Udiliv 300 mg Tablet is used to:

• Dissolve cholesterol gallstones: It is used for small, non-calcified cholesterol stones in people with a working gallbladder, usually when surgery is not suitable or is declined.

• Treat primary biliary cholangitis (PBC): This is a long-term liver disease in which the bile ducts are damaged. Ursodeoxycholic acid is a standard treatment.

• Prevent gallstones during rapid weight loss: It lowers the chance of stones forming in people who are losing weight quickly.

• Support children with liver and bile duct problems linked to cystic fibrosis: This is done only under specialist advice.

Udiliv will not dissolve calcified stones or stones that are not made of cholesterol.

Ursodeoxycholic acid reduces the amount of cholesterol made by the liver and absorbed from the gut. This makes bile less likely to form cholesterol stones and allows existing cholesterol stones to dissolve slowly over months. In PBC it replaces harmful bile acids that build up, protects bile duct cells and helps bile flow.

Tell your doctor about all medicines, supplements and herbal products you take before starting Udiliv.

• Cholestyramine, colestipol and aluminium-containing antacids: They reduce absorption of Udiliv. Take them at least 2 hours before or after Udiliv.

• Oestrogens, oral contraceptives and clofibrate (and some other cholesterol-lowering medicines): They increase cholesterol in bile and can reduce the effect of Udiliv on gallstones. Use non-hormonal contraception if advised.

• Ciclosporin: Udiliv can change its absorption, so your doctor may check its blood levels.

• Ciprofloxacin: Absorption may be reduced in some cases.

• Dapsone and nitrendipine: Their effect may be reduced.

• Rosuvastatin: Its blood level may be slightly higher.

• Store Udiliv 300mg Tablet at room temperature, ideally not above 25°C.

• Keep the tablets in the original strip to protect them from moisture.

• Keep the medicine out of the reach of children.

• Follow any additional storage instructions printed on the product packaging.

• Use Udiliv 300mg Tablet exactly as prescribed by your doctor.

• The dose depends on your body weight and the condition being treated, so the number of tablets differs from person to person. Prescribing information gives doses of about 8 to 12 mg per kg of body weight per day for gallstone dissolution and about 13 to 15 mg per kg per day for PBC. Your doctor will work out your dose and may divide it across the day or advise taking it in the evening. Take it with food, swallowed whole with water.

• Gallstone dissolution can take 6 to 24 months, with ultrasound checks along the way. PBC treatment may continue for a long time. Regular blood tests of liver function are needed, especially in the first months. Do not stop the medicine without your doctor’s advice. If you miss a dose, take it when you remember. If it is almost time for the next dose, skip the missed dose. Do not take two doses together.

Common side effects of Udiliv 300mg Tablet may include:

• Diarrhoea or soft stools

• Nausea

• Vomiting

• Abdominal pain or discomfort

• Constipation

• Indigestion

• Itching

• Skin rash

• Hair thinning

• Headache

• Dizziness

Serious side effects

Seek medical attention if you develop:

• Severe pain in the upper right side of the abdomen.

• Yellowing of the skin or eyes, or worsening jaundice, with dark urine.

• Severe or persistent diarrhoea, because your doctor may need to reduce the dose or stop the medicine.

• Swelling of the face, lips, tongue or throat, hives or difficulty breathing, which can be signs of a severe allergic reaction.

• Repeated vomiting, severe constipation or a swollen abdomen, which can be signs of a bowel blockage, particularly if you have Crohn’s disease or have had bowel surgery.

• Worsening itching at the start of treatment for PBC.

• Take Udiliv regularly with food. Gallstone dissolution takes months, so do not stop early.

• Keep your follow-up ultrasound and blood test appointments.

• Keep at least 2 hours between Udiliv and aluminium antacids or cholestyramine.

• Use non-hormonal contraception if prescribed Udiliv for gallstones.

• For fatty liver, focus on weight loss, a balanced diet, regular exercise and control of diabetes and cholesterol, and avoid alcohol. Do not take Udiliv for fatty liver unless your doctor prescribes it.

• Stones can come back after dissolving, so ask your doctor about diet and weight control.

• Report severe abdominal pain, jaundice or persistent diarrhoea.

• Tell your doctor if you have Crohn’s disease or have had bowel surgery.