Urolesan®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT UROLESAN® (UROLESAN)

Composition:

Active substances: 1 ml of the preparation contains: fir oil (oleum Abies) – 67.60 mg; peppermint oil (oleum Menthae piperitae) – 16.90 mg; liquid extract of wild carrot fruits (1:1) (extractum fructuum Dauci sativi fluidum) (extraction solvent: 96% ethanol) – 194.35 mg; liquid extract of hop cones (1:1) (extractum fructuum Strobili lupuli fluidum) (extraction solvent: 96% ethanol) – 278.80 mg; liquid extract of origanum herb (1:1) (extractum herbae Origani fluidum) (extraction solvent: 96% ethanol) – 192.95 mg;

Excipients: disodium edetate, castor oil.

Pharmaceutical form. Oral drops.

Main physicochemical properties: liquid ranging from greenish-brown to brown in color, with a characteristic minty odor.

Pharmacotherapeutic group.

Agents 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, promote enhanced blood circulation in the kidneys and liver, have 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.

The preparation is well absorbed; its action begins within 20–30 minutes and lasts for 4–5 hours. Maximum effect is achieved within 1–2 hours. It is excreted through the gastrointestinal tract 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 stone formation after their removal); chronic cholecystitis (including calculous), biliary tract dyskinesia, cholelithiasis.

Contraindications.

• Hypersensitivity to the components of the drug;
• gastritis, peptic ulcer of the stomach and duodenum;
• children with a history of seizures (febrile or otherwise).

Interaction with other medicinal products and other forms of interaction. Not studied.

Special precautions for use.

Do not use the drug if the diameter of concrements exceeds 3 mm.

Use with caution in patients with bronchial asthma due to the risk of bronchospasm.

Use during pregnancy or breastfeeding.

Use of the drug during pregnancy or breastfeeding has not been studied.

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

Dosage and Administration.

Take orally before meals.

Recommended dose for adults: 8-10 drops (on sugar; for patients with diabetes mellitus—on bread) 3 times daily. For renal and hepatic colic, the single dose is 15-20 drops. Treatment duration is 5 to 7 days; in chronic conditions, from 7 days up to 1 month.

Recommended dose for children aged 7–14 years: 5-6 drops (on sugar; for patients with diabetes mellitus—on bread) 3 times daily.

The single dose, frequency, and duration of treatment should be individually determined by a physician.

Children. For children under 7 years of age, Urolesan® syrup is recommended when treatment is necessary.

Overdose.

Symptoms of overdose may include: nausea, vomiting, abdominal pain, dizziness.

Treatment: warm fluids, rest, activated charcoal, atropine sulfate (0.0005–0.001 g).

Adverse reactions.

Urolesan® is usually well tolerated. The following adverse reactions may occur during the use of the product:

Gastrointestinal disorders: dyspeptic symptoms (including nausea, vomiting, diarrhea, abdominal pain);

Immune system disorders: allergic reactions, including itching, facial flushing, skin rashes, urticaria, angioedema (burning sensation in the mouth, breathing difficulties, swelling of the face and tongue), anaphylactic shock;

Central and peripheral nervous system disorders: dizziness, general weakness, headache, ataxia, muscle tremor;

Cardiovascular system disorders: arterial hypotension, hypertension, bradycardia.

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.

25 ml in a dropper bottle, 1 dropper bottle per carton;

25 ml in a dropper bottle closed with a cap with a tamper-evident seal; 1 dropper bottle per carton.

Prescription status. Over-the-counter.

Manufacturer.

PJSC "Galychfarm".

Manufacturer's address and place of business.

6/8 Opryshkivska Street, Lviv, 79024, Ukraine.