Fitolith forte h

INSTRUCTIONS for medical use of the medicinal product PHYTOLYTE FORTE N

Composition:

Active substances: 1 capsule contains dry extract of common horsetail herb (7.69:1) (extractant – purified water) 75 mg, dry extract of St. John's wort (9.26:1) (extractant – ethanol 50%) 45 mg, dry extract of field horsetail (9.17:1) (extractant – ethanol 50%) 37.5 mg, dry extract of avens (12.5:1) (extractant – ethanol 70%) 37.5 mg;

Excipients: microcrystalline cellulose, colloidal anhydrous silicon dioxide, calcium stearate; the capsule shell contains indigocarmine (E 132), quinoline yellow (E 104), titanium dioxide (E 171), gelatin.

Pharmaceutical form. Capsules.

Main physicochemical properties: hard gelatin capsules of green color. The capsule contents – a mixture of granules and powder ranging from light brown to dark brown with a greenish tint. The presence of powder particle agglomerates is permissible. The manufacturer's trademark "ZT" may be printed on the capsule.

Pharmacotherapeutic group. Agents promoting dissolution of urinary calculi. Other preparations, including combinations. ATC code G04BC.

Pharmacological properties.

Pharmacodynamics. The medicinal product has spasmolytic, diuretic, analgesic, and anti-inflammatory effects; possesses antimicrobial and antiseptic properties and regulates mineral metabolism. It reduces the frequency and intensity of renal colic, normalizes the physicochemical parameters of urine, promotes restoration of optimal urodynamics and urinary homeostasis, and reduces leukocyturia. It facilitates the flushing out of sand and small concrements and prevents the growth of concrements or the formation of new ones. The drug exerts a beneficial effect on spermatogenesis under conditions of experimental prostatitis (increases spermatozoa concentration, prolongs the duration of spermatozoa motility and the percentage of motile forms, reduces the number of pathologically altered spermatozoa, and improves acid and osmotic resistance).

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications. Treatment and prevention of urolithiasis (presence of primary and recurrent stones of various sizes and locations in the kidneys and urinary tract); complications caused by passage of stone fragments after extracorporeal shock wave lithotripsy; in renal colic; prevention of urinary calculi formation after their surgical removal and/or spontaneous passage; as part of comprehensive supportive therapy for chronic pyelonephritis, chronic inflammatory diseases of the lower urinary tract (cystitis, urethritis), and chronic prostatitis.

Contraindications. Hypersensitivity to any component of the drug, thrombophlebitis, changes in blood rheological properties, acute inflammatory diseases of the kidneys and urinary bladder, presence of stones larger than 6 mm in the urinary tract, nephritis, nephroses, nephronephritis, glomerulonephritis; arterial hypertension.

Interaction with other medicinal products and other types of interactions. It is not recommended for use in patients taking anticoagulants, antibiotics, sulfonamides, contraceptives, calcium channel blockers, female sex hormones, hypolipidemic agents (statins), or cardiac glycosides.

If simultaneous use with any other medicinal products is necessary, a physician should be consulted.

Special precautions for use

The medicinal product can be used in combination with antimicrobial agents.

If any of the following adverse reactions occur, the drug should be taken after food, but treatment should not be discontinued. To facilitate the elimination of concrements, it is recommended to drink a large amount of water (1.5–2 L) within 2–3 hours.

In patients with urolithiasis and pronounced pyuria, administration of antimicrobial agents is indicated.

Use during pregnancy or breastfeeding. The drug is contraindicated during pregnancy and breastfeeding.

Ability to influence reaction rate while driving or operating machinery. Unknown.

Method of Administration and Dosage.

For urolithiasis, adults and children aged 12 years and older should take 2 capsules three times daily before meals. The treatment course lasts 20–30 days. After a break, the course may be repeated.

For prevention of recurrent kidney and urinary tract stone formation, after extracorporeal shock wave lithotripsy, administer 2 capsules three times daily for 5–15 days; after surgical removal of stones or their spontaneous passage – 2 capsules three times daily for 1–2 months. In cases of renal colic, administer 1–2 capsules after alleviating pain with analgesics.

For chronic pyelonephritis, the drug should be used either in parallel with or following basic therapy as monotherapy: 1 capsule three times daily before meals for 3 weeks. Treatment courses (with 1–2 week intervals) may be repeated for 2–3 months.

For chronic cystitis, urethritis, and prostatitis, administer 2 capsules three times daily for 21–28 days. The course may be repeated after a 2-week interval.

The number of treatment courses and their duration should be determined individually by a physician based on the patient's condition.

If lower doses are required, switching to Fitolit capsules is recommended.

Children. The drug is contraindicated in children under 12 years of age.

Overdose. No toxic effects of the drug have been reported. After a single intake of more than 20 capsules, adverse reactions may be intensified. Overdose or prolonged use may cause a bitter taste in the mouth and discomfort in the liver area. In case of overdose, gastric lavage and administration of activated charcoal are recommended. Symptomatic treatment is indicated.

Adverse reactions.

The drug is well tolerated by patients and usually does not cause adverse reactions. Mild dyspeptic symptoms such as nausea, epigastric discomfort, vomiting, diarrhea, photosensitization, and kidney tissue irritation (manifested by back pain and pain at the end of urination) are possible, as well as increased blood pressure.

In individuals with increased sensitivity, allergic reactions may occur (including redness, rashes, itching, swelling). Prolonged use of the drug may lead to discoloration of dental enamel and disturbances in bone tissue structure (osteoporosis).

If any adverse reactions occur, 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.

Packaging. Capsules № 10×3, № 10×6 in blisters in a box.

Availability. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVYA".

Limited Liability Company "FARMEKS GROUP".

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

(LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVYA")

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

(Limited Liability Company "FARMEKS GROUP")