Auden Mckenzie

Group

85mm wide

85mm wide

85mm wide

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

PATIENT INFORMATION LEAFLET

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.

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.

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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.

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

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Auden Mckenzie

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.

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).

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.

Pregnancy and breast feeding

•    Ursodeoxycholic Acid should not betakenduringthe 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.

Do not take Ursodeoxycholic Acid whilst breast-feeding.

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

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.

•    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

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.

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

Common (in less than 1 in 10, but more than 1 in 100 patients)

•    Diarrhoea and pasty stools

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