INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FITYOLIT (PHYTOLYTE)

Composition:

Active substances: 1 ml of the preparation contains liquid extract from medicinal plant raw materials: fruits of Ammi visnaga (fructus Ammi visnagae), common knotgrass herb (herba Polygoni avicularis), St. John's wort herb (herba Hyperici), field horsetail herb (herba Equiseti) (1:1.22:0.88:0.73) (1:2.8) (extraction agent: ethanol 70%) with content of total flavonoids calculated as rutin — not less than 1.58 mg/ml, total chromones calculated as khellin — not less than 0.90 mg/ml;

Excipients: apart from the extraction agent, none present.

Pharmaceutical form. Oral solution.

Main physicochemical characteristics: clear brown solution with yellowish or greenish tint and specific odor. Slight opalescence or formation of a small sediment during storage is permissible.

Pharmacotherapeutic group. Agents used in urology. Agents promoting dissolution of urinary calculi. ATC code G04BC.

Pharmacological properties.

Pharmacodynamics. Phytolite is a combined preparation containing plant extracts.

Phytolite has spasmolytic, diuretic, analgesic, and anti-inflammatory effects, as well as antimicrobial and antiseptic properties; it regulates mineral metabolism. It reduces the frequency and intensity of renal colic, normalizes the physicochemical parameters of urine, restores optimal urodynamics and urinary homeostasis, and decreases leukocyturia. It promotes the flushing out of sand and small concretions, and prevents the growth of existing concretions or the formation of new ones.

In experimental prostatitis, Phytolite prevents the development of lesions in the urinary bladder, urethra, and reproductive organs, and normalizes spermatogenesis parameters.

Clinical characteristics.

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

Contraindications. Hypersensitivity to the components of the drug, glomerulonephritis, pregnancy, lactation period, children under 12 years of age.

Interaction with other medicinal products and other forms of interactions. Not established.

Special precautions for use.

Phytolite can be used in combination with antimicrobial agents.

If adverse effects occur, the administration of the drug should not be discontinued; instead, administration should be continued after meals. To facilitate the excretion of concretions, it is recommended to drink a large amount of water (1.5–2 L) over 2–3 hours.

In patients with urolithiasis and pronounced pyuria, antimicrobial agents are indicated.

This medicinal product contains 69.56% v/v ethanol (alcohol), i.e. 3.29 g per 6 mL dose.
Harmful for patients suffering from alcoholism. Caution is advised when using in children, patients with liver disorders, and patients with epilepsy.
The amount of alcohol in this medicinal product may affect the action of other drugs.

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy.

If use of the drug is necessary, breastfeeding should be discontinued for the duration of treatment.

Ability to affect reaction speed when driving or operating machinery.

Data are lacking. The drug contains alcohol, which should be taken into account when driving or operating machinery.

Method of administration and dosage. Administer orally to adults and children aged 12 years and older, before meals. Children aged 12 to 18 years should dilute the dose (4 mL) in 2 tablespoons (30 mL) of water before administration.

Urolithiasis. Administer 4–6 mL three times daily. The treatment course lasts 20–30 days. After a break, the treatment course may be repeated.

Prevention of recurrent formation of concretions in the kidneys and urinary tract after extracorporeal shock wave lithotripsy. Administer 4–6 mL three times daily for 5–15 days; after surgical removal of stones or their spontaneous passage — 4–6 mL three times daily for 1–2 months.

Renal colic. Administer 4–6 mL after relief of pain with analgesics.

Chronic pyelonephritis. The drug should be administered either concurrently with basic therapy or as monotherapy following basic therapy, 4 mL three times daily before meals for three weeks. Treatment courses (with a 1–2 week break between them) may be repeated for 2–3 months, transitioning to a maintenance dose of 2–4 mL daily.

Chronic cystitis, urethritis, and prostatitis. Administer 4–6 mL three times daily for 21–28 days. The course may be repeated after 2 weeks (4 mL three times daily). The number of treatment courses is determined by the physician depending on the patient's condition.

Maximum daily dose: 18 mL/day.

Maximum course dose: 540 mL.

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

Overdose. No toxic effects of the drug have been reported. A single overdose of the solution by ten times the recommended dose may lead to an intensification of adverse effects. In case of overdose, gastric lavage and administration of activated charcoal are recommended.

Side effects.

The drug is well tolerated by patients and usually does not cause adverse effects. Mild dyspeptic symptoms such as nausea and epigastric discomfort may occur.

In individuals with increased sensitivity, allergic reactions (redness, rash, itching) are possible.

Shelf life. 2 years.

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

Keep out of reach of children.

Packaging. 100 ml in a bottle with a dosing syringe, placed in a box.

Availability. Over-the-counter.

Manufacturer. Limited liability company "Pharmaceutical Company "Zdorovya".

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