Ursofalk 250mg Capsules
1. What Ursofalk 250mg hard capsules are and what they are used for
2. What you need to know before you take Ursofalk 250mg hard capsules
3. How to take Ursofalk 250mg capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER URSOFALK® 250mg Capsules
(ursodeoxycholic acid)
The name of this medicine is Ursofalk 250mg Capsules but it will be referred to as Ursofalk Capsules throughout the remainder of this 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
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.
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 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 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)
If you are taking Ursofalk capsules for the dissolution of gallstones, please inform your doctor, in case you are taking any medicines that contain oestrogenic hormones or blood cholesterol lowering agents such as clofibrate. These medicines stimulate the formation of gallstones, which is a counter-effect to the treatment with Ursofalk.
Please tell your doctor or pharmacist if you are taking or have recently taken 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 breastfeeding or about to start breastfeeding.
Driving and using machines:
No particular precautions are necessary.
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 values 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 | |
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