Ursofalk tablets, capsules and suspension contain the active ingredient ursodeoxycholic acid.
What is it used for?
- Dissolving gallstones that are mainly made up of cholesterol (radiolucent gallstones).
- Treatment of primary biliary cirrhosis, which is a slowly progressive form of liver inflammation that starts around the bile ducts.
How does it work?
- Ursofalk tablets, capsules and suspension contain the active ingredient ursodeoxycholic acid. Ursodeoxycholic acid is also available without a brand name, ie as the generic medicine.
- Ursodeoxycholic acid is a chemical called a bile acid. It occurs naturally in bile and can be used to dissolve gallstones.
- The liver produces bile, which is then stored in the gall bladder. Bile is released by the gall bladder to aid the digestion of fats. It consists of cholesterol dissolved within bile salts. Gallstones occur in the gall bladder as a result of too much cholesterol, or too few bile salts within the bile.
How do I take it?
- Ursofalk tablets, capsules and suspension should be taken with or just after food.
- The tablets and capsules should be swallowed with a glass of water.
- The dose prescribed and how often the medicine needs to be taken depends on the condition being treated. It is important to follow the instructions given by your doctor. These will be printed on the dispensing label your pharmacist has put on the packet of medicine.
- Following a low cholesterol diet may help to increase the effectiveness of this medicine. Your doctor or pharmacist can advise you on this.
Warning!
- Treatment with this medicine for gallstones may have to be continued for up to two years, depending on the size of the gallstones. You should have regular check-ups to see if the medicine is helping to dissolve the gallstones. Treatment with this medicine should be continued for three to four months after the gallstones have dissolved.
- If you are taking this medicine for primary biliary cirrhosis you will need to have regular blood tests to monitor your liver function. These should be every four weeks for the first three months of treatment, then every three months during continued treatment.
Not to be used in
- Treating gallstones that have a high calcium content and show up on X-rays (radio-opaque calcified gallstones).
- People with acute inflammation of the gall bladder or bile duct.
- People with a blockage of the bile duct (biliary obstruction).
- People who frequently experience pain with their gallstones (biliary colic).
- People with a gall bladder that no longer contracts and empties.
- Chronic liver disease (except primary biliary cirrhosis).
- Inflammatory bowel disease such as ulcerative colitis or Crohn's disease.
- Pregnancy.
- Women who could get pregnant (see below).
- Breastfeeding.
This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- The safety of this medicine for use during pregnancy has not been established. The manufacturer states that it should not be used during pregnancy and a non-hormonal method of contraception should be used to prevent pregnancy during the treatment. (Hormonal contraceptives such as the pill can make gallstones worse.) Stop treatment immediately and seek medical advice if you get pregnant while taking the medicine. Ask your doctor for further information and advice.
- It is not known if this medicine passes into breast milk. The manufacturer states that mothers who need to take this medicine should not breastfeed. Seek medical advice from your doctor.
Label warnings
- Take this medication with or after food.
Side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Common
- Diarrhoea or pasty stools.
Very rare
- Nettle-like rash.
- Calcification of gallstones (a process in which the mineral calcium builds up in the gallstones causing them to harden). If this occurs it will stop this medicine dissolving the gallstones and surgery may then be needed to remove them.
- Severe upper right abdominal pain when treating biliary cirrhosis.
Frequency unknown
- Itching.
- Nausea and vomiting.
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.
Ursodeoxycholic acid can increase the absorption of the immunosuppressant medicine ciclosporin from the gut. People taking ursodeoxycholic acid together with ciclosporin should have the level of ciclosporin in their blood checked regularly. Your doctor may need to adjust your dose of ciclosporin.
The following medicines can reduce the absorption of ursodeoxycholic acid from the gut and could make it less effective. These should not be taken at the same time as or within two hours of taking ursodeoxycholic acid:
- antacids for heartburn or indigestion
- charcoal
- colestipol
- colestyramine.
References:
http://www.hpra.ie/img/uploaded/swedocuments/2134853.PPA0465_183_001.ed067cc3-c0bc-4811-9d92-8d35326ead3f.000001Product%20Leaflet%20Approved.130913.pdf
http://www.netdoctor.co.uk/medicines/digestive-health/a7708/ursofalk-ursodeoxycholic-acid/
http://www.medicines.ie/medicine/11534/SPC/Ursofalk+250mg+Hard+Capsules/#MACHINEOPS
https://www.medicines.org.uk/emc/medicine/19091
https://www.medicines.org.uk/emc/medicine/27437
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