Description
Release form
Capsules.
Packing
100 pcs
Indications
Primary biliary cirrhosis with no signs of decompensation
dissolution of small and medium cholesterol stones with functioning gall bladder
biliary reflux gastritis.
Contraindications
X-ray-positive (high calcium) gallstones
non-functioning gallbladder
acute inflammatory diseases of the gallbladder, bile ducts and intestines
cirrhosis in the stage of decompensation
expressed liver dysfunction of the kidneys .
Ursodeoxycholic acid has no age restrictions in use, however, children under the age of 3 years are not recommended to use the drug in this dosage form.
Caution
is used in children aged 3 to 4 years, because difficulty swallowing capsules.
Use during pregnancy and lactation
Contraindicated in pregnancy and lactation.
Composition
Per capsule: active substance:
ursodeoxycholic acid.
excipients:
corn starch – 73.0 mg,
silicon dioxide colloidal anhydrous – 5.0 mg,
magnesium stearate – 2.0 mg.
hard gelatin capsule: gelatin – 98%, titanium dioxide (E171) – 2%.
Dosage and Administration
Inside.
To dissolve cholesterol gallstones
The average daily dose is 250-500 mg (after or with meals), which is 1-2 capsules. The course of treatment is from 4-6 months to 12 months or more. The dose for maintenance therapy is 250 mg once a day.
For biliary reflux gastritis
250 mg once daily. The course of treatment is set by the doctor.
Symptomatic treatment of primary biliary cirrhosis
The daily dose depends on body weight and ranges from 2 to 6 capsules (approximately 10 to 15 mg of ursodeoxycholic acid per 1 kg of body weight).
Recommended use:
Body weight 34-50 kg: 2 capsules (daily dose) in the morning – 1 afternoon – in the evening – 1.
Body weight 51-65 kg: 3 capsules (daily dose) in the morning – 1 afternoon – 1 evening – 1.
Body weight 66-85 kg: 4 capsules (daily dose) in the morning – 1 day – 1 evening – 2.
Body weight 86-110 kg: 5 capsules (daily dose) in the morning – 1 afternoon – 2 in the evening – 2.
Body weight over 110 kg: 6 capsules (daily dose) in the morning – 2 afternoon – 2 in the evening – 2.
Side effects
The frequency of adverse reactions is given in accordance with the following scale: very often (> 10%) often (> 1% and <10%) infrequently (> 0.1% and <1%) rarely (> 0.01 % and <0, 1%) is very rare (<0.01%). From the gastrointestinal tract: often – diarrhea rarely – nausea, vomiting very rarely – acute pain in the upper right abdomen. From the side of the liver and biliary tract: rarely – a transient increase in the activity of “liver” enzymes is very rare – calcification of gallstones. In the treatment of developed stages of primary biliary cirrhosis, it is very rare – decompensation of cirrhosis of the liver, which disappears after drug withdrawal. From the skin: very rarely – urticaria. If any of the adverse events listed in the instructions are exacerbated or any other adverse events not listed in the instructions appear, notify your doctor. Drug Interaction It is not recommended to use concurrently with drugs that reduce intestinal absorption of bile acids (eg, cholestyramine) and with drugs that increase biliary elimination of cholesterol (estrogens, hormonal contraceptives). Concomitant use with potentially hepatotoxic agents is not recommended. Overdose Symptoms: increased side effects. Treatment: carrying out detoxification activities and the appointment of colestyramine (for the formation of chelate complexes with bile acids). Storage conditions Store in a dry, dark place at a temperature not exceeding 25 ° C. Keep out of the reach of children. Expiration 4 years. Deystvuyuschee substances ursodeoxycholic acid Pharmacy terms of sale Prescription Dosage Form A dosage form capsule dosage pharm, Russia
