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URSODEOXYCHOLIC ACID 500MG FILM-COATED TABLETS

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

URSOFALK® 500mg FILM-COATED TABLETS
(ursodeoxycholic acid)
This medicine is available using the above name but will be referred to as Ursofalk tablets throughout the following
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 possible side effects not listed
in this leaflet, see section 4.
What is in this leaflet:
1. What Ursofalk tablets are and what they are used for
2. What you need to know before you take Ursofalk tablets
3. How to take Ursofalk tablets
4. Possible side effects
5. How to store Ursofalk tablets
6. Contents of the pack and other information
1. WHAT URSOFALK TABLETS ARE AND WHAT THEY ARE USED FOR
Ursofalk tablets contain the active substance ursodeoxycholic acid (UDCA). Small amounts of UDCA are found in
human bile.
Ursofalk tablets 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 TABLETS
Do NOT take Ursofalk tablets 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 tablets.
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.
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).
If you are taking Ursofalk tablets 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 tablets.
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 tablets 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 tablets 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 tablets, 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 breast-feeding or about to start breastfeeding.
Driving and using machines:
No particular precautions are necessary.
3. HOW TO TAKE URSOFALK TABLETS
Always take Ursofalk tablets 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 tablets in divided doses during the day. As liver
function tests improve, the total daily dose may be taken once a day in the evening.

Body weight
BW (kg)

Daily dose
(mg/kg BW)

47 – 62
63 – 78
79 – 93
94 – 109
over 110

12 – 16
13 – 16
13 – 16
14 – 16

Ursofalk 500mg film-coated tablets
First 3 months
Morning

Midday

Evening

½
½
½
1
1

½
½
1
1
1

½
1
1
1


Subsequently
Evening
(once daily)

2

3


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.

Duration of treatment
Ursofalk tablets can be continued indefinitely in cases of PBC.
To dissolve cholesterol gallstones
Dosage
Approximately 10 mg per kg body weight (BW) daily, as follows:
up to 60 kg
61 – 80 kg
81 – 100 kg
over 100 kg

1 tablet
1½ tablets
2 tablets
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.
Both indications:
Ursofalk capsules or Ursofalk suspension are available if you weigh less than 47 kg or cannot swallow tablets.
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.
Use in children and adolescents:
There are no age limits to the use of Ursofalk tablets. The administration of Ursofalk tablets is based on body
weight and the medical condition.
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 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

Ursofalk 500mg film-coated tablets
Morning

Midday

Evening

½
½
½
½
1
1
1




½
½
1
1
1



2

½
½
1
1
1



2
2

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.
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 tablets 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.
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 tablets 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 or pharmacist. This includes any possible side effects not listed in this
leaflet.
You can also report side effects directly via:
UK: 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.
5. HOW TO STORE URSOFALK TABLETS
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to
the last day of that month.
• This medicine does not require any special storage conditions.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to protect the environment.
• If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your
doctor or pharmacist, who will tell you what to do.
6. Contents of the pack and other information
What Ursofalk tablets contain:
The active substance is ursodeoxycholic acid (UDCA). Each film-coated tablet contains 500 mg of ursodeoxycholic
acid.
The other ingredients are: magnesium stearate, polysorbate 80, povidone K 25, microcrystalline cellulose, colloidal
anhydrous silica, crospovidone (Type A), talc, hypromellose and macrogol 6000.
What Ursofalk tablets look like and contents of the pack
Ursofalk tablets are white, film-coated, oval shaped, biconvex and scored on both sides. The tablet may be divided
into half.
Ursofalk tablets are available in packs of 50 and 100.
PL: 15814/1313

POM

Ursofalk tablets are manufactured by DR. FALK PHARMA GmbH, 79108 Freiburg, Germany.
Procured from within the EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd., Unit 6
Colonial Way, Watford, Herts WD24 4PR.
Ursofalk is a registered trademark of Dr. Falk Pharma GmbH, Germany.
Leaflet revision and issue date (Ref.): 25.01.2017.

To request a copy of this leaflet in Braille, large print or
audio please call 01923 332 796.

PACKAGE LEAFLET: INFORMATION FOR THE USER

URSODEOXYCHOLIC ACID 500mg FILM-COATED TABLETS
This medicine is available using the above name but will be referred to as Ursodeoxycholic acid tablets throughout
the following 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 possible side effects not listed
in this leaflet, see section 4.
What is in this leaflet:
1. What Ursodeoxycholic acid tablets are and what they are used for
2. What you need to know before you take Ursodeoxycholic acid tablets
3. How to take Ursodeoxycholic acid tablets
4. Possible side effects
5. How to store Ursodeoxycholic acid tablets
6. Contents of the pack and other information
1. WHAT URSODEOXYCHOLIC ACID TABLETS ARE AND WHAT THEY ARE USED FOR
Ursodeoxycholic acid tablets contain the active substance ursodeoxycholic acid (UDCA). Small amounts of UDCA
are found in human bile.
Ursodeoxycholic acid tablets 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 TABLETS
Do NOT take Ursodeoxycholic acid tablets 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 Ursodeoxycholic acid tablets.
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:
• 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.
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).
If you are taking Ursodeoxycholic acid tablets 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 tablets.
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 tablets 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 acid tablets 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 tablets, 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 breast-feeding or about to start breastfeeding.
Driving and using machines:
No particular precautions are necessary.
3. HOW TO TAKE URSODEOXYCHOLIC ACID TABLETS
Always take Ursodeoxycholic acid tablets 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 tablets in divided doses during the
day. As liver function tests improve, the total daily dose may be taken once a day in the evening.

Body weight
BW (kg)

Daily dose
(mg/kg BW)

47 – 62
63 – 78
79 – 93
94 – 109
over 110

12 – 16
13 – 16
13 – 16
14 – 16

Ursodeoxycholic acid 500mg film-coated tablets
First 3 months
Subsequently
Evening
Morning
Midday
Evening
(once daily)
½
½
½

½
½
1
2
½
1
1

1
1
1
3
1
1



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.

Duration of treatment
Ursodeoxycholic acid tablets can be continued indefinitely in cases of PBC.
To dissolve cholesterol gallstones
Dosage
Approximately 10 mg per kg body weight (BW) daily, as follows:
up to 60 kg
61 – 80 kg
81 – 100 kg
over 100 kg

1 tablet
1½ tablets
2 tablets
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 47 kg or
cannot swallow tablets.
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.
Use in children and adolescents:
There are no age limits to the use of Ursodeoxycholic acid tablets. The administration of Ursodeoxycholic acid
tablets is based on body weight and the medical condition.
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 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

Ursodeoxycholic acid 500mg film-coated tablets
Morning

Midday

Evening

½
½
½
½
1
1
1




½
½
1
1
1



2

½
½
1
1
1



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.
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 acid tablets is too strong or too weak, please talk to your doctor or
pharmacist.
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 tablets 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 or pharmacist. This includes any possible side effects not listed in this
leaflet.
You can also report side effects directly via:
UK: 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.
5. HOW TO STORE URSODEOXYCHOLIC ACID TABLETS
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to
the last day of that month.
• This medicine does not require any special storage conditions.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to protect the environment.
• If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your
doctor or pharmacist, who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Ursodeoxycholic acid tablets contain:
The active substance is ursodeoxycholic acid (UDCA). Each film-coated tablet contains 500 mg of ursodeoxycholic
acid.
The other ingredients are: magnesium stearate, polysorbate 80, povidone K 25, microcrystalline cellulose, colloidal
anhydrous silica, crospovidone (Type A), talc, hypromellose and macrogol 6000.
What Ursodeoxycholic acid tablets look like and contents of the pack
Ursodeoxycholic acid tablets are white, film-coated, oval shaped, biconvex and scored on both sides. The tablet
may be divided into half.
Ursodeoxycholic acid tablets are available in packs of 50 and 100.
PL: 15814/1313

POM

Ursodeoxycholic acid tablets are manufactured by DR. FALK PHARMA GmbH, 79108 Freiburg, Germany.
Procured from within the EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd., Unit 6
Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 25.01.2017.

To request a copy of this leaflet in Braille, large print or
audio please call 01923 332 796.

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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