Product Details

Product Information of Ursodeoxycholic Acid 250mg Capsules

What you need to know before you use Ursodeoxycholic Acid

Do not use Ursodeoxycholic Acid: – If you are allergic to bile acids like UDCA or any of the other ingredients of this medicine (listed in section 6). – If you have an acute inflammation of the gall bladder or biliary tract. – If you have a blockage of the common bile duct or cystic duct (obstruction of the biliary tract). – If you have frequent cramp-like upper abdomen pain (biliary colic). – If your doctor has said you have calcified gallstones. – If you have an insufficiency of the contractility of the gall bladder. – If you are or have a child with biliary atresia or has poor bile flow even after surgery. Please ask your doctor about the conditions mentioned above. You should also ask if you have previously had any of these conditions. Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Ursodeoxycholic Acid. Ursodeoxycholic Acid should be administered under medical supervision. Your doctor should test your liver function regularly every 4 weeks for the first 3 months of treatment. After this time, it should be monitored at 3 month intervals. When used to dissolve gallstones, your doctor should arrange for a scan of your gall bladder after the first 6- 10 months of treatment. Talk to your doctor immediately if you have diarrhoea, as this may require a reduction in the dose or discontinuation of the treatment with Ursodeoxycholic Acid. If you suffer from primary biliary cirrhosis and your symptoms get worse at the beginning of the treatment a reduction in the dose may be required and gradually increased again as described in section 3 (How to take Ursodeoxycholic Acid). If you are a woman of childbearing potential you must use contraception. Non-hormonal or oral contraceptives containing small amounts of estrogen are recommended. However, if you take Ursodeoxycholic Acid for dissolve gallstones, you should use non-hormonal contraception because hormonal contraceptives may increase gallstone risk. Other medicines and Ursodeoxycholic Acid Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without medical prescription. Treatment with Ursodeoxycholic Acid may still be allowed. Your doctor will know what is right for you. A reduction in the effects of the following medicines is possible when taking Ursodeoxycholic Acid: – colestyramine, colestipol (to lower blood lipids) or antacids (drugs that bind hydrochloric acid in the gastric juice) containing aluminium hydroxide or smectite (aluminium oxide). If you must take medication that contains any of these ingredients, it must be taken at least two hours before or after Ursodeoxycholic Acid. – rosuvastatin (used to lower blood lipids). It may be necessary for your doctor to alter the dose of these medicines. – ciprofloxacin, dapsone (antibiotics), nitrendipine (used to treat high blood pressure) and other medicines which are metabolised in a similar way. It may be necessary for your doctor to alter the dose of these medicines. Ursodeoxycholic Acid may increase the effects of the following medicines: – ciclosporin (to reduce the activity of the immune system). If you are being treated with ciclosporin, your doctor should check the amount of ciclosporin in your blood. Your doctor will adjust its dose, if necessary. If you are taking Ursodeoxycholic Acid for the dissolution of gallstones, please inform your doctor in case you are taking any medicines that contain oestrogenic hormones or blood cholesterol lowering agents such as clofibrate. These medicines stimulate the formation of gallstones, which is a counter-effect to the treatment with Ursodeoxycholic Acid. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy You should not take Ursodeoxycholic Acid during pregnancy unless your doctor thinks it is absolutely necessary. The use of Ursodeoxycholic Acid during the first 3 months of pregnancy may cause foetal harm. Check that you are not pregnant before taking this medicine Women of child-bearing potential Even if you are not pregnant you should talk to your doctor because women of childbearing potential must use contraception. Non-hormonal or oral contraceptives containing small amounts of estrogen are recommended. However, if you take Ursodeoxycholic Acid for dissolve gallstones, you should use nonhormonal contraception because hormonal contraceptives may increase gallstone risk. Your doctor must exclude the possibility of a pregnancy before beginning of treatment. Breastfeeding You should not take Ursodeoxycholic Acid during breast-feeding. It is not known whether Ursodeoxycholic Acid passes into breast milk. If treatment with Ursodeoxycholic Acid is absolutely necessary, you should stop breastfeeding. Driving and using machines Ursodeoxycholic Acid has no or negligible influence on the ability to drive and use machines.