Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
URSODEOXYCHOLIC ACID
CTS CHEMICAL INDUSTRIES LTD, ISRAEL
A05AA02
TABLETS
URSODEOXYCHOLIC ACID 100 MG
PER OS
Required
CTS CHEMICAL INDUSTRIES LTD, ISRAEL
URSODEOXYCHOLIC ACID
URSODEOXYCHOLIC ACID
Dissolution or reductin in size of radiolucent cholesterol in patient with a functioning gallbladder. Treatment of chronic liver diseases including primary billiary cirrhosis, primary sclerosing cholangitis, cystic fibrosis associated liver disease, biliary atresia, chronic hepatitis, and alcohol cirrhosis.
2021-12-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only URSOLIT 100, 300 TABLETS THE ACTIVE INGREDIENT: URSOLIT 100: Ursodeoxycholic Acid 100 mg URSOLIT 300: Ursodeoxycholic Acid 300 mg Inactive ingredients and allergens in the preparation – see the subsection “Important information about some of the ingredients of the medicine” and section 6. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any other questions, refer to the doctor or the pharmacist. This medicine has been prescribed for treatment of your illness. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended for the dissolution or reduction in size of gallstones composed of cholesterol, and for treatment of certain chronic liver diseases. THERAPEUTIC CLASS: bile acids. Ursodeoxycholic acid affects the bile composition, so that the gallstones dissolve. The effect of ursodeoxycholic acid in some chronic liver diseases results from a variety of mechanisms, such as a protective activity on liver cells and effect on the immune system. 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient (bile acids) or to any of the additional components the medicine contains (for a list of inactive ingredients, see section 6). • You suffer from an inflammatory exacerbation of the gallbladder and/or biliary tract. • You have a biliary obstruction or stenosis. • You suffer from a gastric or intestinal ulcer. • You suffer from calcified gallstones. • Your gallbladder is not contracting properly. • You suffer from biliary colic (can manifest in pain/ frequent cramps in the upper abdomen). SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE • The medicine should be used under medical supervision (see al Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ursolit 100 mg tablets Ursolit 300 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Ursolit 100 mg tablet contains: Ursodeoxycholic acid 100 mg Each Ursolit 300 mg tablet contains: Ursodeoxycholic acid 300 mg Ursolit 100mg also contains 75 mg Lactose monohydrate. Ursolit 300mg also contains 100 mg Lactose monohydrate. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets for oral administration. Appearance: Ursolit 100: white round biconvex scored tablets. Ursolit 300: white round biconvex scored tablets. 4. CLINICAL PARTICULARS. 4.1 THERAPEUTIC INDICATIONS Dissolution or reduction in size of radiolucent cholesterol in patient with a functioning gallbladder. Treatment of chronic liver diseases including primary billiary cirrhosis, primary sclerosing cholangitis, cystic fibrosis associated liver disease, billiary atresia, chronic hepatitis, and alcohol cirrhosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Gallstone dissolution:_ 8 to 12 mg/kg/day given in 2 divided doses. If doses are unequal the larger dose should be taken in late evening to counteract the rise in biliary cholesterol saturation which occurs in the early morning. The late evening dose may usefully be taken with food to help maintain bile flow overnight. The time required for dissolution of gallstones is likely to range from 6 to 24 months depending on stone size and composition. Follow-up cholecystograms or ultrasound investigation may be useful at 6 month intervals until the gallstones have disappeared. Treatment should be continued until 2 successive cholecystograms and/or ultrasound investigations 4-12 weeks apart have failed to demonstrate gallstones. This is because these techniques do not permit reliable visualisation of stones less than 2mm in diameter. The efficiency of Ursolit in treating radio-opaque or partially radio opaque gallstones has not been tested but these are generally thought to be less soluble than radiolucent stones. Non-ch Прочитайте повний документ