URSOFALK 250MG HARD CAPSULES

Active substance: URSODEOXYCHOLIC ACID

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Ursofalk Kapseln Gebrauchsinformation (GI) für Großbritannien
Format: 420 x 150 mm
Druckfarben: 2/2 (Schwarz + Pant. 644)
Mat.-Nr.: Mock-up (Losan Pharma) Laetuscode: 522
Grammatur: 40 g/m2
Falk-Datumscode: GB/02.14

Package leaflet: Information for the user

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE URSOFALK 250mg HARD CAPSULES

Ursofalk® 250mg hard capsules

Do NOT take Ursofalk capsules if:

Ursodeoxycholic acid

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 capsules are and what they are used for
2. What you need to know before you take Ursofalk capsules
3. How to take Ursofalk capsules
4. Possible side effects
5. How to store Ursofalk 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 capsules, is a naturally-occurring bile
acid. Small amounts are found in human bile.

Ursofalk 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).
–  dissolve gallstones caused by excess cholesterol in the gall bladder where the gallstones are
to
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).
–  liver disease associated with a condition called cystic fibrosis in children aged 6 to 18 years.
for

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– 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 (these are 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 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 capsules

The effects of these medicines may be altered:
A reduction in the effects of the following medicines is possible when taking Ursofalk 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 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)

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 capsules 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
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 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 250mg HARD CAPSULES
Always take Ursofalk 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 capsules 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.
Body weight
BW (kg)

Daily dose
(mg/kg BW)

47 – 62
63 – 78
79 – 93
94 – 109
over 110

12 – 16
13 – 16
13 – 16
14 – 16

Ursofalk 250mg hard capsules
First 3 months
Subsequently
Morning
Midday
Evening Evening (once daily)
1
1
1
3
1
1
2
4
1
2
2
5
2
2
2
6
2
2
3
7

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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 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 if 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 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 in children with cystic fibrosis associated hepatobiliary disorders.
If you feel that the effect of Ursofalk capsules is too strong or too weak, please talk to your doctor or
pharmacist.

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If you take more Ursofalk capsules than you should:

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

If you forget to take Ursofalk capsules:

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

If you stop taking Ursofalk capsules:

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

4. POSSIBLE SIDE EFFECTS
Like all medicines, Ursofalk 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. 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 250mg HARD CAPSULES
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the container after
“Expiry date”. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. 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 UDCA. One capsule contains 250 mg UDCA.
The other ingredients are (capsule contents) silica, colloidal anhydrous, magnesium stearate, maize
starch (capsule shell) gelatin, titanium dioxide (E171), sodium lauryl sulphate

What Ursofalk 250mg hard capsules look like and contents of the pack

Ursofalk capsules are white, opaque hard gelatin capsules containing a white powder or granules.
Ursofalk capsules are available in packs of 60 or 100 capsules.
Not all packs may be marketed.

Marketing Authorisation Holder:
Dr Falk Pharma UK Ltd
Unit K, Bourne End Business Park
Cores End Road
Bourne End, Buckinghamshire
SL8 5AS, UK

Manufactured by:
Leinenweberstr. 5
79108 Freiburg
Germany

E-mail: zentrale@drfalkpharma.de
www.drfalkpharma.de
This leaflet was last revised in February 2014.
Other sources of information:
Further information, help, advice and details of local support groups can be found at:
The PBC Foundation
The British Liver Trust
2 York Place
2 Southampton Road
Edinburgh Ringwood
Scotland England
EH1 3EP BH24 1HY
Telephone: +44 (0) 131 556 6811
Telephone: +44 (0) 1425 481320
www.pbcfoundation.org.uk www.britishlivertrust.org.uk

Mock-up GB/02.14

How to take Ursofalk capsules
Swallow the capsules whole with a drink of water or other liquid. Take your medicine regularly.
Duration of treatment
Ursofalk capsules may be continued indefinitely in cases of PBC.

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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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