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URSODEOXYCHOLIC ACID 150 MG TABLETS

Active substance(s): URSODEOXYCHOLIC ACID

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Ursodeoxychloride Acid 150 mg Tablets

PIL Code

P0081-11-01/1

Date started

PIL for 150 mg Tablets pack

Version

001

AW/V

85mm wide

Ireland
Pharmacovigilance Section
Irish Medicines Board, Kevin O’Malley House, Earlsfort
Centre, Earlsfort Terrace, IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.img.ie
E-mail: imbpharmacovigilance@imb.ie
5. How to store Ursodeoxycholic Acid
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use Ursodeoxycholic Acid after the expiry date which is
printed or embossed on the carton and blister as month/year.
The expiry date refers to the last day of the month.
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.
6. Contents of the pack and other information
What Ursodeoxycholic Acid contains:
The active substance is ursodeoxycholic acid. Each tablet
contains 150 mg ursodeoxycholic acid.
The other ingredients are lactose monohydrate, pregelatinised maize starch, sodium starch glycolate, talc and
magnesium stearate.
What Ursodeoxycholic Acid looks like and contents of
the pack:
Ursodeoxycholic Acid Tablets are white, round tablets,
11 mm diameter with a break line. The tablets are also
marked on one side with ‘URS 150’.
Ursodeoxycholic Acid Tablets are available in blisters of 60 tablets.
Marketing authorisation holder:
Auden Mckenzie (Pharma Division) Ltd., Mckenzie House,
Bury Street, Ruislip, Middlesex, HA4 7TL UK
Manufacturer:
Tiofarma, Benjamin Franklinstraat 9,
3261 LW Oud-Beijereland, Netherlands
This leaflet was last revised in November 2013.

P0081-11-01/1

001/v9 20.05.2014

Finished size: 180mm high x 170mm wide (flat)
4pp - 180mm high x 85mm wide (folded)

85mm wide

180mm high

21.03.2011

Auden Mckenzie

85mm wide

Other medicines and Ursodeoxycholic Acid
You should tell your doctor if you are taking:
• hormone replacement therapy or the contraceptive pill,
• colestyramine or clofibrate (which are medicines to lower
blood cholesterol),
• antacids (which are medicines to relieve indigestion or
heartburn),
• ciclosporin (an immunosuppressant).

PATIENT INFORMATION LEAFLET

URSODEOXYCHOLIC ACID 150 mg Tablets
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
or pharmacist.
• 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 or
pharmacist. This includes any possible side effects
not listed in this leaflet.
In this leaflet:
1. What Ursodeoxycholic Acid is and what it is used for
2. What you need to know before you take
Ursodeoxycholic Acid
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 is one of a group of medicines used
to dissolve gallstones. Not all gallstones are suitable for
treatment with Ursodeoxycholic Acid but your doctor has
decided that your condition may be treated this way.
Ursodeoxycholic acid is a chemical present naturally in the
body and it helps to control the amount of cholesterol in the
blood. Ursodeoxycholic Acid Tablets help dissolve
gallstones that are made mainly of cholesterol.
2. What you need to know before you take
Ursodeoxycholic Acid
Do not take Ursodeoxycholic Acid Tablets if:
• You have a stomach or duodenal ulcer
• You have had bowel surgery (removal of a part of the
small bowel)
• You have inflammatory bowel disease
• Your gall bladder does not work properly
• You have any liver disease
• Your doctor has told you that you have gallstones which
are radio-opaque.
Do not take this medicine if any of the above applies to you.
If you are not sure, talk to your doctor or pharmacist before
taking this medicine.

Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
Taking Ursodeoxycholic Acid with food and drink
Ursodeoxycholic Acid should be taken after meals, with one
dose always being taken after the evening meal.

180mm high

Pregnancy and breast feeding
3. How to take
• Ursodeoxycholic Acid should not be Ursodeoxycholic
taken duringAcid
the first
three months of pregnancy unless recommended by your
doctor.
• Women should use adequate contraception during
treatment with Ursodeoxycholic Acid. Contraception
should either be non-hormonal e.g. barrier methods or a
low oestrogen contraceptive pill. Other oral contraceptive
pills should not be taken with Ursodeoxycholic Acid. Ask
your doctor or pharmacist for advice.

85mm wide

• Ursodeoxycholic Acid will work best if taken together with
a low cholesterol and calorie controlled diet. You should
discuss this with your doctor.
• You will not normally take Ursodeoxycholic Acid for more
than 2 years. Your doctor will give you regular check-ups.
If you take more Ursodeoxycholic Acid than you
should:
You should tell your doctor if you have taken more
Ursodeoxycholic Acid than you should. It is unlikely that you
will notice any problems but you may experience diarrhoea.
If you forget to take Ursodeoxycholic Acid:
• Do not worry, take them as soon as you remember. If it is
nearly time for the next dose then take only that dose.
• Do not take a double dose to make up for a forgotten
dose.
If you stop taking Ursodeoxycholic Acid tablets even for
a short amount of time, it may cause the gall stones to
come back. Do not stop taking Ursodeoxycholic Acid until
you are advised by your doctor.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
4. Possible side effects

Do not take Ursodeoxycholic Acid whilst breast-feeding.

Like all medicines, Ursodeoxycholic Acid can cause side
effects, although not everybody gets them.

Ask your doctor or pharmacist for advice before taking any
medicine.

Common (in less than 1 in 10, but more than 1 in 100
patients)
• Diarrhoea and pasty stools

Driving and using machines
Ursodeoxycholic Acid should not affect your ability to drive
or use machines.
Important information about some of the ingredients of
Ursodeoxycholic Acid
This product contains lactose. If you have been told by your
doctor that you have an intolerance to some sugars, please
contact your doctor before taking this medicinal product.
3. How to take Ursodeoxycholic Acid
Always take Ursodeoxycholic Acid exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
• The usual dose is between 3 and 4 tablets a day. The
dose is usually divided up and taken twice a day, i.e. 1 or
2 tablets taken with water after meals. One of the doses
should always be taken after your evening meal.

Very Rare (in less than 1 in 10,000 patients)
• Itchy skin
• Gallstone calcification (a process in which the mineral
calcium builds up in tissue causing it to harden)
Other possible side effects
• Feeling (nausea) or being sick (vomiting)
• Itching usually caused by an allergic reaction
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the
national reporting system (see below). By reporting side
effects you can help provide more information on the safety
of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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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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