Trinefron-zdorovya

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TRINEFROV-ZDOROVIYA

Composition:

Active substances: 1 capsule contains powdered herbal raw material:

Centaurii herba (centaury herb) 18 mg;

Rosmarini folium (rosemary leaf) 18 mg;

Levistici radix (lovage root) 18 mg;

Excipients: lactose monohydrate; povidone; maize starch; colloidal anhydrous silicon dioxide; magnesium stearate; capsule shell containing Yellow West FCF (E 110), titanium dioxide (E 171), gelatin, black printing ink (if the manufacturer's trademark – ZT is applied; contains shellac glaze 45% solution in ethanol, iron oxide black (E 172), propylene glycol, concentrated ammonia solution).

Pharmaceutical form. Capsules.

Main physicochemical properties: hard gelatin capsules of orange color. The capsule contents consist of a mixture containing granules and powder ranging from light brown to brown. Agglomeration of particles may be present. The manufacturer's trademark – ZT may be printed on the capsule.

Pharmacotherapeutic group. Agents used in urology. ATC code G04BX50.

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 determined by substances present in the herbal components of the drug.

Clinical characteristics.

Indications. For complex treatment of inflammatory diseases of the urinary tract.

Prevention of urinary stone formation, including after their removal.

Contraindications. Increased individual sensitivity 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 physician's recommendation to limit fluid intake.

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

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

Special precautions for use.

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

If the patient has known sensitivities to certain sugars, consult a physician before taking this medicinal product.

The formulation contains the colouring agent Sunset Yellow FCF (E110), which may cause allergic reactions.

Use during pregnancy or breastfeeding.

Pregnancy. Observational data in pregnant women indicate no risk of fetal malformations or fetal/neonatal toxicity with the use of these capsules. Experimental studies have shown no evidence of reproductive toxicity. The use of this medicinal product during pregnancy is possible after consultation with a physician.

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

Effect on ability to drive or operate machinery. The medicinal product does not affect the ability to drive or operate machinery.

Dosage and Administration.

Unless otherwise prescribed by a physician, the recommended dose for adults and children aged 12 years and older is 2 capsules three times daily (total daily dose – 6 capsules). The capsules should be swallowed whole, without chewing, with sufficient liquid (e.g., a glass of water). Adequate fluid intake should be maintained during treatment.

The duration of treatment is determined individually by a physician. If the drug is well tolerated, it may be administered long-term.

Children. The drug is not recommended for children under 12 years of age.

Overdose. Cases of poisoning due to overdose have not been reported.

Treatment: 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 urticaria, itching, skin hyperemia.

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

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. Capsules №30 (№10x3), №60 (№10x6) in blisters in a box.

Availability. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Limited Liability Company "FARMEKS GROUP".

Manufacturer's address and place of business. Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenka Street, 22.

(LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA")

Ukraine, 08301, Kyiv region, city of Boryspil, Shevchenka Street, 100.

(Limited Liability Company "FARMEKS GROUP")