iMedi.co.uk

Out of date information, search another

Bilifalk 250mg Capsules

Out of date information, search another

Ref: 1281/170215/1/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 infromation 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 but will referred to as Ursofalk Capsules through out this leaflet.

What is in this leaflet:

^ What Ursofalk capsules are and what they are used for ^ What you need to know before you take Ursofalk capsules ^ How to take Ursofalk capsules ^ Possible side effects

How to store Ursofalk capsules ^ Contents of the pack and other information


"i 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.


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.

-    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)

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 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 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 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 breast-feeding or about to start breastfeeding.

Driving and using machines:

No particular precautions are necessary.


[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 acute inflammation of the gall bladder or biliary tract

-    you have a blockage of the common bile duct or a 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.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Ursofalk 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.


[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 tests improve, the total daily dose may be taken once a day in the evening


Body weight BW (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

4

79 - 93

13 - 16

1

2

2

5

94 - 109

14 - 16

2

2

2

6

over 110

2

2

3

7


Ursofalk 250mg Tablets

(ursodeoxycholic acid)


Patient Information Leaflet (continued)

Duration of treatment

Ursofalk 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

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:
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 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

Body weight BW (kg)

Daily dose (mg/kg BW)

Ursofalk 250mg hard capsules

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

4

100-109

23-25

3

3

4

>110

3

4

4

How to take Ursofalk capsules

Take the capsules two to three times per day, as advised. Take the capsules regularly.

Duration of treatment

Treatment can be continued long term 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:

If you or anyone else take too many of the capsules, seek immediate medical 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.

^ 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. 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 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.


[5) How to store Ursofalk capsules

Keep all medicines out of the sight and reach of children.

Do not use this medicine after the expiry date. This date is stated on the carton and the container after “Expiry date”. The expiry date refers to the last day of that month.

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.


[m Contents of the pack and other information

What Ursofalk capsules contain:

The active substance is ursodeoxycholic acid. One capsule contains 250 mg ursodeoxycholic acid.

The other ingredients are gelatin, colloidal silica, magnesium stearate, maize starch, sodium lauryl sulphate, purified water and titanium dioxide.

What Ursofalk capsules look like and contents of the pack

Ursofalk capsules are white, opaque, hard gelatine capsules containing a white powder.

Ursofalk capsules are available in packs of 60 capsules.

Manufacturer and Licence Holder

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. Manufactured by Losan Pharma GmbH, Otto-Hahn-Strasse 13, Neuenburg, Germany.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

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


POM PL 15184/1281 Ursofalk 250mg capsules Revision date: 17/02/15

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.


Bilifalk 250mg Capsules

(ursodeoxycholic acid)

Patient Information Leaflet


Read all of this leaflet carefully before you start taking this medicine because it contains important infromation 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 Bilifalk 250mg Capsules but will referred to as Bilifalk Capsules through out this leaflet.

What is in this leaflet:

^ What Bilifalk capsules are and what they are used for ^ What you need to know before you take Bilifalk capsules ^ How to take Bilifalk capsules ^ Possible side effects

How to store Bilifalk capsules ^ Contents of the pack and other information


"i What Bilifalk capsules are and what they are used for

Ursodeoxycholic acid (UDCA), the active substance in Bilifalk capsules, is a

naturally-occurring bile acid. Small amounts are found in human bile.

Bilifalk 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.


Other medicines and Bilifalk capsules

The effects of these medicines may be altered:

A reduction in the effects of the following medicines is possible when taking Bilifalk 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 Bilifalk 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 Bilifalk 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)

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 Bilifalk 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 or might take any other medicines, even if they are medicines obtainable without a prescription. Treatment with Bilifalk 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 Bilifalk 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 Bilifalk capsules 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.


[2) What you need to know before you take Bilifalk capsules

Do NOT take Bilifalk 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 Bilifalk 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 acute inflammation of the gall bladder or biliary tract

-    you have a blockage of the common bile duct or a 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.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Bilifalk 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.


[3) How to take Bilifalk capsules

Always take Bilifalk capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Bilifalk 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 Bilifalk capsules in the morning, at midday and in the evening. As liver function tests improve, the total daily dose may be taken once a day in the evening


Body weight BW (kg)

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

4

79 - 93

13 - 16

1

2

2

5

94 - 109

14 - 16

2

2

2

6

over 110

2

2

3

7


Bilifalk 250mg Tablets

(ursodeoxycholic acid)


Patient Information Leaflet (continued)

Duration of treatment

Bilifalk 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

How to take Bilifalk 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:

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 Bilifalk 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

Body weight BW (kg)

Daily dose (mg/kg BW)

Bilifalk 250mg hard capsules

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

4

100-109

23-25

3

3

4

>110

3

4

4

How to take Bilifalk capsules

Take the capsules two to three times per day, as advised. Take the capsules regularly.

Duration of treatment

Treatment can be continued long term in children with cystic fibrosis associated hepatobiliary disorders.

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

If you take more Bilifalk capsules than you should:

If you or anyone else take too many of the capsules, seek immediate medical attention.

If you forget to take Bilifalk capsules:

Do not take more capsules the next time, but just continue the treatment with the prescribed dose.

^ Possible side effects

Like all medicines, Bilifalk 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. 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 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.


[5) How to store Bilifalk capsules

Keep all medicines out of the sight and reach of children.

Do not use this medicine after the expiry date. This date is stated on the carton and the container after “Expiry date”. The expiry date refers to the last day of that month.

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.


[m Contents of the pack and other information

What Bilifalk capsules contain:

The active substance is ursodeoxycholic acid. One capsule contains 250 mg ursodeoxycholic acid.

The other ingredients are gelatin, colloidal silica, magnesium stearate, maize starch, sodium lauryl sulphate, purified water and titanium dioxide.

What Bilifalk capsules look like and contents of the pack

Bilifalk capsules are white, opaque, hard gelatine capsules containing a white powder.

Bilifalk capsules are available in packs of 60 capsules.

Manufacturer and Licence Holder

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. Manufactured by Losan Pharma GmbH, Otto-Hahn-Strasse 13, Neuenburg, Germany.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

Bilifalk is a registered trademark of Dr. Falk Pharma GmbH.


POM PL 15184/1281 Bilifalk 250mg capsules Revision date: 17/02/15

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.


Ursodeoxycholic Acid 250mg Capsules


Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine because it contains important infromation 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 but will referred to as Ursodeoxycholic Capsules through out this leaflet.

What is in this leaflet:

^ What Ursodeoxycholic capsules are and what they are used for ^ What you need to know before you take Ursodeoxycholic capsules ^ How to take Ursodeoxycholic capsules ^ Possible side effects

How to store Ursodeoxycholic capsules ^ Contents of the pack and other information


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.


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)

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 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 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 Ursodeoxycholic capsules, 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.


[2) What you need to know before you take Ursodeoxycholic 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 acute inflammation of the gall bladder or biliary tract

-    you have a blockage of the common bile duct or a 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.

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.


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.

Ursodeoxycholic 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 tests improve, the total daily dose may be taken once a day in the evening


Body weight BW (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

4

79 - 93

13 - 16

1

2

2

5

94 - 109

14 - 16

2

2

2

6

over 110

2

2

3

7


Ursodeoxycholic 250mg Tablets


Patient Information Leaflet (continued)

Duration of treatment

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

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:

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

Body weight BW (kg)

Daily dose (mg/kg BW)

Ursodeoxycholic 250mg hard capsules

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

4

100-109

23-25

3

3

4

>110

3

4

4

How to take Ursodeoxycholic capsules

Take the capsules two to three times per day, as advised. Take the capsules regularly.

Duration of treatment

Treatment can be continued long term 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:

If you or anyone else take too many of the capsules, seek immediate medical attention.

If you forget to take Ursodeoxycholic capsules:

Do not take more capsules the next time, but just continue the treatment with the prescribed dose.

^ 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. 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 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.


[5) How to store Ursodeoxycholic capsules

Keep all medicines out of the sight and reach of children.

Do not use this medicine after the expiry date. This date is stated on the carton and the container after “Expiry date”. The expiry date refers to the last day of that month.

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.


[m Contents of the pack and other information

What Ursodeoxycholic capsules contain:

The active substance is ursodeoxycholic acid. One capsule contains 250 mg ursodeoxycholic acid.

The other ingredients are gelatin, colloidal silica, magnesium stearate, maize starch, sodium lauryl sulphate, purified water and titanium dioxide.

What Ursodeoxycholic capsules look like and contents of the pack

Ursodeoxycholic capsules are white, opaque, hard gelatine capsules containing a white powder.

Ursodeoxycholic capsules are available in packs of 60 capsules. Manufacturer and Licence Holder

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. Manufactured by Losan Pharma GmbH, Otto-Hahn-Strasse 13, Neuenburg, Germany.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.


POM PL 15184/1281 Ursodeoxycholic 250mg capsules Revision date: 17/02/15

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.


If you stop taking Ursodeoxycholic capsules:

Always speak to your doctor before you decide to interrupt treatment with

Ursodeoxycholic capsules or decide to stop your treatment early.