Urolesan®
Ukraine
Table of Contents
INSTRUCTION for medical use of the medicinal product UROLESAN® (UROLESAN)
Composition:
Active substances: 1 capsule contains Urolesan® extract, obtained from a mixture of liquid extracts of Daucus carota L., fructus (wild carrot fruits) (1:1), Humulus lupulus L., flos (hops flowers) (1:1), Oreganum vulgare L., herba (oregano herb) (1:1) in a ratio of 1/1.4/1, extractant – 96% ethanol v/v, calculated to 10% moisture – 10.70 mg; Mentha × piperita L., aetheroleum (peppermint oil) – 7.46 mg; Abies sibirica L., aetheroleum (Siberian fir oil) – 25.50 mg.
Excipients: magnesium aluminometasilicate; castor oil; heavy magnesium carbonate; talc; lactose monohydrate; disodium edetate (EDTA); potato starch.
Pharmaceutical form. Capsules.
Main physicochemical properties: hard gelatin capsules size "0", body and cap of green color. The capsule contents – granular powder and/or compacted mass ranging from yellowish-gray to grayish-brown with a greenish tint, with specks, and with the odor of peppermint and fir oils. The presence of agglomerates which disintegrate upon pressure is permissible.
Pharmacotherapeutic group: Medicinal products used in urology.
ATC code: G04BX.
Pharmacological properties.
A combined herbal preparation. The components of Urolesan® reduce inflammatory phenomena in the urinary tract and kidneys, promote enhanced blood circulation in the kidneys and liver, exhibit diuretic, antibacterial, and choleretic effects, form a protective colloid in urine, and normalize the tone of smooth musculature of the upper urinary tract and gallbladder.
Urolesan® increases excretion of urea and chlorides, promoting the elimination of small calculi and sand from the urinary bladder and kidneys.
Clinical characteristics.
Indications.
Acute and chronic infections of the urinary tract and kidneys (cystitis and pyelonephritis); urolithiasis and uric acid diathesis (prevention of concrement formation after their removal); chronic cholecystitis (including calculous cholecystitis), biliary tract dyskinesia, cholelithiasis.
Contraindications.
- Hypersensitivity to the components of the drug;
- gastritis (except gastritis with secretory insufficiency), peptic ulcer of the stomach and duodenum.
Interaction with other medicinal products and other forms of interaction. Not studied.
Usage Notes.
Do not use the drug if the diameter of concrements exceeds 3 mm.
The drug contains excipients lactose and potato starch; therefore, patients with rare hereditary forms of galactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome, or with increased sensitivity or gluten intolerance should not use this drug in this pharmaceutical form.
Use during pregnancy or breastfeeding.
The use of the drug during pregnancy or breastfeeding has not been studied.
Ability to affect reaction speed when driving or operating machinery.
Has not been studied.
Dosage and Administration
Take the medication orally before meals.
Recommended doses for adults and children aged 14 years and older: 1 capsule three times daily. In acute conditions (including renal and hepatic colic), the treatment course lasts from 5 to 7 days; in chronic conditions, from 7 days to 1 month. In cases of renal or hepatic colic, the single dose may be increased once to 2 capsules; thereafter, resume the usual single dose (1 capsule) at the next administration.
Children.
Children under 14 years of age should be given Urolesan® in the form of syrup or liquid.
Overdose.
Symptoms of overdose may include: nausea, dizziness, and enhanced sedative effect of the drug.
Treatment: Symptomatic therapy. Intensive warm fluid intake, rest, activated charcoal, atropine sulfate (0.0005–0.001 g).
Adverse reactions.
Urolesan® is generally well tolerated. The following may occur during treatment:
Gastrointestinal tract: dyspeptic disorders (including nausea, vomiting);
Allergic reactions, including hyperemia, urticaria, itching sensation, facial flushing, skin rashes, angioneurotic edema (including throat irritation, breathing difficulties, facial swelling, tongue swelling);
Central and peripheral nervous system: dizziness, general weakness;
Cardiovascular system: arterial hypertension, hypotension, chest pain.
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. 10 capsules per blister, 4 blisters per carton.
Availability. Over-the-counter.
Manufacturer. JSC "Kyivmedpreparat".
Manufacturer's address and place of business.
139 Saksahanskoho Street, Kyiv, 01032, Ukraine.
INSTRUCTION
for medical use of medicinal product
UROLESAN®
(UROLESAN)
Composition:
Active ingredients: 1 capsule contains 10.70 mg of dry Urolesan® extract obtained from a mixture of liquid extracts from Daucus carota L., fructus (wild carrot fruits) (1:1), Humulus lupulus L., flos (hops)/ Oreganum vulgare L., herba (oregano herb) (1/1.4/1), extractant – 96% ethanol by volume, calculated to 10% moisture; 7.46 mg of Mentha x piperita L., aetheroleum (peppermint oil); 25.50 mg of Abies sibirica L., aetheroleum (fir oil).
Excipients: magnesium aluminometasilicate; castor oil; heavy magnesium carbonate; talc; lactose monohydrate; disodium edetate (EDTA); potato starch.
Pharmaceutical form. Capsules.
Main physicochemical properties: hard gelatin capsules size №0, green-colored body and cap. Capsule contents – granulated powder and/or compacted mass ranging from yellow-gray to gray-brown with a greenish tint, specks, and odor of peppermint and fir oils. Agglomerates that disintegrate upon pressure may be present.
Pharmacotherapeutic group. Medicinal products used in urology.
ATC code G04BX.
Pharmacological properties.
A combined herbal preparation. The components of Urolesan® reduce inflammatory processes in the urinary tract and kidneys, enhance blood supply to the kidneys and liver, exert diuretic, antibacterial, and choleretic effects, form a protective colloid in urine, and normalize smooth muscle tone of the upper urinary tract and gallbladder.
Urolesan® increases excretion of urea and chlorides and promotes elimination of small calculi and sand from the bladder and kidneys.
Clinical characteristics.
Indications.
Acute and chronic infections of the urinary tract and kidneys (cystitis, pyelonephritis); urolithiasis and uric acid diathesis (prevention of stone formation after their removal); chronic cholecystitis (including calculous), biliary dyskinesia, cholelithiasis.
Contraindications.
- Hypersensitivity to the components of the drug;
- gastritis (except gastritis with secretory insufficiency), peptic ulcer of the stomach and duodenum.
Interaction with other medicinal products and other forms of interaction. Not studied.
Special precautions. Do not use the drug if the diameter of calculi exceeds 3 mm.
The drug contains excipients lactose and corn starch; therefore, patients with rare hereditary forms of galactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome, or with gluten sensitivity or intolerance should not use this drug formulation.
Use during pregnancy or breastfeeding.
Use of the drug during pregnancy or breastfeeding has not been studied.
Effect on reaction rate when operating vehicles or machinery. Not studied.
Dosage and administration.
Take orally before meals.
Recommended doses for adults and children aged 14 years and older: 1 capsule three times daily. In acute conditions (including renal and hepatic colic), treatment duration is 5 to 7 days; in chronic conditions – from 7 days up to 1 month. In case of renal or hepatic colic, the single dose may be increased once to 2 capsules, then return to the usual single dose (1 capsule) at the next administration.
Children.
Children under 14 years of age should be prescribed Urolesan® in syrup or liquid form.
Overdose.
Symptoms of overdose may include: nausea, dizziness, increased sedative effect of the drug.
Treatment: symptomatic therapy. Abundant warm fluid intake, rest, activated charcoal, atropine sulfate (0.0005–0.001 g).
Adverse reactions.
Urolesan® is generally well tolerated. The following may occur during treatment:
Gastrointestinal tract: dyspeptic symptoms (including nausea, vomiting);
Allergic reactions, including hyperemia, urticaria, itching sensation, facial redness, skin rash, angioneurotic edema (including throat irritation, breathing difficulty, facial swelling, tongue swelling);
Central and peripheral nervous system: dizziness, general weakness;
Cardiovascular system: arterial hypertension, hypotension, chest pain.
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. 10 capsules per blister, 4 blisters per carton.
Availability. Over-the-counter.
Manufacturer. JSC "Kyivmedpreparat".
Manufacturer's address and place of business.
139 Saksahanskoho Street, Kyiv, 01032, Ukraine.