NORMOVEN

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

Composition:

Active ingredient: 1 tablet contains 500 mg of flavonoid fraction, comprising diosmin 450 mg and hesperidin 50 mg;

Excipients: sodium starch glycolate (type A), microcrystalline cellulose, hypromellose, cyclodextrin, magnesium stearate;

Coating: film coating mixture Opadry II Yellow (hypromellose; lactose monohydrate; polyethylene glycol; triacetin; quinoline yellow (E 104); titanium dioxide (E 171); indigo carmine (E 132); yellow FCF (E 110)).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: round, biconvex tablets with a film coating ranging in color from yellow to brownish-yellow.

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

Pharmacological Properties

Pharmacodynamics

Normoven exerts venotonic and angioprotective effects, 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.

Experimental studies in animals using the "ischemia/reperfusion" model showed that administration of micronized purified flavonoid fraction has a more pronounced efficacy in reducing vascular wall permeability and plasma extravasation compared to plain diosmin. This effect is attributed to the protective action on microcirculation provided by flavonoids such as hesperidin, diosmetin, linarin, and isorhoifolin, which are components of the fraction expressed as hesperidin. The reduction in vascular wall permeability and plasma extravasation observed with the use of micronized purified flavonoid fraction is more significant than that observed with plain diosmin or each individual component of the flavonoid fraction administered separately.

The aforementioned pharmacological properties have been confirmed in double-blind, placebo-controlled studies using methods capable of assessing the drug's effect on venous hemodynamics.

Dose–response relationship. A statistically significant dose-dependent effect of the medicinal product was established according to the following venous plethysmographic parameters: venous volume, venous distensibility, and venous outflow time. The optimal dose–response relationship was achieved with administration of 2 tablets.

Venotonic activity. The drug increases venous tone: a reduction in venous outflow time has been demonstrated using venous occlusion plethysmography.

Microcirculatory activity. Studies demonstrated a statistically significant difference between the use of the drug and placebo. In patients with symptoms of capillary fragility, treatment increased capillary resistance, as determined by angioscopy.

The medicinal product also reduces leukocyte–endothelium interaction and leukocyte adhesion in postcapillary venules. This diminishes the damaging effects of inflammatory mediators on venous walls and venous valve leaflets.

In clinical practice. Studies have demonstrated the therapeutic efficacy of the drug in phlebology for the treatment of functional and organic chronic venous insufficiency of the lower limbs, as well as in proctology for the treatment of hemorrhoids.

Pharmacokinetics

Elimination of the active substance occurs primarily 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.

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. No interactions with other medicinal products have been reported to date (given the extensive post-marketing experience with the medicinal product).

Special precautions for use.

The use of this medicinal product in acute hemorrhoids does not replace specific therapy and does not preclude 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 treatment regimen reassessed.

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

• avoid prolonged sun exposure, 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 lactose and therefore should not be used in patients with rare hereditary forms of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome.

If you have been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicinal product.

Due to the presence of "Yellow sunset FCF" in the composition of the medicinal product, allergic reactions are possible.

Use during pregnancy or breastfeeding.

Pregnancy. This medicinal product should be used with caution in pregnant women. Consult your doctor before use.

It is known that the combination of active substances contained in this medicinal product does not exhibit teratogenic effects; no adverse effects have been reported.

Breastfeeding. Due to lack of data on penetration of the medicinal product into breast milk, its use during breastfeeding should be avoided.

Fertility. Reproductive toxicity studies in animals showed no effect on fertility.

Ability to influence reaction speed while driving or operating machinery.

Studies on the impact of the flavonoid fraction on the ability to drive or operate machinery have not been conducted. However, considering the overall safety profile of the flavonoid fraction, a significant effect on this ability is not expected. If adverse reactions to the medicinal product occur (see section "Adverse reactions"), caution is advised.

Dosage and Administration.

For oral use. Intended for adults.

Venous and 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 may be taken once daily with food.

Haemorrhoidal disease.

Treatment of acute haemorrhoidal attacks: 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.

Duration of treatment.

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 Normoven in children.

Overdose.

Cases of overdose have not been reported.

Side effects.

Nervous system disorders: dizziness, headache, malaise.

Gastrointestinal disorders: diarrhea, dyspepsia, nausea, vomiting; colitis, abdominal pain.

Skin and subcutaneous tissue disorders: rash, pruritus, urticaria; isolated facial swelling, lip swelling, eyelid swelling. In rare cases – Quincke's edema (angioedema).

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; 3 or 6 blisters per pack.

12 tablets in a blister; 5 blisters per pack.

Dispensing category. Over-the-counter.

Manufacturer: JSC "KYIV VITAMIN PLANT".

Manufacturer's address and place of business activity.

38, Kopilivska St., Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua