Ursofalk 250mg Capsules
Out of date information, search another1. WHAT URSOFALK 250mg HARD CAPSULES ARE AND WHAT THEY ARE USED FOR
2. BEFORE YOU TAKE URSOFALK 250mg HARD 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.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Ursofalk 250mg hard capsules are and what they are used for
2. Before you take Ursofalk 250mg hard capsules
3. How to take Ursofalk 250mg hard capsules
4. Possible side effects
5. How to store Ursofalk 250mg hard capsules
6. Further information
Ursodeoxycholic acid, the active substance in Ursofalk 250mg hard capsules, is a naturally-occurring bile acid. Small amounts are found in human bile.
Ursofalk 250mg hard capsules are used:
- 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 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.
Do NOT take Ursofalk 250mg hard capsules if:
- you are, or have been told you are allergic (hypersensitive) to bile acids like ursodeoxycholic acid or to any of the other ingredients of Ursofalk 250mg hard capsules (these are listed in section “6. Further information”)
- your gall bladder does not work properly
- you have gallstones that are visible on an x-ray
- you have acute inflammation of the gall bladder or biliary tract
- you have an obstruction of the biliary tract (blockage of the common bile duct or a cystic duct)
- you suffer from frequent cramp-like pains in the upper abdomen (biliary colic).
- you have hardening of the gallstones caused by a build-up of calcium.
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.
Further precautions:
Ursofalk 250mg hard capsules must be used under medical supervision.
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.
Please inform your doctor immediately if you have diarrhoea as this may require a reduction in the dose or discontinuation of treatment.
Taking other medicines with Ursofalk 250mg hard capsules
Please tell your doctor if you are taking or have recently taken any other medicines which contain the following ingredients.
The effects of these medicines may be altered (interactions):
A reduction in the effects of the following medicines is possible when taking Ursofalk 250mg hard capsules:
- colestyramine, charcoal, 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.
An increase in the effects of the following medicines is possible when taking Ursofalk 250mg hard 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.
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 250mg hard 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 any other medicines, even if they are medicines obtainable without a prescription. Treatment with Ursofalk 250mg hard capsules may still be allowed. Your doctor will know what is right for you.
Pregnancy and breastfeeding:
Ask your doctor or pharmacist for advice before taking/using any
medicine.
- You should not take Ursofalk 250mg hard capsules during pregnancy unless your doctor thinks it is absolutely necessary. Use of Ursofalk during the first three months of pregnancy may affect the foetus.
- Check that you are not pregnant before taking this medicine.
- Use a reliable method of contraception - non-hormonal contraceptives (barrier methods) or low-oestrogen oral contraceptives are recommended. If you are taking Ursofalk 250mg hard capsules for dissolution of gallstones, only use non-hormonal contraceptives, as hormonal oral contraceptives may stimulate the formation of gallstones.
- Do not take this medicine if you are breastfeeding as the active ingredient in Ursofalk 250mg hard capsules may pass into breast milk. If treatment with Ursofalk 250mg hard capsules is necessary, then stop breastfeeding.
Use in children:
There are no age limits to the use of Ursofalk 250mg hard capsules.
The administration of Ursofalk 250mg hard capsules is based on
body weight and the medical condition.
Driving and using machines:
No particular precautions are necessary.
3. HOW TO TAKE URSOFALK 250mg HARD CAPSULES
Always take Ursofalk 250mg hard capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
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 250mg hard 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.
For primary biliary cirrhosis (chronic inflammation of the bile ducts)
Dosage
During the first 3 months of treatment, you should take Ursofalk 250mg hard 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.
I
I
I
I
I
|
Body weight BW (kg) |
Daily dose (mg/kg BW) |
Ursofalk 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 | |
6. Further information
Ursofalk suspension is available if you weigh less than 47kg or cannot swallow capsules.
How to take Ursofalk 250mg hard capsules
Swallow the capsules whole with a drink of water or other liquid.
Take your medicine regularly.
Duration of treatment
Ursofalk 250mg hard capsules may be continued indefinitely in cases of primary biliary cirrhosis.
Note:
In patients with primary biliary cirrhosis, the symptoms may worsen at the start of treatment, e.g. the itching may increase. This only occurs in rare cases. If this happens, therapy can be continued with a lower daily dose of Ursofalk 250mg hard capsules. Each week, your doctor will then gradually increase the daily dose, until you reach the required dose.
If you feel that the effect of Ursofalk 250mg hard capsules is too strong or too weak, please talk to your doctor or pharmacist.
If you take more Ursofalk 250mg hard 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 250mg hard capsules:
Do not take more capsules the next time, but just continue the treatment with the prescribed dose.
- Keep your medicine out of the reach and sight of children.
- Check the expiry date printed on the carton label or blister pack and do not use the capsules if this date has been passed. The expiry date refers to the last day of that month.
- If your doctor decides to stop treatment, return any left over capsules to the pharmacist. Only keep them if the doctor tells you to.
- 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.
- If the capsules become discoloured or show any other signs of deterioration, you should seek the advice of your doctor or pharmacist who will advise you what to do.
What Ursofalk Capsules contain:
The active ingredient is ursodeoxycholic acid. Each capsule contains 250mg ursodeoxycholic acid.
These capsules also contain gelatin, colloidal silica anhydrous, magnesium stearate, maize starch, titanium dioxide.
What Ursofalk capsules look like and contents of the pack
The white hard gelatin capsules consist of an unmarked body and cap, containing a white powder.
Ursofalk Capsules are available in blister packs of 60 capsules.
Manufacturer and Product Licence holder
Ursofalk is manufactured by LOSAN Pharma GmbH, D-79395 Nevenburg, Germany. Procured from within the EU and repackaged by the Product Licence holder: G. Pharma Ltd., Dakota Avenue, Salford M50 2PU.
PL 16369/1398
POM
4. POSSIBLE SIDE EFFECTS
If you stop taking Ursofalk 250mg hard capsules:
Always speak to your doctor before you decide to interrupt treatment with Ursofalk 250mg hard capsules or to stop your treatment early.
Like all medicines, Ursofalk 250mg hard capsules can cause side effects, although not everybody gets them.
You should contact your doctor immediately if you experience any of the following symptoms after taking Ursofalk 250mg hard capsules: 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.
Date of revision of this leaflet: 13/01/2014
Ursofalk is a registered trade mark of Dr. Falk Pharma GmbH
You may also wish to contact the following national organisation which offers help, advice and local support groups:
Primary Biliary Cirrhosis Foundation,
54 Queen Street,
Edinburgh, EH2 3NS.
Telephone: 0131 225 8586.
Very rare side effects (occurring in less than 1 in 10,000 patients):
- during the treatment of primary biliary cirrhosis: severe right-sided upper abdominal pain, severe worsening of liver scarring - this partially improves 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)
If you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
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.