URSOFALK 250MG CAPSULES

Active substance: URSODEOXYCHOLIC ACID

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Ref: 1274/211112/1/F

®

Ursofalk 250mg Capsules
(ursodeoxycholic acid)
Patient Information Leaflet
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.
Your medicine is called Ursofalk 250mg Capsules, throughout this leaflet it
will be referred to as Ursofalk Capsules.
In this leaflet:
1

What Ursofalk capsules are and what they are used for

2

Before you take Ursofalk capsules

3

How to take Ursofalk capsules

4

Possible side effects

5

How to store Ursofalk capsules

6

Further information

1

What Ursofalk Capsules are and what they are used
for

Ursodeoxycholic acid, the active substance in Ursofalk capsules, is a
naturally-occurring bile acid. Small amounts are found in human bile.
Ursofalk 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 Capsules

Do NOT take Ursofalk 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
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.

Taking other medicines with Ursofalk 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 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 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 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 capsules. The administration
of Ursofalk capsules is based on body weight and the medical condition.
Driving and using machines:
No particular precautions are necessary.

3

How to take Ursofalk 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.
To dissolve cholesterol gallstones

Further precautions:
Ursofalk 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.

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.

Ref: 1274/211112/1/B

®

Ursofalk 250mg Capsules
(ursodeoxycholic acid)
Patient Information Leaflet (continued)
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.

Very rare side effects (occurring in less than 1 in 10,000 patients):
– during the treatment of primary biliary cirrhosis: severe right-sided 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)

For primary biliary cirrhosis (chronic inflammation of the bile ducts)

If you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

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 weight
(kg)

Daily dose
mg/kg BW

Ursofalk 250mg hard capsules
first 3 months

subsequently

morning midday evening evening (once daily)
47 – 62

12 - 16

1

1

1

3

63 – 78

13 - 16

1

1

2

79 – 93

13 – 16

1

2

2

2

2

2

2

3

7

over 110

Ursofalk suspension is available if you weigh less than 47kg or cannot
swallow capsules.
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 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 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 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
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 to stop your treatment early.

4

Keep out of the sight and reach of children.
Do not use Ursofalk after the expiry date which is stated on the pack. The
expiry date refers to the last day of that month.
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your pharmacist who will tell you what to do.
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

2

*

How to store this medicine

5

14 – 16

*
*

4

94 – 109

5

Possible side effects

Like all medicines, Ursofalk 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:
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.

*

6

Further information

What this medicine contains:
The active ingredient is ursodeoxycholic acid and each capsule contains
250mg of this ingredient.
These capsules also contain corn starch, magnesium stearate, silica,
colloidal anhydrous, gelatin, sodium lauryl sulphate, titanium dioxide E171
and purified water.
What this medicine looks like and contents of the pack
Each carton of Ursofalk Capsules are available in a pack size of 100
capsules.
Manufacturer and Licence Holder
This medicine is manufactured by Dr Falk Pharma GmbH, Leinenweberstr.
5, 79108 Freiburg, Germany and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.

POM

15184/1274

Ursofalk is a registered trademark of Dr Falk Pharma GmbH.
Revision date: 21/11/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.
You may also wish to contact the following national organisation which offers
help, advice and local support groups:
Primary Biliary Cirrhosis Foundation, 54 Queen Street, Edinburgh, EH2 3NS.
Telephone: 0131 225 8586.

Ref: 1274/211112/2/F

Ursodeoxycolic Acid 250mg Capsules
Patient Information Leaflet
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.
Your medicine is called Ursodeoxycholic Acid 250mg Capsules, throughout
this leaflet it will be referred to as Ursodeoxycholic Acid Capsules.
In this leaflet:
1

What Ursodeoxycholic Acid Capsules are and what they are used for

2

Before you take Ursodeoxycholic Acid Capsules

3

How to take Ursodeoxycholic Acid Capsules

4

Possible side effects

5

How to store Ursodeoxycholic Acid Capsules

6

Further information

1

What Ursodeoxycholic Acid Capsules are and what
they are used for

Ursodeoxycholic acid, the active substance in Ursodeoxycholic Acid
Capsules, is a naturally-occurring bile acid. Small amounts are found in
human bile.
Ursodeoxycholic Acid Capsules are used:
* to dissolve gallstones caused by excess cholesterol in the gall bladder.
where the gallstones are not be 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 Ursodeoxycholic Acid Capsules

Do NOT take Ursodeoxycholic Acid 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
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:
Ursodeoxycholic Acid 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 Ursodeoxycholic Acid 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 Ursodeoxycholic Acid 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 Ursodeoxycholic Acid.
* 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 Ursodeoxycholic Acid 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 Ursodeoxycholic Acid 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 Ursodeoxycholic Acid 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 Ursodeoxycholic Acid capsules during pregnancy

unless your doctor thinks it is absolutely necessary. Use of
Ursodeoxycholic Acid 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 Ursodeoxycholic Acid 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 Ursodeoxycholic Acid capsules may pass into breast milk. If treatment
with Ursodeoxycholic Acid capsules is necessary, then stop breastfeeding.
Use in children:
There are no age limits to the use of Ursodeoxycholic Acid Capsules. The
administration of Ursodeoxycholic Acid Capsules is based on body weight
and the medical condition.
Driving and using machines:
No particular precautions are necessary.

3

How to take Ursodeoxycholic Acid Capsules

Always take Ursodeoxycholic Acid 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

Ref: 1274/211112/2/B

Ursodeoxycholic Acid 250mg Capsules
Patient Information Leaflet (continued)
How to take Ursodeoxycholic Acid Capsules
Swallow the capsules whole with a drink of water or other liquid. Take the
capsules in the evening at bedtime. Take your medicine regulary.
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 Ursodeoxycholic Acid
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
(kg)

Daily dose
mg/kg BW

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 primary biliary cirrhosis: severe right-sided 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)
If you notice any side effects not listed in this leaflet, please tell your doctor
or pharmacist.

Ursodeoxycholic Acid 250mg Capsules
first 3 months

subsequently

5

morning midday evening evening (once daily)
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

2

2

3

7

47 – 62

over 110

*

How to store this medicine

Keep out of the sight and reach of children.
Do not use Ursodeoxycholic Acid after the expiry date which is stated on
the pack. The expiry date refers to the last day of that month.
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your pharmacist who will tell you what to do.
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.

Ursodeoxycholic Acid suspension is available if you weigh less than 47kg or
cannot swallow capsules.
6
How to take Ursodeoxycholic Acid Capsules
Swallow the capsules whole with a drink of water or other liquid. Take your
medicine regularly.
Duration of treatment
Ursodeoxycholic Acid 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
Ursodeoxycholic Acid 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 Ursodeoxycholic Acid Capsules is too strong or
too weak, please talk to your doctor or pharmacist.
If you take more Ursodeoxycholic Acid Capsules than you should:
If you or anyone else take too many of the capsules, seek immediate
medical attention.
If you forget to take Ursodeoxycholic Acid Capsules:
Do not take more capsules the next time, but just continue the treatment
with the prescribed dose.
If you stop taking Ursodeoxycholic Acid Capsules:
Always speak to your doctor before you decide to interrupt treatment with
Ursodeoxycholic Acid Capsules or to stop your treatment early.

4

Further information

What this medicine contains:
The active ingredient is ursodeoxycholic acid and each capsule contains
250mg of this ingredient.
These capsules also contain corn starch, magnesium stearate, silica,
colloidal anhydrous, gelatin, sodium lauryl sulphate, titanium dioxide E171
and purified water.
What this medicine looks like and contents of the pack
Each carton of Ursodeoxycholic Acid Capsules are available in a pack size
of 100 capsules.
Manufacturer and Licence Holder
This medicine is manufactured by Dr Falk Pharma GmbH, Leinenwebstr. 5,
79108 Freiburg, Germany and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.

POM

15184/1274

Ursodeoxycholic Acid is a registered trademark of Dr Falk Pharma GmbH.
Revision date: 21/11/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Possible side effects

Like all medicines, Ursodeoxycholic Acid 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 Ursodeoxycholic Acid Capsules:

You may also wish to contact the following national organisation which offers
help, advice and local support groups:
Primary Biliary Cirrhosis Foundation, 54 Queen Street, Edinburgh, EH2 3NS.
Telephone: 0131 225 8586.

Expand view ⇕

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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