

In the treatment of postmenopausal osteoporosis
Help protect her with:
- Proven fracture protection in 1 year: Actonel is the only therapy proven to significantly reduce vertebral fractures in just 1 year.1
- Proven tolerability: It has proven tolerability in real world patients.2
Please read the full prescribing information and important safety information.
1Actonel package insert. Cincinnati, Ohio: Procter & Gamble Pharmaceuticals; March 2006.
2Taggart H, Bolognese MA, Lindsay R, et al. Upper gastrointestinal tract safety of risedronate: a pooled analysis of 9 clinical trials. Mayo Clin Proc. 2002;77:262-267.
3Hosking D, Keller M, Hooper M, et al. Risedronate is well-tolerated in postmenopausal osteoporotic women using NSAIDs or with underlying gastrointestinal disorder [abstract]. Calcif Tissue Int. 2000;66(suppl 1):S120.
Actonel is indicated for the treatment and prevention of osteoporosis in postmenopausal women. Actonel (35mg) is indicated for treatment to increase bone mass in men with osteoporosis. Actonel (5mg) is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of = 7.5 mg prednisone or equivalent) for chronic diseases.
Selected Safety Information for ActonelŽ (risedronate sodium) tablets
Actonel is contraindicated in patients with hypocalcemia, known hypersensitivity to any component of this product, or inability to stand or sit upright for at least 30 minutes. Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Actonel therapy. Actonel is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/min).
Bisphosphonates, including Actonel, may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcers. Actonel should be taken according to the dosing instructions to minimize the risk of these events. Patients should discontinue use if new or worsening symptoms occur.
There have been reports of severe and occasionally incapacitating bone, joint and/or muscle pain in patients taking bisphosphonates. Rare occurrences of osteonecrosis, primarily of the jaw (ONJ), have been reported in patients treated with bisphosphonates. Most cases were reported in cancer patients receiving intravenous bisphosphonates, but some have been in patients treated orally for osteoporosis. Most cases were reported in patients undergoing dental procedures such as tooth extraction.
Most common adverse reactions reported in >10% of patients treated with ACTONEL and with a higher frequency than placebo are: back pain, arthralgia, abdominal pain, and dyspepsia. Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions), and eye inflammation (iritis, uveitis) have been reported rarely.
Please See Accompanying Full Prescribing Information for Actonel





