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URSOFALK 250MG CAPSULES

Active substance(s): URSODEOXYCHOLIC ACID / URSODEOXYCHOLIC ACID / URSODEOXYCHOLIC ACID

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Transcript
Ref: 1274/120417/1/F

®

Ursofalk 250mg Capsules
(ursodeoxycholic acid)
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.
Your medicine is called Ursofalk 250mg Capsules, throughout this leaflet it
will be referred to as Ursofalk Capsules.
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 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
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.

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 Capsules.
– 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 Capsules 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 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 values improve,
the total daily dose may be taken once a day in the evening.
How to take Ursofalk Capsules
Swallow the capsules whole with a drink of water or other liquid.
Take your medicine regularly.

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.

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

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

Body weight Daily dose
BW (kg) (mg/kg BW)

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.

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

4

79 – 93

13 – 16

1

2

2

5

94 – 109

14 – 16

2

2

2

6

2

2

3

7

over 110

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: 1274/120417/1/B

®

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

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

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 Capsules 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.
Ursofalk 250mg hard capsules
Body
Daily dose
weight
(mg/kg BW)
BW (kg)
Morning Midday
Evening
20-29

17-25

1

-

1

30-39

19-25

1

1

1

40-49

20-25

1

1

2

50-59

21-25

1

2

2

60-69

22-25

2

2

2

70-79

22-25

2

2

3

80-89

22-25

2

3

3

90-99

23-25

3

3

3

100-109

23-25

3

3

4

3

4

4

>110

How to take Ursofalk Capsules
Take the capsules two to three times per day, as advised. Take the capsules
regularly.

5

*
*
*
*

How to store this medicine

Keep out of the sight and reach of children.
Do not use Ursofalk Capsules 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

Contents of the pack and 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.
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.
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.

Revision date: 12/04/17

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you
Other sources of information:
Further information, help, advice and
found at:
The PBC Foundation
2 York Place
Edinburgh
Scotland
EH1 3EP
Telephone: +44 (0) 131 556 6811
www.pbcfoundation.org.uk

details of local support groups can be
The British Liver Trust
2 Southampton Road
Ringwood
England
BH24 1HY
Telephone: +44 (0) 1425 481320
www.britishlivertrust.org.uk

Ref: 1274/120417/2/F

Ursodeoxycholic Acid 250mg Capsules
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.
Your medicine is called Ursodeoxycholic 250mg Capsules, throughout this
leaflet it will be referred to as Ursodeoxycholic Capsules.
What is in this leaflet:
1

What Ursodeoxycholic Capsules are and what they are used for

2

What you need to know before you take Ursodeoxycholic Capsules

3

How to take Ursodeoxycholic Capsules

4

Possible side effects

5

How to store Ursodeoxycholic Capsules

6

Contents of the pack and further information

1

What Ursodeoxycholic Capsules are and what they
are used for

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

Do NOT take Ursodeoxycholic 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 Ursodeoxycholic 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.

Other medicines and Ursodeoxycholic Capsules
The effects of these medicines may be altered:
A reduction in the effects of the following medicines is possible
when taking Ursodeoxycholic 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 Ursodeoxycholic Capsules.
– 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
Ursodeoxycholic 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 Ursodeoxycholic 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 Ursodeoxycholic 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 Ursodeoxycholic Capsules 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 Ursodeoxycholic Capsules

Always take Ursodeoxycholic 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 Ursodeoxycholic
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.
How to take Ursodeoxycholic Capsules
Swallow the capsules whole with a drink of water or other liquid.
Take your medicine regularly.
Duration of treatment
Body weight Daily dose
BW (kg) (mg/kg BW)

Ursodeoxycholic 250mg hard capsules

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

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

4

79 – 93

13 – 16

1

2

2

5

94 – 109

14 – 16

2

2

2

6

2

2

3

7

over 110

Ursodeoxycholic 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

Ref: 1274/120417/2/B

Ursodeoxycholic Acid 250mg Capsules
Patient Information Leaflet (continued)
How to take Ursodeoxycholic 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:

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

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 Ursodeoxycholic Capsules 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.
Ursofalk 250mg hard capsules
Body
Daily dose
weight
(mg/kg BW)
BW (kg)
Morning Midday
Evening
20-29

17-25

1

-

1

30-39

19-25

1

1

1

40-49

20-25

1

1

2

50-59

21-25

1

2

2

60-69

22-25

2

2

2

70-79

22-25

2

2

3

80-89

22-25

2

3

3

90-99

23-25

3

3

3

100-109

23-25

3

3

4

3

4

4

>110

How to take Ursodeoxycholic Capsules
Take the capsules two to three times per day, as advised. Take the capsules
regularly.

5

How to store this medicine

Keep out of the sight and reach of children.
Do not use Ursodeoxycholic Capsules 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

Contents of the pack and 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 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.
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 Ursodeoxycholic Capsules is too strong or too
weak, please talk to your doctor or pharmacist.
If you take more Ursodeoxycholic 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 Ursodeoxycholic Capsules:
Do not take more capsules the next time, but just continue the treatment
with the prescribed dose.
If you stop taking Ursodeoxycholic Capsules:
Always talk to your doctor before you decide to interrupt treatment with
Ursodeoxycholic Capsules or decide to stop your treatment early.

4

Possible side effects

Like all medicines, Ursodeoxycholic 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.

Revision date: 12/04/17

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you
Other sources of information:
Further information, help, advice and
found at:
The PBC Foundation
2 York Place
Edinburgh
Scotland
EH1 3EP
Telephone: +44 (0) 131 556 6811
www.pbcfoundation.org.uk

details of local support groups can be
The British Liver Trust
2 Southampton Road
Ringwood
England
BH24 1HY
Telephone: +44 (0) 1425 481320
www.britishlivertrust.org.uk

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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