Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Ursofalk 500mg film-coated tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ursodeoxycholic acid may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Ursofalk tablets contain the active substance ursodeoxycholic acid (UDCA). Small amounts of UDCA are found in human bile. Ursofalk tablets 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 stones 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
What you need to know before you take it
e Ursofalk 500mg film-coated tablets Do NOT take Ursofalk tablets 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 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 Ursofalk tablets 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 talk to your doctor immediately if you have diarrhoea, as this may require a reduction in the dose or discontinuation of the treatment with Ursofalk tablets.
Other medicines and Ursofalk tablets The effects of these medicines may be altered: A reduction in the effects of the following medicines is possible when taking Ursofalk tablets:
- 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 tablets.
- ciprofloxacin, dapsone (antibiotics), nitrendipine (used to treat high blood pressure) and other medicines which are metabolised 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 Ursofalk tablets:
- 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 tablets 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. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even if they are medicines obtainable without a prescription. Treatment with Ursofalk tablets may still be allowed. Your doctor will know what is right for you.
Pregnancy breastfeeding and fertility If you are pregnant or breast feeding, 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 500mg film-coated tablets Always take Ursofalk tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
For the treatment of primary biliary cholangitis (inflammation of the bile ducts) Dosage During the first 3 months of treatment, you should take Ursofalk tablets in divided doses during the day. 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)
47 – 62 63 – 78 79 – 93 94 – 109 over 110
12 – 16 13 – 16 13 – 16 14 – 16
Ursofalk 500mg Film-coated Tablets First 3 months Subsequently Morning Midday Evening Evening (once daily) 1⁄2 1⁄2 1⁄2 11⁄2 1⁄2 1⁄2 1 2 1⁄2 1 1 21⁄2 1 1 1 3 1 1 11⁄2 31⁄2
How to take Ursofalk tablets The tablet can be divided into equal doses. Swallow the tablets with a drink of water or other liquid. Do not crush or chew the tablets. Take the tablets regularly. Duration of treatment Ursofalk tablets can be continued indefinitely in cases of PBC.
To dissolve cholesterol gallstones Dosage Approximately 10 mg per kg body weight (BW) daily, as follows: up to 60 kg 1 tablet 61 – 80 kg 11⁄2 tablets 81 – 100 kg 2 tablets over 100 kg 21⁄2 tablets How to take Ursofalk tablets The tablet can be divided into equal doses. Swallow the tablets with a drink of water or other liquid. Do not crush or chew the tablets. Take the tablets in the evening at bedtime. Take the tablets 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 calcification of the stones has occurred since the last time. If this is the case, your doctor will stop the treatment.
Both indications: Ursofalk capsules or Ursofalk suspension are available if you weigh less than 47 kg or cannot swallow tablets. 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 Ursofalk tablets. The administration of Ursofalk tablets 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 30mg per kg body weight daily if necessary Body weight BW (kg)
Daily dose (mg/kg BW)
20 – 29
17-25
1⁄2
—
1⁄2
30 – 39
19-25
1⁄2
1⁄2
1⁄2
40 – 49
20-25
1⁄2
1⁄2
1
50 – 59
21-25
1⁄2
1
1
60 – 69
22-25
1
1
1
70 – 79
22-25
1
1
11⁄2
80 – 89
22-25
1
11⁄2
11⁄2
90 – 99
23-25
11⁄2
11⁄2
11⁄2
100 – 109
23-25
11⁄2
11⁄2
2
11⁄2
2
2
>110
Ursofalk 500mg Film-coated Tablets Morning Midday Evening
How to take it
Ursofalk tablets The tablet can be divided into equal doses. Swallow the tablets with a drink of water or other liquid. Do not crush or chew the tablets. Take the tablets 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 Ursofalk 500mg film-coated tablets is too strong or too weak, please talk to your doctor or pharmacist.
If you take more Ursofalk tablets than you should: Diarrhoea may occur as a result of overdose. Please inform your doctor immediately if you have persistent diarrhoea. If you do suffer from diarrhoea, make sure you drink enough liquids to replace your fluid and salt balance.
If you forget to take Ursofalk tablets Do not take more tablets the next time, but just continue the treatment with the prescribed dose.
If you stop taking Ursofalk tablets: Always speak to your doctor before you decide to interrupt treatment with Ursofalk tablets or decide to stop your treatment early.
4. Possible side effects Like all medicines, Ursofalk tablets can cause side effects, although not everybody gets them. Common: may affect up to 1 in 10 people
- soft, loose stools or diarrhoea Very rare: may affect up to 1 in 10,000 people
- during the treatment of primary biliary cholangitis: 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 or pharmacist. This includes any possible
Possible side effects
not listed in this leaflet. You can also report side effects directly via: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store By reporting side effects, you can help provide more information on the safety of this medicine.
How to store it
Ursofalk 500mg film-coated tablets 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. This medicine does not require any special storage conditions. 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 to protect the environment.
Contents of the pack and other information
What Ursofalk tablets contain: The active substance is ursodeoxycholic acid (UDCA). Each film-coated tablet contains 500 mg UDCA. The other ingredients are: Tablet core: magnesium stearate, polysorbate 80, povidone K 25, microcrystalline cellulose, colloidal anhydrous silica, crospovidone (Type A), talc. Coating: talc, hypromellose and macrogol 6000.
What Ursofalk 500mg film-coated tablets look like and contents of the pack Ursofalk 500mg film-coated tablets are white, oval, biconvex and scored on both sides. The tablet may be divided into half. Ursofalk 500mg film-coated tablets are available in packs of 50 and 100. Not all packs may be marketed.
Marketing authorisation holder: Dr Falk Pharma UK Ltd Unit K, Bourne End Business Park Cores End Road Bourne End Buckinghamshire SL8 5AS UK Tel.: + 44 (0) 1628 536600 Fax: + 44 (0) 1628 536601 Email: [email protected]
Manufactured by: Dr. Falk Pharma GmbH Leinenweberstrasse 5 79108 Freiburg Germany Tel:- +49 (0)761/1514-0 Fax: +49 (0)761/1514-321 E-mail: [email protected]
This leaflet was last revised January 2025. Other sources of information: Further information, help, advice and details of local support groups can be found at: The PBC Foundation The British Liver Trust
2 York Place Edinburgh Scotland EH1 3EP Telephone: +44 (0) 131 556 6811 www.pbcfoundation.org.uk
2 Southampton Road Ringwood England BH24 1HY Telephone: +44 (0) 1425 481320 www.britishlivertrust.org.uk
Frequently asked questions about Ursofalk 500mg film-coated tablets
How do I take Ursofalk 500mg film-coated tablets?
Ursofalk 500mg film-coated tablets comes as tablet containing 500mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Ursofalk 500mg film-coated tablets?
The active substance in Ursofalk 500mg film-coated tablets is ursodeoxycholic acid.
Are there equivalent medicines to Ursofalk 500mg film-coated tablets?
Medicines with the same active substance, strength and form include: Cholurso 500 mg Tablet. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Ursofalk 500mg film-coated tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Ursofalk 500mg film-coated tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: ursodeoxycholic acid
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
For the treatment of primary biliary cholangitis (PBC), provided there is no decompensated hepatic cirrhosis.
For the dissolution of cholesterol gallstones in the gall bladder. The gallstones must not show as shadows on X-ray images and should not exceed 15 mm in diameter. The gall bladder must be functioning despite the gallstone(s).
Paediatric population
Hepatobiliary disorders associated with cystic fibrosis in children aged 6 to 18 years
4.2. Posology and method of administration
There are no age restrictions on the use of Ursofalk tablets in the treatment of PBC and for the dissolution of radiolucent gallstones. For patients weighing less than 47 kg or patients who are unable to swallow Ursofalk tablets, Ursofalk capsules and suspension are available.
The following daily dose is recommended for the various indications:
For the treatment of primary biliary cholangitis (PBC)
The daily dose depends on body weight and ranges from 1½ to 3½ tablets (14 ± 2 mg of UDCA per kg of body weight).
For the first 3 months of treatment, Ursofalk tablets should be taken divided over the day. With improvement of the liver values the daily dose may be taken once daily in the evening.
Body weight (kg)
Daily dose
(mg/kg BW)
Film-coated tablets
first 3 months
subsequently
morning
midday
evening
evening (1 x daily)
47 – 62
12 – 16
½
½
½
1½
63 – 78
13 – 16
½
½
1
2
79 – 93
13 – 16
½
1
1
2½
94 – 109
14 - 16
1
1
1
3
Over 110
1
1
1½
3½
The tablets should be swallowed with some liquid. The tablets should not be crushed or chewed. Care should be taken to ensure that they are taken regularly.
The use of Ursofalk tablets in PBC may be continued indefinitely.
For dissolution of cholesterol gallstones
Approximately 10 mg of UDCA per kg of body weight, equivalent to:
up to 60 kg
1 tablet
61-80 kg
1½ tablets
81-100 kg
2 tablets
over 100 kg
2½ tablets
The tablets should be swallowed with some liquid in the evening at bedtime. The tablets should not be crushed or chewed.
The tablets must be taken regularly.
The time required for dissolution of gallstones is generally 6-24 months, depending on stone size and composition. If there is no reduction in the size of the gallstones after 12 months, the therapy should not be continued.
The success of the treatment should be checked by means of ultrasound or X-ray examination every 6 months. At the follow-up examinations, a check should be made to see whether calcification of the stones has occurred in the meantime. Should this be the case, the treatment must be ended.
The likelihood of recurrence of gallstones after dissolution by bile acid treatment has been estimated as up to 50% at 5 years. The efficiency of Ursofalk in treating radio-opaque or partially radio-opaque gallstones has not been tested but these are generally thought to be less soluble than radiolucent stones. Non-cholesterol stones account for 10-15% of radiolucent stones and may not be dissolved by bile acids.
Older people
In both indications there is no evidence to suggest that any alteration in the adult dose is needed but the relevant precautions should be taken into account.
Paediatric population
Both indications are very rare in children and adolescents. Therefore there are no adequate data on the efficacy and safety in this population.
The administration of Ursofalk is based on body weight and the medical condition.
For the treatment of hepatobiliary disorders associated with cystic fibrosis
Paediatric population
Children with cystic fibrosis aged 6 to 18 years: 20 mg/kg/day in 2-3 divided doses, with a further increase to 30 mg/kg/day if necessary
Body weight BW (kg)
Daily dose UDCA
(mg/kg BW)
Ursofalk 500mg Film-coated Tablets
Morning
Midday
Evening
20 – 29
17-25
½
--
½
30 – 39
19-25
½
½
½
40 – 49
20-25
½
½
1
50 – 59
21-25
½
1
1
60 – 69
22-25
1
1
1
70 – 79
22-25
1
1
1½
80 – 89
22-25
1
1½
1½
90 – 99
23-25
1½
1½
1½
100 – 109
23-25
1½
1½
2
>110
1½
2
2
4.3. Contraindications
Ursofalk tablets should not be used in patients with:
- acute inflammation of the gall bladder or biliary tract
- occlusion of the biliary tract (occlusion of the common bile duct or cystic duct)
- frequent episodes of biliary colic
- radio-opaque calcified gallstones
- impaired contractility of the gall bladder
- hypersensitivity to bile acids or any excipient of the formulation
When used in hepatobiliary disorders associated with cystic fibrosis in children aged 6 to 18 years:
- unsuccessful portoenterostomy or without recovery of good bile flow in children with biliary atresia
4.4. Special warnings and precautions for use
Ursofalk tablets should be taken under medical supervision.
During the first 3 months of treatment, liver function parameters AST (SGOT), ALT (SGPT) and γ-GT should be monitored by the physician every 4 weeks, thereafter every 3 months.
Apart from allowing for identification of responders and non-responders in patients being treated for PBC, this monitoring would also enable early detection of potential hepatic deterioration, particularly in patients with advanced stage PBC.
When used for treatment of advanced stage of primary biliary cholangitis:
In very rare cases decompensation of hepatic cirrhosis has been observed, which partially regressed after the treatment was discontinued.
In patients with PBC, in rare cases the clinical symptoms may worsen at the beginning of treatment, e.g. the itching may increase. In this case the dose should be reduced to 250mg daily and then gradually increased to the recommended dose described in section 4.2.
If diarrhoea occurs, the dose must be reduced and in cases of persistent diarrhoea, the therapy should be discontinued.
When used for dissolution of cholesterol gallstones:
In order to assess therapeutic progress and for timely detection of any calcification of the gallstones, depending on stone size, the gall bladder should be visualised (oral cholecystography) with overview and occlusion views in standing and supine positions (ultrasound control) 6-10 months after the beginning of treatment.
If the gall bladder cannot be visualised on X-ray images, or in cases of calcified gallstones, impaired contractility of the gall bladder or frequent episodes of biliary colic, Ursofalk should not be used.
Female patients taking Ursofalk for dissolution of gallstones should use an effective non- hormonal method of contraception, since hormonal contraceptives may increase biliary lithiasis (see section 4.5. and 4.6.)
4.5. Interaction with other medicinal products and other forms of interaction
Ursofalk should not be administered concomitantly with colestyramine, colestipol or antacids containing aluminium hydroxide and/or smectite (aluminium oxide), because these preparations bind UDCA in the intestine and thereby inhibit its absorption and efficacy. Should the use of a preparation containing one of these substances be necessary, it must be taken at least 2 hours before or after Ursofalk.
Ursofalk can affect the absorption of ciclosporin from the intestine. In patients receiving ciclosporin treatment, blood concentrations of this substance should therefore be checked by the physician and the ciclosporin dose adjusted if necessary.
In isolated cases, Ursofalk can reduce the absorption of ciprofloxacin.
In a clinical study in healthy volunteers concomitant use of UDCA (500mg/day) and rosuvastatin (20mg/day) resulted in slightly elevated plasma levels of rosuvastatin. The clinical relevance of this interaction also with regard to other statins is unknown.
UDCA has been shown to reduce peak plasma concentrations (Cmax) and area under the curve (AUC) of the calcium antagonist nitrendipine in healthy volunteers. Close monitoring of the outcome of concurrent use of nitrendipine and UDCA is recommended. An increase of the dose of nitrendipine may be necessary. An interaction with a reduction of the therapeutic effect of dapsone was also reported. These observations together with in vitro findings could indicate a potential for UDCA to induce cytochrome P450 3A enzymes. Induction has, however, not been observed in a well-designed interaction study with budesonide, which is a known cytochrome P450 3A substrate.
Oestrogenic hormones and blood cholesterol lowering agents such as clofibrate increase hepatic cholesterol secretion and may therefore encourage biliary lithiasis, which is a counter-effect to UDCA used for dissolution of gallstones.
4.6. Fertility, pregnancy and lactation
Animal studies did not show an influence of UDCA on fertility (see section 5.3). Human data on fertility effects following treatment with UDCA are not available.
Pregnancy
There are no or limited amounts of data from the use of UDCA in pregnant women. Studies in animals have shown reproductive toxicity during the early phase of gestation (see section 5.3). Ursofalk must not be used during pregnancy unless clearly necessary.
Women of childbearing potential
Women of childbearing potential should be treated only if they use reliable contraception: non-hormonal or low-oestrogen oral contraceptive measures are recommended.
However, in patients taking Ursofalk for dissolution of gallstones, effective non- hormonal contraception should be used, since hormonal oral contraceptives may increase biliary lithiasis.
The possibility of a pregnancy must be excluded before beginning treatment.
Breastfeeding
According to few documented cases of breastfeeding women milk levels of UDCA are very low and probably no adverse reactions are to be expected in breastfed infants.
4.7. Effects on ability to drive and use machines
UDCA has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
The evaluation of undesirable effects is based on the following frequency data:
Very common: (≥ 1/10)
Common : (≥ 1/100 to < 1/10)
Uncommon: (≥ 1/1,000 to < 1/100)
Rare : (≥ 1/10,000 to < 1/1,000)
Very rare: / Not known (:< 1/10,000 / cannot be estimated from available data)
MedDRA system organ class
Common
Very rare
Not known
Gastrointestinal disorders
Soft stools or diarrhoea
Severe right upper abdominal pain during treatment of PBC
Nausea, vomiting
Hepatobiliary disorders
Calcification of gallstones, decompensation of hepatic cirrhosis1
Skin and subcutaneous tissue disorders
Urticaria
Pruritus
1 Observed during therapy of the advanced stages of PBC and which partially regressed after treatment was discontinued.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
4.9. Overdose
Diarrhoea may occur in cases of overdose. In general, other symptoms of overdose are unlikely because the absorption of UDCA decreases with increasing dose and therefore more is excreted with the faeces.
No specific counter-measures are necessary and the consequences of diarrhoea should be treated symptomatically with restoration of fluid and electrolyte balance.
Additional information on special populations:
Long-term, high-dose UDCA therapy (28-30 mg/kg/day) in patients with primary sclerosing cholangitis (off-label use) was associated with higher rates of serious adverse events.
💬 Ask about this leaflet
Ask anything about Ursofalk 500mg film-coated tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
Medicines containing Ursodeoxycholic acid
- Cholurso 250 mg Tablet
- Cholurso 500 mg Tablet
- DEOXXA 250 mg / 5 ml Oral Suspension
- Ursodeoxycholic acid 150mg Tablets
- Ursodeoxycholic Acid 250 mg hard capsule
- Ursodeoxycholic Acid 250 mg hard capsules
- Ursodeoxycholic acid 250mg Hard Capsules
- Ursodeoxycholic Acid 300mg Film-Coated Tablets
- Ursodeoxycholic acid 300mg Tablets
- Ursodeoxycholic acid 450mg Tablets
- Ursofalk 250mg Hard Capsules
- Ursofalk 250mg/5ml Suspension