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URSOFALK 250 MG HARD CAPSULES

Active substance: URSODEOXYCHOLIC ACID

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Ursofalk® 250mg hard capsules
(ursodeoxycholic acid)
Ursofalk® is available in other strengths and forms.
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 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 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 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
Daily dose
Ursofalk 250mg hard capsules
weight (mg/kg BW)
First 3 months
Subsequently
BW (kg)
Morning Midday Evening
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.

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

Duration of treatment
Ursofalk capsules may be continued indefinitely in cases of PBC.

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.

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 is 20 mg per kg body weight, divided
in 2-3 doses. Your doctor may want to increase the dose further to
30 mg if necessary.
Body weight
BW (kg)

Daily dose
(mg/kg BW)

20 - 29
30 - 39
40 - 49
50 - 59
60 - 69
70 - 79
80 - 89
90 - 99
100 - 109
>110

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 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:
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.

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 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 all medicines out of the sight and reach of children.
Do not use this medicine after the expiry date. This date is stated
on the carton and the container after “Expiry date”. The expiry date
refers to the last day of that month.
The capsules require no special storage conditions.
If your capsules show any signs of deterioration or discolouration,
take them to your pharmacist who will advise you.
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 FURHER INFORMATION
What Ursofalk 250mg hard capsules contain:
The active substance is ursodeoxycholic acid. Each capsule
contains 250 mg ursodeoxycholic acid.
The other ingredients are gelatin, colloidal silica, magnesium
stearate, maize starch, titanium dioxide, sodium lauryl sulphate
and purified water.
What Ursofalk 250mg hard capsules look like and contents of
the pack
Ursofalk 250mg hard capsules are white, opaque, unmarked, hard
gelatin capsules.
Ursofalk 250mg hard capsules are available in packs of 60 or 100
capsules.
Procured within the EU
Manufacturer: LOSEN Pharma GmbH,
D-79395 Neuenburg, Germany.
Product Licence holder: Ecosse Pharmaceuticals Limited,
3 Young Place, East Kilbride G75 0TD.
Re-packaged by: Munro Wholesale Medical Supplies Limited,
3 Young Place, East Kilbride G75 0TD.
PL 19065/0411
This leaflet was last revised 27/02/2015

POM

E0411/2
Ursofalk® is a registered trade mark of Dr. Falk Pharma GmbH.

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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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