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URSOFALK 250MG HARD CAPSULES

Active substance(s): URSODEOXYCHOLIC ACID

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Ursofalk Kapseln Gebrauchsinformation (GI) für Großbritannien-Irland
Format: 540 x 200 mm
Druckfarben: (2/2) Schwarz + Pantone 644
Mat.-Nr.: Mock-up (Losan Pharma) Laetuscode: 522
Grammatur: 40 g/m2
Falk-Datumscode: GB-IE/04.15
Machart: vorgefalzt

Package leaflet: Information for the user

Ursofalk® 250mg hard capsules
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).
– 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.

Mockup_URC_GI_GB-IE.indd 1

2. What you need to know before you take
Ursofalk 250mg hard capsules
Do NOT take Ursofalk 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
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 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)
If you are taking Ursofalk 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 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 breastfeeding or about to
start breastfeeding.

Driving and using machines:

No particular precautions are necessary.

3. How to take Ursofalk 250mg 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
values improve, the total daily dose may be taken once a day in the
evening.

Ursofalk 250mg hard capsules
Daily dose
First 3 months
Subsequently
(mg/kg
Evening
BW)
Morning Midday Evening
(once daily)
47 – 62
12 – 16
1
1
1
3
63 – 78
13 – 16
1
1
2
4
79 – 93
13 – 16
1
2
2
5
94 – 109
14 - 16
2
2
2
6
over 110
2
2
3
7
Body
weight
BW (kg)

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 20mg 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.
Ursofalk 250mg hard capsules

Body weight
BW [kg]

Daily dose
[mg/kg BW]

Morning

Midday

Evening

20 – 29

17-25

1

--

1

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.

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

To dissolve cholesterol gallstones
Dosage
Approximately 10mg per kg body weight (BW) daily, as follows:
50 - 62kg 2 capsules daily
63 - 85kg 3 capsules daily
86 - 120kg 4 capsules daily

80 – 89

22-25

2

3

3

90 – 99

23-25

3

3

3

100 – 109

23-25

3

3

4

3

4

4

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.

>110

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 (up to 12 years) 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.

If you take more Ursofalk 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.

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If you forget to take Ursofalk capsules:

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

5. How to store Ursofalk 250mg capsules

Manufactured by:

4. Possible side effects

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.
This medicinal product does not require any special storage conditions.
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.

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

6. Contents of the pack and further information

This leaflet was last revised in: May 2015

What Ursofalk 250mg hard capsules contain

Other sources of information:

If you stop taking Ursofalk capsules:

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

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 or pharmacist. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly as follows:
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie
UK
Yellow Card Scheme
Tel: Freephone 0808 100 3352
Website: www.mhra.gov.uk/yellowcard

The active substance is UDCA. One capsule contains 250mg 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.

Leinenweberstr. 5
79108 Freiburg
Germany

E-mail: zentrale@drfalkpharma.de
www.drfalkpharma.de

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

Marketing Authorisation Holder
Ireland
Dr Falk Pharma GmbH
Leinenweberstr. 5
79108 Freiburg
Germany
Tel.: +49 (0) 761/1514-0
Fax.: +49 (0) 761/1514-321
E-mail: zentrale@drfalkpharma.de

UK
Dr Falk Pharma UK Ltd.
Unit K, Bourne End Business Park,
Cores End Road,
Bourne End, Buckinghamshire.
SL8 5AS. UK.

By reporting side effects you can help provide more information on the
safety of this medicine.
Mock-up GB-IE/04.15

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13.05.15 09:10

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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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