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URSODEOXYCHOLIC ACID 250MG HARD CAPSULES

Active substance(s): URSODEOXYCHOLIC ACID / URSODEOXYCHOLIC ACID / URSODEOXYCHOLIC ACID

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PACKAGE LEAFLET: INFORMATION FOR THE USER

URSOFALK® 250mg HARD CAPSULES
URSODEOXYCHOLIC ACID 250mg HARD CAPSULES
(ursodeoxycholic acid)
This product is available as any of the above names but will be referred to as Ursofalk 250mg hard capsules
throughout the following 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 250mg hard capsules are and what they are used for
2. What you need to know before you take Ursofalk 250mg hard capsules
3. How to take Ursofalk 250mg hard capsules
4. Possible side effects
5. How to store Ursofalk 250mg hard capsules
6. Contents of the pack and further information
1. WHAT URSOFALK 250mg HARD CAPSULES ARE AND WHAT THEY ARE USED FOR
Ursodeoxycholic acid (UDCA), the active substance in Ursofalk 250mg hard capsules, is a naturally
occurring bile acid. Small amounts are found in human bile.
Ursofalk 250mg hard capsules are 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 250mg HARD CAPSULES
Do NOT take Ursofalk 250mg hard capsules 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 250mg hard 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 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 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 250mg hard capsules.
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 250mg hard capsules
The effects of these medicines may be altered:
A reduction in the effects of the following medicines is possible when taking Ursofalk 250mg hard
capsules:
• 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 250mg hard capsules:
• 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 250mg hard capsules 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 or might take any other
medicines, even if they are medicines obtainable without a prescription. Treatment with Ursofalk 250mg
hard capsules 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 250mg hard capsules 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 250mg hard capsules, 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 breastfeeding or about to start breastfeeding.
Driving and using machines:
No particular precautions are necessary.
3. HOW TO TAKE URSOFALK 250mg HARD CAPSULES
Always take Ursofalk 250mg hard capsules 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 250mg hard capsules in the morning, at
midday and in the evening. As liver function values improve, the total daily dose may be taken once a day in
the evening.
Ursofalk 250mg hard capsules

47 – 62

12 – 16

1

1

1

Subsequently
Evening
(once daily)
3

63 – 78

13 – 16

1

1

2

4

79 – 93

13 – 16

1

2

2

5

94 – 109

14 – 16

Body weight BW (kg)

First 3 months

Daily dose (mg/kg BW)
Morning

over 110

Midday

Evening

2

2

2

6

2

2

3

7

How to take Ursofalk 250mg hard capsules
Swallow the capsules whole with a drink of water or other liquid. Take your medicine regularly.
Duration of treatment
Ursofalk 250mg hard capsules 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 250mg hard capsules
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 per kg body weight daily if necessary.
Body weight BW (kg)

Daily dose (mg/kg BW)

Ursofalk 250mg hard capsules
Morning

Midday

Evening

20 – 29

17 – 25

1



1

30 – 39

19 – 25

1

1

1

40 – 49

20 – 25

1

1

2

50 – 59

21 – 25

1

2

2

60 – 69

22 – 25

2

2

2

70 – 79

22 – 25

2

2

3

80 – 89

22 – 25

2

3

3

90 – 99

23 – 25

3

3

3

100 – 109

23 – 25

3

3

4

3

4

4

>110

How to take Ursofalk 250mg hard capsules
Take the capsules two to three times per day, as advised. Take the capsules regularly.
Duration of treatment
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 250mg hard capsules is too strong or too weak, please talk to your
doctor or pharmacist.
If you take more Ursofalk 250mg hard capsules than you should:
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
electrolyte balance.
If you forget to take Ursofalk 250mg hard capsules:
Do not take more capsules the next time, but just continue the treatment with the prescribed dose.
If you stop taking Ursofalk 250mg hard capsules:
Always talk to your doctor before you decide to interrupt treatment with Ursofalk 250mg hard capsules or
decide to stop your treatment early.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ursofalk 250mg hard capsules 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.
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, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
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 250mg HARD CAPSULES
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Do not use this medicine after the expiry date. This date is stated on the carton after “EXP”. The expiry
date refers to the last day of that month.
• If your medicine becomes discoloured, or shows any signs of deterioration, consult your pharmacist who
will tell you what to do.
• 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.
6. CONTENTS OF THE PACK AND FURTHER INFORMATION
What Ursofalk 250mg hard capsules contain:
The active substance is ursodeoxycholic acid.
Each capsule contains 250mg ursodeoxycholic acid.
The other ingredients are maize starch, colloidal silica anhydrous, magnesium stearate, gelatin, titanium
dioxide, sodium lauryl sulfate and purified water.
What Ursofalk 250mg hard capsules look like and contents of the pack
Ursofalk is a white, opaque, hard gelatin capsule containing a white compressed powder.
Ursofalk 250mg hard capsules are available in packs of 100 capsules.
PLPI 15814/1078

POM

Manufactured by: Dr Falk Pharma GmbH, Freiburg, Germany. Procured from within the EU and repackaged
by the Product Licence Holder: OPD Laboratories Ltd, 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 10.09.2015.
Ursofalk is a trade mark of Dr Falk Pharma GmbH, Germany.
To request a copy of this in Braille, large print or audio please call 01923 332 796.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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