Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
for Ursodeoxycholic Acid influences the composition of the bile, by which cholesterol gallstones can be solved. The effects of Ursodeoxycholic Acid in primary biliary cholangitis and cystic fibrosis can be explained by various mechanisms, such as a protective effect on the liver cells and an effect on the immune system. 1. Ursodeoxycholic Acid Tablets is used in patients: • with small gallstones • who do not want to undergo surgery or are not eligible for gallstone surgery • in whom too much cholesterol has been found in the bile 2. Ursodeoxycholic Acid Tablets is used in patients with primary biliary cholangitis. Primary biliary cholangitis is a disease in which liver tissue is damaged by an impaired drainage of the bile. 3. Ursodeoxycholic Acid Tablets is used in children aged 6 years to 18 years old with liver and biliary diseases caused by cystic fibrosis. Cystic fibrosis, also referred to as mucoviscidosis, is an inherited disorder in which the mucus is particularly tough in the whole body. This may cause, among other conditions, clogging and inflammation in the liver and in the bile ducts.
e Ursodeoxycholic Acid Tablets Do not take Ursodeoxycholic Acid Tablets if:
•
You have an active gastric or duodenal ulcer.
Children In children with disrupted biliary drainage due to production of connective tissue in the bile duct (biliary atresia) in whom the bile flow is not restored by healing or by an artificial bile duct (portoenterostomy). Warnings and precautions This medicine must be used under medical supervision. Your doctor should examine your liver every 4 weeks during the first three months of treatment. Then this should be done every 3 months. Apart from allowing for identification of responders and non-responders in patients being treated for primary biliary cholangitis, this monitoring would also enable an early detection of potential hepatic deterioration, particularly in patients with advanced primary biliary cholangitis. When used for dissolving gallstones: In order to be able to assess the therapeutic progression of the dissolution of gallstones and to timely identify a possible calcification of the stones, the gall bladder, depending on the size of the stones, should be visualized 6 to 10 months after the start of the treatment (oral cholecystography) with total image and occlusions and in the standing and lying position (ultrasound control). If the gallbladder cannot be visualized on X-rays, or in cases of calcified gallstones, impaired contractility of the gall bladder or frequent episodes of biliary colic, the treatment with Ursodeoxycholic Acid Tablets should be discontinued. When used for the treatment of advanced primary biliary cholangitis: In very rare cases decompensation of liver cirrhosis is observed which partially decreased after treatment discontinuation. Women who use Ursodeoxycholic Acid for dissolving gallstones should stop using the birth control pill and other methods used to prevent pregnancy, because the hormones in the birth control pill can promote the production of gallstones. When you are in the final stage of primary biliary cholangitis it can in very rare cases occur that your liver function is strongly reduced. The liver function will partly recover after stopping the treatment. If you experience problems with diarrhoea, your doctor will reduce the dose. If the diarrhoea persists, your doctor may decide to stop the treatment. Contact your doctor or pharmacist before you start to use this medicine. Other medicines and Ursodeoxycholic Acid Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This also applies for medicines obtained without a prescription. The effect of the following drugs can be influenced (interactions): A reduced effect of the following medicines is possible when using this medicine:
•
Ursodeoxycholic acid may increase the absorption of cyclosporine from the intestine: if necessary, the dosing guided by the cyclosporine concentration should be adjusted in the blood.
Oestrogens, oral contraceptives ("the pill") and cholesterol-lowering agents (such as clofibrate) may promote the forming of gallstones, and can thus counteract the effect of the treatment of gallstones with Ursodeoxycholic Acid Tablets Inform your doctor or pharmacist, if you are taking or have recently taken other medicines. This also applies for medicines obtained without a prescription. Pregnancy and breast-feeding 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 should not use this medicine during pregnancy unless your doctor considers it absolutely necessary. Women of child-bearing potential Even if you are not pregnant, you should discuss this possibility with your doctor, because women of childbearing age may only be treated, if they use a reliable method of contraception. Non-hormonal contraception or contraception with low dose oestrogens is recommended. However, if you use this medicine for solving gallstones, you may only use non-hormonal contraception, because hormonal contraception promotes the formation of gallstones. Breast-feeding Tell your doctor if you are breastfeeding or about to start breastfeeding. According to few documented cases of breastfeeding women milk levels of ursodeoxycholic acid in milk are very low and probably no adverse reactions are to be expected in breastfed infants. Driving and using machines Ursodeoxycholic Acid has no or negligible influence on driving ability or the ability to operate machines.
Ursodeoxycholic Acid Tablets Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will determine your dose based on your body weight. Take the tablets after a meal with a glass of milk or a small snack. Take the prescribed number of tablets distributed throughout the day. 1. Dissolving of gallstones: Four to six tablets of 150 mg, two to three tablets of 300 mg or two tablets of 450 mg per day (600900 mg ursodeoxycholic acid per day). Two tablets should always be taken after dinner. When taking a dose two or three times daily: for example, one tablet after lunch and two tablets after dinner. When taking one dose of two tablets daily: take both tablets preferably two hours after dinner one hour before going to sleep. 2. Primary biliary cholangitis (damage to liver tissue by impaired bile flow):
Take the prescribed dose in two to three servings per day after meals.
Like all medicines, this medicine can cause side effects, although not everyone gets them. Common side effects (occurring in fewer than 1 in 10 patients but more than 1 in 100 patients)
Reporting of side effects If you get any side effects, talk to your doctor or 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.co.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.
Ursodeoxycholic Acid 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: 'Do not use after'. The expiry date refers to the last day of that month. Do not store above 25oC. 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 package and other information
What Ursodeoxycholic Acid Tablets contains
Croxley Green, Hertfordshire, WD18 8YA United Kingdom. Glenmark Pharmaceuticals s.r.o. Fibichova 143 56617 Vysoke Myto Czech Republic. This medicinal product is authorised in the Member States of the EEA under the following names: United Kingdom – Ursodeoxycholic acid 150 mg / 300 mg / 450 mg Tablets Spain – Adisocol 150 mg / 300 mg / 450 mg comprimidos EFG The Netherlands – Ursodeoxycholzuur Glenmark 150 mg / 300 mg / 450 mg tabletten This leaflet was last revised in 03/2019
Ursodeoxycholic acid 150mg Tablets comes as tablet containing 150mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Ursodeoxycholic acid 150mg Tablets is ursodeoxycholic acid.
This leaflet reproduces the patient information leaflet approved for Ursodeoxycholic acid 150mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
1. The dissolution of cholesterol stones in patients:
• with one or more X-ray radiolucent (X-ray negative) gallstones, preferably with a diameter of not more than 2 cm, in a well-functioning gall bladder;
• refusing a surgical procedure or in which surgical intervention is not indicated;
• with whom an oversaturation of cholesterol has been shown by chemical analysis of the bile produced by duodenum drainage.
2. Primary Biliary Cholangitis.
Paediatric population
3. Hepatobiliary disorder associated with cystic fibrosis in children aged 6 years to 18 years.
Dosage
The dosage should be calculated based on the patient's body weight. The calculated dosage should be rounded to the nearest number of tablets.
Dissolving of cholesterol stones
Usual dosage: 8 to 10 mg/kg/day, corresponding to, for example, four to six 150 mg tablets, or two to three tablets of 300 mg, or two tablets of 450 mg. The daily dose can be administered two or three times after the meals: two tablets should always be taken after the evening meal.
Also a single evening dose can be selected (e.g., a patient of 60 kg, in the evening two tablets of 300 mg). Preferably, this single dose should be taken one hour before bedtime and ± two hours after the evening meal with a glass of milk or a small snack.
The duration of the treatment in order to obtain lysis of the gallstones depends on their size, but is usually not shorter than three to four months. To assess the result of the therapy properly, it is necessary to determine the size of the stones accurately at the start of the treatment and to check this further regularly, for example every six months, by means of a new contrast X-ray recording and/or sonographic recording.
In patients in whom, after six months of treatment with the indicated dosage, the stones are not reduced in size, it is recommended to determine the lithogenic index in the bile by means of a duodenum drainage. When the bile has an index of > 1.0, it is unlikely that a favourable result can be obtained, and it is better to consider a different form of treatment for the gallstones.
Treatment should be continued for three to four months after it is established by means of ultrasound check that the gallstones are completely dissolved. An interruption of the treatment for three to four weeks results in a return to over-saturation of the bile and prolongs the overall duration of the therapy. The interruption of the treatment after the dissolving of the gallstones can be followed by a recurrence.
Primary Biliary Cholangitis
The dosage of ursodeoxycholic acid in primary biliary cholangitis (stages I-III), amounts to 12-15 mg/kg/day, which is equivalent to four to eight tablets of 150 mg, two to four tablets of 300 mg, to be taken in two to three portions during the day, or with two tablets of 450 mg, to be taken in two portions during the day.
The dosage of ursodeoxycholic acid in primary biliary cholangitis stage IV and an increase of the serum bilirubin contents (> 40 μg/l), should be in the first instance, only a half of the normal dose (6 to 8 mg/kg/day). Thereafter, the liver function should be closely monitored for several weeks (once every two weeks for six weeks). If there is no deterioration of the liver function (AF, ALT (SGPT), AST (SGOT), γ-GT, bilirubin) and no increase in itching occurs, the dose may be further increased to the usual level. Moreover, the liver function must then again be closely monitored for several weeks. If again no deterioration of the liver function takes place, the patient may be held at the normal dosage for a long time.
In patients with primary biliary cholangitis stage IV without elevated serum bilirubin, the usual starting dose is allowed to be administered directly. Anyway, here too an accurate control of the liver function should be executed.
The treatment of the primary biliary cholangitis should be regularly assessed on the basis of liver values (laboratory) and clinical findings.
Paediatric population
Children with cystic fibrosis aged 6 years to 18 years
Treatment of hepatobiliary diseases as a result of cystic fibrosis 20 mg/kg/day divided in two to three divided doses. If necessary, increase to 30 mg/kg/day. This corresponds with four to ten tablets of 150mg, two to five tablets of 300 mg, or with two to three tablets of 450 mg, to be taken in one or two portions during the day.
Method of administration
If the patient has difficulty in swallowing because of the size of the tablet, the tablet can be halved if necessary on the dividing score, so that one half tablet can be taken twice directly in sequence.
Ursodeoxycholic acid tablets should not be used in patients with:
- Acute inflammation of the gall bladder or bile ducts.
- Occlusion of the biliary tract (occlusion of the common bile duct or a cystic duct).
- Frequent episodes of biliary colic.
- X-ray radiolucent calcified gallstones.
- Impaired contractility of the gallbladder.
- Hypersensitivity to bile acids or to any of the excipient listed in section 6.1.
- Active gastric and duodenal ulcers;
Paediatric population
- Unsuccessful portoenterostomy or without recovery of good bile flow in children with biliary atresia.
Ursodeoxycholic acid tablets should be taken under medical supervision.
During the first three months of the 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 primary biliary cholangitis, this monitoring would also enable an early detection of potential hepatic deterioration, particularly in patients with advanced primary biliary cholangitis.
When used for dissolving gallstones:
In order to be able to assess the therapeutic progression of the dissolution of gallstones and to timely identify a possible calcification of the stones, the gall bladder, depending on the size of the stones, should be visualized 6 to 10 months after the start of the treatment (oral cholecystography) with total image and occlusions and in the standing and lying position (ultrasound investigation).
If the gallbladder cannot be visualized on X-rays, or in cases of calcified gallstones, impaired contractility of the gall bladder or frequent episodes of biliary colic, the treatment with Ursodeoxycholic acid should be discontinued.
When used for the treatment of advanced primary biliary cholangitis:
In very rare cases decompensation of liver cirrhosis is observed which partially decreased after treatment discontinuation.
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 therapy is to be continued with a dose reduction and subsequently should be gradually increased to the recommended dose as described in section 4.2.
If diarrhoea occurs, the dosage should be reduced, and treatment should be discontinued in case of persistent diarrhoea.
Female patients who use Ursodeoxycholic acid for dissolving gall stones must use an effective non-hormonal method of contraception, since hormonal contraception may increase biliary lithiasis (see sections 4.5 and 4.6).
Ursodeoxycholic acid tablets should not be used concurrently with colestyramine, colestipol, or an antacid, on the basis of aluminium hydroxide and/or smectite (aluminium oxide), because these preparations bind ursodeoxycholic acid in the intestine and thereby inhibits its absorption and efficacy. If the use of such a medicine is necessary, must it be taken at least 2 hours before or after Ursodeoxycholic acid.
Ursodeoxycholic acid may affect the absorption of ciclosporin from the intestine. In patients treated with ciclosporin the blood level of ciclosporin should be monitored and the ciclosporin dose should be adjusted, if necessary.
In isolated cases Ursodeoxycholic acid can reduce the absorption of ciprofloxacin.
In a clinical study in healthy volunteers, the concomitant use of UDCA (500 mg/day) and rosuvastatin (20 mg/day) resulted in slightly elevated plasma levels of rosuvastatin. The clinical relevance of this interaction, also with other statins, is not known.
Ursodeoxycholic acid has been shown to reduce the peak plasma concentration (Cmax) and the AUC of the calcium antagonist nitrendipine in healthy volunteers. Close monitoring of the outcome of concurrent use of nitrendipine and ursodeoxycholic acid 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 be an indication that ursodeoxycholic acid can 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.
Oestrogens and blood cholesterol lowering agents such as clofibrate increase hepatic cholesterol secretion and may therefore encourage biliary lithiasis; which is a counter-effect to ursodeoxycholic acid used for dissolution of gallstones.
Pregnancy
There are no or limited amount of data from the use of ursodeoxycholic acid in pregnant women. Studies in animals have shown reproductive toxicity during the early gestation phase (see section 5.3).
Ursodeoxycholic acid must not be used during pregnancy, unless clearly necessary.
Women of childbearing potential
Women of childbearing potential should be treated with ursodeoxycholic acid, only if they practice reliable contraception: non-hormonal contraceptives or oral contraceptives with low oestrogen dose are recommended. However, in patients taking Ursodeoxycholic acid for dissolving gallstones an 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 ursodeoxycholic acid levels in milk are very low and probably no adverse reactions are to be expected in breastfed infants.
Fertility
Animal studies did not show an influence of ursodeoxycholic acid on fertility (see section 5.3). Human data on fertility treatment with ursodeoxycholic acid are not available.
Ursodeoxycholic acid has no or negligible influence on the ability to drive and use machines.
The following adverse reactions have been reported during clinical trials and are ranked using the following frequency:
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 the available data).
Gastrointestinal disorders:
In clinical studies, reports of pasty stools or diarrhoea during treatment with ursodeoxycholic acid were common.
In very rare cases, severe right upper abdominal pain has occurred during the treatment of primary biliary cholangitis.
Hepatobiliary disorders:
During treatment with ursodeoxycholic acid calcification of gallstones can occur in very rare cases.
During the treatment of advanced stages of primary biliary cholangitis decompensation of cirrhosis has been observed in very rare cases, which partially regressed after treatment discontinuation.
Hypersensitivity reactions:
Very rarely urticaria may occur.
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 at www.mhra.gov.co.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
In the case of overdose diarrhoea may occur. In general, other symptoms of overdose are unlikely, because the absorption of the ursodeoxycholic acid decreases with increasing dose and therefore more is excreted in the faeces.
If diarrhoea occurs, the dosage should be reduced, and treatment should be discontinued in case of persistent diarrhoea.
No specific measures are needed and the consequences of diarrhoea should be treated symptomatically with restoration of fluid and electrolyte balance.
Additional information or special populations
Long-term, high-dose UDCA therapy (28-30 mg/kg/day) by patients with primary sclerosing cholangitis (off-label use) was associated with a higher frequency of serious adverse events.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Ursodeoxycholic acid 150mg 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.
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