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BILIFALK 250MG CAPSULES

Active substance(s): URSODEOXYCHOLIC ACID

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Bilifalk® 250mg Capsules/
Ursofalk® 250mg Capsules/
Ursodeoxycholic acid 250mg Capsules
(ursodeoxycholic acid)
Your medicine is known by either of the above names but will be referred to
as Ursofalk throughout this patient information leaflet.
Patient Information 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 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.

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.

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.

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

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.

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

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.

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

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 10mg 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

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.

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.
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 capsules
• Keep all medicines out of the reach and sight of children.
• Check the expiry date on the side of the carton or blister pack and do not
use the capsules if this date has been passed.
• If your doctor decides to stop treatment, return any left-over capsules to
the pharmacist. Only keep them if the doctor tells you to.
• If the capsules look to be deteriorating in any way, do not take them, and
return them to the pharmacist.

6) Further information
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.
Body weight
BW [kg]
20 – 29
30 – 39
40 – 49
50 – 59
60 – 69
70 – 79
80 – 89
90 – 99
100 – 109
>110

Daily dose
[mg/kg BW]
17–25
19–25
20–25
21–25
22–25
22–25
22–25
23–25
23-25

Ursofalk 250mg hard capsules
Morning
Midday
Evening
1
-1
1
1
1
1
1
2
1
2
2
2
2
2
2
2
3
2
3
3
3
3
3
3
3
4
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 (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.
If you forget to take Ursofalk capsules:
Do not take more capsules the next time, but just continue the treatment
with the prescribed dose.

What Ursofalk capsules contain:
Each capsule contains 250mg of ursodeoxycholic acid as the active
ingredient.
The other ingredients are gelatin, colloidal anhydrous silica, magnesium
stearate, maize starch, titanium dioxide, sodium lauryl sulphate and purified
water.
What Ursofalk capsules look like and contents of the pack
Ursofalk capsules are white, opaque hard gelatine capsules containing a
white powder or granules.
Ursofalk capsules are available in packs of 60 capsules.
PL 10383/1893

Bilifalk 250mg Capsules/
POM
Ursofalk 250mg Capsules/
Ursodeoxycholic acid 250mg Capsules

Who makes and repackages your medicine
Your medicine is manufactured by LOSAN Pharma GmbH, D-79395
Nevenburg, Germany. Procured from within the EU and repackaged by
Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet Date: 22.09.2015

Ursofalk and Bilifalk are registered trademarks of Dr. Falk Pharma GmbH,
Germany.

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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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