired” legs.

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

Symptomatic treatment of acute and chronic hemorrhoids.

ICD codes

ICD-10 code Indication
I83.2 Varicose veins of lower extremities with ulcer and inflammation
I87.2 Venous insufficiency (chronic) (peripheral)
I89.0 Lymphedema, not elsewhere classified
K64 Hemorrhoids and perianal venous thrombosis
ICD-11 code Indication
BD74.Z Chronic venous insufficiency of lower extremities, unspecified
BD93.Z Lymphedema, unspecified
DB6Z Hemorrhoids or perianal venous diseases, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets

For oral administration.

For venous-lymphatic 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 with 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, morning and evening), during the next 3 days the daily dose is 1.8 g of diosmin + 200 mg of hesperidin (in 2 doses, morning and evening).

Adverse Reactions

Nervous system disorders rarely – dizziness, headache.

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

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

General disorders rarely – 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 hemorrhoid flare-up, the use of this medicinal product does not replace specific treatment for other anal disorders.

If symptoms do not disappear after the recommended course of therapy, a proctologist examination 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 sun exposure, prolonged standing, and weight reduction is recommended. Walking and, in some cases, wearing special stockings help 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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Krka-Rus, LLC (Russia)

Dosage Form

Bottle OTC Icon Flebaven® Film-coated tablets, 1000 mg: 30, 32, 60, or 64 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets orange-pink in color, oval, biconvex, with a score on one side.

1 tab.
Purified micronized flavonoid fraction, substance – granules* 1226 mg,
   Equivalent to the content of purified micronized flavonoid fraction 1000 mg, incl.
      Diosmin (90%)
      flavonoids expressed as hesperidin (10%)		 900 mg
100 mg

* Excipients of the substance-granules microcrystalline cellulose (type 101), povidone (K30).

Excipients : microcrystalline cellulose (type 105), sodium carboxymethyl starch (type A), talc, magnesium stearate.

Film coating composition film-forming mixture**, iron oxide red dye (E172), iron oxide yellow dye (E172).

8 pcs. – blister packs (4) – cardboard boxes.
8 pcs. – blister packs (8) – cardboard boxes.
10 pcs. – blister packs (3) – cardboard boxes.
10 pcs. – blister packs (6) – cardboard boxes.

** hypromellose, titanium dioxide (E171), talc, propylene glycol.

Marketing Authorization Holder

Krka-Rus, LLC (Russia)

Dosage Form

Bottle OTC Icon Flebaven® Film-coated tablets, 500 mg: 30, 32, 60, 64, or 96 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets light orange-pink in color, capsule-shaped, biconvex; the fractured surface is a rough mass from yellow to brownish-yellow with a light orange-pink film coating.

1 tab.
Purified micronized flavonoid fraction* 500 mg,
   Incl. Diosmin 450 mg (90%)
   Flavonoids expressed as hesperidin 50 mg (10%)

* in the form of purified micronized flavonoid fraction, substance-granules – 613 mg.
Excipients of the substance-granules microcrystalline cellulose (type 101), povidone (K30).

Excipients : sodium carboxymethyl starch, talc, magnesium stearate.

Film coating composition Opadry orange 03H325991.

10 pcs. – blister packs (3) – cardboard boxes.
10 pcs. – blister packs (6) – cardboard boxes.
16 pcs. – blister packs (2) – cardboard boxes.
16 pcs. – blister packs (4) – cardboard boxes.
16 pcs. – blister packs (6) – cardboard boxes.

1 Opadry orange 03H32599 contains: hypromellose, titanium dioxide (E171), talc, propylene glycol, iron oxide yellow dye (E172), iron oxide red dye (E172).

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