URDOX 300MG FILM-COATED TABLETS

Active substance: URSODEOXYCHOLIC ACID

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PACKAGE LEAFLET : INFORMATION FOR THE USER

Urdox® 300mg Film-Coated Tablets
Ursodeoxycholic Acid
Read all of this leaflet carefully before you start using this
medicine.
- 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 Urdox® 300mg Film-Coated Tablets. In the rest of this leaflet
it is called Urdox® Tablets.
In this leaflet:
1. What Urdox® Tablets are and what they are used for
2. Before you take Urdox® Tablets
3. How to take Urdox® Tablets
4. Possible side effects
5. How to store Urdox®Tablets
6. Further information

1. WHAT URDOX® TABLETS ARE AND WHAT THEY ARE USED FOR
The active ingredient in Urdox® Tablets is ursodeoxycholic acid, which is a naturally
occurring substance (bile acid) normally present in the bile.
Urdox® Tablets may be used for the following:
• To dissolve certain types of gall stones (stones in the gall bladder), which contain
cholesterol. Urdox® Tablets may be suitable for patients who are unable to have surgery
or do not wish to have surgery.
• To treat a type of liver disease known as primary biliary cirrhosis (PBC).

2. BEFORE YOU TAKE URDOX® TABLETS
Do not take Urdox® Tablets if you:
• 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 Urdox®
Tablets (see 'What Urdox® 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 Urdox® Tablets.

Taking other medicines
Taking another medicine while you are taking Urdox® 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 Urdox® 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 Urdox® 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.
Pregnancy and breast-feeding
You should not take Urdox® 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 Urdox® Tablets (but see precautions above in
“Taking other medicines” section).
If at any point during treatment with Urdox® Tablets you think you might have become
pregnant, contact your doctor immediately.
You should not breast-feed whilst taking Urdox® Tablets.
Driving and operating machines
Urdox® Tablets do not affect the ability to drive or operate machinery.
Important information for patients who have an intolerance to some sugars
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.

3. HOW TO TAKE URDOX® TABLETS
Your doctor will decide the dose which is best for you. Always follow your doctor’s
instructions completely and also follow any special instructions or warnings which appear
on the label which the pharmacist has put on the package. If you do not understand, or are
in any doubt, ask your doctor or pharmacist.
Unless instructed differently, take your tablets with a drink of water.
During treatment you should have regular blood tests to check your liver function.
Adults and Elderly
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.

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Your doctor may tell you to take Urdox® 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 than the usual adult dose.
The doctor will calculate the dose depending on the child's
weight.
If you take more Urdox® Tablets than you should
Too many Urdox® 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 miss a dose of Urdox® Tablets
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.
Stopping Urdox® Tablets
You should continue to take Urdox® Tablets for as long as your doctor tells you to. Do not
stop taking the medicine without talking to your doctor first.

4. POSSIBLE SIDE EFFECTS
Like many medicines Urdox® Tablets may cause side effects in some patients, although not
everybody gets them.
The following side effects are common (affect less than 1 out of 10 people):
• pasty stools
• diarrhoea.
The following side effects are very rare (affect less than 1 out of 10,000 people):
• severe right upper stomach pain
• worsening of liver disease
• a red, itchy rash ('hives').
The following side effects may also occur (how often these side effects occur is not known):
• feeling sick
• being sick
• itching.
Very rarely gall-stones get a layer of calcium on them, which may mean you will need an
operation to remove them.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please contact your doctor or pharmacist immediately.

5. HOW TO STORE URDOX® TABLETS
Keep out of the reach and sight of children.
Do not take this medicine if the expiry date on the label has passed. The expiry date refers
to the last day of that month.
Urdox® Tablets should not be taken if they show signs of deterioration.
Do not store above 25°C.
Store in the original container or package in order to protect from light and moisture. Do not
transfer the tablets to another container.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.

6. FURTHER INFORMATION
What Urdox® Tablets contain
The active ingredient in Urdox® 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.
What Urdox® Tablets look like and contents of the pack
The tablets are white, film-coated, have a curved shape and are marked “Urdox®” on one
side.
Urdox® 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.
Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham,
LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
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

Urdox® 300mg Film-Coated Tablets

29831/0198

This is a service provided by the Royal National Institute of Blind People.
Date of leaflet preparation: September 2010.
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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