Ursofalk Capsules

URSOFALK

URSODEOXYCHOLIC ACID 250mg

Please read this leaflet carefully before you start to take your medicine.
It does not contain complete information about your treatment. If you have any other questions, or are not sure about anything, ask your doctor or pharmacist (chemist). Keep this leaflet until you have finished all your medicine. You may want to read it again.

The name of this medicine is Ursofalk. The active ingredient is ursodeoxycholic acid and each capsule contains 250mg of this ingredient. These capsules also contain maize starch, silicon dioxide, magnesium stearate, gelatin and titanium dioxide.

Each carton of Ursofalk is available in pack sizes of 60 and 100 capsules.

Ursodeoxycholic acid is a bile salt which may have a protective effect on the liver by reducing the absorption of other potentially toxic bile salts. It is also used to lower the amount of cholesterol excreted in the bile.

Product Licence Holder:

Dr Falk Pharma UK Ltd

Unit K

Bourne End Business Park

Cores End Road

Bourne End

Bucks

SL8 5AS

UK

Manufactured by:

Dr Falk Pharma GmbH

D-79041 Freiburg

Germany

Ursofalk may be used to treat the following:

• A type of liver disease known as primary biliary cirrhosis (PBC).


• Certain types of gallstones known by doctors as cholesterol or radiolucent gallstones.

Before taking Ursofalk

If the answer to any of the following questions is yes, tell your doctor.

• Are you allergic to any of the ingredients?


• Are you pregnant, think you may be pregnant or are trying to become pregnant?


• Have you been told that you have another type of stone (non-cholesterol or radioopaque gallstone) or that your gall bladder doesn’t work properly?


• Are you taking an oral contraceptive or any other female hormones such as hormone replacement therapy?


• Are you taking cholestyramine, colestipol, clofibrate or any other medicine to lower your blood cholesterol?


• Are you taking an adsorbent such as charcoal?


• Are you taking any antacids or medicines for indigestion?


• Are you taking cyclosporin?


• Are you taking any other medicines which your doctor does not know about?

Taking Ursofalk

It is important to take Ursofalk as directed by your doctor. The usual adult dose is one or two capsules taken two to four times daily. The dose for a child may be less. The label will tell you how many to take and how often, but if it does not or you are unsure ask your doctor or pharmacist. If you are being treated for gallstones take the last dose with food before you go to bed.

• The capsules should be swallowed whole with a glass of water.


• You may need to take Ursofalk for many months for it to work.


• If you accidentally take too many capsules either contact your doctor as soon as possible or go to the nearest hospital casualty department.


• If you forget to take your capsules, take a dose as soon as you remember and then continue with the next dose as instructed on the label.


• If you go into hospital or visit a dentist or another doctor tell them you are taking this medicine.


• If you become pregnant whilst taking Ursofalk tell your doctor.

Like all medicines, Ursofalk may occasionally cause side-effects in some people. Normally these are mild but if you experience the following effect stop taking the capsules and tell your doctor as soon as possible.

• Diarrhoea.

If you experience any other undesirable effects then tell your doctor or pharmacist, particularly if they are severe or persistent.

Storing Ursofalk

• You may store your Ursofalk capsules wherever you like. Keep them out of the reach of children because your medicine could harm them.


• Check the expiry date on the side of the carton or blister pack and do not use the capsules if this date has been passed.


• If your doctor decides to stop treatment, return any left over capsules to the pharmacist. Only keep them if the doctor tells you to.


• If the capsules look to be deteriorating in any way, do not take them, and return them to the pharmacist.

Date leaflet prepared: November 2004.

PL 10341/0006.

This leaflet provides a summary of the information available on your medicine.

This information applies only to Ursofalk. If you have any questions or are not sure of anything, ask your doctor or pharmacist who have access to additional information.

You may also wish to contact the following national organisation which offers help, advice and local support groups:

Primary Biliary Cirrhosis Foundation

54 Queen Street

Edinburgh

EH2 3NS

Telephone:0131 225 8586

REMEMBER: This medicine is yours. Never give it to others. It may not be suitable for them even if their symptoms are the same as yours.

Dr Falk Pharma UK Ltd

Unit K

Bourne End Business Park

Cores End Road

Bourne End

Bucks

SL8 5AS

UK

60004516

GB/01.05