UROCHOLUM®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT UROCHOLUM® (UROCHOLUM)

Composition:

Active substances:

1 capsule contains 50 mg of dry urocholum extract obtained from aqueous-ethanolic extract (1 : 1) (extraction solvent — 40 % ethanol) from a mixture: wild carrot fruits (Dauci carotae fructus) — 200 mg, staminal orthosiphon leaf (Orthosiphonis staminei folia) — 180 mg, bird's-foot grass herb (Polygoni avicularis herba) — 150 mg, maize styles with stigmas (Zeae maydis styli cum stigmatis) — 120 mg, black elder flowers (Sambuci nigrae flores) — 100 mg, horsetail herb (Equiseti herba) — 100 mg, hops strobiles (Lupuli flos) — 50 mg, birch buds (Betulae gemmae) — 50 mg, St. John's wort herb (Hyperici herba) — 40 mg, peppermint leaf (Menthae piperitae folia) — 10 mg; 2 % maltodextrin;

Excipients: lactose monohydrate, magnesium stearate;

hard gelatin capsule: gelatin, titanium dioxide (E 171), iron oxide (E 172), azorubine (E 122), indigotine (E 132), patent blue V (E 131).

Pharmaceutical form. Capsules.

Main physicochemical properties: hard gelatin capsules with a straw-colored body and dark green cap. The capsule contents are a powder ranging from light yellow to brown in color, containing small particles from light to dark. The presence of particle agglomerates is permissible.

Pharmacotherapeutic group. Urological agents. Other urological agents.

ATC code G04BX.

Pharmacological Properties.

Pharmacodynamics.

A plant-derived medicinal product. The complex of biologically active substances of urocholum, readily absorbed into the blood and stimulating renal and hepatic circulation, promotes increased urine and bile secretion, normalizes the tone of the smooth musculature of the upper urinary tract and gallbladder, reduces inflammatory processes, and exerts bactericidal, diuretic, choleretic, and spasmolytic effects.

Urocholum produces an anti-azotemic effect, eliminating urea, uric acid, and chlorides from the body. It promotes the excretion of sand and stones from the kidneys, urinary bladder, and gallbladder.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications. To be used as part of complex therapy for acute and chronic diseases (non-specific infections) of the urinary tract (cystitis, urethritis) and kidneys (pyelonephritis), chronic non-infectious kidney diseases (nephritis, nephrosis); urolithiasis, nephrolithiasis, and salt diathesis (for prevention of concrement formation, including after their removal); chronic cholecystitis, biliary tract dyskinesia.

Contraindications.

Hypersensitivity to the components of the medicinal product. Alterations in blood rheological properties, obstructive jaundice.

Special precautions.

Use with caution in patients with gastroesophageal reflux (due to possible occurrence or exacerbation of heartburn).

Do not use the medicinal product if the diameter of stones exceeds 3 mm.

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

Special precautions for use.

The gelatin capsule contains azorubine (E 122), which may cause allergic reactions.

The medicinal product contains lactose; therefore, if the patient has been diagnosed with intolerance to certain sugars, consult a physician before taking this medication.

Use during pregnancy or breastfeeding. The medicinal product is not used during pregnancy and breastfeeding.

Ability to influence reaction rate when driving or operating machinery. Not studied.

Dosage and Administration.

For adults and children aged 12 years and older, take 1 capsule three times daily before meals. The capsules should be swallowed whole, without chewing, with sufficient liquid (e.g., a glass of water). The duration of treatment is determined by a physician based on the course of the disease and concomitant therapy, and usually lasts from 5 days to 1 month. The treatment course may be repeated upon physician's recommendation.

Children. The medicinal product is not intended for children under 12 years of age.

Overdose.

Exaggeration of adverse reactions.

Treatment: in case of overdose, administer large amounts of warm fluids and provide symptomatic treatment.

Adverse reactions.

Central nervous system: frequency unknown — dizziness.

Gastrointestinal disorders: frequency unknown — dyspeptic symptoms (nausea, vomiting).

Skin and subcutaneous tissue disorders: frequency unknown — allergic reactions (including rash, itching, hyperemia, skin swelling).

Reporting of adverse reactions after drug registration is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of drug efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 ºC. Keep out of reach of children.

Packaging. 10 capsules per blister; 2, 4, 6, or 9 blisters per carton.

Supply category. Over-the-counter.

Manufacturer. LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and location of business activity. 4, Korolova St., Stanyshivka Village, Zhytomyr District, Zhytomyr Region, 12430, Ukraine.