SIMPLE REASONS TO CHOOSE
GRANULES
ENEMAS
FOAM
TABLETS
SUPPOSITORIES
Make the switch to Salofalk ®
Before prescribing please review the Product Information available from www. aspenpharma. com. au or call 1300 659 646
Minimum Product Information- Salofalk ®( mesalazine) tablets, enemas, foam enemas, granules and suppositories. Indications: Acute and maintenance treatment of ulcerative colitis of mild to moderate severity( enemas, foam enemas, granules and tablets); long term treatment of ulcerative colitis( granules); ulcerative proctitis( suppositories); acute and maintenance treatment of Crohn’ s ileitis and colitis( tablets). Dosage and Administration: Tablets and Granules Acute ulcerative colitis: 1.5g-3g daily; remission / long term treatment of ulcerative colitis: 1.5g daily. Enema and Foam Enema Acute and maintenance of ulcerative colitis: 2g or 4g daily. Suppositories Ulcerative proctitis: 1g daily. Tablets Acute Crohn’ s ileitis and colitis: 3g-4.5g daily; maintenance of Crohn’ s ileitis and colitis: 1.5g-3g daily( see full PI). Contraindications: Hypersensitivity to salicylic acid, its derivatives or any other ingredient in dosage form; severe hepatic and renal impairment; bronchial asthma( enema and foam enema). Precautions: Take under medical supervision; blood and renal status should be determined prior to and during treatment; may monitor hepatic and cholestasis parameters; impaired renal function; pericarditis, hepatitis and pancreatitis; pulmonary function impairment and sulfasalazine hypersensitivity; lactation; pregnancy; propylene glycol associated lactic acidosis, hyperosmolality, haemolysis and CNS depression( foam enema); driving or operating machinery( foam enema); granules contain aspartame, caution with phenylketonuria( see full PI). Pregnancy: C. Interactions: Coumarin-type anticoagulants, glucocorticoids, sulphonylureas, methotrexate, rifampicin, azathioprine, 6-mercaptopurine( see full PI). Adverse Effects: Headache, abdominal pains, exacerbation of ulcerative colitis, abnormal hepatic function, upper respiratory tract infection, hair loss, diarrhoea, rash( see full PI).( Enema, tablet and granule PI’ s last amended 06 / 05 / 2010; foam enema PI last amended 04 / 05 / 2011; suppository PI last amended 20 / 10 / 2010).
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Salofalk ® is a registered trademark of Dr. Falk Pharma GmbH, used under license by Orphan Australia Pty Ltd, a member of the Aspen Australia group of companies. Aspen Pharma Pty Ltd. 34-36 Chandos St, St Leonards NSW 2065 ABN 88004118594 Email: info @ aspenspecialty. com. au www. aspenpharma. com. au Infoline: 1300 656 755 Date of prepatation: April 2013
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