Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Ursofalk. It does not contain all of the available information. Reading this leaflet does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Ursofalk against the benefits they expect it will have for you or your child.
If you have any concerns about taking Ursofalk, ask your doctor or pharmacist.
Keep this leaflet. You or your child may want to read it again.
What Ursofalk is used for
Ursofalk contains ursodeoxycholic acid. Ursodeoxycholic acid is a bile acid, which may have a protective effect on the liver by reducing the absorption of other potentially toxic bile salts.
Ursofalk may be used to treat liver diseases such as primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), and cystic fibrosis (CF)-related cholestasis.
However, your doctor may prescribe this medicine for another use.
If you or your child wants more information, ask your doctor.
Ask your doctor if you or your child has any questions about why this medicine has been prescribed for you or your child.
Ursofalk is not addictive.
Ursofalk does not cause any negative effect on driving ability and operating machinery.
Before you or your child takes Ursofalk
Ursofalk is not suitable for everyone.
When you or your child must not take Ursofalk
Do not take Ursofalk if:
- you or your child is allergic to ursodeoxycholic acid or any other ingredients listed at the end of this leaflet
- you or your child has a bile duct or gall bladder that is swollen, painful or blocked
- the packaging is torn or shows signs of tampering
- the capsules, tablets or suspension, look to be deteriorating in any way
- the expiry date (EXP) printed on the pack has passed, as it may not work as well
- do not use Ursofalk suspension after 4 months of opening the bottle
If you are not sure whether you or your child should start taking this medicine, talk to your doctor.
Before you or your child starts to take it
Tell your doctor if you or your child:
- have allergies to any other medicines, foods, preservatives or dyes
- have kidneys that do not work properly
- have a gall bladder that cannot be seen on X-ray
- have calcified gallstones
- have a gall bladder which is not able to contract properly
- suffer from frequent cramp-like pains in the upper abdomen (biliary colic)
- is on a controlled sodium diet (for patients taking Ursofalk suspension).
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.
If you or your child has not told your doctor any of the above, tell him/her before you or your child starts taking Ursofalk.
Taking other medicines
Tell your doctor or pharmacist if you or your child is taking any other medicines, including any that you or your child gets without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Ursofalk may interfere with each other. These include:
- cholestyramine, or colestipol, medicines used to lower high levels of cholesterol in the blood
- an absorbent such as charcoal
- antacids or medicines used for indigestion that contains aluminium hydroxide and/or smectite (aluminium oxide)
- cyclosporine, medicine used to suppress the immune system
- ciprofloxacin and dapsone, an antibiotic used to prevent certain infections
- nitrendipine (used to treat high blood pressure) and other medicines which are metabolised in a similar way
These medicines may be affected by Ursofalk