Skip to Content

URSOGAL CAPSULES 250MG

Active substance(s): URSODEOXYCHOLIC ACID

View full screen / Print PDF » Download PDF ⇩
Transcript
Ursogal Capsules PX720-3 187.5x190:Layout 1 13/01/2014 10:29 Page 1

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Ursogal®
Capsules 250mg
(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
Capsules
3. How to take Ursogal Capsules
4. Possible side effects
5. How to store Ursogal Capsules
6. Contents of the pack and other information
1. WHAT URSOGAL IS AND WHAT IT IS USED
FOR
Ursogal Capsules contain ursodeoxycholic acid
(UDCA) as the active substance. UDCA is a bile
acid normally only found in small amounts in
human bile. Ursogal Capsules are used to dissolve
gallstones that are rich in cholesterol. Ursogal
Capsules are also used in the treatment of a
condition called primary biliary cirrhosis and 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 CAPSULES
Do not take Ursogal Capsules:
- 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
primary biliary cirrhosis and 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).
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 Capsules.
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 Capsules.

taken at least two hours before or after Ursogal
Capsules.
- ciclosporin (an immunosuppressant)
- ciprofloxacin or dapsone (antibiotics)
- rosuvastatin or clofibrate (used to lower
cholesterol)
- oral contraceptives or any other female hormones,
such as estrogenic hormones or hormone
replacement therapy (HRT). Female patients
taking Ursogal Capsules 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.
It may still be safe for you to take Ursogal
Capsules, your doctor or pharmacist will be able
to advise you.
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a
prescription.

Ursogal Capsules must be used under medical
supervision. 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.

Pregnancy and breast-feeding
In the absence of adequate evidence of safety in
pregnancy, Ursogal Capsules should not be taken
if you are pregnant, think you might be pregnant
or are trying to become pregnant.

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 Capsules.

Use a reliable method of contraception during
treatment with Ursogal Capsules. Female patients
taking Ursogal Capsules 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.
If you are being treated for primary biliary cirrhosis,
in rare cases your symptoms may worsen at the
beginning of your treatment e.g. the itching may
increase. If this happens please inform your
doctor immediately, as you might require a
reduction in your dose of Ursogal Capsules.
Excessive dietary intake of calories and cholesterol
should be avoided while you are taking Ursogal
Capsules.
Other medicines and Ursogal Capsules
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

The levels of the active ingredient of this medicine
in breast milk are low and are not expected to
cause your baby any problems.
Ask your doctor or pharmacist for advice before
taking any medicine during pregnancy or while
breast-feeding.
Driving and using machines
Ursogal Capsules will have little or no influence on
your ability to drive or use machines.
3. HOW TO TAKE URSOGAL CAPSULES
Always take Ursogal Capsules 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.

PX720/3

Ursogal Capsules PX720-3 187.5x190:Layout 1 13/01/2014 10:29 Page 2

Ursogal Capsules should be taken orally (by
mouth). The usual adult dose, which is used to
dissolve cholesterol-rich gallstones, is two or
three capsules daily, taken in two divided doses
after meals. The usual adult dose for the treatment
of primary biliary cirrhosis is two to five capsules
daily, taken in two to four divided doses.
However, these doses may vary depending on
your body weight.
Elderly patients and children will be prescribed a
dose depending on their body weight.
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.
The label on the container will tell you exactly how
many capsules to take and how often. You should
check with your doctor or pharmacist if you are
not sure.
In patients with primary biliary cirrhosis, the
symptoms may worsen at the start of treatment,
e.g. the itching may increase. This only occurs in
rare cases. If this happens, therapy can be
continued with a lower daily dose of Ursogal
Capsules. Each week, your doctor will then
gradually increase the daily dose, until you reach
the required dose.
If you have any questions about the dose you have
been prescribed please ask your doctor or
pharmacist.
You may need to take Ursogal Capsules for many
months for them to work. During this time your
doctor will monitor your condition.
If you take more Ursogal Capsules than you
should
This may cause diarrhoea. If you take too many
capsules, contact your nearest hospital casualty
department or doctor immediately. Take this leaflet
and any remaining capsules with you to show the
doctor.
If you forget to take Ursogal Capsules
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.
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 Capsules 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 Capsules.
If you are being treated for primary biliary cirrhosis,
in rare cases your symptoms may worsen at the
beginning of your treatment e.g. the itching may
increase. If this happens please inform your
doctor immediately, as you might require a
reduction in your dose of Ursogal Capsules.
Other side effects
The following side effect is common (may affect
up to 1 in 10 people):
- pasty stools.
The following side effects are very rare (may affect
up to 1 in 10,000 people):
- during the treatment of primary biliary cirrhosis:
severe right upper abdominal pain, worsening of
liver disease – this partially improves after
treatment is stopped
- hardening of gallstones due to build up of
calcium
- a red itchy rash.
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

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 Capsules contain
The active substance is ursodeoxycholic acid
(UDCA). Each Ursogal Capsule contains 250mg of
ursodeoxycholic acid.
The powder in the capsule shells also contains
other ingredients: microcrystalline cellulose and
magnesium stearate. The capsule shells are made
of gelatin and contain titanium dioxide (E171),
erythrosine (E127) and quinoline yellow (E104) as
colouring agents. The ink on the capsule shells
contains shellac, black iron oxide (E172) and
propylene glycol.
What Ursogal Capsules look like and the
contents of the pack
Ursogal Capsules are ivory coloured gelatin
capsules marked ‘UDCA 250mg’ in black ink.
Ursogal Capsules are available in packs of 60
capsules.
Marketing Authorisation Holder
Galen Limited
Seagoe Industrial Estate
Craigavon
BT63 5UA
UK

By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE URSOGAL CAPSULES
Keep this medicine out of the sight and reach of
children.
Do not use Ursogal Capsules after the expiry date,
which is stated on the container. The expiry date
refers to the last day of that month.
This product should be stored at normal room
temperature (below 25˚C). Do not use Ursogal
Capsules if you notice that the container or any of
the capsules are damaged.

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.

PX720/3
08/01/2014

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.

Hide