Ursodeoxycholic Acid 300mg Film-Coated Tablets

• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

The name of your medicine is Ursodeoxycholic Acid 300mg Film-Coated Tablets. In the rest of this leaflet it is called Ursodeoxycholic Acid Tablets.

1. What Ursodeoxycholic Acid Tablets are and what they are used for
2. Before you take Ursodeoxycholic Acid Tablets
3. How to take Ursodeoxycholic Acid Tablets
4. Possible side effects
5. How to store Ursodeoxycholic Acid Tablets
6. Further information

• are pregnant, planning to become pregnant or are breastfeeding

or if you have:

• ever had an allergic reaction to bile acids or to any of the other ingredients in Ursodeoxycholic Acid Tablets (see ‘What Ursodeoxycholic Acid Tablets Contain' in section 6 ‘Further Information‘)
• a gall bladder which is not working properly or you have gall-stones that contain calcium
• severe liver disease other than primary biliary cirrhosis
• peptic ulcers
• inflammation of the bowel
• inflammation of the gall bladder or biliary tract (the ducts that transport bile from the liver to the small intestine)
• blockage of the biliary tract
• frequent episodes of biliary colic (often characterised by upper right stomach pain).

If any of the above statements apply to you, do not take Ursodeoxycholic Acid Tablets.

Not to be taken if the child has had unsuccessful surgery to restore the flow of bile to the small intestine.

Taking another medicine while you are taking Ursodeoxycholic Acid Tablets can affect how it or the other medicine works. Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those you may have bought yourself without a prescription.

Please check with your doctor if you are taking any of the following (or any other medication):

• oral contraceptives (the pill) or oestrogen (a female sex hormone)
• medicines used to lower blood cholesterol (clofibrate, colestipol and colestyramine). If it is necessary to take a medicine containing colestipol or colestyramine, you must take it at least 2 hours before or after Ursodeoxycholic Acid Tablets
• medicines used to treat stomach problems (charcoal and antacids containing aluminium).
  If it is necessary to take one of these medicines, you must take it at least 2 hours before or after Ursodeoxycholic Acid Tablets
• ciclosporin (used after transplants)
• ciprofloxacin (used to treat infections)
• nitrendipine (used to treat high blood pressure)
• dapsone (used to treat leprosy and other skin conditions).

If you have any doubts about whether you should take this medicine then discuss matters with your doctor before taking it.

You should not take Ursodeoxycholic Acid Tablets if you are pregnant or trying to become pregnant.

You should use extra contraceptive precautions that do not contain hormones (e.g. condoms, caps or certain coils) whilst taking Ursodeoxycholic Acid Tablets (but see precautions above in “Taking other medicines” section).

If at any point during treatment with Ursodeoxycholic Acid Tablets you think you might have become pregnant, contact your doctor immediately.

You should not breast-feed whilst taking Ursodeoxycholic Acid Tablets.

Ursodeoxycholic Acid Tablets do not affect the ability to drive or operate machinery.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product, as it contains lactose.

To dissolve gall stones that contain cholesterol

The usual daily dose is one to three tablets depending on your weight, either in divided doses or as a single night time dose.

Your doctor may tell you to take Ursodeoxycholic Acid Tablets for up to two years depending on the size of your gall-stone. You should continue your treatment for three months after your stone appears to have gone.

To treat primary biliary cirrhosis

The usual daily dose is two to four tablets, depending on your weight, to be taken in two to four divided doses.

Children

The dose for a child may be less than the usual adult dose. The doctor will calculate the dose depending on the child‘s weight.

For children with cystic fibrosis aged 6 years to less than 18 years

The dose will be calculated by the doctor depending on the child's weight.

Too many Ursodeoxycholic Acid Tablets may cause diarrhoea. If you accidentally take too many tablets contact your doctor, pharmacist or nearest hospital casualty department.

Take this leaflet and any remaining tablets with you to show the doctor or pharmacist.

If you forget to take a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. Do not take a double dose to make up for a forgotten tablet.

You should continue to take Ursodeoxycholic Acid Tablets for as long as your doctor tells you to. Do not stop taking the medicine without talking to your doctor first.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

The active ingredient in Ursodeoxycholic Acid Tablets is ursodeoxycholic acid. Each tablet contains 300mg.

The other ingredients are lactose, maize starch, povidone, sodium starch glycollate, magnesium stearate, hydroxypropylmethylcellulose (E464), titanium dioxide (E171), polyethylene glycol and purified water.

The tablets are white, film-coated, have a curved shape and are marked “Urdox" on one side.

Ursodeoxycholic Acid Tablets are available in polyethylene/polypropylene (plastic) containers containing 60, 100 or 500 tablets and in blister strips of 60 tablets in cartons.

Not all pack sizes may be marketed.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name Reference number

Ursodeoxycholic Acid 300mg Film-Coated Tablets 29831/0198

This is a service provided by the Royal National Institute of Blind People.