BIRCH BUDS

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

Composition:

Active substance: 1 packet contains birch buds (Betulae gemmae) – 10 g, 50 g.

Pharmaceutical form. Buds.

Main physico-chemical properties: buds are elongated-conical, pointed or blunt, often sticky. Scales are arranged imbricately, tightly pressed at the edges, slightly pubescent (lower scales shorter than upper ones, sometimes with tips slightly spreading apart); bud length 3–7 mm, width – 1.5–3 mm. Bud color is brown, sometimes greenish at the base. Odor is balsamic, pleasant. Taste is slightly mucilaginous, resinous.

Pharmacotherapeutic group. Non-thiazide diuretics with moderately expressed activity. ATC code C03BX.

Pharmacological properties.

Pharmacodynamics. Birch buds contain essential oil, saponins, flavonoids (apigenin, isorhamnetin), tannins, resins, ascorbic and nicotinic acids, carotene, and hyperoside. The preparation from birch buds exerts diuretic, choleretic, spasmolytic, anti-inflammatory, antiseptic, wound-healing, expectorant, antiviral, and antiparasitic effects.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

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

Contraindications.

Renal insufficiency, acute inflammatory diseases of the kidneys, hypersensitivity to biologically active substances of the medicinal product, history of bleeding from pelvic organs; anemia; epilepsy.

Interaction with other medicinal products and other types of interactions.

Unknown.

Special precautions for use.

"Buds of Birch" is a traditional herbal medicinal product for use according to indications supported by long-standing use.

The patient should consult a physician if symptoms do not resolve during treatment or if adverse reactions occur that are not listed in the product's instructions for medical use.

Prior to initiating treatment, a medical consultation is recommended. If dysuric symptoms, fever, spasms, or blood in urine occur, medical advice should be sought.

Use during pregnancy or breastfeeding.

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

Ability to influence reaction rate while driving or operating machinery.

Has no effect.

Method of administration and dosage.

Place 1 tablespoon of buds into an enameled container, pour 200 ml of boiled water, cover with a lid, and let steep on a boiling water bath for 15 minutes. Cool at room temperature for 45 minutes, then strain, squeeze the residue into the strained infusion, and adjust the volume of the infusion to 200 ml with boiled water. Adults should take warm, ⅓ cup 2–3 times daily, 15–20 minutes before meals; children aged 12–14 years – ¼ cup, and from 14 years of age – ⅓ cup, 2–3 times daily, 15–20 minutes before meals. The infusion is recommended to be shaken 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 reported.

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 medication and consult a physician immediately.

Shelf life. 2 years.

Storage conditions.

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

The prepared infusion should be stored at a temperature not exceeding 15 °C for no more than 2 days.

Keep out of reach of children!

Packaging.

10 g or 50 g per package with an inner pouch.

Availability. Over-the-counter.

Manufacturer/Applicant.

LLC "Ternopharm".

Manufacturer's address and location of business activity / Applicant's address.

4 Haharina Street, Ternopil, 46010, Ukraine.