• 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, see section 4.

1. What Ursofalk tablets are and what they are used for
2. What you need to know before you take Ursofalk tablets
3. How to take Ursofalk tablets
4. Possible side effects
5. How to store Ursofalk tablets
6. Contents of the pack and other information

• for the treatment of primary biliary cirrhosis (PBC) 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 (cirrhosis of the liver). The liver should not be so damaged that it is not functioning properly.
• to dissolve cholesterol gallstones. These stones must not be visible on a plain X-ray (radiolucent) and be no larger than 15 mm in diameter because they will not dissolve with UDCA. The gall bladder must still be working despite the gallstone(s).
• for liver disease associated with a condition called cystic fibrosis in children aged 6 to 18 years

• You are, or have been told you are, allergic (hypersensitive) to bile acids like UDCA or to any of the other ingredients of this medicine (listed in section 6).
• You have an acute inflammation of the gall bladder or biliary tract.
• You have a blockage of the common bile duct or cystic duct (obstruction of the biliary tract).
• You have frequent cramp-like upper abdomen pain (biliary colic).
• Your doctor has said you have calcified gallstones (they are visible on an x-ray).
• Your gall bladder does not work properly.
• You are a child with biliary atresia and have poor bile flow, even after surgery.

Please ask your doctor about 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.

Talk to your doctor or pharmacist before taking Ursofalk tablets

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 talk to your doctor immediately if you have diarrhoea, as this may require a reduction in the dose or discontinuation of the treatment with Ursofalk tablets.

Please tell your doctor if you are taking or have recently taken or might take any other medicines

The effects of these medicines may be altered:

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

• 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 tablets.
• ciprofloxacin, dapsone (antibiotics), nitrendipine (used to treat high blood pressure) and other medicines which are metabolised in a similar way. 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 tablets:

• 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).

If you are taking Ursofalk tablets for the dissolution of gallstones, please inform your doctor in case you are taking any medicines that contain oestrogenic hormones or blood cholesterol lowering agents such as clofibrate. These medicines stimulate the formation of gallstones, which is a counter-effect to the treatment with Ursofalk.

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

If you are pregnant or breast feeding, 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.

No particular precautions are necessary.

Dosage

During the first 3 months of treatment, you should take Ursofalk tablets in divided doses during the day. As liver function tests improve, the total daily dose may be taken once a day in the evening.

Body weight (BW): 47 to 62kg. Daily dose: 12 to 16 mg/kg BW

½ tablet in the morning, at midday and in the evening for the first 3 months; then 1½ tablets once a day, taken in the evening.

Body weight (BW): 63 to 78kg. Daily dose: 13 to16 mg/kg BW

½ tablet in the morning and at midday and 1 tablet in the evening for the first 3 months; then 2 tablets, once a day, taken in the evening.

Body weight (BW): 79 to 93kg. Daily dose: 13 to16 mg/kg BW

½ tablet in the morning, 1 tablet at midday and in the evening for the first 3 months; then 2½ tablets, once a day, taken in the evening.

Body weight (BW): 94 to 109kg. Daily dose: 14 to16 mg/kg BW

1 tablet in the morning, midday and evening for the first 3 months; then 3 tablets, once a day, taken in the evening.

Body weight (BW): over 110kg.

1 tablet in the morning and at midday and 1½ tablets in the evening for the first 3 months; then 3½ tablets, once a day, taken in the evening.

The tablet can be divided into equal doses. Swallow the tablets with a drink of water or other liquid. Do not crush or chew the tablets. Take the tablets in the evening at bedtime. Take the tablets regularly.

Ursofalk tablets can be continued indefinitely in cases of PBC.

Dosage

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

up to 60 kg 1 tablet

61 – 80 kg 1½ tablets

81 – 100 kg 2 tablets

over 100 kg 2½ tablets

The tablet can be divided into equal doses. Swallow the tablets with a drink of water or other liquid. Do not crush or chew the tablets. Take the tablets in the evening at bedtime. Take the tablets regularly.

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 calcification of the stones has occurred since the last time. If this is the case, your doctor will stop the treatment.

Ursofalk capsules or Ursofalk suspension are available if you weigh less than 47 kg or cannot swallow tablets.

Use in elderly:

There is no evidence to suggest that any alteration in the adult dose is needed but the relevant precautions should be taken into account.

Use in children and adolescents:

There are no age limits to the use of Ursofalk tablets. The administration of Ursofalk tablets is based on body weight and the medical condition.

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 per kg body weight daily if necessary

Body weight (BW): 20 to 29kg. Daily dose: 17 to 25 mg/kg BW

½ tablet in the morning and in the evening.

Body weight (BW): 30 to 39kg. Daily dose: 19 to 25 mg/kg BW

½ tablet in the morning, at midday and in the evening.

Body weight (BW): 40 to 49kg . Daily dose: 20 to 25 mg/kg BW

½ tablet in the morning and at midday and 1 tablet in the evening.

Body weight (BW): 50 to 59kg. Daily dose: 21 to 25 mg/kg BW

½ tablet in the morning, 1 tablet at midday and in the evening.

Body weight (BW): 60 to 69kg. Daily dose: 22 to 25 mg/kg BW

1 tablet in the morning, at midday and in the evening.

Body weight (BW): 70 to 79kg . Daily dose: 22 to 25 mg/kg BW

1 tablet in the morning and at midday and 1½ tablets in the evening.

Body weight (BW): 80 to 89kg. Daily dose: 22 to 25 mg/kg BW

1 tablet in the morning, 1½ tablets at midday and in the evening.

Body weight (BW): 90 to 99kg. Daily dose: 23 to 25 mg/kg BW

1½ tablets in the morning, at midday and in the evening.

Body weight (BW): 100 to 109kg . Daily dose: 23 to 25 mg/kg BW

1½ tablets in the morning and at midday and 2 tablets in the evening.

Body weight (BW): over 110kg.

1½ tablets in the morning, 2 tablets at midday and in the evening.

The tablet can be divided into equal doses. Swallow the tablets with a drink of water or other liquid. Do not crush or chew the tablets. Take the tablets regularly.

Treatment can be continued long term (up to 12 years) in children with cystic fibrosis associated hepatobiliary disorders.

If you feel that the effect of Ursofalk 500mg film-coated tablets is too strong or too weak, please talk to your doctor or pharmacist.

Diarrhoea may occur as a result of overdose. Please inform your doctor immediately if you have persistent diarrhoea. If you do suffer from diarrhoea, make sure you drink enough liquids to replace your fluid and salt balance.

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

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

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:

UK:

Ireland:

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

The active substance is ursodeoxycholic acid (UDCA). Each film-coated tablet contains 500 mg UDCA.

The other ingredients are:

Tablet core: magnesium stearate, polysorbate 80, povidone K 25, microcrystalline cellulose, colloidal anhydrous silica, crospovidone (Type A), talc. Coating: talc, hypromellose and macrogol 6000.

Ursofalk 500mg film-coated tablets are white, oval, biconvex and scored on both sides. The tablet may be divided into half.

Ursofalk 500mg film-coated tablets are available in packs of 50 and 100.

Not all packs may be marketed.

Ireland: PA 573/5/3

UK: PL 10341/0010