Ursosan 250mg 50 capsules — Made in Czech — Free Delivery

Product description 

Ursosan® capsules are used for the following indications:

• to dissolve X-ray negative cholesterol gallstones no larger than 15 mm in diameter in patients with a functioning gallbladder, despite the presence of gallstone(s) in it(s);
• for the treatment of biliary reflux gastritis;
• for the 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.

Compound

The active substance is ursodeoxycholic acid (one capsule contains 250 mg of ursodeoxycholic acid).

Excipients: corn starch, pregelatinized starch, anhydrous colloidal silicon dioxide, magnesium stearate.

Capsule composition: gelatin, titanium dioxide (E 171).

Contraindications

• hypersensitivity to any substance that is part of the preparation;
• acute inflammation of the gallbladder or bile ducts;
• obstruction of the bile ducts (blockage of the common bile duct or duct);
• frequent episodes of hepatic colic;
• radiopaque calcified gallstones;
• violation of the contractility of the gallbladder;
• late stages of primary biliary cirrhosis due to insufficient therapeutic effect;
• use in children: unsuccessful result of portoenterostomy or lack of adequate biliary outflow in children with biliary atresia.

Mode 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.

To dissolve cholesterol gallstones

Approximately 10 mg ursodeoxycholic acid/kg.

Capsules should be swallowed whole with water, 1 time per day in the evening before bedtime.

Capsules should be taken regularly.

The time required for gallstones to dissolve is usually 6-24 months. If a decrease in the size of the gallstone is not observed after 12 months of administration, therapy should not be continued.

The success of the treatment should be checked every 6 months by ultrasound or X-ray. Additional studies need to check whether stones have calcified over time. If this happens, treatment should be discontinued.

For the treatment of biliary reflux gastritis

One capsule of the preparation "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 condition of the patient. The doctor must decide on the duration of treatment in each case individually.

For the symptomatic treatment of primary biliary cirrhosis (PBC)

The daily dose depends on body weight and varies from 3 to 7 capsules (14±2 mg ursodeoxycholic acid/kg body weight).

In the first 3 months of treatment, Ursosan® capsules 250 mg should be taken throughout the day, distributing the daily dose into 3 doses. With improvement in liver function, the dose can be taken 1 time per day in the evening.

The capsules must be swallowed whole with a liquid. It is necessary to observe the regularity of taking the capsules.

The use of Ursosan® 250 mg capsules for the treatment of primary biliary cirrhosis can be unlimited in time.

In patients with primary biliary cirrhosis, rarely at the beginning of treatment, worsening of clinical symptoms is possible, for example, itching may increase. In this case, treatment should be continued by taking one capsule of Ursosan® 250 mg per day, after which the dose should be gradually increased (increasing the daily dose by one capsule every week) until the prescribed dosing regimen is reached.

Application to children

For children with cystic fibrosis aged 6 to 18 years, the dosage is 20 mg / kg / day and divided into 2-3 doses, followed by an increase in dose to 30 mg / kg / day if necessary.

Application features

pregnant

Ursosan® 250 mg capsules should not be used during pregnancy unless absolutely necessary. Women of reproductive age can only take the preparation if they use reliable contraceptives.

According to several recorded cases of the use of the preparation in women who are breastfeeding, the content of ursodeoxycholic acid in milk was extremely low, so no adverse events should be expected in children receiving such milk.

Drivers

There was no effect on the ability to drive a car and use other mechanisms.

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 its amount is excreted in the feces.

If diarrhea occurs, the dose should be reduced, and if diarrhea persists, therapy should be discontinued.

There is no need for specific activities. The effects of diarrhea should be treated symptomatically with fluid and electrolyte rebalancing.

Side effects

From the gastrointestinal tract: in clinical studies, there were frequent (> 1/100 and < 1/10) reports of pasty stools or diarrhea during treatment with ursodeoxycholic acid.

Storage conditions

Store in the original packaging at a temperature not exceeding 25°C, out of the reach of children.

Shelf life - 4 years.