URDOX 300MG FILM-COATED TABLETS

Active substance: URSODEOXYCHOLIC ACID

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4th fold

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3rd fold

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1st fold

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Neutral code not required on the leaflet artworks.
PACKAGE LEAFLET : INFORMATION FOR THE USER

Ursodeoxycholic Acid 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 Ursodeoxycholic Acid 300mg Film-Coated Tablets. In the
rest of this leaflet it is called Ursodeoxycholic Acid Tablets.
In this leaflet:
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 AcidTablets
6. Further information

6th fold

(26.25mm)

5th fold

(26.25mm)

1. WHAT URSODEOXYCHOLIC ACID TABLETS ARE AND WHAT
THEY ARE USED FOR
The active ingredient in Ursodeoxycholic Acid Tablets is ursodeoxycholic acid, which is a
naturally occurring substance (bile acid) normally present in the bile.
Ursodeoxycholic Acid Tablets may be used for the following:
• To dissolve certain types of gall stones (stones in the gall bladder), which contain
cholesterol. Ursodeoxycholic Acid 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).
• To treat liver disease associated with cystic fibrosis in children aged 6 years to less than
18 years.

(26.25mm)

13th fold

(26.25mm)

12th fold

(26.25mm)

11th fold

(26.25mm)

10th fold

9th fold

(26.25mm)

8th fold

(26.25mm)

7th fold

(26.25mm)

2. BEFORE YOU TAKE URSODEOXYCHOLIC ACID TABLETS
Do not take Ursodeoxycholic Acid 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
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.
Children aged 6 years to less than 18 years with cystic fibrosis
Not to be taken if the child has had unsuccessful surgery to restore the flow of bile to the
small intestine.
Taking other medicines
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.
Pregnancy and breast-feeding
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.

(26.25mm)

16th fold

(26.25mm)

15th fold

(26.25mm)

14th fold

You should not breast-feed whilst taking Ursodeoxycholic Acid Tablets.
Driving and operating machines
Ursodeoxycholic Acid 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 URSODEOXYCHOLIC ACID 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.

ART WORK CHECK BOX
PRODUCT :
CUSTOMER :
FP CODE:
PLANT LOCATION :
DIMENSIONS :
PHARMACODE No. :
SAP CODE No. :
TEXT FONT SIZE :
FILE NAME :
SOFTWARE :
TYPEFACES :
ARTWORK (DETAILS)
RECEIVED ON :
PROOF REVISION :
Process
Black

Urdox 300mg - 60 Tabs
Wockhardt UK
FP1757; FP2498
EOU
(w)148 x (h)420mm
2449
219469
9 pt.
Urdox 300mg_Leaflet_103415-4.ai
Adobe Illustrator CS5
Helvetica Medium / Bold
20th & 22nd January, 2014
R 1st PDF sent on - 23RD JAN. 2014
R 2nd PDF sent on - 30TH SEPT. 2014
R 3rd PDF sent on - 16TH OCT. 2014

CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Non-Regulatory
Changes in detail: • Regulatory text amends • Wockhardt logo updation
• Removed pre-printed neutral code
• Pharmacode placed on 8mm from cutting edge

103415/4

pg1/2

1st fold

(26.25mm)

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.

If you miss a dose of Ursodeoxycholic Acid 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 Ursodeoxycholic Acid Tablets
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.

4. POSSIBLE SIDE EFFECTS

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6th fold

(26.25mm)

Like many medicines Ursodeoxycholic Acid Tablets may cause side effects in some
patients, although not everybody gets them.

4th fold

If you take more Ursodeoxycholic Acid Tablets than you should
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.

(26.25mm)

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.

5th fold

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.

(26.25mm)

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.

(26.25mm)

2nd fold

(26.25mm)

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.

The following side effects are common (affect less than 1 out of 10 people):
• pasty stools
• diarrhoea.

5. HOW TO STORE URSODEOXYCHOLIC ACID 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.

8th fold

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.

9th fold

Very rarely gall-stones get a layer of calcium on them, which may mean you will need an
operation to remove them.

(26.25mm)

The following side effects may also occur (how often these side effects occur is not
known):
• feeling sick
• being sick
• itching.

(26.25mm)

7th fold

(26.25mm)

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').

What Ursodeoxycholic Acid Tablets contain
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.
What Ursodeoxycholic Acid 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.

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)

(26.25mm)
(26.25mm)

Not all pack sizes may be marketed.

14th fold

(26.25mm)

13th fold

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.

(26.25mm)

6. FURTHER INFORMATION

11th fold

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.

(26.25mm)

Store in the original container or package in order to protect from light and moisture. Do not
transfer the tablets to another container.

12th fold

Do not store above 25°C.

10th fold

Ursodeoxycholic Acid Tablets should not be taken if they show signs of deterioration.

Please be ready to give the following information:
29831/0198

(26.25mm)

This is a service provided by the Royal National Institute of Blind People.
Date of leaflet preparation: October 2014.

103415/4
219469

pg2/2

(26.25mm)

Ursodeoxycholic Acid 300mg Film-Coated Tablets

15th fold

Reference number

16th fold

Product name

DUMMY

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(26.25mm)

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(26.25mm)

3rd fold

(26.25mm)

4th fold

(26.25mm)

5th fold

(26.25mm)

6th fold

(26.25mm)

7th fold

(26.25mm)

8th fold

(26.25mm)

PACKAGE LEAFLET : INFORMATION FOR THE USER

Ursodeoxycholic Acid 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 Ursodeoxycholic Acid 300mg Film-Coated Tablets. In the
rest of this leaflet it is called Ursodeoxycholic Acid Tablets.
In this leaflet:
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 AcidTablets
6. Further information

1. WHAT URSODEOXYCHOLIC ACID TABLETS ARE AND WHAT
THEY ARE USED FOR
The active ingredient in Ursodeoxycholic Acid Tablets is ursodeoxycholic acid, which is a
naturally occurring substance (bile acid) normally present in the bile.
Ursodeoxycholic Acid Tablets may be used for the following:
• To dissolve certain types of gall stones (stones in the gall bladder), which contain
cholesterol. Ursodeoxycholic Acid 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).
• To treat liver disease associated with cystic fibrosis in children aged 6 years to less than
18 years.

2. BEFORE YOU TAKE URSODEOXYCHOLIC ACID TABLETS
Do not take Ursodeoxycholic Acid 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
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).

(26.25mm)

13th fold

(26.25mm)

12th fold

(26.25mm)

11th fold

(26.25mm)

10th fold

9th fold

(26.25mm)

If any of the above statements apply to you, do not take Ursodeoxycholic Acid Tablets.
Children aged 6 years to less than 18 years with cystic fibrosis
Not to be taken if the child has had unsuccessful surgery to restore the flow of bile to the
small intestine.
Taking other medicines
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.
Pregnancy and breast-feeding
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.

(26.25mm)

14th fold

Driving and operating machines
Ursodeoxycholic Acid 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.

(26.25mm)

15th fold

3. HOW TO TAKE URSODEOXYCHOLIC ACID 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.
(26.25mm)

16th fold

During treatment you should have regular blood tests to check your liver function.
107260/1

DUMMY

pg1/2
ART WORK CHECK BOX

Process
Black

PRODUCT :
CUSTOMER :
FP CODE:
PLANT LOCATION :
DIMENSIONS :
PHARMACODE No. :
SAP CODE No. :
TEXT FONT SIZE :
FILE NAME :
SOFTWARE :
TYPEFACES :
ARTWORK (DETAILS)
RECEIVED ON :
PROOF REVISION :

Urdox 300mg - 60 Tabs
Wockhardt UK
FP1757; FP2498
WUK alternate (Oman pharma)
(w)148 x (h)420mm
DUMMY

9 pt.
Urdox 300mg_Leaflet_107260-1.ai
Adobe Illustrator CS5
Helvetica Medium / Bold
29th September, 2014
R 1st PDF sent on - 30TH SEPT. 2014
R 2nd PDF sent on - 16TH OCT. 2014

If you take more Ursodeoxycholic Acid Tablets than you should
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 miss a dose of Ursodeoxycholic Acid 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 Ursodeoxycholic Acid Tablets
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.

4. POSSIBLE SIDE EFFECTS

1st fold

(26.25mm)

2nd fold

(26.25mm)

3rd fold

(26.25mm)

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.

4th fold

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.

(26.25mm)

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.

5th fold

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.

(26.25mm)

DUMMY

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.

Like many medicines Ursodeoxycholic Acid Tablets may cause side effects in some
patients, although not everybody gets them.

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.

7th fold

DUMMY

8th fold

The following side effects may also occur (how often these side
effects occur is not known):
• feeling sick
• being sick
• itching.

(26.25mm)

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').

(26.25mm)

6th fold

(26.25mm)

The following side effects are common (affect less than 1 out of 10 people):
• pasty stools
• diarrhoea.

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.

9th fold

Keep out of the reach and sight of children.

(26.25mm)

5. HOW TO STORE URSODEOXYCHOLIC ACID TABLETS

Ursodeoxycholic Acid Tablets should not be taken if they show signs of deterioration.

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

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:
29831/0198

(26.25mm)
(26.25mm)

This is a service provided by the Royal National Institute of Blind People.
Date of leaflet preparation: October 2014.

107260/1

pg2/2

(26.25mm)

Ursodeoxycholic Acid 300mg Film-Coated Tablets

15th fold

Reference number

16th fold

Product name

(26.25mm)

Not all pack sizes may be marketed.

14th fold

(26.25mm)

13th fold

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.

(26.25mm)

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

11th fold

6. FURTHER INFORMATION

(26.25mm)

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.

12th fold

Store in the original container or package in order to protect from light and moisture. Do not
transfer the tablets to another container.

10th fold

Do not store above 25°C.

Expand view ⇕

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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