FLAVENORM

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

Composition:

Active substances: diosmin, hesperidin;

One tablet contains 500 mg of purified micronized flavonoid fraction containing 450 mg diosmin (90%) and 50 mg flavonoids in the form of 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, iron oxide yellow (E 172)].

Pharmaceutical form. Film-coated tablets.

Main physico-chemical properties: round-shaped, biconvex tablets, coated with a film coating ranging in color from yellowish mustard to dark mustard.

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

Pharmacological Properties

Pharmacodynamics. FLAVENORM 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 diminishes the damaging effects 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 undergoes extensive metabolism, as confirmed by the presence of various phenolic acids in urine.

Clinical characteristics

Indications

The medicinal product FLAVENORM is indicated for the symptomatic treatment of:

• venous and lymphatic insufficiency (heavy legs, pain, nocturnal cramps, swelling);
• haemorrhoids.

Contraindications

Hypersensitivity to any of the active or excipient ingredients listed in the section "Composition".

Interaction with other medicinal products and other forms of interaction

Interaction studies have not been conducted. However, despite extensive post-marketing experience with the 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 resolve during a short course of treatment, a proctological examination should be performed and the therapy re-evaluated.

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

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

This medicinal product contains 3.5 mg of sodium croscarmellose per 1 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 purified micronized flavonoid fraction or its metabolites are excreted in human breast milk.

Risk to newborns/infants 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

No studies on the effect of purified micronized flavonoid fraction on the ability to drive or operate machinery have been conducted. However, based on the overall safety profile of the flavonoid fraction, FLAVENORM has no effect or has a negligible effect on this ability. If adverse reactions that may impair reaction speed occur (see section "Adverse reactions"), caution should be exercised when driving or operating machinery.

Dosage and Administration

For oral use.

For use in adults.

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

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, 2 tablets daily may be taken once daily with food.

Haemorrhoidal disease

Treatment of acute haemorrhoidal episodes: 6 tablets daily for 4 days, followed by 4 tablets daily for the next 3 days. Administer with meals. The daily dose should be divided into 2–3 doses. Maintenance therapy: 2 tablets once daily with meals. The recommended duration of treatment is usually up to 3 months.

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

Children. There are no data on the use of FLAVENORM in children.

Overdose

Symptoms

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

Treatment

In case of overdose, symptomatic treatment is recommended.

Adverse reactions

The adverse reactions listed below have been observed 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 drug registration is of great importance. It enables monitoring of the benefit-risk balance associated with the use of this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of drug efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 10 tablets in a blister; 6 blisters per cardboard pack.

Availability. Over-the-counter.

Manufacturer/Marketing Authorization Holder. Ternofarm LLC.

Address of manufacturer and location of its operations / address of marketing authorization holder. 4 Fabrychna Street, Ternopil, 46010, Ukraine.