Product Details

What you need to know before you take Ursofalk suspension

Do NOT take Ursofalk suspension if – you are, or have been told you are, allergic (hypersensitive) to bile acids (like ursodeoxycholic acid) or to any of the other ingredients of this medicine (listed in section 6.) – your gall bladder does not work properly. – you have gallstones that are visible on an x-ray (calcified). – you have 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 abdominal pain (biliary colic). – you are a child with biliary atresia and have poor bile flow, even after surgery. Please ask your doctor about any of 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 suspension. 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 gallbladder after the first 6 – 10 months of treatment. When used in the treatment of PBC, in rare cases the symptoms may worsen when you start treatment. Talk to your doctor if this happens as the dose may need to be reduced. Please inform your doctor immediately if you have diarrhoea as this may require a reduction in the dose or discontinuation of treatment. Other medicines and Ursofalk 250mg/5ml suspension The effects of these medicines may be altered: A reduction in the effects of the following medicines is possible when taking Ursofalk suspension: – 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. – ciprofloxacin and dapsone (antibiotics), nitrendipine (used to treat high blood pressure). 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 suspension: – 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) Please inform your doctor if you are taking any blood cholesterol lowering agents such as clofibrate or medicines that contain oestrogen (estrogen); especially if you are taking Ursofalk for the dissolution of gallstones as they may stimulate the formation of gallstones. Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, even if they are medicines obtainable without a prescription. Treatment with Ursofalk suspension 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. Breast-feeding Tell your doctor if you are breastfeeding or about to start breastfeeding. Driving and using machines: No particular precautions are necessary. Ursofalk 250mg/5ml suspension contains benzoic acid, propylene glycol and sodium This medicine contains 7.5 mg benzoic acid in each 5 ml of suspension. Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old). This medicine contains 50 mg propylene glycol in each 5 ml of suspension. If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol. This medicine contains 11 mg sodium in each 5 ml of suspension. This is equivalent to 0.6 % of the recommended maximum daily dietary intake of sodium for an adult.