INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BIRCH BUDS (GEMMAEBETULAE)

Composition:

Active substance: birch buds.

Dosage form. Buds.

Main physico-chemical properties: elongated-conical buds, pointed or blunt, often sticky. Scales arranged imbricately, closely pressed at the edges, slightly tomentose (lower scales shorter than upper ones and sometimes with tips slightly spreading apart); bud length 3–7 mm, width 1.5–3 mm;

bud color brown, slightly greenish at the base. Aromatic, pleasant odor. Taste slightly astringent, resinous.

Pharmacotherapeutic group.

Non-thiazide diuretics with moderately expressed activity. ATC Code C03BX.

Pharmacological properties.

Pharmacodynamics.

Due to its chemical composition, birch bud preparations exhibit mild choleretic, diuretic, anti-inflammatory, and expectorant effects.

Clinical characteristics.

Indications.

Chronic inflammatory diseases of the kidneys and urinary bladder; urolithiasis; cardiac edema; liver and biliary tract disorders with impaired bile secretion; laryngitis, bronchitis, tracheitis.

Contraindications.

Renal insufficiency, acute inflammatory kidney diseases, hypersensitivity to biologically active components of the drug, history of bleeding from pelvic organs; anemia; epilepsy.

Special precautions. Consult a physician before starting treatment. In case of dysuric symptoms, fever, spasms, or presence of blood in urine, seek medical advice.

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

Usage characteristics.

Use during pregnancy or breastfeeding.

The safety and clinical efficacy of the medicinal product during pregnancy or breastfeeding have not been studied.

Ability to affect reaction speed when driving or operating machinery. Not described.

Method of Administration and Dosage.

Place 1 tablespoon of buds into an enameled container, pour 200 ml of hot boiled water, cover with a lid, and place on a boiling water bath for 15 minutes. Cool at room temperature for 45 minutes, then strain and squeeze the residue into the strained infusion. Adjust the volume of the infusion to 200 ml with boiled water. Adults should take ⅓ cup of the warm infusion 2–3 times daily, 15–20 minutes before meals. Children aged 12–14 years: ¼ cup; children aged 14 years and older: ⅓ cup, 2–3 times daily, 15–20 minutes before meals. It is recommended to shake the infusion before use.

The duration of treatment is determined individually by a physician.

Children.

Do not administer to children under 12 years of age.

Overdose.

No reports of overdose have been received.

Side effects.

Diarrhea. Possible signs of irritant effect of the infusion on kidney tissue; allergic reactions, including itching, skin rash, allergic rhinitis, urticaria, hyperemia and skin swelling. If adverse reactions occur, discontinue use of the product and consult a physician immediately.

Shelf life. 2 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C; prepared infusion – in a cool place (8–15 °C) for no more than 2 days.

Packaging. 10 g in sachets; 10 g, 20 g, or 50 g in pouches, with insertion into a carton.

Availability. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's address and place of business.

69050, Ukraine, Zaporizhzhia, Skladska St., 4.

Marketing Authorization Holder. JSC Pharmaceutical Factory "Viola".

Address of the Marketing Authorization Holder.

69063, Ukraine, Zaporizhzhia, Akademika Amosova St., 75.