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Urolesan® (Capsules, Drops) Instructions for Use

ATC Code

G04BC (Drugs for the treatment of nephrourolithiasis)

Clinical-Pharmacological Group

Herbal preparation with diuretic, choleretic, litholytic, and spasmolytic action

Pharmacotherapeutic Group

Spasmolytic agent of plant origin

Pharmacological Action

The drug exerts spasmolytic, anti-inflammatory, antiseptic action, enhances bile formation and bile secretion, increases diuresis, acidifies urine, and increases the excretion of urea and chlorides.

Indications

  • In the complex therapy of acute and chronic infections of the urinary tract and kidneys (cystitis, pyelonephritis);
  • Urolithiasis;
  • Cholelithiasis;
  • Chronic cholecystitis;
  • Biliary dyskinesia of the hyperkinetic type.

ICD codes

ICD-10 code Indication
K80 Cholelithiasis [cholelithiasis] (including biliary colic)
K81.1 Chronic cholecystitis
K82.8 Other specified diseases of gallbladder and cystic duct (including dyskinesia)
N10 Acute tubulointerstitial nephritis (acute pyelonephritis)
N11 Chronic tubulointerstitial nephritis (chronic pyelonephritis)
N20 Calculus of kidney and ureter
N21 Calculus of lower urinary tract
N23 Unspecified renal colic
N30 Cystitis
ICD-11 code Indication
DC11.Z Cholelithiasis, unspecified
DC12.1 Chronic cholecystitis
DC1Z Diseases of gallbladder and biliary tract, unspecified
DD94 Functional disorder of the gallbladder
GB50 Acute tubulo-interstitial nephritis
GB51 Acute pyelonephritis
GB55.Z Chronic tubulo-interstitial nephritis, unspecified
GB5Z Renal tubulo-interstitial diseases, unspecified
GB70.Z Calculus of upper urinary tract, unspecified
GB71.Z Calculus of lower urinary tract, unspecified
GC00.Z Cystitis, unspecified
MF56 Renal colic

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Drops

Sublingually, 8-10 drops on a piece of sugar, 3 times/day, before meals.

The course of treatment depends on the severity of the disease and lasts from 5 days to 1 month.

For renal and hepatic colic, a single dose can be increased to 15-20 drops.

Capsules

The drug is taken orally, before meals, 1 capsule 3 times a day.

In case of renal and hepatic colic, the single dose can be increased once to 2 capsules, then return to the usual single dose (1 capsule) at subsequent administrations.

Capsules should be taken without chewing, with a small amount of water.

For acute conditions (including renal and hepatic colic), the duration of the treatment course is from 5 to 7 days; for chronic conditions – up to 1 month.

Increasing the duration and conducting a repeated course of treatment is possible only on the recommendation of a doctor.

Adverse Reactions

From the digestive system dyspeptic phenomena (heartburn, nausea, vomiting, diarrhea);

Allergic reactions itching, facial redness, skin rash, angioedema (sensation of throat irritation, difficulty breathing, swelling of the face, tongue);

From the central and peripheral nervous system dizziness, general weakness;

From the cardiovascular system increase/decrease in blood pressure.

Contraindications

Hypersensitivity to the components of the combination; hyperacid gastritis, gastric and duodenal ulcer; kidney stone diameter exceeding 3 mm; age under 18 years.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is not recommended.

Use in Renal Impairment

Contraindicated in kidney stone diameter exceeding 3 mm.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

In chronic conditions, if there is no effect while taking the drug for 5-7 days, a doctor should be consulted.

Effect on ability to drive vehicles, operate machinery

In case of adverse reactions from the nervous system (dizziness), patients should refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions (driving vehicles, working with moving machinery).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Art-Pharm, LLC (Russia)

Manufactured By

Halychpharm, JSC (Ukraine)

Dosage Form

Bottle OTC Icon Urolesan® Oral drops: 25 ml dropper bottle.

Dosage Form, Packaging, and Composition

Oral drops as a liquid from greenish-brown to brown in color, with a characteristic mint odor.

1 ml
Fir oil 67.6 mg
Peppermint leaf oil 16.9 mg
Ricinus communis seed oil 92.95 mg
Wild carrot seed liquid extract (1:1) 194.35 mg
Extract of hop cones liquid (1:1) 278.8 mg
Origanum vulgare herb liquid extract (1:1) 192.95 mg

Excipients : disodium edetate – 0.04 mg.

25 ml – dropper bottles of dark glass (1) – packs.
25 ml – dropper bottles of dark glass (1) complete with a dropper cap – packs.

Marketing Authorization Holder

Art-Pharm, LLC (Russia)

Manufactured By

Kirov Pharmaceutical Factory, JSC (Russia)

Dosage Form

Bottle OTC Icon Urolesan® Oral drops: bottle 25 ml

Dosage Form, Packaging, and Composition

Oral drops as a liquid from greenish-brown to brown in color, with a characteristic odor.

1 ml
Siberian fir needle oil 67.6 mg
Peppermint leaf oil 16.9 mg
Wild carrot seed liquid extract (1:1) 194.35 mg
Common hop fruit extract liquid (1:1) 278.8 mg
Origanum vulgare herb extract liquid (1:1) 192.95 mg
Ricinus communis seed oil 92.95 mg

Excipients : disodium edetate – 0.04 mg.

25 ml – bottles of dark glass (1) with a dropper cap× – cardboard packs.

× the use of dropper caps without a plug is allowed.

Marketing Authorization Holder

Art-Pharm, LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle OTC Icon Urolesan® Capsules: 10, 20, 30, 40, 50, 60, 100 or 120 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size 0, body and cap green in color; capsule contents – granulated powder from yellow-gray to gray-brown with a greenish tint with inclusions and a characteristic odor; the presence of agglomerates that crumble when pressed is allowed.

1 caps.
Urolesan® dry extract* 145.14 mg
Peppermint leaf oil 7.46 mg
Fir oil 25.5 mg

* Urolesan® dry extract [Urolesan® thick extract (10-26:1)**, obtained from a mixture of liquid extracts from wild carrot seeds (Daucus carota L., fructus, fam. Apiaceae) (1:1)** / common hop fruits (Humulus lupulus L., flos, fam. Cannabaceae) (1:1)** / common oregano herb (Origanum vulgare L., herba, fam. Lamiaceae) (1:1)** in a ratio of 1:1.4:1 (w/w), calculated on a moisture content of 10% – 10.7 mg, magnesium hydroxycarbonate – 100.29 mg, potato starch – 5.62 mg, magnesium aluminometasilicate (neusilin UFL2) – 4.61 mg, Ricinus communis seed oil (castor oil) – 23.9 mg, disodium edetate (Trilon B) – 0.02 mg].
** indicates the ratio of medicinal plant material : obtained extract (DER, w/w), extractant – ethanol (ethyl alcohol) 96%.

Excipients : magnesium hydroxycarbonate – 31.67 mg, lactose monohydrate – 50.1 mg, Ricinus communis seed oil (castor oil) – 11.25 mg, magnesium aluminometasilicate (neusilin UFL2) – 22.5 mg, talc – 6.38 mg.

Capsule body composition: quinoline yellow dye – 1%, titanium dioxide – 0.8%, iron oxide yellow dye – 0.3%, patent blue dye – 0.16%, gelatin – up to 100%.
Capsule cap composition: quinoline yellow dye – 1%, titanium dioxide – 0.8%, iron oxide yellow dye – 0.3%, patent blue dye – 0.16%, gelatin – up to 100%.

10 pcs. – blister strip packs (4) – cardboard packs.
10 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
20 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
30 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
40 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
50 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
60 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
100 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
120 pcs. – polyethylene terephthalate jars (1) – cardboard packs.

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