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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 not take Ursodeoxycholic Acid Tablets if you:
- are pregnant, planning to become pregnant or are breastfeeding
or if you have:
- ever had an allergic reaction to bile acids or to any of the other ingredients in Ursodeoxycholic Acid Tablets (see 'What Ursodeoxycholic Acid Tablets Contain' in section 6 'Further Information')
- a gall bladder which is not working properly or you have gall-stones that contain calcium
- severe liver disease other than primary biliary cirrhosis
- peptic ulcers
- inflammation of the bowel
- inflammation of the gall bladder or biliary tract (the ducts that transport bile from the liver to the small intestine)
- blockage of the biliary tract
- frequent episodes of biliary colic (often characterised by upper right stomach pain).
If any of the above statements apply to you, do not take Ursodeoxycholic Acid Tablets.
Children aged 6 years to less than 18 years with cystic fibrosis
Not to be taken if the child has had unsuccessful surgery to restore the flow of bile to the small intestine.
Taking other medicines
Taking another medicine while you are taking Ursodeoxycholic Acid Tablets can affect how it or the other medicine works. Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those you may have bought yourself without a prescription.
Please check with your doctor if you are taking any of the following (or any other medication):
- oral contraceptives (the pill) or oestrogen (a female sex hormone)
- medicines used to lower blood cholesterol (clofibrate, colestipol and colestyramine). If it is necessary to take a medicine containing colestipol or colestyramine, you must take it at least 2 hours before or after Ursodeoxycholic Acid Tablets
- medicines used to treat stomach problems (charcoal and antacids containing aluminium). If it is necessary to take one of these medicines, you must take it at least 2 hours before or after Ursodeoxycholic Acid Tablets
- ciclosporin (used after transplants)
- ciprofloxacin (used to treat infections)
- nitrendipine (used to treat high blood pressure)
- dapsone (used to treat leprosy and other skin conditions).
If you have any doubts about whether you should take this medicine then discuss matters with your doctor before taking it.
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