1 . Supported by long-term data and real-world evidence . 1-4 2 . Reduction in fracture risk from as early as 6 months . 5 3 . No rebound effect on cessation of therapy . 6-8 4 . Clinical monitoring of calcium levels not required before each dose . 6

Please see Product Information for monitoring requirements in special populations .

5 . Enteric coated formula offers the convenience of morning dosing with or without food . 6

Does the treatment you ’ re prescribing offer these benefits ?

PROVEN FRACTURE PROTECTION 1-6

PBS Information : Restricted Benefit . Actonel EC Combi , Actonel EC Combi D . Authority Required ( STREAMLINED ). Refer to PBS schedule for full restricted and authority information .

ACTONEL ® EC , ACTONEL ® EC COMBI & ACTONEL ® EC COMBI D . PRESENTATIONS : Actonel EC is available as 4 x 35mg risedronate sodium tablets . Actonel EC Combi contains : 4 Actonel EC 35 mg tablet and 24 calcium carbonate 1250mg ( equivalent to 500mg elemental calcium ) tablets . Actonel EC Combi D contains : 4 Actonel 35 mg tablets and 24 sachets containing 2500mg calcium carbonate and 22μg cholecalciferol , equivalent to 1000mg elemental calcium and 22μg ( 880IU ) vitamin D3 respectively . INDICATIONS : Actonel EC 35mg tablet , Actonel EC Combi , Actonel EC Combi D : Treatment of osteoporosis , treatment of glucocorticoid-induced osteoporosis , preservation of bone mineral density in patients on long term corticosteroid therapy . CONTRAINDICATIONS : Risedronate : Hypersensitivity to the drug or ingredients , hypocalcaemia , inability to stand or sit upright for at least 30 minutes . Calcium carbonate : Hypersensitivity to the drug or ingredients ; hypercalcaemia ; hypercalciuria ; nephrolithiasis . Cholecalciferol : Hypercalcaemia ; hypercalciuria ; nephrolithiasis ; hypervitaminosis D ; diseases associated with hypercalcaemia and / or hypercalciuria ; pregnancy and lactation ; severe renal impairment . PRECAUTIONS : Risedronate : Hypocalcaemia ; bone and mineral metabolism dysfunction ; calcium and vitamin D if dietary intake is inadequate ; severe renal impairment ; oesophageal reaction , inflammatory bowel disease ; osteonecrosis of the jaw ; osteonecrosis of the external auditory canal ; dental examination with preventive dentistry ; avoid invasive dental procedures ; atypical stress fractures ; pregnancy ( Category B3 ); certain medications ( e . g . calcium supplements , antacids ) should not be taken with Actonel EC ; patients with a history of oesophagitis , gastritis , oesophageal ulcerations and gastroduodenal ulcerations . Calcium carbonate and / or Cholecalciferol : Impairment of renal functions ; monitoring of serum calcium levels and renal function ; other drugs containing vitamin D ; sarcoidosis ; immobilised patients due to the increased risk of hypercalcaemia ; disease associated with unregulated overproduction of calcitriol ; malabsorption . Actonel EC Combi / Actonel EC Combi D presentations only : for patients with mild-moderate renal impairment , absorptive or renal hypercalciuria , nephrocalcinosis , kidney stone formation , hypophosphataemia , renal function , serum and urinary calcium and phosphate should be monitored . INTERACTIONS : Risedronate does not induce or inhibit CYP450 enzymes . Calcium Carbonate / Cholecalciferol ; serum calcium should be regularly monitored during concomitant use of thiazide diuretics ; systemic corticosteroids reduce calcium absorption ; may interfere with tetracycline absorption ; may reduce bisphosphonate and sodium fluoride absorption ; calcium absorption may be inhibited by oxalic acid and phytic acid ; concomitant treatment with ion exchange resins ( e . g . cholestyramine ) or laxatives may reduce vitamin D absorption . Not recommended for concurrent use with antacids containing aluminium hydroxide in patients on haemodialysis . Hypercalcaemia may increase the toxicity of cardiac glycosides during treatment with calcium combined with vitamin D . Such patients should be monitored with regard to electrocardiogram ( ECG ) and serum calcium levels . ADVERSE EVENTS : Risedronate : Very Common : nasopharyngitis . Common : abdominal and musculoskeletal pain , influenza , urinary tract infection , bronchitis , diarrhoea , constipation , vomiting , nausea , arthralgia , back pain , hypertension , hypercholesterolaemia . Uncommon : glossitis , iritis , and duodenitis , abnormal liver function tests . Postmarketing : vary rare : hypersensitivity and skin reactions , including angioedema , generalised rash and bulbous skin reaction , uveitis and osteonecrosis of the jaw . See full PI for others . Calcium carbonate and / or Cholecalciferol : Uncommon : hypercalcaemia , hypercalciuria . Rare : flatulence , constipation , nausea , abdominal pain , diarrhea , pruritus , rash and urticaria . DOSAGE AND ADMINISTRATION : Actonel EC 35mg tablets : take with a glass of plain water with or without food , Actonel EC should be taken in an upright position . Patient should avoid lying down for 30 minutes . Tablets must be swallowed whole . Actonel EC Combi : The recommended dose in adults is 1 Actonel EC 35mg tablet on the first day , then , beginning on the next day , 1 calcium 500 mg tablet daily for 6 days . This 7 day sequence is then repeated each week . Actonel EC Combi D : Intended for patients for whom the amount of calcium and cholecalciferol included is considered to provide adequate supplementation . The recommended dose is 1 Actonel EC 35mg tablet on the first day , followed by , beginning on the next day , 1 calcium carbonate / cholecalciferol sachet daily for 6 days . This 7 day sequence is then repeated each week starting with the Actonel EC 35mg tablet . See full PI for full information . STORAGE : store below 25 ° C . Sponsored in Australia by TEVA Pharma Australia Pty Ltd , ABN 41 169 715 664 , Level 1 , 37 Epping Road , Macquarie Park , Sydney , NSW 2113 . Based on the PI last updated 11 May 2016 .

REFERENCES : 1 . Silverman SL et al . Osteoporos Int 2007 ; 18:25 – 34 . 2 . Harrington JT et al . Calcif Tissue Int 2004 ; 74:129 – 35 . 3 . Mellstrom DD et al . Calcif Tissue Int 2004 ; 75:462 – 68 . 4 . McClung MR et al . N End J Med 2001 ; 344:333-40 . 5 . Roux C et al . Curr Med Res Opin 2004 ; 20:433 – 39 . 6 . Actonel EC ® Product Information . 7 . Adler RA et al . J Bone Miner Res 2016 ; 31:16 – 35 . 8 . Lamy O et al . J Clin Endocrinol Metab 2016 Oct 12 [ Epub ahead of print ].

TEVA Pharma Australia Pty Ltd , ABN 41 169 715 664 . Level 1 , 37 Epping Road , Macquarie Park , Sydney NSW 2113 . P : 1800 AU TEVA ( 1800 28 8382 ) F : + 61 2 8061 9999 www . tevapharma . com . au .

Date of preparation : May 2017 . TEVA0118AD . ACTO-AU-00013 .