Prescribing Information Ursofalk Oral IE

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 cirrhosis (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. Treatment can continue indefinitely. For gallstones: approximately 10mg UDCA/kg/day taken in the evening. Treatment is usually 6 – 24 months (suspension/tablets). Stop after 12 months if stones are not reduced. Check every 6 months. 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. 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 initially 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. Do not use where there is a radio opaque gall bladder. Stop treatment in cases of persistent diarrhoea. Where used for gallstone dissolution, effective non-hormonal contraception should be used. 5ml suspension contains 11 mg sodium, equivalent to 0.6 % of the WHO recommended maximum daily intake of 2g 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. No adverse reactions are expected in breastfed infants. Undesirable effects: pasty stools, diarrhea (common). Upper abdominal pain (in PBC treatment), calcification of gallstones, decompensation of hepatic cirrhosis, urticaria (very rarely). Legal category: POM. Cost: Ursofalk 250mg capsules, 100-capsule pack: €23.69. Ursofalk 250mg/5ml suspension, 250ml bottle: €26.66. Ursofalk 500mg tablet, 100-tablet pack: €51.51. Product licence holder: Dr Falk Pharma GmbH, Leinenweberstrasse 5, 79108 Freiburg, Germany. Product licence number: Ursofalk capsules: PA573/5/1. Ursofalk suspension: PA573/5/2. Ursofalk 500mg tablets: PA573/5/3. Date of preparation: January 2023

Further information is available on request.

Adverse events should be reported at: https://www.hpra.ie/homepage/about-us/report-an-issue/human-adverse-reaction-form Adverse events should also be reported to Dr Falk Pharma UK Ltd at PV@drfalkpharma.co.uk