País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ursodeoxycholic acid
Alliance Healthcare (Distribution) Ltd
A05AA02
Ursodeoxycholic acid
300mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01090100
CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Non-Regulatory Changes in detail: • Regulatory text amends _1st fold_ _(26.25mm)_ _2nd fold_ _(26.25mm)_ _3rd fold_ _(26.25mm)_ _4th fold_ _(26.25mm)_ _5th fold_ _(26.25mm)_ _6th fold_ _(26.25mm)_ _7th fold_ _(26.25mm)_ _8th fold_ _(26.25mm)_ _9th fold_ _(26.25mm)_ _10th fold_ _(26.25mm)_ _11th fold_ _(26.25mm)_ _12th fold_ _(26.25mm)_ _13th fold_ _(26.25mm)_ _14th fold_ _(26.25mm)_ _15th fold_ _(26.25mm)_ _16th fold_ _(26.25mm)_ pg1/2 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. − Keep this leaflet. You may need to read it again. − If you have further questions, please ask your doctor or pharmacist. − This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. The name of your medicine is Ursodeoxycholic Acid 300mg Film-Coated Tablets. In the rest of this leaflet it is called Ursodeoxycholic Acid Tablets. IN THIS LEAFLET: 1. What Ursodeoxycholic Acid Tablets are and what they are used for 2. Before you take Ursodeoxycholic Acid Tablets 3. How to take Ursodeoxycholic Acid Tablets 4. Possible side effects 5. How to store Ursodeoxycholic Acid Tablets 6. Further information 1. WHAT URSODEOXYCHOLIC ACID TABLETS ARE AND WHAT THEY ARE USED FOR The active ingredient in Ursodeoxycholic Acid Tablets is ursodeoxycholic acid, which is a naturally occurring substance (bile acid) normally present in the bile. Ursodeoxycholic Acid Tablets may be used for the following: • To dissolve certain types of gall stones (stones in the gall bladder), which contain cholesterol. Ursodeoxycholic Acid Tablets may be suitable for patients who are unable to have surgery or do not wish to have surgery. • To treat a type of liver disease known as primary biliary cirrhosis (PBC). • To treat liver disease associated with cystic fibrosis in children aged 6 years to less than 18 years. 2. BEFORE YOU TAKE URSODEOXYCHOLIC ACID TABLETS DO NO Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Urdox 300mg Film-Coated Tablets, Ursodeoxycholic Acid 300mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ursodeoxycholic acid 300mg. Excipients: lactose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Urdox tablets are white. film coated, convex tablets with “URDOX” on one side. 4.1 THERAPEUTIC INDICATIONS Urdox tablets are indicated in the treatment of primary biliary cirrhosis (PBC) and for the dissolution of small to medium sized radiolucent, cholesterol-rich gall-stones in patients with a functioning gall bladder. Cholesterol stones coated with calcium or stones composed of bile pigments are not dissolved by ursodeoxycholic acid. Urdox has a particular place in the treatment of patients in whom surgery is contraindicated or who are anxious to avoid surgery. Paediatric population Hepatobiliar disorder associated with cystic fibrosis in children aged 6 years to less than 18 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Urdox tablets are for oral administration To be taken with a drink of water. _ _ Primary Biliary Cirrhosis _Adults and Elderly:_ 10 - 15mg ursodeoxycholic acid (UDCA) per kg per day in two to four divided doses. _Children:_ Dosage should be related to bodyweight. Dissolution of gallstones _ _ _Adults and Elderly:_ The usual dose is 6 - 12mg/kg/day either as a single night time dose or in divided doses. This may be increased to 15mg/kg/day in obese patients, if necessary. The duration of treatment may be up to two years, depending on the size of the stone(s), and should be continued for three months after the apparent dissolution of the stone(s). _ _ _Children: _Dosage should be related to bodyweight. Paediatric population Children with cystic fibrosis aged 6 year to less than 18 years: 20 mg/kg/day in 2-3 divided doses, with further increase to 30 mg/kg/day if necessary. 4.3 CONTRAINDICATIONS Ursodeoxycholic acid should not be used in patients: 1. with radio-opaque calcified gall-st Leia o documento completo