Venosmin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VENOSMIN®

Composition:

Active substances: diosminum, hesperidinum;

One tablet contains a total of 500 mg of flavonoid fractions: diosminum equivalent to 100% substance 450 mg; hesperidinum equivalent to 100% substance 50 mg;

Excipients: microcrystalline cellulose, copovidone, colloidal anhydrous silicon dioxide, sodium croscarmellose, magnesium stearate; coating composition: Opadry II Pink (titanium dioxide (E 171), talc, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172), polyethylene glycol (macrogol) 4000, polyvinyl alcohol).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: film-coated tablets ranging in color from light brownish-pink to orange-pink, elongated in shape, with convex upper and lower surfaces, and a score line for division.

Pharmacotherapeutic group.

Capillary-stabilizing agents. Bioflavonoids. Diosmin, combinations. ATC code C05CA53.

Pharmacological properties.

Pharmacodynamics. The medicinal product has venotonic and angioprotective effects, increases venous tone, reduces venous distensibility and venous stasis, improves microcirculation, decreases capillary permeability and increases their resistance, improves lymphatic drainage by enhancing lymphatic outflow.

The drug also reduces leukocyte-endothelium interaction and leukocyte adhesion in postcapillary venules. This reduces the damaging effect of inflammatory mediators on venous walls and venous valve leaflets.

Pharmacokinetics. The elimination half-life of the drug is 11 hours.

Elimination of the active substance occurs mainly via the intestine. On average, 14% of the administered dose is excreted through urine.

Clinical characteristics.

Indications. Symptomatic treatment of venous and lymphatic insufficiency (leg heaviness, pain, nocturnal cramps, edema, trophic disorders, including varicose ulcers).

Symptomatic treatment of hemorrhoids.

Contraindications. Hypersensitivity to the active substance or to any of the excipients.

Interaction with other medicinal products and other forms of interaction. Unknown.

Special precautions for use.

The use of this medicinal product in acute hemorrhoids does not replace specific treatment and does not interfere with the management of other proctological diseases. If symptoms do not rapidly resolve during a short course of treatment, a proctological examination should be performed and the therapy re-evaluated.

For venous circulation disorders, more effective treatment is supported by adherence to the following lifestyle recommendations:

• avoid prolonged exposure to sunlight, extended periods of standing, and excessive body weight;
• walk regularly; in some cases, wear special compression stockings to improve circulation.

Use during pregnancy or breastfeeding. To date, there have been no reports of adverse effects associated with the use of diosmin and hesperidin in pregnant women. Nevertheless, the product should be used with caution during pregnancy. Consult a physician before use. Breastfeeding is not recommended during treatment (due to insufficient data on the passage of the drug into breast milk).

Ability to affect reaction speed when driving or operating machinery. This medicinal product does not impair the ability to drive or operate machinery. However, if signs of adverse reactions occur (see "Side effects"), caution should be exercised.

Method of administration and dosage.

For oral use.

To be prescribed to adults.

Treatment of venous-lymphatic insufficiency (symptoms: edema, pain, heaviness in legs, nocturnal cramps, trophic ulcers, lymphedema): 2 tablets daily (in two divided doses) taken with meals. After 1 week of treatment, 2 tablets daily may be taken as a single dose with meals.

Chronic hemorrhoids: 2 tablets daily (in two divided doses) taken with meals. After 1 week of treatment, 2 tablets daily may be taken as a single dose with meals.

Acute hemorrhoids: 6 tablets daily for the first 4 days and 4 tablets daily for the following 3 days. Administer with meals. Divide the daily dose into 2–3 administrations.

Duration of treatment. The treatment duration depends on the indication and course of the disease. The average duration of treatment is 2–3 months.

Children. There are no data on the use of the drug in children; therefore, the drug should not be used in pediatric practice.

Overdose. Not described.

Adverse reactions.

The following adverse reactions have been reported during the use of the medicinal product containing the active substance flavonoid fraction of the combination of diosmin and hesperidin, categorized by frequency as follows: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (< 1/10000); frequency not known (cannot be estimated from the available data).

Shelf life. 4 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 10 tablets per blister, 3 or 6 blisters per carton.

Prescription status. Over-the-counter.

Manufacturer. JSC «FITOPHARM».

Manufacturer's address.

2 Sybirtseva Street, Bakhmut, Donetsk region, 84500, Ukraine.

Marketing Authorization Holder. JSC «FITOPHARM».

Address of the Marketing Authorization Holder.

7, Verkhovnoyi Rady Boulevard, Building 7, 3rd floor, Room 18, Kyiv, 02100, Ukraine.

INSTRUCTION

for medical use of the medicinal product

VENOSMIN®

Composition:

Active substances: diosminum, hesperidinum;

One tablet contains 500 mg of flavonoid fractions: diosminum, calculated as 100% substance, 450 mg; hesperidinum, calculated as 100% substance, 50 mg;

Excipients: microcrystalline cellulose, copovidone, colloidal anhydrous silicon dioxide, sodium croscarmellose, magnesium stearate; coating composition: Opadry II pink (titanium dioxide (E 171), talc, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172), polyethylene glycol (macrogol) 4000, polyvinyl alcohol).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: film-coated tablets, from light brownish-pink to orange-pink in color, elongated in shape, with convex upper and lower surfaces, and a score line.

Pharmacotherapeutic group.

Capillary stabilizing agents. Bioflavonoids. Diosmin, combinations. ATC code C05CA53.

Pharmacological properties.

Pharmacodynamics. The medicinal product has venotonic and angioprotective effects, increases venous tone, reduces venous distensibility and venous stasis, improves microcirculation, decreases capillary permeability and increases their resistance, improves lymphatic drainage by enhancing lymphatic outflow.

The drug also reduces interaction between leukocytes and endothelium, as well as leukocyte adhesion in postcapillary venules. This reduces the damaging effects of inflammatory mediators on venous walls and venous valve leaflets.

Pharmacokinetics. The elimination half-life of the drug is 11 hours.

Elimination of the active substance occurs mainly via the intestine. On average, 14% of the administered dose is excreted through urine.

Clinical characteristics.

Indications. Symptomatic treatment of venous-lymphatic insufficiency (leg heaviness, pain, nocturnal cramps, edema, trophic disorders, including varicose ulcers).

Symptomatic treatment of hemorrhoids.

Contraindications. Hypersensitivity to the active substance or to any of the excipients.

Interaction with other medicinal products and other forms of interaction. Unknown.

Special precautions.

The use of this medicinal product in acute hemorrhoids does not replace specific treatment and does not preclude the treatment of other proctological diseases. If symptoms do not rapidly resolve during a short course of treatment, a proctological examination should be performed and therapy reconsidered.

For disorders of venous circulation, more effective treatment is supported by adherence to the following lifestyle recommendations:

• avoid prolonged exposure to sunlight, prolonged standing, and excessive body weight;
• walk regularly; in some cases, wear special compression stockings to improve circulation.

Use during pregnancy or breastfeeding. Currently, there are no reports of adverse effects associated with the use of diosmin and hesperidin in pregnant women. Nevertheless, the drug should be used with caution during pregnancy. Consult a physician before use. Breastfeeding is not recommended during treatment due to insufficient data on the passage of the drug into breast milk.

Ability to influence reaction speed when driving or operating machinery. This medicinal product does not affect the ability to drive or operate machinery. However, if signs of adverse reactions occur (see section "Adverse effects"), caution is advised.

Dosage and Administration.

For oral use.

For adults only.

Treatment of venous and lymphatic insufficiency (symptoms: edema, pain, heaviness in legs, nocturnal cramps, trophic ulcers, lymphedema): 2 tablets daily (in two divided doses) taken with meals. After 1 week of treatment, dosage may be reduced to 2 tablets once daily taken with meals.

Chronic hemorrhoids: 2 tablets daily (in two divided doses) taken with meals. After 1 week of treatment, dosage may be reduced to 2 tablets once daily taken with meals.

Acute hemorrhoids: 6 tablets daily for the first 4 days, followed by 4 tablets daily for the next 3 days. Take with meals. Divide the daily dose into 2–3 administrations.

Duration of treatment. The treatment duration depends on the indication and disease course. The average duration of treatment is 2–3 months.

Children. There is no data available on the use of the drug in children; therefore, the drug should not be used in pediatric practice.

Overdose. Not reported.

Adverse Reactions

The adverse reactions listed below have been reported during the use of the medicinal product containing the active ingredient flavonoid fraction of the combination of diosmin and hesperidin, categorized by frequency as follows: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10,000, < 1/1000); very rare (< 1/10,000); frequency not known (cannot be estimated from the available data).

Shelf life. 4 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 10 tablets in a blister pack; 3 or 6 blisters per carton.

Supply category. Over-the-counter.

Manufacturer. JSC "FITOPHARM" (responsible for batch release, excluding batch control/testing).

Manufacturer's address.

17, Chumatska Street, Boryspil, Kyiv region, 08303, Ukraine.

Marketing authorization holder. JSC "FITOPHARM".

Address of the marketing authorization holder.

18, 3rd floor, 7, Verkhovnoyi Rady Avenue, Kyiv, 02100, Ukraine.