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S0011-RM-PIL-28.01.2015

PACKAGE LEAFLET:

INFORMATION FOR THE USER

Ursofalk® 250mg Capsules / Ursodeoxycholic Acid 250mg Capsules

(Ursodeoxycholic Acid)

Your medicine is available using the above two names, but will be referred to as Ursofalk throughout the remainder of this leaflet.

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 side effects not listed in this leaflet, see section 4.

What is in this leaflet:

1.    What Ursofalk is and what it is used for

2.    What you need to know before you take Ursofalk

3.    How to take Ursofalk

4.    Possible side effects

5.    How to store Ursofalk

6.    Contents of the pack and other information

1.    WHAT URSOFALK IS AND WHAT IT IS USED FOR

Ursodeoxycholic acid (UDCA), the active substance in Ursofalk, is a naturally-occurring bile acid. Small amounts are found in human bile.

Ursofalk is used:

•    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 (PBC).

•    to dissolve gallstones caused by excess cholesterol in the gall bladder 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 liver disease associated with a condition called cystic fibrosis in children aged 6 to 18 years.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE URSOFALK

Do NOT take Ursofalk if:

•    you are, or have been told you are allergic (hypersensitive) to bile acids like UDCA or to any of the other ingredients of Ursofalk capsules (listed in section 6)

•    your gall bladder does not work properly

•    your doctor has said you have calcified gallstones (they are visible on an x-ray)

•    you have acute inflammation of the gall bladder or biliary tract

•    you have a blockage of the common bile duct or a cystic duct (obstruction of the biliary tract)

•    you have frequent cramp-like pains in the upper abdomen (biliary colic).

•    you are a child with biliary atresia and have poor bile flow, even after surgery.

Please 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.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Ursofalk.

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.

When used in the treatment of PBC, in rare cases the symptoms may worsen at the beginning of treatment. If this happens, please speak to your doctor about reducing your initial dose.

When used to dissolve gallstones, your doctor should arrange for a scan of your gall bladder after the first 6-10 months of treatment.

Please inform your doctor immediately if you have diarrhoea as this may require a reduction in the dose or discontinuation of treatment.

Other medicines and Ursofalk

The effects of these medicines may be altered:

A reduction in the effects of the following medicines is possible when taking Ursofalk:

•    colestyramine, colestipol (to lower blood lipids) or antacids containing aluminium hydroxide or smectite (aluminium oxide). If you must take medication that contains any of these ingredients, it must be taken at least two hours before or after Ursofalk.

•    ciprofloxacin and dapsone (antibiotics), nitrendipine (used to treat high blood pressure). It may be necessary for your doctor to alter the dose of these medicines.

A change in the effects of the following medicines is possible when taking Ursofalk:

•    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.

•    rosuvastatin (for high cholesterol and related conditions)

Please 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 Ursofalk for the dissolution of gallstones, as they may stimulate the formation of gallstones.

Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, even if they are medicines obtainable without a prescription. Treatment with Ursofalk may still be allowed. Your doctor will know what is right for you.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy: You should not take Ursofalk during pregnancy unless your doctor thinks it is absolutely necessary.

Women of child-bearing potential: Even if you are not pregnant, you should still discuss this possibility with your doctor. Before starting treatment with Ursofalk, your doctor will check that you are not pregnant and review your contraceptive method to make sure it is appropriate.

Breastfeeding: Tell your doctor if you are breast-feeding or about to start breastfeeding.

Driving and using machines:

No particular precautions are necessary.

3. HOW TO TAKE URSOFALK

Always take Ursofalk exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Ursofalk suspension is available if a lower dose is needed or you cannot swallow capsules.

For primary biliary cirrhosis (chronic inflammation of the bile ducts)

Dosage

During the first 3 months of treatment, you should take Ursofalk in the morning, at midday and in the evening. As liver function tests improve, the total daily dose may be taken once a day in the evening.

How to take Ursofalk

Swallow the capsules whole with a drink of water or other liquid. Take your medicine regularly.

Duration of treatment

Ursofalk may be continued indefinitely in cases of PBC.

To dissolve cholesterol gallstones Dosage

Approximately 10 mg per kg body weight (BW) daily, as follows:

50 - 62 kg 2 capsules daily 63 - 85 kg 3 capsules daily 86 - 120 kg 4 capsules daily

How to take Ursofalk

Swallow the capsules whole with a drink of water or other liquid. Take the capsules in the evening at bedtime. Take your medicine regularly.

Duration of treatment

It generally takes 6-24 months to dissolve gallstones. 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 treatment.

Both indications:

Use in elderly:

There is no evidence to suggest that any alteration in the adult dose is needed but your doctor will take your age and health into consideration.

Use in children and adolescents:

The administration of Ursofalk is based on body weight and the condition being treated.

Use in children (6 to 18 years) for treatment of liver disease

associated with cystic fibrosis

Dosage

The recommended daily dose is 20 mg per kg body weight, divided in 2-3 doses. Your doctor may want to increase the dose further to 30mg if necessary.

How to take Ursofalk

Take the capsules two to three times per day, as advised. Take the capsules regularly.

Duration of treatment

Treatment can be continued long term in children with cystic fibrosis associated hepatobiliary disorders.

If you feel that the effect of Ursofalk is too strong or too weak, please talk to your doctor or pharmacist.

If you take more Ursofalk than you should:

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

If you forget to take Ursofalk:

Do not take more capsules the next time, but just continue the treatment with the prescribed dose.

If you stop taking Ursofalk:

Always speak to your doctor before you decide to interrupt treatment with Ursofalk or decide to stop your treatment early.

4. POSSIBLE SIDE EFFECTS

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

Common side effects (occurring in less than 1 in 10 but more than 1 in 100 patients):

•    soft, loose stools or diarrhoea. Inform your doctor immediately if you have persistent diarrhoea, as this may require a reduction in the dose. 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 (occurring in less than 1 in 10,000 patients):

•    during the treatment of PBC: severe right-sided upper abdominal pain, severe worsening of liver scarring- this partially eases after treatment is stopped.

•    hardening of gallstones due to build up of calcium. There are no additional symptoms of this but it will show up in tests.

•    nettle rash (urticaria)

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:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

By reporting side effects, you can help provide more information on the safety of this medicine.

5.    HOW TO STORE URSOFALK

•    Do not store above 25°C.

•    Store in the original container.

•    Keep out of the sight and reach of children

•    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.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What Ursofalk contain:

The active ingredient is ursodeoxycholic acid and each capsule contains 250mg of this ingredient. These capsules also contain maize starch, colloidal anhydrous silica, magnesium stearate, gelatin, titanium dioxide (E171), sodium lauryl sulphate and purified water.

What Ursofalk looks like and the contents of the pack

Each carton of Ursofalk is available in pack sizes of 50 and 100 capsules.

The capsules are opaque, white, hard gelatine capsules containing a white powder.

Manufactured by:

Dr Falk Pharma GmbH, Leinenweberstr. 5, D-79041 Freiburg, Germany

Product Licence Holder:

Sam Pharma Ltd, Unit 20 Garrick Industrial Estate, Irving Way,

Hendon, London, NW9 6AQ.

Procured from within the EU and repackaged by:

Amimed Direct Ltd, Hendon, London, nW9 6AQ.

| POM | PL No: 33902/0011

Ursofalk® is a registered trademark of Dr Falk Pharma, GmbH, Germany.

This leaflet was last revised: 28/01/2015.

Other sources of information:

Further information, help, advice and can be found at:

The PBC Foundation 2 York Place Edinburgh Scotland EH1 3EP

Telephone: +44 (0) 131 556 6811 www.pbcfoundation.org.uk