Medicines & treatments centre

URSODEOXYCHOLIC ACID WARNINGS

Ursodeoxycholic acid should be used with caution in: women who are likely to become pregnant or who are breastfeeding.

It should not be used in: women who are pregnant, patients with a gall bladder that is not working properly, or who have gallstones which contain calcium (i.e. are opaque on an X-ray), have severe liver problems, stomach ulcers or inflammation of the bowel.

Also see list of precautions and interactions.

STORAGE

Protect from light and store below 25°C.

URSODEOXYCHOLIC ACID USES

What is it used for?

• Ursodeoxycholic acid is used to treat a number of problems.
• It is a biliary composition and flow-altering drug occurring naturally in mammals, and is sometimes known as a bile acid.
• It is used to reduce the cholesterol content of biliary fluid (produced by the liver and stored in the gall bladder for secretion into the intestine to digest fats).
• In general this drug is used to dissolve gallstones made of cholesterol and to treat a condition called primary biliary cirrhosis (in which the bile ducts are damaged, causing bile to accumulate in the liver, which is then damaged itself).
• Benefits of being on this drug in patients with primary biliary cirrhosis include the prevention or treatment of lack of bile flow from the liver to the intestine (cholestasis), and the dissolving of gallstones in patients who have this problem.

Listed below are the typical uses of ursodeoxycholic acid.

• Treatment of primary biliary cirrhosis
• Dissolving gallstones that are radiolucent (they do not show up on X-rays) that are in patients with a functioning gallbladder.

On occasion your doctor may prescribe this medicine to treat a condition not on the above list. Such conditions are listed below.

• None known.

HOW TO USE/TAKE

How often do I take it?

• Take this medication by mouth, usually during the day as divided doses or once daily before bedtime. Tablets or capsules should be taken whole with a glass of water. It is also available as a suspension.
• Use this medication regularly in order to get the most benefit from it.
• Remember to use it at the same time each day - unless specifically told otherwise by your doctor.
• It may take some time before the full benefit of this drug takes effect.
• Certain medical conditions may require different dosage instructions as directed by your doctor.

What dose?

• Dosage is based on your age, gender, medical condition, response to therapy, and use of certain interacting medicines.

Do I need to avoid anything?

• No. Consult your doctor or pharmacist for more details.

When can I stop?

• It is important to continue taking this medication even if you feel well, unless your doctor tells you to stop.

URSODEOXYCHOLIC ACID SIDE EFFECTS

• Feeling sick (nausea)
• Vomiting
• Diarrhoea
• Gallstone calcification (calcium deposits form in the gallstone)
• Itching.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the UK you may report side-effects to the MHRA

URSODEOXYCHOLIC ACID PRECAUTIONS

Before taking ursodeoxycholic acid, tell your doctor or pharmacist if you are allergic to it; or to other drugs affecting bile composition or flow; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a gall bladder that is not working properly, have gallstones which contain calcium (i.e. are opaque on an X-ray), have severe liver problems, stomach ulcers or inflammation of the bowel, or if you are pregnant.

Before using this medication, tell your doctor or pharmacist your medical history, especially any of the following: method of contraception (if taking any precautions and are of child-bearing age), history of any inflammatory bowel disorders or liver problems.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Does alcohol intake affect this drug?

• Alcohol intake is not known to affect ursodeoxycholic acid.

The elderly: ursodeoxycholic acid can be used in the elderly.

Pregnancy and breastfeeding - please ensure you read the detailed information below

PREGNANCY

Ursodeoxycholic acid is not safe to take if you are, or are planning to become, pregnant.

It is sensible to limit use of medication during pregnancy whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.

If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.

BREAST FEEDING

Ursodeoxycholic acid is not safe to take if you are breastfeeding.

It is sensible to limit use of medication during breastfeeding whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.

If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.

URSODEOXYCHOLIC ACID INTERACTIONS

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious, possibly fatal interactions may occur:

• None known.

Before using this medication, tell your doctor or pharmacist of all prescription and non-prescription/herbal products you may use, especially of:

• Immunosuppressants (ciclosporin)
• Antacids, used to treat stomach problems
• Oral contraceptives (oestrogens)
• Lipid-regulating drugs (colestipol and colestyramine).

This information does not contain all possible interactions. Therefore, before using ursodeoxycholic acid, tell your doctor or pharmacist of all the products you use.

URSODEOXYCHOLIC ACID OVERDOSE

Serious adverse effects are unlikely to occur with an overdose.

If you think you, or someone you care for, might have accidentally taken more than the recommended dose of ursodeoxycholic acid or intentional overdose is suspected, contact your local hospital, GP or if in the UK call NHS Direct on 0845 4647.

MISSED DOSE

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.