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URSOFALK 250MG HARD CAPSULES

Active substance: URSODEOXYCHOLIC ACID

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Ursofalk Kapseln Gebrauchsinformation (GI) für Großbritannien
Format: 600 x 140 mm
Druckfarben: 2/2 (Schwarz + Pant. 644)
Mat.-Nr.: Mock-up (Losan Pharma) Laetuscode: 522
Grammatur: 40 g/m2
Falk-Datumscode: GB/11.14

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.

Mockup_URC_GI_GB.indd 1

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
to
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).
–  liver disease associated with a condition called cystic fibrosis
for
in children aged 6 to 18 years.

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.

– 
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.

Warnings and precautions:
Talk to your doctor or pharmacist before taking Ursofalk capsules.

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)

2.  hat you need to know before you take
W
Ursofalk 250mg hard capsules

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

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 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.

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.

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.

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.

Ursofalk 250mg hard capsules
Body
Daily dose
First 3 months
Subsequently
weight
(mg/kg BW)
Evening
BW (kg)
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
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.
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.

25.11.14 09:36

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.

Body
Daily dose
weight
(mg/kg BW)
BW (kg)
20 – 29
17-25
30 – 39
19-25
40 – 49
20-25
50 – 59
21-25
60 – 69
22-25
70 – 79
22-25
80 – 89
22-25
90 – 99
23-25
100 – 109
23-25
>110

Ursofalk 250mg hard capsules
Morning

Midday

Evening

1
1
1
1
2
2
2
3
3
3


1
1
2
2
2
3
3
3
4

1
1
2
2
2
3
3
3
4
4

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.

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.

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

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.
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.
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)

If you forget to take Ursofalk capsules:
Do not take more capsules the next time, but just continue the
treatment with the prescribed dose.

Mockup_URC_GI_GB.indd 2

If you take more Ursofalk capsules than you should:
If you or anyone else take too many of the capsules, seek
immediate medical attention.

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

5. How to store Ursofalk 250mg hard capsules

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

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.

E-mail: zentrale@drfalkpharma.de
www.drfalkpharma.de
This leaflet was last revised in November 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/11.14

25.11.14 09:36

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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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