Actonel EC Portal

ACTONEL® EC 35MG ONCE-A-WEEK MINIMAL PRODUCT INFORMATION. INDICATIONS: Treatment of: 1) osteoporosis, 2) glucocorticoid-induced osteoporosis, 3) 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. 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. INTERACTIONS: Risedronate does not induce or inhibit CYP450 enzymes. 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. DOSAGE AND ADMINISTRATION: Tablet needs to be swallowed as a whole with plain water in an upright position (patient needs to stay upright for 30 minutes). STORAGE: store below 30°C. Refer to full PI before prescribing. Based on the PI last updated 31 March 2025.

Sponsored in Australia by Theramex Australia Pty Ltd, ABN 37 623 186 845, 60 Margaret Street, Sydney, NSW 2000. www.theramex.com.au; Date of preparation, September 2025; ACTOEC_AU_EN_13283_v1