HCL Issue 10 - Page 5

OCTASA 400mg Modified Release Tablets (mesalazine) and OCTASA 800mg Modified Release Tablets (mesalazine) - Prescribing Information Presentation: Modified Release tablets containing 400mg mesalazine or 800mg mesalazine. Indications: Ulcerative Colitis - Treatment of mild to moderate acute exacerbations. Maintenance of remission. Crohn’s ileocolitis - Maintenance of remission. Dosage and administration: 400mg tablets – Adults: Mild acute disease: 6 tablets (2.4g) once daily or in divided doses, with concomitant steroid therapy where indicated. Moderate acute disease: 6 to 12 tablets (2.4g – 4.8g) daily. 2.4g may be taken once daily or in divided doses, higher doses should be taken in divided doses. Maintenance therapy: 3 to 6 tablets (1.2g – 2.4g) once daily or in divided doses. 800mg tablets - Adults: Mild acute disease: 3 tablets (2.4g) once daily or in divided doses with concomitant steroid therapy where indicated. Moderate acute disease: 3 to 6 tablets (2.4g – 4.8g) daily. 2.4g may be taken once daily, higher doses should be taken in divided doses. Maintenance therapy: 2 to 3 tablets (1.6g - 2.4g) once daily or in divided doses. 400mg and 800mg tablets – No more than 2.4g should be taken at one time. Tablets must be swallowed whole. Elderly: Normal adult dose may be used unless liver or renal function is severely impaired. Children: Limited documentation of efficacy in children >6 years old. Dose to be determined individually. Generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg. Contra-indications: Hypersensitivity to salicylates, mesalazine or any of the excipients, severe impairment of hepatic or renal function (GFR less than 30 ml/min). Warnings and Precautions: Urinary status (dip sticks) should be determined prior to and during treatment, at discretion of treating physician. Caution in patients with raised serum creatinine or proteinuria. Stop treatment immediately if renal impairment is evident. Haematological investigations are recommended prior to and during treatment, at discretion of treating physician. Stop treatment immediately if blood dyscrasias are suspected or evident. Caution in patients with impaired hepatic function. Liver function should be determined prior to and during treatment, at the discretion of the treating physician. Do not use in patients with previous mesalazine-induced cardiac hypersensitivity and use caution in patients with previous myo- or pericarditis of allergic background. Monitor patients with pulmonary disease, in particular asthma, very carefully. In patients with a history of adverse drug reactions to sulphasalazine, discontinue immediately if acute intolerance reactions occur (e.g. abdominal cramps, acute abdominal pain, fever, severe headache and rash). Use with caution in patients with gastric or duodenal ulcers. Intact tablets in the stool may be largely empty shells. If this occurs repeatedly patients should consult their physician. Use with caution in the elderly subject to patients having normal or non-severely impaired renal and liver function. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this medicine. Interactions: No interaction studies have been performed. May decrease the anticoagulant activity of warfarin. May increase the myelosuppressive effects of azathioprine, 6-mercaptopurine or thioguanine. Monitoring of blood cell counts is recommended if these are used concomitantly. Fertility, pregnancy and lactation: Only to be used during pregnancy and lactation when the potential benefit outweighs the possible risk. No effects on fertility have been observed. Adverse reactions: Common: dyspepsia, rash. Uncommon: eosinophilia (as part of an allergic reaction), paraesthesia, urticaria, pruritus, pyrexia, chest pain. Rare: headache, dizziness, myocarditis, pericarditis, abdominal pain, diarrhoea, flatulence, nausea, vomiting, photosensitivity. Very rare: altered blood counts (aplastic anemia, granulocytosis, pancytopenia, neutropenia, leucopenia, thrombocytopenia), hypersensitivity reactions (such as allergic exanthema, drug fever, lupus erythematosus syndrome, pancolitis), peripheral neuropathy, allergic and fibrotic lung reactions (including dyspnoea, cough, bronchospasm, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis), interstitial pneumonia, eosinophilic pneumonia, lung disorder, acute pancreatitis, changes in liver function parameters (increase in transaminases and cholestasis parameters), hepatitis, cholestatic hepatitis, alopecia, myalgia, arthralgia, impairment of renal function including acute and chronic interstitial nephritis and renal insufficiency, renal failure which may be reversible on withdrawal, nephrotic syndrome, oligospermia (reversible). Not known: pleurisy, lupus-like syndrome with pericarditis and pleuropericarditis as prominent symptoms as well as rash and arthralgia, intolerance to mesalazine with C-reactive protein increased and/or exacerbation of symptoms of underlying disease, blood creatinine increased, weight decreased, creatinine clearance decreased, amylase increased, red blood cell sedimentation rate increased, lipase increased, BUN increased. Consult the Summary of Product Characteristics in relation to other adverse reactions. Marketing Authorisation Numbers, Package Quantities and basic NHS price: 400mg - PL36633/0002; packs of 90 tablets (£16.58) and 120 tablets (£22.10). 800mg - PL36633/0001; packs of 90 tablets (£40.38) and 180 tablets (£80.75). Legal category: POM. Marketing Authorisation Holder: Tillotts Pharma UK Ltd, The Larbourne Suite, The Stables, Wellingore Hall, Wellingore, Lincolnshire, LN5 0HX, UK. Octasa is a trademark. ©2010 Tillotts Pharma UK Ltd. Further Information is available from the Marketing Authorisation Holder. Date of preparation of API: November 2017 Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk. Adverse events should also be reported to Tillotts Pharma UK Ltd. (address as above) Tel: 01522 813500. Reference: 1. MIMS. Accessed online, December 2017. PU-00105. Date of preparation: December 2017. You can maintain MORE patients with Octasa ® for the same cost as Asacol ® * 1 ● For £50,000, you can maintain 54 more patients at 2.4g/day for a year with Octasa ® 400mg than with Asacol ® 400mg* †1 123 † Asacol ® 400mg 1 Octasa ® 400mg 1 69 Small changes add up to BIG savings † modified release mesalazine 400mg and 800mg For mild to moderate ulcerative colitis * Using the same daily maintenance dose of 2.4g/day for a year. † Rounded down to the nearest whole patient. There are no clinical comparisons of Octasa ® 400mg and 800mg vs Asacol ® 400mg and 800mg. SmPCs may differ; consult individual SmPCs before prescribing.