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.
− 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. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.
− If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Ursofalk 250mg hard capsules are and what they are
used for
2. Before you take Ursofalk 250mg hard capsules
3. How to take Ursofalk 250mg hard capsules
4. Possible side effects
5. How to store Ursofalk 250mg hard capsules
6. Further information
1. WHAT URSOFALK 250mg HARD CAPSULES ARE AND
WHAT THEY ARE USED FOR
Ursodeoxycholic acid, the active substance in Ursofalk 250mg
hard capsules, is a naturally-occurring bile acid. Small amounts
are found in human bile.
Ursofalk 250mg hard capsules are used:
− 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 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.
2. BEFORE YOU TAKE URSOFALK 250mg HARD CAPSULES
Do NOT take Ursofalk 250mg hard capsules if:
− you are, or have been told you are allergic (hypersensitive) to
bile acids like ursodeoxycholic acid or to any of the other
ingredients of Ursofalk 250mg hard capsules (these are listed
in section “6. Further information”)
− your gall bladder does not work properly
− you have gallstones that are visible on an x-ray
− you have acute inflammation of the gall bladder or biliary tract
− you have an obstruction of the biliary tract (blockage of the
common bile duct or a cystic duct)
− you suffer from frequent cramp-like pains in the upper
abdomen (biliary colic).
− you have hardening of the gallstones caused by a build-up of
calcium.
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.
Further precautions:
Ursofalk 250mg hard capsules must be used under medical
supervision.
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.
Please inform your doctor immediately if you have diarrhoea as
this may require a reduction in the dose or discontinuation of
treatment.
Taking other medicines with Ursofalk 250mg hard capsules
Please tell your doctor if you are taking or have recently taken any
other medicines which contain the following ingredients.
The effects of these medicines may be altered (interactions):

A reduction in the effects of the following medicines is possible
when taking Ursofalk 250mg hard capsules:
− colestyramine, charcoal, 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.
An increase in the effects of the following medicines is possible
when taking Ursofalk 250mg hard 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.
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 250mg
hard 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 any other medicines, even if they are medicines
obtainable without a prescription. Treatment with Ursofalk 250mg
hard capsules may still be allowed. Your doctor will know what is
right for you.
Pregnancy and breastfeeding:
Ask your doctor or pharmacist for advice before taking/using any
medicine.
− You should not take Ursofalk 250mg hard capsules during
pregnancy unless your doctor thinks it is absolutely necessary.
Use of Ursofalk during the first three months of pregnancy may
affect the foetus.
− Check that you are not pregnant before taking this medicine.
− Use a reliable method of contraception – non-hormonal
contraceptives (barrier methods) or low-oestrogen oral
contraceptives are recommended. If you are taking Ursofalk
250mg hard capsules for dissolution of gallstones, only use
non-hormonal contraceptives, as hormonal oral contraceptives
may stimulate the formation of gallstones.
− Do not take this medicine if you are breastfeeding as the active
ingredient in Ursofalk 250mg hard capsules may pass into
breast milk. If treatment with Ursofalk 250mg hard capsules is
necessary, then stop breastfeeding.
Use in children:
There are no age limits to the use of Ursofalk 250mg hard
capsules. The administration of Ursofalk 250mg hard capsules is
based on body weight and the medical condition.
Driving and using machines:
No particular precautions are necessary.
3. HOW TO TAKE URSOFALK 250mg HARD CAPSULES
Always take Ursofalk 250mg hard capsules exactly as your doctor
has told you. You should check with your doctor or pharmacist if
you are not sure.
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 250mg hard 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.
For primary biliary cirrhosis (chronic inflammation of the bile
ducts)
Dosage
During the first 3 months of treatment, you should take Ursofalk
250mg hard 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)
47-62
63-78
79-93
94-109
Over
110

Daily
dose
(mg/kg
BW)
12-16
13-16
13-16
14-16

Ursofalk 250mg hard capsules
First 3 months
Subsequently
Morning
Midday Evening Evening
1
1
1
2
2

1
1
2
2
2

1
2
2
2
3

3
4
5
6
7

Ursofalk suspension is available if you weigh less than 47kg or
cannot swallow capsules.
How to take Ursofalk 250mg hard capsules
Swallow the capsules whole with a drink of water or other liquid.
Take your medicine regularly.
Duration of treatment
Ursofalk 250mg hard capsules may be continued indefinitely in
cases of primary biliary cirrhosis.
Note:
In patients with primary biliary cirrhosis, the symptoms may worsen
at the start of treatment, e.g. the itching may increase. This only
occurs in rare cases. If this happens, therapy can be continued
with a lower daily dose of Ursofalk 250mg hard capsules. Each
week, your doctor will then gradually increase the daily dose, until
you reach the required dose.
If you feel that the effect of Ursofalk 250mg hard capsules is too
strong or too weak, please talk to your doctor or pharmacist.
If you take more Ursofalk 250mg hard 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 250mg hard capsules:
Do not take more capsules the next time, but just continue the
treatment with the prescribed dose.

Very rare side effects (occurring in less than 1 in 10,000
patients):
− during the treatment of primary biliary cirrhosis: severe rightsided upper abdominal pain, severe worsening of liver scarring
- this partially improves 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. FURTHER 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

POM

This leaflet was last revised 04/06/2014
If you stop taking Ursofalk 250mg hard capsules:
Always speak to your doctor before you decide to interrupt
treatment with Ursofalk 250mg hard capsules or to stop your
treatment early.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ursofalk 250mg hard capsules can cause side
effects, although not everybody gets them.
You should contact your doctor immediately if you experience any
of the following symptoms after taking Ursofalk 250mg hard
capsules:
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.

E0411/1
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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