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WHAT YOU NEED TO KNOW BEFORE YOU TAKE URSOFALK 500mg FILM COATED TABLETS

Do NOT take Ursofalk tablets if: – You are, or have been told you are, allergic (hypersensitive) to bile acids like UDCA or to any of the other ingredients of this medicine (listed in section 6). – You have an acute inflammation of the gall bladder or biliary tract. – You have a blockage of the common bile duct or cystic duct (obstruction of the biliary tract). – You have frequent cramp-like upper abdomen pain (biliary colic). – Your doctor has said you have calcified gallstones (they are visible on an x-ray). – Your gall bladder does not work properly. – You are a child with biliary atresia and have 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 or if you are unsure whether you have any of them. Warnings and precautions: Talk to your doctor or pharmacist before taking Ursofalk tablets 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 in the treatment of PBC, in rare cases the symptoms may worsen at the beginning of treatment. If this happens, please speak to your doctor about reducing your initial dose. When used to dissolve gallstones, your doctor should arrange for a scan of your gall bladder after the first 6-10 months of treatment. Please talk to your doctor immediately if you have diarrhoea, as this may require a reduction in the dose or discontinuation of the treatment with Ursofalk tablets. Other medicines and Ursofalk tablets Please tell your doctor if you are taking or have recently taken or might take any other medicines The effects of these medicines may be altered: A reduction in the effects of the following medicines is possible when taking Ursofalk tablets: – colestyramine, colestipol (to lower blood lipids) or antacids 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 Ursofalk tablets. – 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. A change in the effects of the following medicines is possible when taking Ursofalk tablets: – 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. – rosuvastatin (for high cholesterol and related conditions). If you are taking Ursofalk tablets 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 Ursofalk. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are medicines obtainable without a prescription. Treatment with Ursofalk tablets may still be allowed. Your doctor will know what is right for you. Pregnancy breastfeeding 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 Ursofalk during pregnancy unless your doctor thinks it is absolutely necessary. Women of child-bearing potential. Even if you are not pregnant, you should still discuss this possibility with your doctor. Before starting treatment with Ursofalk your doctor will check that you are not pregnant and review your contraceptive method to make sure it is appropriate. Breastfeeding Tell your doctor if you are breast-feeding or about to start breastfeeding. Driving and using machines: No particular precautions are necessary.