VENORM

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VENORM (VENORM)

Composition:

Active substances: diosminum, hesperidinum;

One tablet contains 500 mg of purified micronized flavonoid fraction (calculated as 100% anhydrous substance), consisting of 450 mg diosmin (90%) and 50 mg flavonoids as hesperidin (10%);

Excipients: microcrystalline cellulose, copovidone, colloidal anhydrous silicon dioxide, sodium croscarmellose, magnesium stearate, film coating "Wincoat WT-AQ-01121 Yellow" [hypromellose, polyethylene glycol 400, titanium dioxide (E 171), polyethylene glycol 6000, yellow iron oxide (E 172)].

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: round, biconvex tablets, film-coated, ranging in color from yellowish mustard to dark mustard.

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

Pharmacological properties

Pharmacodynamics. Venorm exerts a venotonic and angioprotective effect, reduces venous distensibility and venous stasis, improves microcirculation, decreases capillary permeability and increases their resistance, as well as enhances lymphatic drainage by increasing lymphatic outflow.

The medicinal product also reduces interaction between leukocytes and endothelium, and leukocyte adhesion in postcapillary venules. This reduces the damaging effect of inflammatory mediators on venous walls and venous valve leaflets.

Pharmacokinetics. Elimination of the active substance occurs mainly via feces. On average, 14% of the administered dose is excreted in urine.

The elimination half-life is 11 hours.

The drug is actively metabolized, which is confirmed by the presence of various phenolic acids in 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

Interaction studies have not been conducted. However, despite extensive post-marketing experience with the use of purified micronized flavonoid fraction, no clinically significant interactions with medicinal products have been reported to date.

Special precautions for use

The use of this medicinal product in acute haemorrhoids does not replace specific therapy 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 the therapy re-evaluated.

In disorders of venous circulation, therapy combined with adherence to the following lifestyle recommendations is more effective:

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

This medicinal product contains 3.5 mg of sodium croscarmellose per tablet. Caution is advised when administering to patients on a sodium-controlled diet.

Use during pregnancy or breastfeeding

Pregnancy

Data on the use of purified micronized flavonoid fraction in pregnant women are lacking or limited in quantity.

Animal studies have not shown reproductive toxicity.

As a precautionary measure, it is advisable to avoid using this medicinal product during pregnancy.

Breastfeeding

It is unknown whether the active substance or its metabolites are excreted in human breast milk.

Risk to the newborn/infant cannot be excluded.

The decision on whether to discontinue breastfeeding or to discontinue/abstain from treatment with this medicinal product should be made taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Fertility

Reproductive toxicity studies in animals showed no effect on fertility.

Effect on ability to drive and use machines

Studies on the effect of purified micronized flavonoid fraction on the ability to drive or operate machinery have not been conducted. However, based on the general safety profile of the flavonoid fraction, Venorm has no effect or a negligible effect on this ability. If adverse reactions occur (see section "Adverse reactions"), caution is recommended.

Method of Administration and Dosage

For oral use.

Intended for adults.

Venous Lymphatic Insufficiency. The recommended dose is 2 tablets daily: 1 tablet during the day and 1 tablet in the evening, taken with meals. After one week of treatment, it is possible to take 2 tablets daily as a single dose with food. The duration of treatment is determined by the physician depending on the course of the disease. Treatment may last from 1 to 6 months. The average duration of treatment is 2–3 months.

Hemorrhoidal Disease. Treatment of acute hemorrhoid episodes: 6 tablets daily for 4 days, followed by 4 tablets daily for the next 3 days. Take with meals. The daily dose should be divided into 2–3 doses. Maintenance therapy: 2 tablets daily as a single dose with meals, treatment duration up to 3 months.

The duration of therapy is determined by the physician depending on the indication and course of the disease.

Children. Data on the use of Venorm in children are lacking.

Overdose

Symptoms

There is limited information on cases of overdose with the use of purified micronized flavonoid fraction. The most commonly reported adverse reactions in overdose were gastrointestinal reactions (such as diarrhea, nausea, abdominal pain) and skin reactions (such as pruritus, rash).

Treatment

Treatment of overdose should be symptomatic.

Adverse reactions

The adverse reactions listed below have been reported during the use of purified micronized flavonoid fraction. Frequency is defined according to the following categories: 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).

Reporting of adverse reactions after marketing authorization of a medicinal product is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions

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

Keep out of reach and sight of children.

Packaging. 10 tablets in a blister; 3 or 6 blisters per cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer/Marketing Authorization Holder. LLC "Ternopharm".

Address of manufacturer and location of its business activity / address of the marketing authorization holder

4 Fabrychna Street, Ternopil, 46010, Ukraine.

Tel./Fax: (0352) 521-444, www.ternopharm.com.ua