Prescribing Information (Refer to full SPC before prescribing). 

Presentations: Ursofalk 250mg  hard capsules containing 250mg ursodeoxycholic acid (UDCA), Ursofalk 250mg/5ml suspension,  containing 250mg UDCA per 5ml suspension, Ursofalk 500mg film-coated tablets containing 500mg  UDCA. 

Indications: Treatment of primary biliary cholangitis (PBC) where there is no  decompensated hepatic cirrhosis; stages I-III. Dissolution of radiolucent cholesterol gallstones of less  than 15mm, in patients with a functioning gall bladder. Paediatric population: hepatobiliary disorders  associated with cystic fibrosis in children aged 6 to 18 years (capsules and tablets) or 1 month to 18  years (suspension). 

Dosage: For PBC - adults and elderly: 12-16mg UDCA/kg/day in 3 divided  doses during the first three months and once daily in the evening when liver values improve. For  gallstones: approximately 10mg UDCA/kg/day taken in the evening. Follow up cholecystograms may  be useful. Children: PBC and gallstones are rare in children and adolescents. Data are limited.  Dose should be related to body weight and condition. For hepatobiliary disorders associated with  cystic fibrosis in children aged 1 month to 18 years: 20 mg/kg/day in 2-3 divided doses, with a further  increase to 30 mg/kg/day if necessary. 

Contra-indications: Acute inflammation of the gall bladder or  biliary tract. Occlusion of the biliary tract. Radio opaque gall bladder. 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 for hepatobiliary disorders associated with  cystic fibrosis in children aged 1 month to 18 years - unsuccessful portoenterostomy or without  recovery of good bile flow in children with biliary atresia. 

Warnings/Precautions: Carry out liver  function tests every 4 weeks in the first 3 months of treatment, then every 3 months.  Decompensation of hepatic cirrhosis may occur when used for advanced PBC, which partially  regresses on discontinuation of treatment. Rarely, in PBC, clinical symptoms may worsen. Reduce  dose to 250mg daily and gradually increase to recommended dose. Monitor gallstone dissolution with  oral cholecystography, ultrasound control, at 6 - 10 months after starting treatment. Stop treatment in  cases of persistent diarrhoea. 5ml suspension contains 11 mg sodium, equivalent to 0.6 % of the  WHO recommended maximum daily intake of 2 g sodium for an adult. 5ml suspension also contains  7.5 mg benzoic acid which may increase jaundice in neonates and 50 mg propylene glycol which may induce serious adverse effects in neonates. 

Interactions: Cholestyramine, colestipol and certain  antacids (e.g. aluminium hydroxide, aluminium oxide) bind bile acids and may interfere with  absorption/efficacy. Leave a 2-hour gap between taking these substances and Ursofalk. The absorption of ciclosporin may be affected and absorption of ciprofloxacin and nitrendipine reduced.  Concomitant UDCA and rosuvastatin resulted in slightly elevated plasma levels of rosuvastatin.  Therapeutic effect of dapsone may also be affected. Oestrogenic hormones and cholesterol lowering  agents e.g., clofibrate, increase biliary lithiasis. 

Use in pregnancy: There are no adequate data.  Use only in pregnancy if clearly necessary. When treating women of childbearing potential non hormonal or low oestrogen oral contraceptive measures are recommended. If used for gallstone  dissolution, then effective non-hormonal contraception should be used. No adverse reactions are  expected in breastfed infants. 

Undesirable effects: soft stools, diarrhea, severe right upper  abdominal pain (in PBC treatment), calcification of gallstones, decompensation of hepatic cirrhosis,  urticaria, pruritus, nausea, vomiting. 

Legal category: POM. 

Cost: Ursofalk 250mg capsules, 100- capsule pack: £31.88; €23.56. 60-capsule pack: £30.17. Ursofalk 250mg/5ml suspension, 250ml  bottle: £26.98, €26.66. Ursofalk 500mg tablet, 100-tablet pack: £80; €50.95. 

Product licence  holder: In the UK: Dr Falk Pharma UK Ltd; Unit K, Bourne End Business Park, Cores End Road,  Bourne End, SL8 5AS. In Ireland: Dr. Falk Pharma GmbH, Leinenweberstrasse 5, 79108 Freiburg,  Germany. 

Product licence number: Ursofalk capsules: PL10341/0006; PA573/5/1. Ursofalk  suspension: PL10341/0007; PA573/5/2. Ursofalk tablets: PL10341/0010; PA573/5/3. Date of  preparation: July 2024 

Further information is available on request.

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