Ursofalk 250mg Capsules
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.
a
a
s
a
a
s
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 further information
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 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)
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 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 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 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 | |
How to take Ursofalk Capsules
Swallow the capsules whole with a drink of water or other liquid. Take your medicine regularly.
Duration of treatment
Ursofalk Capsules may be continued indefinitely in cases of PBC.
Ursofalk ® 250mg Capsules
(ursodeoxycholic acid)
Patient Information Leaflet (continued)
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 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) |
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.
If you stop taking Ursofalk Capsules:
Always speak 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. 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 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.
[£) 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.
Revision date: 13/03/15
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
Other sources of information:
Further information, help, advice and details of local support groups can be found at:
The PBC Foundation The British Liver Trust
2 York Place 2 Southampton Road
Edinburgh Ringwood
Scotland England
EH1 3EP BH241HY
Telephone: +44 (0) 131 556 6811 Telephone: +44 (0) 1425 481320
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 Acid 250mg Capsules, throughout this leaflet it will be referred to as Ursodeoxycholic Acid Capsules.
What is in this leaflet:
^ What Ursodeoxycholic Acid Capsules are and what they are used for ^2| What you need to know before you take Ursodeoxycholic Acid Capsules
How to take Ursodeoxycholic Acid Capsules [4) Possible side effects
^5| How to store Ursodeoxycholic Acid Capsules ^ Contents of the pack and further information
What Ursodeoxycholic Acid Capsules are and what they are used for
Ursodeoxycholic Acid (UDCA), the active substance in Ursodeoxycholic Acid
Capsules, is a naturally-occurring bile acid. Small amounts are found in
human bile.
Ursodeoxycholic Acid Capsules are used:
- 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 Acid Capsules
The effects of these medicines may be altered:
A reduction in the effects of the following medicines is possible when taking Ursodeoxycholic Acid 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 Acid 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 Acid Capsules:
- ciclosporin (to reduce the activity of the immune system). If you are being treated with ciclosporin, your doctor should check the amount of ciclosporin in your blood. Your doctor will adjust its dose, if necessary.
- 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 Acid Capsules for the dissolution of gallstones, as they may stimulate the formation of gallstones.
Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, even if they are medicines obtainable without a prescription. Treatment with Ursodeoxycholic Acid Capsules may still be allowed. Your doctor will know what is right for you.
Pregnancy, 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 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 Acid 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.
[h What you need to know before you take Ursodeoxycholic Acid Capsules
Do NOT take Ursodeoxycholic Acid Capsules if:
- you are, or have been told you are, allergic (hypersensitive) to bile acids like UDCA or to any of the other ingredients of Ursodeoxycholic Acid 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 Acid 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.
rp How to take Ursodeoxycholic Acid Capsules
Always take Ursodeoxycholic Acid Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. 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 Acid Capsules in the morning, at midday and in the evening. As liver function tests improve, the total daily dose may be taken once a day in the evening.
|
Body weight BW (kg) |
Daily dose (mg/kg BW) |
Ursodeoxycholic Acid 250mg 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 | |
How to take Ursodeoxycholic Acid Capsules
Swallow the capsules whole with a drink of water or other liquid.
Take your medicine regularly.
Duration of treatment
Ursodeoxycholic Acid Capsules may be continued indefinitely in cases of PBC.
Ref: 1274/130315/2/B
Patient Information Leaflet (continued)
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 Acid Capsules
Swallow the capsules whole with a drink of water or other liquid.
Take the capsules in the evening at bedtime. Take your medicine 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 Acid 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 Acid 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 Acid Capsules is too strong or too weak, please talk to your doctor or pharmacist.
If you take more Ursodeoxycholic Acid Capsules than you should:
If you or anyone else take too many of the capsules, seek immediate medical attention.
If you forget to take Ursodeoxycholic Acid Capsules:
Do not take more capsules the next time, but just continue the treatment with the prescribed dose.
If you stop taking Ursodeoxycholic Acid Capsules:
Always speak to your doctor before you decide to interrupt treatment with Ursodeoxycholic Acid Capsules or decide to stop your treatment early.
[4) Possible side effects
Like all medicines, Ursodeoxycholic Acid 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 this medicine
* Keep out of the sight and reach of children.
* Do not use Ursodeoxycholic Acid 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.
[£) 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 Acid 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
Revision date: 13/03/15
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
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 BH241HY
Telephone: +44 (0) 1425 481320 www.britishlivertrust.org.uk