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.
Ursodeoxycholic Acid 250 mg hard capsules
⚠ 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
This medicine contains ursodeoxycholic acid – a natural bile acid. However, only a small amount is found in human bile. Ursodeoxycholic Acid Capsules is used:
- For the dissolution of gallstones that are composed of cholesterol in patients:
- having one or more radiolucent (radio-negative) gallstones, preferably with a diameter of no more than 2 cm, in a properly functioning gallbladder;
- for whom surgery is not an option;
- in whom cholesterol supersaturation has been demonstrated by chemical testing on bile.
- Before and after gallstone shockwave dissolution (lithotripsy).
- 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 cholangitis (PBC, also known as primary biliary cirrhosis).
- For the treatment of liver disease associated with cystic fibrosis (mucoviscidosis) in children and adolescents aged 6-18 years. 2.
What you need to know before you take it
e Ursodeoxycholic Acid Capsules
Do not take Ursodeoxycholic Acid Capsules if you are allergic to ursodeoxycholic acid or bile acids, or any of the other ingredients of this medicine (listed in section 6); if you have an acute inflammation of the gallbladder or biliary tract; if your bile ducts are closed (common duct or cystic duct occlusion); if you suffer from frequent cramp-like pains in the upper abdomen (biliary colic);
–
if your doctor has told you that you have a gallstone calcification; if your gallbladders ability to contract is impaired;
–
if you are a child with a closure of bile ducts (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 Ursodeoxycholic Acid Capsules. This medicine should be used under medical supervision. In the first 3 months of treatment your doctor should monitor your liver function regularly every 4 weeks. Thereafter, the controls should be carried out every 3 months. If you are taking this medicine to dissolve gallstones, your doctor should perform scans of your gallbladder after 6-10 months of treatment. If you are a woman and are taking this medicine to dissolve gallstones, you should use effective non- hormonal contraceptive measures because hormonal contraceptives (such as the "pill") may promote the formation of gallstones. If you take this medicine for the treatment of PBC, in rare cases, the symptoms (e.g. itching) may worsen at the beginning of treatment. In this case you should talk to your doctor about reducing your initial dose. Inform your doctor if you suffer from diarrhoea as this may require a reduction of the dose or discontinuation of the treatment with Ursodeoxycholic Acid Capsules. Children There are no age restrictions for the use of Ursodeoxycholic Acid Capsules except for cystic fibrosis (ages 6 to 18 years). Other medicines and Ursodeoxycholic Acid Capsules Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The effects of the following medicines can be changed (interactions): A reduction in the effects of Ursodeoxycholic Acid Capsules is possible when taking it with the following medicines: colestyramine, colestipol (medicines used to lower blood lipid levels) or antacids containing aluminium hydroxide or smectite (aluminium oxide) (preparations binding gastric acids). If you are taking a medicine containing one of these active ingredients, it should be taken at least 2 hours before or after taking Ursodeoxycholic Acid Capsules.
A reduction in the effects of the following medicines is possible when taking Ursodeoxycholic Acid Capsules: ciprofloxacin, dapsone (antibiotics), nitrendipine (medicine used to treat high blood pressure) and other medicines that are eliminated in a similar way: it may be necessary for your doctor to alter the dose of these medicines.
A change of the effects of the following medicines is possible by taking Ursodeoxycholic Acid Capsules: ciclosporin (medicine that reduces the activity of the immune system). If you are being treated with ciclosporin your doctor should check the ciclosporin concentration in your blood. Your doctor will adjust the dose, if necessary; rosuvastatin (medicine used to treat high blood lipids). If you are taking Ursodeoxycholic Acid Capsules to dissolve gallstones please inform your doctor if you are simultaneously taking medicines containing oestrogen (e.g. the "pill") or certain medicines for lowering cholesterol, e.g. clofibrate. These medicines may promote the formation of gallstones and thus counteract the dissolution of gallstones by Ursodeoxycholic Acid Capsules. Pregnancy, breast-feeding 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 There are no or limited amounts of data from the use of ursodeoxycholic acid in pregnant women. You should not take Ursodeoxycholic Acid Capsules during pregnancy unless your doctor considers it absolutely necessary. Based on animal studies, use of ursodeoxycholic acid during pregnancy may affect development of the unborn child. Women of childbearing potential Even if you are not pregnant, you should still discuss this matter with your doctor. Women of childbearing potential should only be treated with concomitant use of reliable contraceptive measures. Non-hormonal contraceptive measures or oral contraceptives containing a low dose of oestrogen (the "pill") are recommended. If you are taking Ursodeoxycholic Acid Capsules to dissolve gallstones you should use effective nonhormonal contraceptive measures because hormonal contraceptives can promote the formation of gallstones. Before starting treatment your doctor will check that you are not pregnant. Breast-feeding There are only a few documented cases of taking ursodeoxycholic acid during lactation. The levels of ursodeoxycholic acid in breast milk are very low. Therefore adverse reactions in nursing infants are unlikely. Fertility/ability to give birth Animal studies have shown no effect of this medicine on the fertility/ability to give birth. So far there is no experience showing an influence of this medicine on human fertility/childbearing. Driving and using machines No particular precautions are necessary. 3.
How to take it
Ursodeoxycholic Acid Capsules
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. For dissolution of cholesterol gallstones (alone or in combination with lithotripsy) Dosage The recommended dose is 2-4 capsules of Ursodeoxycholic Acid Capsules (8-10 mg/kg body weight of ursodeoxycholic acid), to be taken with a meal as follows:
- at a daily dose of 2 capsules: both capsules with an evening meal;
- at a daily dose of 3 capsules: 1 capsule in the morning and 2 in the evening;
- at a daily dose of 4 capsules: 2 capsule in the morning and 2 in the evening; OR take a daily dose of 2-4 capsules in the evening before bedtime. Method of administration Swallow the capsules whole with a drink of water or other liquid. Take the capsules regularly. Duration of treatment It generally takes 6-24 months to dissolve the gallstones. The duration of the treatment depends on the size of the existing gallstones at the start of the treatment. 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. Even if your symptoms have disappeared, you should continue treatment: interruption of treatment results in the extension of the total treatment duration. After the dissolution of gallstones, treatment should be continued for 3-4 months. For the treatment of primary biliary cholangitis (chronic inflammatory disease of the bile ducts) Dosage Stage I-III The daily dose depends on body weight. During the first 3 months of treatment you should take Ursodeoxycholic Acid Capsules in the morning, afternoon and in the evening. With improvement of the liver function values the daily dose may be taken once a day in the evening. Body weight (kg)
47-62 63-78 79-93
Ursodeoxycholic Acid 250 mg Capsules, hard First 3 months Subsequently Morning
Afternoon
Evening
Evening (once daily)
1 1 1
1 1 2
1 2 2
3 4 5
94-109 over 110
2 2
2 2
2 3
6 7
Stage IV In the beginning of the treatment 2 to 3 capsules per day of Ursodeoxycholic Acid Capsules should be taken with a meal:
- at a daily dose of 2 capsules: 1 capsule in the morning and 1 in the evening;
- at a daily dose of 3 capsules: 1 capsule in the morning and 2 in the evening. If you have good response to this dosage (after blood test and/or in the judgment of your doctor), your doctor will prescribe a higher dose (dosage as for the treatment of stage I-III). Method of administration Swallow the capsules whole with a drink of water or other liquid. Take the capsules regularly. Duration of administration The administration of Ursodeoxycholic Acid Capsules in primary biliary cholangitis is not time limited. Note If you suffer from primary biliary cholangitis the symptoms of your illness, e.g. the itching, may worsen at the beginning of treatment. This occurs in rare cases only. In this case the therapy can be continued with a reduced daily dose of Ursodeoxycholic Acid Capsules. Then your doctor will increase the daily dose every week until the required dose is reached again. Use in children and adolescents (from 6 to 18 years) for the treatment of liver disease associated with cystic fibrosis Dosage The recommended daily dose is 20 mg/kg of body weight, divided into 2-3 doses. If necessary, your doctor may increase the dose to 30 mg/kg of body weight daily. Body weight (kg)
20-29 30-39 40-49 50-59 60-69 70-79 80-89 90-99 100-109 > 110
Daily dose (mg/kg of body weight ) 17-25 19-25 20-25 21-25 22-25 22-25 22-25 23-25 23-25
Ursodeoxycholic Acid 250 mg Capsules, hard Morning 1 1 1 1 2 2 2 3 3 3
Afternoon -1 1 2 2 2 3 3 3 4
Evening 1 1 2 2 2 3 3 3 4 4
Method of administration Swallow the capsules whole with a drink of water or other liquid. Take the capsules regularly.
If you have difficulty swallowing or have a bodyweight below 47 kg, other formulations with ursodeoxycholic acid are available. Please talk to your doctor or pharmacist if you feel that the effect of Ursodeoxycholic Acid Capsules is too strong or too weak. If you take more Ursodeoxycholic Acid Capsules than you should Diarrhoea may occur as a result of overdose. 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 (electrolyte) 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 talk to your doctor before you decide to interrupt treatment with Ursodeoxycholic Acid Capsules or decide to stop your treatment early. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Common (may affect less than 1 in 10 patients): soft, loose stools or diarrhoea. Very rare (may affect less than 1 in 10 000 patients): in the treatment of primary biliary cholangitis: severe right-sided upper abdominal pain, severe worsening of liver scarring which partially eases after treatment is stopped; calcification (hardening of gallstones due to build-up of calcium) of gallstones; hives (urticaria). Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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. 5.
How to store it
Ursodeoxycholic Acid Capsules
Do not store above 30°C. Store in the original packaging in order to protect from moisture. 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 the "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 Capsules contain The active substance is ursodeoxycholic acid. Each hard capsule contains 250 mg ursodeoxycholic acid. The other excipients are: maize starch, silicon dioxide (E 551), magnesium stearate (E 470B), hard gelatin capsule (body and cap composition): titanium dioxide (E 171), gelatin (E 441). What Ursodeoxycholic Acid Capsules look like and contents of the pack White hard gelatin capsules size 0, approximately 21.7 mm x 7.64 mm. The content – white or almost white powder. The capsules are packed in PVC/aluminium blisters. 10 capsules per blister. 5, 6 or 10 blisters (50, 60 or 100 capsules) are packed per cardboard box. Not all pack sizes may be marketed. Marketing Authorisation Holder & Manufacturer AS GRINDEKS, Krustpils iela 53, Rīga, LV-1057, Latvia This medicinal product is authorised in the Member States of the EEA under the following names:
Austria
Ursogrix 250 mg Hartkapseln
Bulgaria
Ursogrix 250 mg hard capsules Урсогрикс 250 mg твърди капсули
Czech Republic Croatia Denmark Estonia
URSOGRIX URSOGRIX 250 mg tvrde kapsule Ursogrix URSOGRIX
France Germany Greece Hungary Ireland
ACIDE URSODESOXYCHOLIQUE GRINDEKS 250 mg, gélule Ursogrix 250 mg Hartkapseln Ursogrix 250 mg Σκληρά καψάκια Urzodezoxikólsav Grindeks 250 mg kemény kapszula Ursogrix 250 mg hard capsules
Latvia Lithuania the Netherlands Norway Poland Portugal
URSOGRIX 250 mg cietās kapsulas URSOGRIX 250 mg kietosios kapsulės GRINTEROL 250 mg harde capsules URSOGRIX 250 mg harde kapsler URSOXYN GRINTEROL 250 mg cápsulas duras
Belgium
URSOGRIX 250 mg harde capsules
Romania Slovakia Spain
Ursogrix 250 mg capsule Ursogrix 250 mg tvrdé kapsuly Ácido Ursodesoxicólico Grindeks 250 mg cápsulas duras
Sweden United Kingdom
Ursogrix 250 mg hårda kapslar Ursodeoxycholic Acid 250 mg Capsules, hard
This leaflet was last revised in 11/2021
Frequently asked questions about Ursodeoxycholic Acid 250 mg hard capsules
How do I take Ursodeoxycholic Acid 250 mg hard capsules?
Ursodeoxycholic Acid 250 mg hard capsules comes as capsule containing 250mg. 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 Ursodeoxycholic Acid 250 mg hard capsules?
The active substance in Ursodeoxycholic Acid 250 mg hard capsules is ursodeoxycholic acid.
Are there equivalent medicines to Ursodeoxycholic Acid 250 mg hard capsules?
Medicines with the same active substance, strength and form include: Ursofalk 250mg Hard Capsules, Ursodeoxycholic Acid 250 mg hard capsule, Ursodeoxycholic acid 250mg Hard Capsules. 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 Ursodeoxycholic Acid 250 mg hard capsules, 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 Ursodeoxycholic Acid 250 mg hard capsules 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
- Dissolution of cholesterol gallstones in patients:
- having one or more radiolucent (radio-negative) gallstones, preferably with a diameter of no more than 2 cm, in a properly functioning gallbladder;
- refusing surgical intervention or for whom surgical procedures are not indicated;
- in whom cholesterol supersaturation has been demonstrated by chemical testing on bile obtained via duodenal drainage.
- As adjuvant medicine before and after gallstone shockwave dissolution (lithotripsy).
- Primary biliary cholangitis (PBC, also known as primary biliary cirrhosis).
Paediatric population
Hepatobiliary disorders as a result of cystic fibrosis in children and adolescents aged 6 to 18 years.
4.2. Posology and method of administration
Posology
Dissolution of gallstones (alone or in combination with lithotripsy).
The recommended daily dose is 8-10 mg/kg body weight of ursodeoxycholic acid, equivalent to 2-4 capsules, to be taken with a meal as follows:
- at a daily dose of 2 capsules: both capsules with an evening meal;
- at a daily dose of 3 capsules: 1 in the morning and 2 in the evening;
- at a daily dose of 4 capsules: 2 in the morning and 2 in the evening;
OR
take a daily dose of 2-4 capsules in the evening before bedtime.
The duration of the dissolution process with this medicinal product is 6 months to 2 years, depending on the initial size of the stones. For a proper assessment of the therapeutic outcome, it is necessary, at the start of treatment, to accurately determine the size of the existing stones and subsequently to monitor them regularly, for example, every 3-4 months, via new X-rays and/or ultrasound scans.
In patients whose stones have not decreased in size after 6 months of treatment at the dosage stated, it is recommended that the biliary lithogenic index be determined via duodenal drainage. If the bile has an index of >1.0, it is unlikely that a favourable outcome can be obtained and it is better to consider a different form of treatment for gallstones. Treatment must be continued for 3 to 4 months after ultrasound follow-up has confirmed complete dissolution of the gallstones.
Discontinuation of treatment
Discontinuation of treatment for 3-4 weeks leads to a return of bile supersaturation and prolongs the overall duration of therapy. Discontinuation of treatment after dissolution of the gallstones may be followed by a relapse.
Treatment of primary biliary cholangitis (PBC).
Stage I-III
The daily dose depends on body weight and ranges from 12-16 mg/kg body weight of ursodeoxycholic acid (3-7 capsules).
During the first 3 months of treatment this medicinal product should be taken in divided doses throughout the day. If liver function improves, the total daily dose can be taken once daily in the evening.
Body weight
(kg)
Daily dose
(mg/kg body weight)
Capsules
First 3 months
Subsequently
Morning
Afternoon
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
More than 110
2
2
3
7
Stage IV
In combination with increased serum bilirubin levels (> 40 μg/L; conjugated), only half the normal dosage (see dosage for stages I-III) should initially be given (6-8 mg/kg/day of ursodeoxycholic acid, equivalent to about 2-3 capsules).
Thereafter, liver function should be properly monitored for several weeks (once every 2 weeks for 6 weeks). If there is no deterioration in liver function (AP, ALAT, ASAT, gamma-GT, bilirubin) and if no increase in pruritus occurs, the dosage can be increased further to the usual level. However, liver function should again be closely monitored for several weeks. Once again, if there is no deterioration in liver function, the patient can be maintained at the normal dosage over the long term.
Patients with primary biliary cholangitis (stage IV) without increased serum bilirubin levels are permitted to receive the normal starting dose immediately (see dosage stages I-III).
However, close monitoring of liver function, as described above, is likewise applicable in such cases; treatment of PBC will need to be regularly assessed on the basis of liver parameters (laboratory) and clinical findings.
The use of this medicinal product in PBC is not limited in terms of time.
Paediatric population
Children and adolescents with cystic fibrosis aged 6 to 18 years:
20 mg/kg/day of ursodeoxycholic acid in 2 to 3 divided doses, with an increase up to 30 mg/kg/day if necessary.
Body weight
(kg)
Daily dose (mg/kg body weight)
<Product name> 250 mg hard capsules
Morning
Afternoon
Evening
20-29
17-25
1
--
1
30-39
19-25
1
1
1
40-49
20-25
1
1
2
50-59
21-25
1
2
2
60-69
22-25
2
2
2
70-79
22-25
2
2
3
80-89
22-25
2
3
3
90-99
23-25
3
3
3
100-109
23-25
3
3
4
>110
3
4
4
Method of administration
For oral use.
The capsules should be swallowed whole with some liquid. The medicine should be used regularly.
For patients weighing less than 47 kg or patients who are unable to swallow Ursodeoxycholic Acid, other formulations with ursodeoxycholic acid are available.
4.3. Contraindications
- Hypersensitivity to the active substance, bile acids or to any of the excipients listed in section 6.1;
- acute inflammation of the gallbladder or biliary tract;
- biliary tract occlusion (occlusion of the common bile duct or a cystic duct);
- repeated biliary colic;
- radio-opaque calcified gallstones;
- impaired contractility of the gallbladder.
Paediatric population:
- unsuccessful portoenterostomy or missing recovery of normal bile flow in children with biliary atresia.
4.4. Special warnings and precautions for use
Ursodeoxycholic acid should be used under medical supervision.
During the first 3 months of treatment, liver function parameters AST (SGOT), ALT (SGPT), ALP and γ-GT should be monitored by the physician every 4 weeks, and every 3 months thereafter. As well as allowing for differentiation between responsive and non-responsive patients treated for PBC, this monitoring also enables early detection of potential deterioration in liver function, especially in patients with advanced PBC.
When used for dissolution of gallstones
In order to assess the therapeutic progression of gallstone dissolution and to promptly detect any calcification of the gallstones, the gallbladder should be visualised (oral cholecystography) 6-10 months after the start of treatment, depending on stone size, with overview and occlusions in standing and supine positions (ultrasound control).
If the gallbladder cannot be visualised on X-ray images, or in cases of calcified gallstones, impaired contractility of the gallbladder or frequent episodes of biliary colic, treatment with this medicinal product must be discontinued.
Female patients taking this medicinal product to dissolve gallstones should use an effective non-hormonal contraceptive, as hormonal contraceptives may promote the formation of gallstones (see sections 4.5 and 4.6).
When used to treat patients with advanced PBC
In very rare cases decompensation of liver cirrhosis has been observed, which partially regressed upon discontinuation of treatment.
In patients with PBC, the clinical symptoms may worsen in rare cases at the start of treatment, e.g. pruritus may increase. In this case, the dosage of this medicinal product can be reduced to one 250 mg capsule per day and subsequently should be gradually increased to the recommended dose as described in section 4.2.
If diarrhoea occurs, the dosage must be reduced and, in the event of persistent diarrhoea, treatment must be discontinued.
4.5. Interaction with other medicinal products and other forms of interaction
This medicine should not be used concomitantly with colestyramine, colestipol or antacids containing aluminium hydroxide and/or smectite (aluminium oxide), as these substances can bind Ursodeoxycholic Acid in the intestine, thereby reducing absorption and efficacy. If the use of any such medicine is needed, it must be taken at least 2 hours before or after Ursodeoxycholic Acid.
This medicinal product can affect the absorption of ciclosporin from the intestine. In patients treated with ciclosporin, blood levels of the latter must therefore be monitored by the physician and the ciclosporin dosage adjusted if necessary.
Due to the effect of ursodeoxycholic acid on the secretion of bile acids there is a theoretical possibility that the absorption of other lipophilic substances could be affected.
In isolated cases, Ursodeoxycholic Acid can reduce the absorption of ciprofloxacin.
In a clinical study with healthy volunteers, concomitant use of this medicinal product (500 mg/day) and rosuvastatin (20 mg/day) resulted in slightly elevated plasma levels of rosuvastatin. The clinical relevance of this interaction also with regard to other statins is unknown.
This medicinal product reduces the peak plasma concentration (Cmax) and the area under the curve (AUC) of the calcium antagonist nitrendipine in healthy volunteers. Close monitoring of the outcome of concomitant use of nitrendipine and Ursodeoxycholic Acid Capsules is recommended. It may be necessary to increase the dosage of nitrendipine. An interaction with dapsone has also been reported, with a reduction in its therapeutic effect. These observations, together with in vitro data, might indicate that Ursodeoxycholic Acid Capsules can induce cytochrome P450 3A enzymes. However, induction has not been observed in a well-designed interaction study with budesonide, a known cytochrome P450 3A substrate.
Oestrogens and blood cholesterol-lowering agents, such as clofibrate, increase hepatic cholesterol secretion and may thereby stimulate formation of gallstones; this effect is counteractive in the use of this medicinal product for gallstone dissolution.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no or limited data from the use of Ursodeoxycholic Acid Capsules in pregnant women. Studies in animals have shown reproductive toxicity during the early phase of gestation (see section 5.3). Therefore, this medicinal product should not be used during pregnancy unless clearly necessary.
Women of childbearing potential
Women of childbearing potential may only be treated with Ursodeoxycholic Acid Capsules if they use reliable contraception: non-hormonal contraception or oral contraception with a low oestrogen dosage is recommended. However, in patients using this medicinal product to dissolve gallstones, effective non-hormonal contraception should be used, as hormonal oral contraceptives can increase formation of gallstones (see section 4.4).
The possibility of a pregnancy must be excluded before beginning of the treatment.
Breast-feeding
According to a few documented cases of breast-feeding women, the amount of Ursodeoxycholic Acid in milk was very low and no adverse reactions are to be expected in breastfed infants.
Fertility
Animal studies did not indicate any effect of this medicinal product on fertility (see section 5.3). Human data on fertility effects after treatment with this medicinal product are not available.
4.7. Effects on ability to drive and use machines
Ursodeoxycholic Acid Capsules have 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 frequencies: 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 (< 1/10 000), not known (cannot be estimated from available data).
Gastrointestinal disorders
Common: pasty stools or diarrhoea.
Very rare: severe right upper abdominal pain has occurred during treatment of PBC.
Hepatobiliary disorders
Very rare: calcification of gallstones; decompensation of liver cirrhosis (during the treatment of advanced stages of PBC), which partially regressed upon discontinuation of treatment.
Skin and subcutaneous tissue disorders:
Very rarely: urticaria.
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 Yellow Card Scheme. Website: ww.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Diarrhoea may occur in the event of overdose. In general, other symptoms of overdose are unlikely, as the absorption of this medicinal product decreases with increasing dose and therefore more is excreted with the faeces.
No specific measures are needed and the consequences of diarrhoea must be treated symptomatically with restoration of the fluid and electrolyte balance.
Additional information on special populations
Long-term use of high doses of this medicinal product (28-30 mg/kg/day) in patients with primary sclerosing cholangitis (off-label use) was associated with an increase in severe adverse reactions.
💬 Ask about this leaflet
Ask anything about Ursodeoxycholic Acid 250 mg hard capsules. 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.
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