Ursosan capsules are used for the following indications:
- for the dissolution of radiopaque cholesterol gallstones no larger than 15 mm in diameter in patients with a functioning gallbladder, despite the presence of gallstone(s) in it;
- for the treatment of biliary reflux gastritis;
- for symptomatic treatment of primary biliary cirrhosis (PBC) in the absence of decompensated liver cirrhosis;
- for the treatment of hepatobiliary disorders in cystic fibrosis in children aged 6 to 18 years.
Composition
Active ingredient: ursodeoxycholic acid;
1 capsule contains 250 mg of ursodeoxycholic acid;
Excipients: corn starch, corn starch, colloidal silicon dioxide, magnesium stearate;
Ingredients: gelatin, titanium dioxide (E 171).
Contraindication
- hypersensitivity to any substance included in the composition of the medicinal product;
- acute inflammation of the gallbladder or bile ducts;
- bile duct obstruction (blockage of the common bile duct or duct);
- frequent episodes of hepatic colic;
- radiopaque calcified gallstones;
- gallbladder contractility disorders;
- late stages of primary biliary cirrhosis due to insufficient therapeutic effect;
- Use in children: unsuccessful outcome of portoenterostomy or lack of adequate bile outflow in children with biliary atresia.
Method of application
For patients whose body weight is less than 47 kg or who have difficulty swallowing capsules, it is recommended to use ursodeoxycholic acid in a different dosage form.
One capsule of Ursosan 250 mg is taken once a day with some liquid in the evening before bedtime.
Usually, for the treatment of gastritis with bile reflux, Ursosan 250 mg capsules are taken for 10-14 days. The duration of treatment depends on the patient’s condition. The doctor should decide on the duration of treatment in each case individually.
Application features
Pregnant women
Ursosan 250 mg capsules should not be used during pregnancy unless clearly necessary. Women of childbearing age should only take the drug if they are using reliable contraception.
Children
Apply to children aged 6 to 18 years.
Drivers
No effect on the ability to drive or use other mechanisms was observed.
Overdose
In cases of overdose, diarrhea may occur. In general, other symptoms of overdose are unlikely, since the absorption of ursodeoxycholic acid decreases with increasing dose and therefore most of it is excreted in the feces.
If diarrhea occurs, the dose should be reduced, and if diarrhea is persistent, therapy should be discontinued.
No specific measures are required. The consequences of diarrhea should be treated symptomatically with restoration of fluid and electrolyte balance.
Side effects
Gastrointestinal: In clinical studies, there were frequent (> 1/100 and <1/10) reports of pasty stools or diarrhea during treatment with ursodeoxycholic acid.
Interaction
Extragenic hormones, as well as drugs to reduce the concentration of cholesterol in the blood, can increase the secretion of cholesterol by the liver, and thus contribute to the formation of stones in the gallbladder, which is the opposite effect of ursodeoxycholic acid, which is used to dissolve them.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life – 4 years.









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