xi) Overdosage Otezla was studied in healthy subjects at a maximum total daily dose of 100 mg (given as 50 mg twice daily) for 4.5 days without evidence of dose limiting toxicities. Patients should be managed by symptomatic and supportive care should there be an overdose. Contact the Poisons Advisory Centre on 13 11 26 for advice on management. xii) Presentation and storage conditions Presentation# A two-week titration pack (4 x 10 mg, 4 x 20 mg and 5 x 30 mg for the first week for dose titration and 14 x 30 mg tablets for the second week). A four-week pack (56 x 30 mg tablets) A 12 week pack (168 x 30 mg tablets) # Not all pack sizes are marketed in Australia Otezla 10 mg Tablets: Pink, diamond shaped 10 mg film-coated tablet with engraved on one “APR” side and on the opposite side. “10” Otezla 20 mg Tablets: Brown, diamond shaped 20 mg film-coated tablet with engraved on one “APR” side and on the opposite side. “20” Otezla 30 mg Tablets: Beige, diamond shaped 30 mg film-coated tablet with engraved on one “APR” side and on the opposite side. “30” Composition Active Apremilast Excipients See Description section, for a list of the excipients. Storage conditions Store below 30C. Container type The tablets are provided in polyvinylchloride (PVC) blisters with push through aluminium foil. Name and address of the sponsor Sponsored in Australia by: Celgene Pty Limited 7, 607 St Kilda Road, Melbourne, VIC 3004, Australia. Telephone: 1800 CELGENE (1800 235 4363)
xi) Overdosage Otezla was studied in healthy subjects at a maximum total daily dose of 100 mg (given as 50 mg twice daily) for 4.5 days without evidence of dose limiting toxicities. Patients should be managed by symptomatic and supportive care should there be an overdose. Contact the Poisons Advisory Centre on 13 11 26 for advice on management. xii) Presentation and storage conditions Presentation# A two-week titration pack (4 x 10 mg, 4 x 20 mg and 5 x 30 mg for the first week for dose titration and 14 x 30 mg tablets for the second week). A four-week pack (56 x 30 mg tablets) A 12 week pack (168 x 30 mg tablets) # Not all pack sizes are marketed in Australia Otezla 10 mg Tablets: Pink, diamond shaped 10 mg film-coated tablet with “APR” engraved on one side and “10” on the opposite side. Otezla 20 mg Tablets: Brown, diamond shaped 20 mg film-coated tablet with “APR” engraved on one side and “20” on the opposite side. Otezla 30 mg Tablets: Beige, diamond shaped 30 mg film-coated tablet with “APR” engraved on one side and “30” on the opposite side. Composition Active Apremilast Excipients See Description section, for a list of the excipients. Storage conditions Store below 30C. Container type The tablets are provided in polyvinylchloride (PVC) blisters with push through aluminium foil. Name and address of the sponsor Sponsored in Australia by: Celgene Pty Limited 7, 607 St Kilda Road, Melbourne, VIC 3004, Australia. Telephone: 1800 CELGENE (1800 235 4363)
auspar-apremilast-151022-pi.docx