Trinefron-zdorovya

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TRINEPHRON-ZDOROVYE (TRINEPHRON-ZDOROVYE)

Composition:

Active ingredient: 1 g (27 drops) of the preparation contains 290 mg of liquid extract from medicinal plant raw materials: centaury herb (Herba Centaurii), rosemary leaf (Folia Rosmarini officinalis), and lovage root (Radix Levistici officinalis) (1:1:1) (1:16) (extraction solvent: ethanol 59%);

Excipient (besides extraction solvent): purified water.

Pharmaceutical form. Oral drops.

Main physicochemical properties: clear, slightly cloudy yellow-brown liquid with a characteristic odor. Slight opalescence or formation of a minor sediment during storage is permissible.

Pharmacotherapeutic group. Agents used in urology. ATC code G04BX.

Pharmacological properties.

Pharmacodynamics.

The components contained in the herbal medicinal product exhibit complex activity, manifested as anti-inflammatory, antioxidant, spasmolytic, and analgesic effects. The preparation also has antibacterial and diuretic effects, which are due to substances present in the herbal components of the preparation.

Clinical characteristics.

Indications.

For complex treatment of inflammatory diseases of the urinary tract.

Prevention of urinary stone formation, including after their removal.

Contraindications.

Hypersensitivity to any component of the medicinal product or to other plants of the Apiaceae family, e.g. anise, fennel, or to anethole (i.e. a component of essential oils found, for example, in anise and fennel).

Peptic ulcer in the stage of exacerbation.

Edema due to heart failure or impaired kidney function and/or when reduced fluid intake has been recommended.

Interaction with other medicinal products and other forms of interaction.

If concomitant use with any other medicinal products is necessary, consult a physician.

Special precautions for use.

During storage of the medicinal product, turbidity or precipitation may occur; however, this does not affect the efficacy of the medicinal product.

If fever persists, spasms occur, blood appears in the urine, urinary disturbances develop, or acute urinary retention occurs, medical advice must be sought immediately.

This medicinal product contains 13.73–14.92% ethanol (alcohol), i.e. 254–276 mg/dose. The product should not be used in patients suffering from alcoholism or in patients who have completed treatment for alcoholism. The alcohol content of the product must be taken into account when administering to patients at high risk, such as those with liver disease, epilepsy, or brain disorders. Use with caution in children.

Use during pregnancy or breastfeeding.

Pregnancy.

No experimental adverse effects of direct or indirect action of the medicinal product have been identified. Currently, experience with use of the medicinal product in pregnant women is limited. Therefore, as a precaution, use of the medicinal product during pregnancy should be avoided.

Breastfeeding.

Due to the lack of data regarding passage of the medicinal product or its metabolites into breast milk, a risk to the infant cannot be excluded. Therefore, the medicinal product should not be used during breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

The medicinal product, at recommended doses, does not affect the ability to drive or operate machinery; however, it should be noted that the product contains ethanol.

Dosage and Administration.

Unless otherwise prescribed by a physician, the medication should be administered to adults and children aged 12 years and older at a dose of 50 drops three times daily (total daily dose − 150 drops).

Adult patients should take the drops undiluted. If necessary (e.g., due to bitter taste in children), the drops may be taken with any liquid. Shake well before use! When administering the drops, hold the bottle vertically.

Adequate fluid intake should be ensured during treatment.

The duration of treatment is determined individually by a physician. If the medication is well tolerated, it may be prescribed for a prolonged period.

Children. The medication should not be used in children under 12 years of age.

Overdose.

Cases of poisoning due to overdose have not been reported. Treatment is symptomatic.

Side effects.

Gastrointestinal disturbances (nausea, vomiting, diarrhea) are common. Allergic reactions may occur in case of hypersensitivity to the components of the drug, including skin rash, urticaria, itching, and skin hyperemia.

If any adverse reactions occur, discontinue use of the drug and consult a physician.

Shelf life. 3 years.

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

Keep out of reach of children.

Shelf life of the drug after opening the bottle – 6 months.

Packaging. 50 ml or 100 ml in a bottle closed with a dropper stopper and cap, in a box.

Availability. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVYA".

Manufacturer's address and place of business.

22 Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.