Patient leaflet - Ursodeoxycholic Acid 500 mg capsules, hard
1. What Ursodeoxycholic Acid Capsules are and what they are used for
Ursodeoxycholic Acid Capsules contain the active substance ursodeoxycholic acid (UDCA). Small amounts of UDCA are found in human bile.
Ursodeoxycholic Acid Capsules are used:
- for the treatment of primary biliary cholangitis (PBC) 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 (cirrhosis of the liver). The liver should not be so damaged that it is not functioning properly.
to dissolve cholesterol gallstones. These gallstones must not be visible on a plain x-ray
(radiolucent) and be no larger than 15 mm in diameter because they will not dissolve with UDCA. The gall bladder must 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 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 this medicine (listed in section 6).
- you have an acute inflammation of the gall bladder or the biliary tract.
- you have a blockage of the common bile duct or cystic duct (obstruction of the biliary tract).
- you have frequent cramp-like upper abdomen pain (biliary colic).
- your doctor has said you have calcified gallstones (they are visible on an x-ray).
- your gall bladder does not work properly.
- you are a child with biliary atresia and have poor bile flow, even after surgery.
Please ask your doctor about 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 months 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 talk to 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)
Package leaflet: Information for the user
Ursodeoxycholic Acid 500 mg Capsules, hard
Ursodeoxycholic acid
If you must take medication that contains any of these ingredients, it must be taken at least 2 hours before or after Ursodeoxycholic Acid Capsules.
ciprofloxacin, dapsone (antibiotics), nitrendipine (used to treat high blood pressure) and
other medicines which are metabolized in a similar way. 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).
If you are taking Ursodeoxycholic Acid 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 Ursodeoxycholic Acid Capsules.
Please tell your doctor or pharmacist if you are talking or have recently taken any other medicines, even if they are medines 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 must 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 with Ursodeoxycholic Acid Capsules your doctor will check that you are not pregnant and review your contraceptive method to make sure it is approriate.
Breastfeeding
Tell your doctor if you are breastfeeding or about to start breastfeeding.
Driving and using machines
No particular precautions are necessary.
3. How to take Ursodeoxycholic Acid Capsules
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Depending on your body weight, you might have to take an Ursodeoxycholic Acid 250 mg Capsule in addition to Ursodeoxycholic Acid 500 mg Capsules. Your doctor will prescribe you two products.
Please note the following information in order to achieve the appropriate dosage:
Ursodeoxycholic Acid 500 mg Capsules: the number of capsules will be mentioned in the tables below.
- Ursodeoxycholic Acid 250 mg Capsules: the symbol will be used if a 250 mg capsule is required as single dose or in addition to Ursodeoxycholic Acid 500 mg Capsules.
For the treatment of primary biliary cholangitis (inflammation of the bile ducts):
Dosage
During the first 3 months of treatment, you should take Ursodeoxycholic Acid Capsules in divided doses during the day. As liver function tests improve, the total daily dose may be taken once a day in the evening.
How to take Ursodeoxycholic Acid Capsules
Swallow the capsules with a drink of water or other liquid. Take the capsules 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:
How to take Ursodeoxycholic Acid Capsules
Swallow the capsules with a drink of water or other liquid. Take the capsules in the evening at bedtime. Take the capsules 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, treatment 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 calcification of the stones has occurred since the last time. If this is the case, your doctor will stop the treatment.
Both Indications:
If you need an even lower dose or you cannot swallow capsules, other formulations (suspension) are available.
Use in elderly:
There is no evidence to suggest that any alteration in the adult dose is needed but the relevant precautions should be taken into account.
Use in children and adolescents:
There are no age limits to the use of Ursodeoxycholic Acid Capsules. The administration of Ursodeoxycholic Acid Capsules is based on body weight and the medical condition.
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 30 mg per kg body weight daily if necessary.
How to take Ursodeoxycholic Acid Capsules
Swallow the capsules with a drink of water or other liquid. Take the capsules regularly.
Duration of treatment
Treatment can be continued long-term (up to 12 years) 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.
Body weight BW (kg) | Daily dose (mg/kg BW) | Ursodeoxycholic Acid 500 mg Capsules (Number of 500 mg capsules + ❶ for 250 mg capsule) | |||
| First 3 months | Subsequently | ||||
| Morning | Midday | Evening | Evening (once daily) | ||
| 47 – 62 | 12 – 16 | ❶ | ❶ | ❶ | 1 + ❶ |
| 63 – 78 | 13 – 16 | ❶ | ❶ | 1 | 2 |
| 79 – 93 | 13 – 16 | ❶ | 1 | 1 | 2 + ❶ |
| 94 – 109 | 14 – 16 | 1 | 1 | 1 | 3 |
| over 110 | 1 | 1 | 1 + ❶ | 3 + ❶ | |
Ursodeoxycholic Acid 500 mg Capsules (Number of 500 mg capsules + ❶ for 250 mg capsule) | |
| Body weight (kg) | Daily dose |
| Up to 60 | 1 |
| 61 – 80 | 1 + ❶ |
| 81 – 100 | 2 |
| Over 100 | 2 + ❶ |
Body weight BW (kg) | Daily dose (mg/kg BW) | Ursodeoxycholic Acid 500 mg Capsules (Number of 500 mg capsules + ❶ for 250 mg capsule) | ||
| Morning | Midday | Evening | ||
| 20 – 29 | 17 – 25 | ❶ | -- | ❶ |
| 30 – 39 | 19 – 25 | ❶ | ❶ | ❶ |
| 40 – 49 | 20 – 25 | ❶ | ❶ | 1 |
| 50 – 59 | 21 – 25 | ❶ | 1 | 1 |
| 60 – 69 | 22 – 25 | 1 | 1 | 1 |
| 70 – 79 | 22 – 25 | 1 | 1 | 1 + ❶ |
| 80 – 89 | 22 – 25 | 1 | 1 + ❶ | 1 + ❶ |
| 90 – 99 | 23 – 25 | 1 + ❶ | 1 + ❶ | 1 + ❶ |
| 100 – 109 | 23 – 25 | 1 + ❶ | 1 + ❶ | 2 |
| >110 | 1 + ❶ | 2 | 2 | |
If you take more Ursodeoxycholic Acid Capsules than you should
Diarrhoea may occur as a result of overdose. Please inform your doctor immediately, if you have persistent diarrhoea. If you suffer from diarrhoea, make sure you drink enough liquids to replace your fluid and salt balance.
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, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 patients):
- soft, loose stools or diarrhoea
Very rare side effects (may affect up to 1 in 10,000 patients):
during the treatment of PBC: severe right-sided upper abdominal pain, severe worsening of
liver cirrhosis which partially eases after treatment is discontinued
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)
Not known (frequency cannot be estimated from the available data):
- itching
- feeling sick, vomiting
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 Website: yellowcard.mhra.gov.uk or via the free Yellow card app. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Ursodeoxycholic Acid Capsules
This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Ursodeoxycholic Acid 500 mg Capsules contain:
The active substance is ursodeoxycholic acid. One capsule contains 500 mg ursodeoxycholic acid.
The other ingredients are magnesium stearate, maize starch, colloidal anhydrous silica, titanium dioxide (E171) and gelatin.
What Ursodeoxycholic Acid 500 mg Capsules look like and contents of the pack
White capsules (500 mg: approx. 9 x 23 mm).
Blister (PVC/Alu): 60, 100 capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Ursodeoxycholic Acid 500 mg Capsules is held by: Alissa Healthcare Research Ltd
Unit 5, Fulcrum 1, Solent Way,
Whiteley, Fareham, Hampshire PO15 7FE,
United Kingdom
Ursodeoxycholic Acid 500 mg Capsules are manufactured by:
ICE S.p.A., Canton Moretti, 29, San Bernardo-Ivrea, 10015 Turin, Italy
This leaflet was last revised in February 2026.
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