Ursodeoxycholic Acid 250mg Capsules
Out of date information, search anotherS1018 LEAFLET Ursofalk 20150304
PACKAGE LEAFLET: INFORMATION FOR THE USER URSOFALK® 250mg CAPSULES (ursodeoxycholic acid)
Your medicine is known as Ursofalk 250mg Capsules but will be referred to as Ursofalk 250mg hard capsules or Ursofalk capsules throughout the following patient information leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet, see section 4.
What is in this leaflet:
1. What Ursofalk capsules are and what they are used for
2. What you need to know before you take Ursofalk capsules
3. How to take Ursofalk capsules
4. Possible side effects
5. How to store Ursofalk capsules
6. Contents of the pack and further information
1. WHAT URSOFALK 250mg HARD CAPSULES ARE AND WHAT THEY ARE USED FOR
Ursodeoxycholic acid (UDCA), the active substance in Ursofalk capsules, is a naturally-occurring bile acid. Small amounts are found in human bile.
Ursofalk capsules are used:
- for the treatment of a condition where the bile ducts in the liver become damaged leading to a build-up of bile. This may cause scarring of the liver. The liver should not be so damaged that it is not functioning properly. This condition is called primary biliary cirrhosis (PBC).
- to dissolve gallstones caused by excess cholesterol in the gall bladder where the gallstones are not visible on a plain x-ray (gallstones that are visible will not dissolve) and not more than 15 mm in diameter. The gall bladder should still be working despite the gallstone(s).
- for liver disease associated with a condition called cystic fibrosis in children aged 6 to 18 years.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE URSOFALK 250mg HARD 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. Please inform your doctor immediately if you have diarrhoea as this may require a reduction in the dose or discontinuation of treatment. 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.
3. HOW TO TAKE URSOFALK 250mg HARD 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 | |
|
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 |
3 |
|
100 - 109 |
23-25 |
3 |
3 |
4 |
|
>110 |
3 |
4 |
4 | |
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.
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._
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.
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, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE URSOFALK 250mg HARD CAPSULES
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C.
• Do not use after the expiry date printed on the carton label or blister
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND FURTHER INFORMATION
What Ursofalk 250mg Hard Capsules contain:
• Each hard capsule contains 250mg of the active ingredient, ursodeoxycholic acid.
• Ursofalk also contain the following inactive ingredients: maize starch, colloidal anhydrous silica, magnesium stearate, gelatin, titanium dioxide (E171) and sodium lauryl sulphate.
What Ursofalk 250mg Hard Capsules looks like and contents of
the pack
• Ursofalk are unmarked opaque hard gelatin capsule with a white to off-white body and cap.
• Ursofalk are available as blister packs of 60 or 100 capsules.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by
• Dr. Falk Pharma Portugal, Socidedade Unipessoal Lda, Miraflores, 1495-139 Alges, Portugal.
• Dr. Falk Pharma GmbH, Leinenweberstr. 5, 79108 Freiburg, Germany.
| POM| PL No. 19488/1018
Leaflet revision date: 04 March 2015
Ursofalk is a registered trade mark of Dr. Falk Pharma GmbH,
Germany.
S1018 LEAFLET Ursofalk 20150304
S1018 LEAFLET Ursodeoxycholic Acid 20150304
PACKAGE LEAFLET: INFORMATION FOR THE USER URSODEOXYCHOLIC ACID 250mg CAPSULES
Your medicine is known as Ursodeoxycholic acid 250mg Capsules but will be referred to as Ursodeoxycholic acid 250mg hard capsules or Ursodeoxycholic acid capsules throughout the following patient information leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects talk to your doctor or pharmacist.
This includes any side effects not listed in this leaflet, see section 4.
What is in this leaflet:
1. What Ursodeoxycholic acid capsules are and what they are used for
2. What you need to know before you take Ursodeoxycholic acid capsules
3. How to take Ursodeoxycholic acid capsules
4. Possible side effects
5. How to store Ursodeoxycholic acid capsules
6. Contents of the pack and further information
1. WHAT URSODEOXYCHOLIC ACID 250mg HARD 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE URSODEOXYCHOLIC ACID 250mg HARD 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. Please inform your doctor immediately if you have diarrhoea as this may require a reduction in the dose or discontinuation of treatment. 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.
- 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 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.
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 250mg HARD 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 acid 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 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 | |
|
Body weight BW (kg) |
Daily dose (mg/kg BW) |
Ursodeoxycholic acid 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 |
3 |
|
100 - 109 |
23-25 |
3 |
3 |
4 |
|
>110 |
3 |
4 |
4 | |
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.
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 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.__
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.
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, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE URSODEOXYCHOLIC ACID 250mg HARD CAPSULES
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C.
• Do not use after the expiry date printed on the carton label or blister
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND FURTHER INFORMATION
What Ursodeoxycholic acid 250mg Hard Capsules contain:
• Each hard capsule contains 250mg of the active ingredient, ursodeoxycholic acid.
• Ursodeoxycholic Acid also contain the following inactive ingredients: maize starch, colloidal anhydrous silica, magnesium stearate, gelatin, titanium dioxide (E171) and sodium lauryl sulphate.
What Ursodeoxycholic acid 250mg Hard Capsules looks like
and contents of the pack
• Ursodeoxycholic Acid 250mg hard capsules are unmarked opaque hard gelatin capsule with a white to off-white body and cap.
• Ursodeoxycholic Acid 250mg hard capsules are available as blister packs of 60 or 100 capsules.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by
• Dr. Falk Pharma Portugal, Socidedade Unipessoal Lda, Miraflores, 1495-139 Alges, Portugal.
• Dr. Falk Pharma GmbH, Leinenweberstr. 5, 79108 Freiburg, Germany.
| POM| PL No. 19488/1018
Leaflet revision date: 04 March 2015
S1018 LEAFLET Ursodeoxycholic Acid 20150304