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URSOFALK 500MG TABLETS

Active substance(s): URSODEOXYCHOLIC ACID / URSODEOXYCHOLIC ACID

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Package leaflet: Information for the user

Ursofalk® 500mg tablets
(ursodeoxycholic acid)

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 possible side effects not
listed in this leaflet, see section 4.

The name of your medicine is Ursofalk 500mg tablets but will
be referred to as Ursofalk throughout this leaflet.
What is in this leaflet:
1. What Ursofalk is and what it is used for
2. What you need to know before you take Ursofalk
3. How to take Ursofalk
4. Possible side effects
5. How to store Ursofalk
6. Contents of the pack and other information

1. What Ursofalk is and what it is used for
Ursofalk contains the active substance ursodeoxycholic acid
(UDCA). Small amounts of UDCA are found in human bile.

Ursofalk are used:
− for the treatment of primary biliary cirrhosis (PBC) 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 (cirrhosis of the liver). The liver
should not be so damaged that it is not functioning
properly.
− to dissolve cholesterol gallstones. These stones must not
be visible on a plain X-ray (radiolucent) and be no larger
than 15 mm in diameter because they will not dissolve
with UDCA. The gall bladder must 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
Do NOT take Ursofalk if:
− You are, or have been told you are, allergic
(hypersensitive) to bile acids like UDCA or to any of the
other ingredients of this medicine (listed in section 6).
− 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 upper abdomen pain
(biliary colic).
− Your doctor has said you have calcified gallstones (they
are visible on an x-ray).
− Your gall bladder does not work properly.
− You are a child with biliary atresia and have poor bile
flow, even after surgery.

Please ask your doctor about 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.

A change in the effects of the following medicines is
possible when taking Ursofalk tablets:
− 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).

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 talk to your doctor immediately if you have diarrhoea,
as this may require a reduction in the dose or discontinuation
of the treatment with Ursofalk tablets.
Other medicines and Ursofalk tablets
Please tell your doctor if you are taking or have recently
taken or might take any other medicines.
The effects of these medicines may be altered:
A reduction in the effects of the following medicines is
possible when taking Ursofalk tablets:
− 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 tablets.

ciprofloxacin, dapsone (antibiotics), nitrendipine (used to
treat high blood pressure) and other medicines which are
metabolised in a similar way. It may be necessary for
your doctor to alter the dose of these medicines.

If you are taking Ursofalk 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 any other medicines, even if they are
medicines obtainable without a prescription. Treatment with
Ursofalk may still be allowed. Your doctor will know what is
right for you.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, 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.
Breast-feeding: Tell your doctor if you are breast-feeding or
about to start breast-feeding.

Driving and using machines:
No particular precautions are necessary.

3. How to take Ursofalk
Always take Ursofalk exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
not sure.
For the treatment of primary biliary cirrhosis
(inflammation of the bile ducts)
Dosage
During the first 3 months of treatment, you should take
Ursofalk in divided doses during the day. As liver function
tests improve, the total daily dose may be taken once a day
in the evening.
Daily
Ursofalk
Body
dose
weight
Subsequently
BW (kg) (mg/kg First 3 months
BW) Morning Midday Evening
Evening
(once daily)
½
½
47 - 62 12 - 16

½
63 - 78 13 - 16
½
½
1
2
½

79 - 93 13 - 16
1
1
94 - 109 14 - 16
1
1
3
1

1

1
Over 110
How to take Ursofalk
The tablet can be divided into equal doses. Swallow the
tablets with a drink of water or other liquid. Do not crush or
chew the tablets. Take the tablets regularly.
Duration of treatment
Ursofalk tablets can be continued indefinitely in cases of
PBC.

To dissolve cholesterol gallstones
Dosage
Approximately 10mg per kg body weight (BW) daily, as
follows:
up to 60kg
1 tablet
61 – 80kg
1½ tablets
81 – 100kg
2 tablets
over 100kg
2½ tablets
How to take Ursofalk tablets
The tablet can be divided into equal doses. Swallow the
tablets with a drink of water or other liquid.
Do not crush or chew the tablets. Take the tablets in the
evening at bedtime. Take the tablets 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 calcification of
the stones has occurred since the last time. If this is the case,
your doctor will stop the treatment.

Use in children (6 to 18 years) for treatment of liver
disease associated with cystic fibrosis
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)

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

Morning

½
½
½
½
1
1
1




Ursofalk
Midday

½
½
1
1
1



2

Evening

½
½
1
1
1



2
2

Both indications:
Ursofalk capsules or Ursofalk suspension are available if you
weigh less than 47kg or cannot swallow tablets.

How to take Ursofalk tablets
The tablet can be divided into equal doses. Swallow the
tablets with a drink of water or other liquid. Do not crush or
chew the tablets. Take the tablets regularly.

Use in elderly:
There is no evidence to suggest that any alteration in the
adult dose is needed but the relevant precautions should be
taken into account.

Duration of treatment
Treatment can be continued long-term (up to 12 years) in
children with cystic fibrosis associated hepatobiliary
disorders.

Use in children and adolescents:
There are no age limits to the use of Ursofalk. The
administration of Ursofalk is based on body weight and the
medical condition.

If you feel that the effect of Ursofalk is too strong or too weak,
please talk to your doctor or pharmacist.

If you take more Ursofalk tablets 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 salt balance.

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

If you forget to take Ursofalk tablets
Do not take more tablets the next time, but just continue the
treatment with the prescribed dose.




If you stop taking Ursofalk tablets:
Always speak to your doctor before you decide to interrupt
treatment with Ursofalk tablets or decide to stop your
treatment early.



4. Possible side effects
Like all medicines, Ursofalk 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 primary biliary cirrhosis: severe
right-sided upper abdominal pain, severe worsening of
liver cirrhosis which partially eases after treatment is
discontinued
− 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.

5. How to store Ursofalk



Keep out of the sight and reach of children.
Do not take the tablet after the expiry date which is stated
on the carton and blister label after ‘Exp’. The expiry date
refers to the last day of that month.
If the tablet becomes discoloured or show any signs of
deterioration, seek the advice of your pharmacist.
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 other information
What Ursofalk contains
The active ingredient in the Ursofalk is ursodeoxycholic acid.
Each film-coated tablet contains 500mg ursodeoxycholic
acid.
The other ingredients are:
Tablet core: magnesium stearate, polysorbate 80, povidone
K25, microcrystalline cellulose, colloidal anhydrous silica,
crospovidone (type A), talc.
Coating: hypromellose, macrogol 6000, talc.
What Ursofalk looks like and contents of the pack
Ursofalk is white, oval, biconvex tablet scored on both sides.
It is available in pack size of 100 tablets.
Manufactured by: Dr. Falk Pharma GmbH,
Leinenweberstr. 5, 79108 Freiburg, Germany.

Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
®

Ursofalk 500mg tablets; PL 18799/3005
Leaflet date: 16.02.2017

POM

Ursofalk is the registered trademark of Dr. Falk Pharma
GmbH.

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call 0208 515 3763 to obtain
the leaflet in a format suitable
for you.

Package leaflet: Information for the user

Ursodeoxycholic acid
500mg tablets
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 possible side effects not
listed in this leaflet, see section 4.

The name of your medicine is Ursodeoxycholic acid 500mg
tablets but will be referred to as Ursodeoxycholic acid
throughout this leaflet.
What is in this leaflet:
1. What Ursodeoxycholic acid is and what it is used for
2. What you need to know before you take Ursodeoxycholic
acid
3. How to take Ursodeoxycholic acid
4. Possible side effects
5. How to store Ursodeoxycholic acid
6. Contents of the pack and other information

1. Wha t Ursodeoxycholic acid is and what it is
used for
Ursodeoxycholic acid contains the active substance
ursodeoxycholic acid (UDCA). Small amounts of UDCA are
found in human bile.
Ursodeoxycholic acid are used:
− for the treatment of primary biliary cirrhosis (PBC) 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 (cirrhosis of the liver). The liver
should not be so damaged that it is not functioning
properly.
− to dissolve cholesterol gallstones. These stones must not
be visible on a plain X-ray (radiolucent) and be no larger
than 15 mm in diameter because they will not dissolve
with UDCA. The gall bladder must 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
Ursodeoxycholic acid
Do NOT take Ursodeoxycholic acid if:
− You are, or have been told you are, allergic
(hypersensitive) to bile acids like UDCA or to any of the
other ingredients of this medicine (listed in section 6).
− 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 upper abdomen pain
(biliary colic).





Your doctor has said you have calcified gallstones (they
are visible on an x-ray).
Your gall bladder does not work properly.
You are a child with biliary atresia and have poor bile
flow, even after surgery.



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 acid tablets.
ciprofloxacin, dapsone (antibiotics), nitrendipine (used to
treat high blood pressure) and other medicines which are
metabolised in a similar way. It may be necessary for
your doctor to alter the dose of these medicines.

Please ask your doctor about 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
Ursodeoxycholic acid.

A change in the effects of the following medicines is
possible when taking Ursodeoxycholic acid tablets:
− 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).

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 talk to your doctor immediately if you have diarrhoea,
as this may require a reduction in the dose or discontinuation
of the treatment with Ursodeoxycholic acid tablets.
Other medicines and Ursodeoxycholic acid tablets
Please tell your doctor if you are taking or have recently
taken or might take any other medicines.
The effects of these medicines may be altered:
A reduction in the effects of the following medicines is
possible when taking Ursodeoxycholic acid tablets:

If you are taking Ursodeoxycholic acid 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 Ursodeoxycholic acid.
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 may still be allowed. Your doctor will
know what is right for you.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, 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 acid
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 Ursodeoxycholic acid,
your doctor will check that you are not pregnant and review
your contraceptive method to make sure it is appropriate.
Breast-feeding: Tell your doctor if you are breast-feeding or
about to start breast-feeding.
Driving and using machines:
No particular precautions are necessary.

3. How to take Ursodeoxycholic acid
Always take Ursodeoxycholic acid exactly as your doctor has
told you. You should check with your doctor or pharmacist if
you are not sure.
For the treatment of primary biliary cirrhosis
(inflammation of the bile ducts)
Dosage
During the first 3 months of treatment, you should take
Ursodeoxycholic acid in divided doses during the day. As
liver function tests improve, the total daily dose may be taken
once a day in the evening.
Daily
Ursodeoxycholic acid
Body
dose
weight
Subsequently
BW (kg) (mg/kg First 3 months
BW) Morning Midday Evening
Evening
(once daily)
½

½
½
47 - 62 12 - 16
63 - 78 13 - 16
½
2
1
½
½

1
79 - 93 13 - 16
1
3
1
1
1
94 - 109 14 - 16


1
1
Over 110

How to take Ursodeoxycholic acid
The tablet can be divided into equal doses. Swallow the
tablets with a drink of water or other liquid. Do not crush or
chew the tablets. Take the tablets regularly.

Use in elderly:
There is no evidence to suggest that any alteration in the
adult dose is needed but the relevant precautions should be
taken into account.

Duration of treatment
Treatment can be continued long-term (up to 12 years) in
children with cystic fibrosis associated hepatobiliary
disorders.



Duration of treatment
Ursodeoxycholic acid tablets can be continued indefinitely in
cases of PBC.

Use in children and adolescents:
There are no age limits to the use of Ursodeoxycholic acid.
The administration of Ursodeoxycholic acid is based on body
weight and the medical condition.

If you feel that the effect of Ursodeoxycholic acid is too strong
or too weak, please talk to your doctor or pharmacist.

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.

To dissolve cholesterol gallstones
Dosage
Approximately 10mg per kg body weight (BW) daily, as
follows:
up to 60kg
1 tablet
61 – 80kg
1½ tablets
81 – 100kg
2 tablets
over 100kg
2½ tablets
How to take Ursodeoxycholic acid tablets
The tablet can be divided into equal doses. Swallow the
tablets with a drink of water or other liquid.
Do not crush or chew the tablets. Take the tablets in the
evening at bedtime. Take the tablets 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 calcification of
the stones has occurred since the last time. If this is the case,
your doctor will stop the treatment.
Both indications:
Ursodeoxycholic acid capsules or Ursodeoxycholic acid
suspension are available if you weigh less than 47kg or
cannot swallow tablets.

Use in children (6 to 18 years) for treatment of liver
disease associated with cystic fibrosis
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)

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

Morning

Ursofalk
Midday

Evening

½
½
½
½
1
1
1



½
½
1
1
1




½
½
1
1
1



2



2

2

How to take Ursodeoxycholic acid tablets
The tablet can be divided into equal doses. Swallow the
tablets with a drink of water or other liquid. Do not crush or
chew the tablets. Take the tablets regularly.

If you take more Ursodeoxycholic acid tablets 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 salt balance.
If you forget to take Ursodeoxycholic acid tablets
Do not take more tablets the next time, but just continue the
treatment with the prescribed dose.
If you stop taking Ursodeoxycholic acid tablets:
Always speak to your doctor before you decide to interrupt
treatment with Ursodeoxycholic acid tablets or decide to stop
your treatment early.

4. Possible side effects
Like all medicines, Ursodeoxycholic acid 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 primary biliary cirrhosis: severe
right-sided upper abdominal pain, severe worsening of
liver cirrhosis which partially eases after treatment is
discontinued



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)

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

5. How to store Ursodeoxycholic acid





Keep out of the sight and reach of children.
Do not take the tablet after the expiry date which is stated
on the carton and blister label after ‘Exp’. The expiry date
refers to the last day of that month.
If the tablet becomes discoloured or show any signs of
deterioration, seek the advice of your pharmacist.
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 other information
What Ursodeoxycholic acid contains
The active ingredient in the Ursodeoxycholic acid is
ursodeoxycholic acid.
Each film-coated tablet contains 500mg ursodeoxycholic
acid.

The other ingredients are:
Tablet core: magnesium stearate, polysorbate 80, povidone
K25, microcrystalline cellulose, colloidal anhydrous silica,
crospovidone (type A), talc.
Coating: hypromellose, macrogol 6000, talc.
What Ursodeoxycholic acid looks like and contents of
the pack
Ursodeoxycholic acid is white, oval, biconvex tablet scored
on both sides.
It is available in pack size of 100 tablets.
Manufactured by: Dr. Falk Pharma GmbH,
Leinenweberstr. 5, 79108 Freiburg, Germany.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Ursodeoxycholic acid 500mg tablets; PL 18799/3005
Leaflet date: 16.02.2017

POM

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call 0208 515 3763 to obtain
the leaflet in a format suitable
for you.

Expand Transcript

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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