URSOFALK™

Ursofalk^® (Ursodeoxycholic Acid)

What is this leaflet?
This leaflet answers some common questions about Ursofalk. It does not contain all of the available information. Reading this leaflet does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of your taking Ursofalk against the benefits they expect it will have for you.

If you have any concerns about taking Ursofalk, ask your doctor or pharmacist.

Keep this leaflet. You may want to read it again.

What Ursofalk is used for
Ursofalk contains ursodeoxycholic acid. Ursodeoxycholic acid is a bile salt acid, which may have a protective effect on the liver by reducing the absorption of other potentially toxic bile salts.

Ursofalk may be used to treat a type of liver diseases known such as primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC) and cystic fibrosis-related cholestasis.

The Government has approved URSOFALK for the use mentioned above. However, your doctor may prescribe this medicine for another use. If you want more information, ask your doctor.

Ursofalk is not addictive.

Before you take Ursofalk
Ursofalk is not suitable for everyone.

Before you start to use it
Be sure that your doctor knows about the following before you start to take Ursofalk:

• if your are allergic to any of the ingredients in Ursofalk
• if you are pregnant, think you may be pregnant, or are trying to become pregnant
• if your kidneys do not work properly
• if you are taking any of these medicines:

  • cholestyramine, or colestipol
  • an absorbent such as charcoal
  • antacids or medicines for indigestion
  • cyclosporin
  • ciprofloxacin
  • any other medicines which your doctor does not know about and which you may have bought from a pharmacy, health food store or supermarket.

When you must not take Ursofalk
Do not take Ursofalk:

• if your bile duct or gall bladder is swollen, painful or blocked
• if you are pregnant or breast feeding unless your doctor tells you it is safe
• if the packaging is torn or shows signs of being tampered with;
• if the capsules, or suspension, look to be deteriorating in any way
• after the expiry date (EXP) printed on the pack
• to treat any other conditions unless advised by your doctor.

Do not give Ursofalk to anyone else, even if his or her symptoms seem similar to yours.

Using Ursofalk
Take Ursofalk, or give URSOFALK to your child, as directed by your doctor or pharmacist. Never change the dose yourself.

The usual adult dose is one or two capsules (or one to two 5 mL spoonfuls of the suspension) taken two to four times a day. 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 have any questions about the dose that you have been prescribed, you should ask your doctor or pharmacist.

Your may need to take Ursofalk for many months for it to work.

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

If you become pregnant while taking Ursofalk tell your doctor.

How to take Ursofalk
Ursofalk Capsules should be swallowed whole with a full glass of water because the content is bitter.

Shake the bottle of Ursofalk Suspension before use. Do not use the Suspension after 4 months of opening the bottle.

If you forget to take it
Take it as soon as you remember, and then go back to taking it as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose that you missed.

If you have trouble remembering when to take, or give, the medicine, ask your pharmacist for some hints.

In case of overdosage
Telephone your doctor or go to casualty at your nearest hospital if you think that you or anyone else may have taken too much Ursofalk. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Keep telephone numbers for these places handy.

When to stop taking Ursofalk
Do not stop taking Ursofalk just because you feel better. Your doctor will advise when to stop taking Ursofalk. If you are unsure whether you should stop taking Ursofalk, talk to your doctor or pharmacist. 

While you are taking Ursofalk
Ursofalk does not cause any negative effect on driving ability and operating machinery.

Some medicines may affect the way Ursofalk works. Tell your doctor if you are taking any of those medicines listed in the section "Before you take Ursofalk".

Your doctor or pharmacist will be able to tell you whether there are any special instructions while you are taking Ursofalk.

See your doctor if you feel that your condition is not improving or is getting worse.

Side Effects
Like all medicines, Ursofalk may occasionally cause side effects in some people. Normally these are mild, but if you experience the following effects, stop taking Ursofalk and tell your doctor immediately.

• Diarrhoea
• Itching/pruritus
• Allergic reactions
• Nausea/vomiting
• Sleep disturbance

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

After using Ursofalk
Storage
Keep the Ursofalk Capsules in the blister pack until it is time to take them. If you take capsules out of the box or blister pack they will not keep well.

Keep Ursofalk Capsules or Suspension in a cool, dark and dry place where the temperature stays below 25°C.

Do not store Ursofalk in the bathroom or near a sink.

Keep Ursofalk and all other medicines where children cannot reach them. A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

Do not leave Ursofalk in the car on hot days.

Check the expiry date on the side of the carton or blister pack of the Ursofalk Capsules, or on the side of the bottle of the Ursofalk Suspension. Do not use the Capsules or the Suspension if this date has been passed.

Disposal
Return any unused medicine to your pharmacist.

Product description
What Ursofalk looks like
Ursofalk Capsules are white, opaque, hard gelatin capsules. A box contains blister packs of 100 capsules.

Ursofalk Suspension is a white liquid containing small air bubbles, and has a lemon flavour (Giovaudan 87017). It comes in bottles of 250 mL.

Ingredients
The active ingredient in Ursofalk is ursodeoxycholic acid.

Each Ursofalk Capsule contains 250 mg of ursodeoxycholic acid. These capsules also contain maize starch, silicon dioxide, magnesium stearate, gelatin and titanium dioxide.

Each 5 mL of the Ursofalk Suspension contains 250 mg of ursodeoxycholic acid. The suspension also contains benzoic acid, purified water, xylitol, glyerol, microcrystalline cellulose and carmellose sodium, propylene glycol, sodium citrate, sodium cyclamate, anhydrous citric acid, sodium chloride and lemon flavouring (Giovaudan 87017).

Distributor
Ursofalk is distributed by:

Orphan Australia Pty. Ltd.
48 Kangan Drive Berwick Victoria 3806 Australia.

*Ursofalk is a registered trademark of Dr Falk Pharma GmbH.

This leaflet was prepared in May 2000.

Australian Registration Number:

Ursofalk Capsules AUST R 66042
Ursofalk Suspension AUST R 75484