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URSODEOXYCHOLIC ACID TABLETS 150MG

Active substance(s): URSODEOXYCHOLIC ACID

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Ursogal Tablets PX721-4 187.5x190:Layout 1 13/01/2014 09:03 Page 1

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Ursogal®
Tablets 150mg
(Ursodeoxycholic acid)
Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your
doctor, pharmacist or nurse.
- This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
- If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Ursogal is and what it is used for
2. What you need to know before you take Ursogal
Tablets
3. How to take Ursogal Tablets
4. Possible side effects
5. How to store Ursogal Tablets
6. Contents of the pack and other information
1. WHAT URSOGAL IS AND WHAT IT IS USED
FOR
Ursogal Tablets contain ursodeoxycholic acid
(UDCA) as the active substance. UDCA is a bile
acid normally only found in small amounts in
human bile. Ursogal Tablets are used to dissolve
gallstones that are rich in cholesterol. They can
also be used to treat children, aged 6 years to less
than 18 years, who have liver problems associated
with cystic fibrosis.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE URSOGAL TABLETS
Do not take Ursogal Tablets:
- if you have acute inflammation of the gall
bladder or biliary tract
- if you have a blockage of the biliary tract
- if you have frequent episodes of biliary colic
(recurrent pain in the upper abdomen)
- if your gall bladder does not work correctly
- if you have gallstones that are visible on an x-ray
- if you are pregnant or you think you might be
pregnant
- if there is a chance you might become pregnant
- if you have a stomach or duodenal ulcer

- if you have a stoma because part of your bowel
has been removed
- if you suffer from any liver problems (apart from
liver problems associated with cystic fibrosis in
children aged 6 years to less than 18 years)
- if you are allergic to ursodeoxycholic acid
(UDCA) or any of the other ingredients of this
medicine (listed in section 6).

- oral contraceptives or any other female
hormones, such as estrogenic hormones or
hormone replacement therapy (HRT). Female
patients taking Ursogal Tablets for the
dissolution of gallstones should only use
non-hormonal contraceptive methods e.g. barrier
methods, because hormonal contraceptives may
stimulate the formation of gallstones.

Children with a condition where their bile ducts
have not developed correctly (biliary atresia), who
have had an operation (portoenterostomy) to treat
this which has been unsuccessful or who have not
had recovery of good bile flow, should not take
Ursogal Tablets.

It may still be safe for you to take Ursogal Tablets,
your doctor or pharmacist will be able to advise you.

Talk to your doctor, pharmacist or nurse if any of
the above apply to you.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
taking Ursogal Tablets.
Ursogal Tablets must be used under medical
supervision.

Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a
prescription.
Pregnancy and breast-feeding
In the absence of adequate evidence of safety in
pregnancy, Ursogal Tablets should not be taken if
you are pregnant, think you might be pregnant or
are trying to become pregnant.

Your doctor should test your liver function
regularly every four weeks for the first three
months of treatment. After this time, it should be
monitored at three month intervals.

Use a reliable method of contraception during
treatment with Ursogal Tablets. Female patients
taking Ursogal Tablets for the dissolution of
gallstones should only use non-hormonal
contraceptive methods e.g. barrier methods,
because hormonal contraceptives may stimulate
the formation of gallstones.

If you are being treated for gallstones, your doctor
will monitor the progress of the dissolution of
your gallstones.

The levels of the active ingredient of this medicine
in breast milk are low and are not expected to
cause your baby any problems.

Please inform your doctor immediately if you have
diarrhoea, as this might require a reduction in the
dose or discontinuation of the treatment with
Ursogal Tablets.

Ask your doctor or pharmacist for advice before
taking any medicine during pregnancy or while
breast-feeding.

Excessive dietary intake of calories and cholesterol
should be avoided while you are taking Ursogal
Tablets.
Other medicines and Ursogal Tablets
Please tell your doctor or pharmacist if you are
taking, have recently taken or might take any of
the following medicines, including those
medicines obtained without a prescription:
- Colestyramine, colestipol (medicines to lower
your blood cholesterol level), charcoal or
antacids containing aluminium (indigestion
remedies). If you must take a medicine
containing any of these ingredients, it should be
taken at least two hours before or after Ursogal
Tablets.
- ciclosporin (an immunosuppressant)
- ciprofloxacin or dapsone (antibiotics)
- rosuvastatin or clofibrate (used to lower
cholesterol)

Driving and using machines
Ursogal Tablets will have little or no influence on
your ability to drive or use machines.
Ursogal Tablets contain lactose
If you have been told by your doctor that you have
an intolerance to some sugars, contact your
doctor before taking this medicinal product.
3. HOW TO TAKE URSOGAL TABLETS
Always take Ursogal Tablets exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure. Your doctor will
advise you of the dose you should take.

PX721/4

Ursogal Tablets PX721-4 187.5x190:Layout 1 13/01/2014 09:03 Page 2

Ursogal Tablets should be taken orally (by mouth).
The usual adult dose for the dissolution of
cholesterol-rich gallstones is three or four tablets
daily, taken in two divided doses after meals.
However, this dose may vary depending on your
body weight.

Other side effects
The following side effect is common (may affect
up to 1 in 10 people):
- pasty stools.

Elderly patients and children will be prescribed a
dose depending on their body weight.

The following side effects are very rare (may affect
up to 1 in 10,000 people):
- hardening of gallstones due to build up of calcium
- a red itchy rash.

The dose for children with cystic fibrosis, aged 6
years to less than 18 years, is calculated using
their body weight. The usual daily starting dose is
20mg per kg of body weight in two to three
divided doses, with a further increase to 30mg per
kg of body weight per day if necessary.

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

The label on the container will tell you exactly how
many tablets to take and how often. You should
check with your doctor or pharmacist if you are
not sure.

By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE URSOGAL TABLETS

If you have any questions about the dose you have
been prescribed please ask your doctor or
pharmacist.

Keep this medicine out of the sight and reach of
children.

You may need to take Ursogal Tablets for many
months for them to work. During this time your
doctor will monitor your condition.

Do not use Ursogal Tablets after the expiry date,
which is stated on the container. The expiry date
refers to the last day of that month.

If you take more Ursogal Tablets than you should
This may cause diarrhoea. If you take too many
tablets, contact your nearest hospital casualty
department or doctor immediately. Take this
leaflet and any remaining tablets with you to show
the doctor.

This product should be stored at normal room
temperature (below 25˚C). Do not use Ursogal
Tablets if you notice that the container or any of
the tablets are damaged.

If you forget to take Ursogal Tablets
If you miss a dose, take it as soon as you
remember and then continue as before. Do not
take a double dose to make up for a forgotten
dose.

Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Ursogal Tablets contain
The active substance is ursodeoxycholic acid
(UDCA). Each Ursogal Tablet contains 150mg of
ursodeoxycholic acid.
Ursogal Tablets also contain other ingredients;
they are lactose, microcrystalline cellulose and
magnesium stearate.
What Ursogal Tablets look like and the contents
of the pack
Ursogal Tablets are round, white, uncoated, scored
tablets marked ‘UDCA 150mg’.
Ursogal Tablets are available in packs of 60 tablets.
Marketing Authorisation Holder
Galen Limited
Seagoe Industrial Estate
Craigavon
BT63 5UA
UK
Manufacturer
Almac Pharma Services Limited
Almac House
20 Seagoe Industrial Estate
Craigavon
BT63 5QD
UK
This leaflet was last revised in January 2014.
Ursogal is a trademark.

If you have any further questions on the use of
this product, ask your doctor, pharmacist or
nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ursogal Tablets can cause side
effects, although not everybody gets them.
Diarrhoea is a side effect that has been reported
commonly (may affect up to 1 in 10 people).
Please inform your doctor immediately if you have
diarrhoea, as this might require a reduction in the
dose or discontinuation of the treatment with
Ursogal Tablets.

PX721/4
08/01/2014

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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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