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Active substance(s): URSODEOXYCHOLIC ACID

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Package leaflet: Information for the user

Ursodeoxycholic acid 250mg Hard Capsules
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 Ursodeoxycholic acid is and what it is used for
2. What you need to know before you take Ursodeoxycholic
3. How to take Ursodeoxycholic acid
4. Possible side effects
5. How to store Ursodeoxycholic acid
6. Contents of the pack and other information
1. What Ursodeoxycholic acid is and what it is used for
Ursodeoxycholic acid contains the active substance
ursodeoxycholic acid.
Ursodeoxycholic acid is a chemical present naturally in the
body and it helps to control the amount of cholesterol in the
Ursodeoxycholic acid is used

2. What you need to know before you take Ursodeoxycholic acid

Warning and precautions
Talk to your doctor, pharmacist or nurse before taking
Ursodeoxycholic acid.
Ursodeoxycholic acid must be used under medical
Your doctor should test your liver function regularly every 4
weeks for the first 3 months of treatment. After this time, it
should be monitored at 3 month intervals.
Inform your doctor immediately if you have diarrhoea as
this may require a reduction in the dose or stopping the
Other medicines and Ursodeoxycholic acid
Tell your doctor, pharmacist or nurse if you are taking, have
recently taken or might take any other medicines, even if
they are obtainable without a prescription. Treatment with
Ursodeoxycholic acid may still be allowed. Your doctor will
know what is right for you.
A reduction in the effects of the following medicines is
possible when taking Ursodeoxycholic acid:

Dimension - 180 x 420 mm

Driving and using machines
No particular precautions are necessary.
3. How to take Ursodeoxycholic acid
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Swallow the capsules whole with a drink of water or other
liquid. Take the capsules regularly.
The daily dose below serves as an example of how you can
take the capsules.
Use in patients with damage to liver tissue by impaired
bile flow (Primary Biliary Cirrhosis)
Your doctor will determine your dose depending on your
body weight. During the first 3 months of treatment, you
should take 3-7 capsules in divided doses throughout the day.
As the liver function improves, the total daily dose can be
taken once, in the evening.
Primary Biliary Cirrhosis
Stage I-III
First 3 months
(how many capsules to take
throughout the day)
Morning Afternoon Evening
(once daily)
Primary Biliary Cirrhosis
Stage IV
Daily dose
number of



2 capsules



3 capsules



How many capsules to take throughout
the day

If you do not experience any problems at this dose (after
blood tests and/or according to an evaluation), your doctor
will prescribe you a higher dose (dosage in accordance with
the treatment of stage I-III).
Duration of treatment
Your doctor will determine the duration of treatment. It
may be necessary to get your blood checked regularly by
the laboratory. Ursodeoxycholic acid may be continued
indefinitely in cases of primary biliary cirrhosis.

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Do not take Ursodeoxycholic acid:
– if you are allergic to bile acids like ursodeoxycholic
acid or any of the other ingredients of this medicine
(listed in section 6);
– if your gall bladder does not work properly;
– if you have gallstones that are visible on an x-ray;
– if you have acute inflammation of the gall bladder or
biliary tract;
– if you have an obstruction of the biliary tract (blockage
of the common bile duct or a cystic duct);
– if you suffer from frequent cramp-like pains in the
upper abdomen (biliary colic);
– if you have hardening of the gallstones caused by a
build-up of calcium;
Children with a condition where the 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 ursodeoxycholic acid.
Ask your doctor about any of the conditions mentioned
above. You should also ask if you have previously had any of
these conditions or if you are unsure whether you have any
of them.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
− You should not take this medicine during pregnancy
unless your doctor thinks it is absolutely necessary. Use
of Ursodeoxycholic acid during the first three months of
pregnancy may affect the foetus.
− Check that you are not pregnant before taking this
− Use a reliable method of contraception – non-hormonal
contraceptives (barrier methods) or low-oestrogen oral
contraceptives are recommended. If you are taking this
medicine for dissolution of gallstones, only use nonhormonal contraceptives, as hormonal oral contraceptives
may stimulate the formation of gallstones.
− Do not take this medicine if you are breast-feeding as the
active ingredient in this medicine may pass into breast
milk. If treatment with Ursodeoxycholic acid is necessary,
then stop breast-feeding.


− to dissolve gallstones caused by excess cholesterol in
the gall bladder (in patients for whom surgery is not an
option), where the gallstones are not visible on a plain
x-ray (gallstones that are visible will not dissolve) and not
more than 15 mm in diameter. The gall bladder should
still be working despite the gallstone(s).
− for the treatment of a condition where the bile ducts in the
liver become damaged leading to a build-up of bile. This
may cause scarring of the liver. The liver should not be so
damaged that it is not functioning properly. This condition
is called primary biliary cirrhosis.
− for Paediatric population: to treat children, aged 6 years
to less than 18 years, who have liver problems associated
with cystic fibrosis.

− colestyramine, charcoal, colestipol (to lower blood lipids)
or antacids containing aluminium hydroxide or smectite
(aluminium oxide). If you must take medicines that
contain any of these ingredients, you should take these at
least two hours before or after Ursodeoxycholic acid.
− ciprofloxacin and dapsone (antibiotics), nitrendipine (used
to treat high blood pressure). It may be necessary for your
doctor to change the dose of these medicines.
An increase in the effects of the following medicines is
possible when taking Ursodeoxycholic acid:
− ciclosporin (to reduce the activity of the immune system).
If you are being treated with ciclosporin, your doctor
should check the amount of ciclosporin in your blood.
Your doctor will adjust its dose, if necessary.
Inform your doctor if you are taking any blood cholesterol
lowering agents such as clofibrate or medicines that
contain oestrogen (estrogen), especially if you are taking
Ursodeoxycholic acid for the dissolution of gallstones, as
they may stimulate the formation of gallstones.

In patients with primary biliary cirrhosis, the symptoms
may worsen at the start of treatment, for example the
itching may increase. This only occurs in rare cases. If
this happens, therapy can be continued with a lower daily
dose of Ursodeoxycholic acid. Each week, your doctor will
then gradually increase the daily dose, until you reach the
required dose.
Use in patients with gallstones
The recommended dose is approximately 10 mg
ursodeoxycholic acid per kg body weight per day, taken as
Patients with gallstones
How many capsules to take in the
Body Weight (kg)
evening before bedtime
Up to 60 kg
2 capsules

− in patients with cirrhosis, exacerbation (increase in
severity) of pruritus (itching) at the beginning of the
treatment cannot be completely ruled out.
− in patients with stage IV primary biliary cirrhosis,
there may be an increase in the concentration of
certain enzymes (alkaline phosphates, gammaglutamyltransferase) and bilirubin.
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 Yellow Card
Scheme at agency’s website:
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Ursodeoxycholic acid

61-80 kg

3 capsules

81-100 kg

4 capsules

Expiry date

More than 100 kg

5 capsules

Do not use this medicine after the expiry date which is stated
on the blister label and carton after ‘EXP’. The expiry date
refers to the last day of that month.

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

Duration of treatment
It generally takes 6-24 months to dissolve gallstones. The
duration of your treatment depends on the size of the existing
gallstones at the beginning of the treatment. Even if your
symptoms have disappeared, you should continue with the
treatment. Stopping treatment may result in the extension
of the total treatment time. After the gallstones have been
dissolved, the treatment should be continued for 3-4 months.
If there is no reduction in the size of the gallstones after 12
months, therapy should be stopped.
Every 6 months, your doctor should check whether
the treatment is working. At each of these follow-up
examinations, it should be checked whether a build-up of
calcium causing hardening of the stones has occurred since
the last time. If this happens, your doctor will stop the
If you feel that the effect of Ursodeoxycholic acid is too
strong or too weak, talk to your doctor or pharmacist.
Use in children
Children with cystic fibrosis aged 6 years to less than 18
years: 20 mg/kg/day in 2-3 divided doses, with a further
increase to 30 mg/kg/day if necessary
There are no age limits to the use of Ursodeoxycholic
acid 250mg hard capsules. The administration of
Ursodeoxycholic acid is based on body weight and the
medical condition. If the patient cannot swallow capsules or
has a bodyweight below 47 kg, other pharmaceutical forms
(suspension) are available.

This medicinal product does not require any special storage
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
protect the environment.

Contents of the pack and other information

What Ursodeoxycholic acid contains
− The active substance is ursodeoxycholic acid. Each
capsule contains 250 mg ursodeoxycholic acid.
− The other ingredients are:
− Capsule contents: povidone (Kollidon K-30) (E1201),
sodium lauril sulphate (E487), maize starch, magnesium
stearate (E572)
− Capsule Shell: gelatin (E441), titanium dioxide (E 171)
What Ursodeoxycholic acid looks like and contents of the
Ursodeoxycholic acid are white hard gelatin capsules (size
‘0’) containing a white to off white powder.
The capsules are available in colourless PVC film with
aluminium blister foil packed in cardboard cartons.
Ursodeoxycholic acid is available in packs of 20, 28, 30, 50,
56, 60, 100 and 120 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:

If you or anyone else take too many capsules, seek
immediate medical attention.

Strides Arcolab International Ltd.
Unit 4, Metro Centre, Tolpits Lane,
Watford, Hertfordshire, WD18 9SS,
United Kingdom.

If you forget to take Ursodeoxycholic acid
Do not take a double dose to make up for a forgotten dose.
If you stop taking Ursodeoxycholic acid
Always speak to your doctor before you decide to interrupt
treatment with Ursodeoxycholic acid or to stop your
treatment early.
If you have any further questions on the use of this medicine,
ask your doctor, pharmacist or nurse.


If you take more Ursodeoxycholic acid than you should

Manufacturer & Distributor:
Co-Pharma Limited
Unit 4, Metro Centre, Tolpits Lane, Watford,
Hertfordshire WD18 9SS,
United Kingdom.
This leaflet was last revised in {08/2015}.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Contact your doctor immediately if you experience any
of the following symptoms after taking Ursodeoxycholic


Dimension - 180 x 420 mm


Common side effects (may affect up to 1 in 10 people):
− soft, loose stools or diarrhoea. Inform your doctor
immediately if you have persistent diarrhoea, as this may
require a reduction in the dose of your medicine. If you
do suffer from diarrhoea, make sure you drink enough
liquids to replace your fluid and salt balance.
Diarrhoea may also occur as a result of overdose.
Very rare side effects (may affect up to 1 in 10,000 people):
− during the treatment of primary biliary cirrhosis: severe
right-sided upper abdominal pain, severe worsening of
liver scarring - this partially improves after treatment is
− hardening of gallstones due to build up of calcium. There
are no additional symptoms of this but it will show up in
− nettle rash (urticaria)
Not known (frequency cannot be estimated from the
available data)
− vomiting

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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.