Flebofa^® (Tablets) Instructions for Use

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Or

Ozon Pharm, LLC (Russia)

Contact Information

OZON LLC (Russia)

ATC Code

C05CA03 (Diosmin)

Active Substance

Diosmin (Rec.INN registered by WHO)

Dosage Form

Flebofa®

Tablets 600 mg: 10, 15, 20, 30, 40, 45, 50, 60, 70, 75, 80, 90, 100, 105, 120, 135, or 150 pcs.

Dosage Form, Packaging, and Composition

Tablets oval, biconvex, with a score, from grayish-brown to grayish-yellow in color, inclusions of lighter and darker shades are allowed.

Excipients: gelatin – 50 mg, sodium starch glycolate – 40 mg, magnesium stearate – 10 mg, microcrystalline cellulose (MCC-101) – up to 1000 mg.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (7) – cardboard packs.
10 pcs. – blister packs (8) – cardboard packs.
10 pcs. – blister packs (9) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.

Clinical-Pharmacological Group

Venotonic drug

Pharmacotherapeutic Group

Angioprotectors; agents that reduce capillary permeability; bioflavonoids

Pharmacological Action

Diosmin belongs to the group of bioflavonoids.

It has a venotonic effect (reduces venous distensibility, increases venous tone (dose-dependent effect), reduces venous stasis), improves lymphatic drainage (increases the tone and frequency of contraction of lymphatic capillaries, increases their functional density, reduces lymphatic pressure), improves microcirculation (increases capillary resistance (dose-dependent effect), reduces their permeability), reduces the adhesion of leukocytes to the venous wall and their migration into paravenous tissues, improves oxygen diffusion and perfusion in skin tissue, and has an anti-inflammatory effect.

It enhances the vasoconstrictive effect of adrenaline and noradrenaline, blocks the production of free radicals, and the synthesis of prostaglandins and thromboxane.

Pharmacokinetics

Absorption and Distribution

Diosmin is rapidly absorbed from the gastrointestinal tract.

It is detected in blood plasma 2 hours after administration. The bioavailability of the drug after oral administration is approximately 40-57.9%. C_max in blood plasma is reached 5 hours after administration.

The drug accumulates in all layers of the wall of hollow veins and subcutaneous veins of the lower extremities, to a lesser extent in the kidneys, liver, lungs, and other tissues. The volume of distribution of the drug is 62.1 L. The maximum selective accumulation of diosmin and/or its metabolites in the wall of venous vessels is noted 9 hours after administration and persists for 96 hours.

Metabolism and Excretion

Part of the drug is metabolized by bacteria in the cecum to form hippuric and benzoic acids.

Diosmin is rapidly metabolized in the liver. The main metabolite is hydroxyphenylpropionic acid. Metabolites of diosmin are excreted mainly by the kidneys in the form of conjugates with glucuronic acid. Enterohepatic circulation of the drug is noted.

79% of the administered diosmin is excreted by the kidneys, 11% through the intestines, 2.4% with bile. After administration of diosmin labeled with a radioactive isotope, approximately 86% of the drug is excreted by the kidneys and intestines within 48 hours.

Indications

• Varicose veins of the lower extremities (symptom relief);
• Chronic lymphovenous insufficiency of the lower extremities (symptom relief);
• Acute hemorrhoids (as part of complex therapy to alleviate symptoms);
• Microcirculation disorders (e.g., in idiopathic edema).

ICD codes

Dosage Regimen

The drug is intended for oral administration.

For varicose veins of the lower extremities and chronic lymphovenous insufficiency, the drug is used at a dose of 1 tablet per day in the morning on an empty stomach.

The duration of therapy is usually 2 months.

For severe forms of chronic lymphovenous insufficiency (edema, pain, cramps, etc.), treatment may be longer (the total duration of continuous therapy should not exceed 3-4 months).

Courses of treatment with Flebofa^® are repeated after 2-3 months.

For the treatment of chronic lymphovenous insufficiencyduring the II and III trimesters of pregnancy, the drug is used at a dose of 1 tablet once/day.

The duration of therapy is no more than 30 days. It is necessary to stop taking the drug 2-3 weeks before delivery.

For acute hemorrhoids, the drug is used at a dose of 2-3 tablets per day with meals for 7 days.

Then, if necessary, the drug can be continued at a dose of 1 tablet once/day for 1-2 months.

For microcirculation disorders, the drug is used at a dose of 1 tablet per day in the morning on an empty stomach.

The duration of therapy is usually 1-2 months.

If one or more doses of the drug are missed, it is necessary to continue using the drug in the usual regimen and at the usual dose.

Adverse Reactions

The frequency of side effects is determined in accordance with the WHO classification of adverse drug reactions by frequency of occurrence: very common (>1/10), common (<1/100 and <1/10), uncommon (> 1/1000 and <1/100), rare (>1/10,000 and <1/1000), very rare (<1/10,000, including isolated cases); unknown frequency (it is impossible to determine the frequency of the adverse reaction based on available data).

Gastrointestinal disorders common – nausea, vomiting, diarrhea, dyspeptic phenomena, heartburn, constipation; uncommon – colitis.

Central nervous system disorders rare – headache, dizziness.

Skin and subcutaneous tissue disorders: rare – skin rash, skin itching.

Allergic reactions rare – urticaria, unknown frequency – isolated edema of the face, lips, eyelids; in exceptional cases – angioedema (Quincke’s edema).

General disorders rare – malaise.

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Contraindications

• Hypersensitivity to the components of the drug;
• Children under 18 years of age (experience of use is limited);
• First trimester of pregnancy;
• Breastfeeding period (experience of use is limited).

Use in Pregnancy and Lactation

Experience with the use of the drug in pregnant women is limited.

No adverse reactions have been reported in clinical practice with the use of diosmin in pregnant women. Experimental studies have not revealed a teratogenic effect of diosmin on the course of pregnancy, embryofetal and postnatal development. Nevertheless, for safety reasons, the use of the drug in the first trimester of pregnancy is contraindicated. If it is necessary to use the drug during the second and third trimesters of pregnancy, it is recommended to consult a doctor first.

During breastfeeding, the use of the drug is not recommended, as there are no data on the penetration of diosmin into breast milk.

Special Precautions

Treatment of acute hemorrhoids is carried out in combination with other drugs.

In the absence of a rapid clinical effect, it is recommended to consult a proctologist, and if necessary, conduct an additional examination and adjust the therapy.

For venous circulation disorders (varicose veins of the lower extremities, chronic lymphovenous insufficiency of the lower extremities), the maximum treatment effect is achieved by combining therapy with lifestyle changes: it is advisable to avoid prolonged standing, and reduce excess body weight. In some cases, wearing special stockings (compression hosiery) helps improve blood circulation.

If there is no reduction or if the symptoms of the disease worsen, consult a doctor!

Do not exceed the maximum duration and recommended doses of the drug without consulting a doctor!

Effect on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and mechanisms.

Overdose

Cases of overdose have not been described.

Given the wide therapeutic range of diosmin, the risk of intoxication in case of overdose appears to be insignificant.

A specific antidote is unknown.

In case of drug overdose, seek medical help immediately.

Drug Interactions

Clinically significant interactions of diosmin with other drugs have not been described.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F) in the original packaging (carton).

Shelf Life

The shelf life is 3 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

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.