composition
active substance: ursodeoxycholic acid;
1 capsule contains ursodeoxycholic acid 250 mg;
excipients: maltodextrin 150 mg.
Indications for use
Dissolution of radiopaque cholesterol gallstones up to 15 mm in diameter in patients with a functioning gallbladder, despite the presence of gallstone(s). Prophylactic treatment of gastritis with bile reflux. Symptomatic prophylactic treatment of primary biliary cirrhosis (PBC) in the absence of decompensated liver cirrhosis. For the prophylactic treatment of hepatobiliary disorders in cystic fibrosis in children aged 6 to 18 years.
Dosage and use
There are no age restrictions for the use of Ursaz dietary supplement. The dietary supplement should be administered orally to patients weighing more than 47 kg. For patients weighing less than 47 kg or who have difficulty swallowing capsules, the drug should be administered in the form of a suspension.
To dissolve cholesterol gallstones.
Take once a day in the evening before bedtime at a dose of about 10 mg/kg of body weight.
| Body weight (kg) | Capsules |
| 47-60 kg | 2 |
| 61-80 kg | 3 |
| 81-100 kg | 4 |
| over 100 kg | 5 |
The capsules should be swallowed whole with a small amount of liquid. Regular dosing should be followed.
The duration of preventive treatment is usually 6-24 months. If after 12 months there is no reduction in the size of the gallstones, treatment should be discontinued.
For the preventive treatment of gastritis with bile reflux.
Take 1 capsule once a day in the evening before bedtime. The capsules should be swallowed whole with a small amount of liquid.
The duration of prophylactic treatment depends on the patient's condition and is usually 10-14 days. The doctor should decide on the duration of treatment in each specific case together with the patient.
For the symptomatic treatment of primary biliary cirrhosis (PBC).
The daily dose depends on body weight and is approximately 14 ± 2 mg/kg body weight. In the first 3 months of preventive treatment, the daily dose should be divided into 3 doses, and then, when liver function indicators improve, the drug should be administered once a day in the evening.
| Body weight (kg) | Daily dose (mg/kg body weight) | Capsules |
| during the first 3 months | thereafter |
| morning | day | evening | evening (once a day) |
| 47-62 | 12-16 | 1 | 1 | 1 | 3 |
| 63-78 | 13-16 | 1 | 1 | 2 | 4 |
| 79-93 | 14-16 | 1 | 2 | 2 | 5 |
| 94-109 | 15-16 | 2 | 2 | 2 | 6 |
| over 110 | | 2 | 2 | 3 | 7 |
The capsules should be swallowed whole with a small amount of liquid. Regular dosing should be followed.
The duration of use in primary biliary cirrhosis may be unlimited in time.
Use in children
In children with cystic fibrosis aged 6 to 18 years, the dose is 20 mg/kg/day, divided into 2-3 doses, if necessary, increasing to 30 mg/kg/day.
| Body weight (kg) | Daily dose (mg/kg) | Ursaza, capsules 250 mg |
| Morning | Day | Evening |
| 20-29 | 17-25 | 1 | - | 1 |
| 30-39 | 19-25 | 1 | 1 | 1 |
| 40-49 | 20-25 | 1 | 1 | 2 |
| 50-59 | 21-25 | 1 | 2 | 2 |
| 60-69 | 22-25 | 2 | 2 | 2 |
| 70-79 | 22-25 | 2 | 2 | 3 |
| 80-89 | 22-25 | 2 | 3 | 3 |
| 90-99 | 23-25 | 3 | 3 | 3 |
| 100-109 | 23-25 | 3 | 3 | 4 |
| >110 | | 3 | 4 | 4 |
Children
For the dissolution of cholesterol gallstones, prophylactic treatment of gastritis with bile reflux, and symptomatic treatment of PBC.
There are no fundamental age restrictions for the use of Ursaz in children, but if the child weighs less than 47 kg and/or the child has difficulty swallowing, it is recommended to use the drug in suspension form.
For the prevention of hepatobiliary disorders in cystic fibrosis
Use in children aged 6 to 18 years.
Reservation
Hypersensitivity to any substance included in the dietary supplement. Acute inflammation of the gallbladder or bile ducts. Bile duct obstruction (blockage of the common bile duct or duct). Frequent attacks of hepatic colic. Radiopaque calcified gallstones. Impaired contractile function of the gallbladder. Failed portenterostomy or inadequate bile outflow in children with biliary atresia.
Special application
The dietary supplement Ursaz should be prescribed after consultation with a doctor and under his supervision.
Liver function tests (AST, ALT, and GGT) should be monitored every 4 weeks during the first 3 months of prophylactic treatment, and every 3 months thereafter. This allows for the determination of whether or not patients with PBC are responding to prophylactic treatment and for early detection of liver dysfunction, especially in patients with advanced PBC.
Animal studies have shown no effect of ursodeoxycholic acid on fertility. There are no publicly available data on the effect on fertility in humans.
There are insufficient data on the use of ursodeoxycholic acid in pregnant women. Ursodeoxycholic acid should not be used during pregnancy unless clearly necessary. Consultation with a doctor is mandatory.
According to several reported cases of use of the drug during breastfeeding, the content of ursodeoxycholic acid in breast milk was extremely low, so no adverse effects should be expected in children receiving such milk.
Impact on reaction speed when driving or working with other mechanisms.
The dietary supplement does not affect the reaction rate when driving or working with other mechanisms.
Overdose
In case of overdose, diarrhea may occur. Other symptoms of overdose are unlikely, since the absorption of ursodeoxycholic acid decreases with increasing dose, so most of it is excreted in the feces.
If diarrhea occurs, the dose should be reduced, and if diarrhea persists, therapy should be discontinued.
No special measures are required. The consequences of diarrhea should be treated symptomatically, with restoration of fluid and electrolyte balance.
Additional information about special patient groups.
Long-term therapy with high doses of ursodeoxycholic acid (28-30 mg/kg/day) in patients with primary sclerosing cholangitis (off-label use) was associated with a higher incidence of serious adverse events.
Side effects
Gastrointestinal effects: In available open-label clinical trials, pasty stools or diarrhea were commonly reported during treatment with ursodeoxycholic acid.
Severe abdominal pain localized in the right hypochondrium has been reported very rarely during prophylaxis treatment of primary biliary cirrhosis.
Liver and biliary tract diseases: Very rarely, calcification of gallstones may occur during treatment with ursodeoxycholic acid.
During the treatment of late stages of primary biliary cirrhosis, decompensation of liver cirrhosis was very rarely observed, which partially regressed after discontinuation of treatment.
Immune system disorders: very rare - allergic reactions, including rash, urticaria.
Skin and subcutaneous tissue disorders: very rare - allergic reactions, including rash, urticaria.
Expiration date
2 years.
Storage conditions
Store out of the reach of children in the manufacturer's original packaging at a temperature not exceeding 25 °C.
Producer
LLC "Pharmaceutical Company "Element of Health", Ukraine, Kyiv, Estonska St., 120
