URSODEOXYCHOLIC ACID 300MG FILM-COATED TABLETS
Active substance(s): URSODEOXYCHOLIC ACID
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1st fold
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7th fold
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XXXXXXXXX
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 Acid Tablets
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.
(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.
(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.
(26.25mm)
16th fold
Unless instructed differently, take your tablets with a drink of water.
During treatment you should have regular blood tests to check your liver function.
106788/3
pg1/2
ART WORK CHECK BOX
Process
Black
PRODUCT :
CUSTOMER :
FP CODE:
PLANT LOCATION :
DIMENSIONS :
PHARMACODE No. :
TEXT FONT SIZE :
FILE NAME :
SOFTWARE :
TYPEFACES :
ARTWORK (DETAILS)
RECEIVED ON :
PROOF REVISION :
Urdox 300mg - 60 Tabs
Wockhardt UK
FP1757
UK alternate supply
(w)148 x (h)420mm
Dummy
9 pt.
Urdox 300mg_Leaflet_106788-3 (UK).ai
Adobe Illustrator CS5
Helvetica Medium / Bold
8th April, 2015
R 1st PDF sent on - 9TH APRIL 2015
CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Changes in detail: • Regulatory text amends
Non-Regulatory
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
2nd fold
(26.25mm)
1st fold
(26.25mm)
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.
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 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)
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.
6th fold
(26.25mm)
The following side effects are common (affect less than 1 out of 10 people):
• pasty stools
• diarrhoea.
Very rarely gall-stones get a layer of calcium on them, which may mean you will need an
operation to remove them.
9th fold
(26.25mm)
Reporting of side effects
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.
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)
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').
5. HOW TO STORE URSODEOXYCHOLIC ACID TABLETS
Keep out of the reach and sight of children.
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.
(26.25mm)
(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
Ursodeoxycholic Acid Tablets should not be taken if they show signs of deterioration.
Do not store above 25°C.
10th fold
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.
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)
(26.25mm)
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.
14th fold
(26.25mm)
13th fold
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.
Reference number
Ursodeoxycholic Acid 300mg Film-Coated Tablets
29831/0198
(26.25mm)
Product name
15th fold
Please be ready to give the following information:
This is a service provided by the Royal National Institute of Blind People.
pg2/2
(26.25mm)
106788/3
Code: PB/Drugs/1802-OSP
16th fold
Date of leaflet preparation: April 2015.
(26.25mm)
2nd fold
(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)
XXXXXXXXX
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 Acid Tablets
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.
(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.
(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.
(26.25mm)
16th fold
Unless instructed differently, take your tablets with a drink of water.
During treatment you should have regular blood tests to check your liver function.
106788/3
pg1/2
ART WORK CHECK BOX
Process
Black
PRODUCT :
CUSTOMER :
FP CODE:
PLANT LOCATION :
DIMENSIONS :
PHARMACODE No. :
TEXT FONT SIZE :
FILE NAME :
SOFTWARE :
TYPEFACES :
ARTWORK (DETAILS)
RECEIVED ON :
PROOF REVISION :
Urdox 300mg - 60 Tabs
Wockhardt UK
FP1757
UK alternate supply
(w)148 x (h)420mm
Dummy
9 pt.
Urdox 300mg_Leaflet_106788-3 (UK).ai
Adobe Illustrator CS5
Helvetica Medium / Bold
8th April, 2015
R 1st PDF sent on - 9TH APRIL 2015
CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Changes in detail: • Regulatory text amends
Non-Regulatory
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
2nd fold
(26.25mm)
1st fold
(26.25mm)
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.
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 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)
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.
6th fold
(26.25mm)
The following side effects are common (affect less than 1 out of 10 people):
• pasty stools
• diarrhoea.
Very rarely gall-stones get a layer of calcium on them, which may mean you will need an
operation to remove them.
9th fold
(26.25mm)
Reporting of side effects
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.
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)
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').
5. HOW TO STORE URSODEOXYCHOLIC ACID TABLETS
Keep out of the reach and sight of children.
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.
(26.25mm)
(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
Ursodeoxycholic Acid Tablets should not be taken if they show signs of deterioration.
Do not store above 25°C.
10th fold
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.
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)
(26.25mm)
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.
14th fold
(26.25mm)
13th fold
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.
Reference number
Ursodeoxycholic Acid 300mg Film-Coated Tablets
29831/0198
(26.25mm)
Product name
15th fold
Please be ready to give the following information:
This is a service provided by the Royal National Institute of Blind People.
pg2/2
(26.25mm)
106788/3
Code: PB/Drugs/1802-OSP
16th fold
Date of leaflet preparation: April 2015.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
