Felita

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT FELITA (FELITA)

Composition:

Active substance: 1 tablet contains 100 mg of dried extract of soybean seeds (Glycine max semen extr. sicc.), which contains 26 mg of isoflavones complex;

Excipients: microcrystalline cellulose, crospovidone, povidone, magnesium stearate, hypromellose, talc, glycerin.

Pharmaceutical form. Film-coated tablets.

Main physicochemical characteristics: elongated biconvex film-coated tablets of beige color with specks ranging from white to dark beige, with a score line on one side.

Pharmacotherapeutic group.

Agents used in gynecology. ATC code G02CX.

Pharmacological properties.

Pharmacodynamics.

The medicinal product reduces symptoms occurring during the menopausal period: hot flashes, excessive sweating, sleep disturbances, increased irritability, depression. Due to their chemical similarity to estrogens, soy isoflavones (genistein and daidzein) can bind to receptors of female reproductive organs (particularly ER beta). This leads to a reduction in the severity of disorders associated with decreased production of female sex hormones during menopause. This effect is approximately 10,000 times weaker compared to 17-beta-estradiol.

In addition, the use of the medicinal product, when combined with an appropriate diet, helps prevent the development of cardiovascular diseases.

Soy seed extract contains, in particular, isoflavones and soy protein.

Pharmacokinetics.

Data on the pharmacokinetics of Felit are unavailable.

The pharmacokinetics of soy isoflavones contained in the medicinal product significantly depends on intestinal microflora and varies according to individual organism characteristics.

With the involvement of intestinal enzymes (β-glucosidase produced by intestinal bacteria), glycosides are hydrolyzed to active forms—aglycones—primarily in the small intestine, and subsequently in the large intestine.

Glycosides hydrolyzed in the intestine to biologically active forms (aglycones) are absorbed, enter the enterohepatic circulation, and then undergo conjugation in the liver (95%). Some of these conjugates re-enter the enterohepatic circulation, while the remainder are excreted in urine and feces within 24 hours.

Clinical characteristics.

Indications.

Relief of symptoms associated with menopause in women: hot flashes, excessive sweating, sleep disturbances, increased irritability, depression, including prevention of cardiovascular disorders.

Contraindications.

Hypersensitivity to soy or to any of the components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

There are currently no known cases of interaction between Felit and other medicinal products.

Special precautions for use.

Filita should be used with caution in women with a history of breast neoplasms or endometrial hyperplasia.

Due to the weak estrogenic effect of the medicinal product, it is recommended to obtain from the patient a history of concomitant use of oral contraceptives.

Use during pregnancy or breastfeeding.

The medicinal product is contraindicated during pregnancy and during breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

Filita does not affect the ability to drive or operate complex machinery.

Dosage and Administration.

Felita is recommended to be taken 1-2 tablets twice daily during meals, with a small amount of liquid.

The treatment course lasts 6–12 months. It should not be used for longer than 2 years.

Children.

The medicinal product should not be administered to children.

Overdose.

Cases of overdose have not been reported. Overdose may enhance manifestations of adverse reactions.

Symptomatic treatment is recommended.

Side effects.

Allergic reactions are possible in individuals sensitive to any component of the drug. Vaginal discharge, including bloody discharge, is possible.

Shelf life. 3 years.

Storage conditions.

Store in a dry place at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Packaging.

10 tablets in a blister pack. 1, 3 or 6 blisters in a cardboard package.

Availability. Over-the-counter.

Manufacturer.

BIOFARM Ltd.

Manufacturer's location and address of business activity.

Valbzhyska Street 13, 60-198 Poznan, Poland.