Regulatory Information
ZUELLIG PHARMA PTE. LTD.
ZUELLIG PHARMA PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
TABLET, FILM COATED
**DOSAGE AND ADMINISTRATION** Actonel must only be taken with plain water. Actonel must be taken 30 minutes before the first food or drink other than water. To facilitate delivery to the stomach, Actonel should be taken in an upright position and the patient should avoid lying down for 30 minutes. Patients should not chew or suck on the tablet because of the potential for oropharyngeal irritation. Osteoporosis: The recommended dose is 35mg once a week, taken on the same day each week. Patients should be instructed that if they miss a dose of ACTONEL 35mg Once-A-Week, they should take 1 tablet on the morning after they remember and return to taking 1 tablet once a week, as originally scheduled on their chosen day. Patient should not take 2 tablets on the same day. _Use in the elderly:_ No dose adjustment is necessary. _Renal impairment:_ No dose adjustment is necessary in patients with mild to moderate renal insufficiency (creatinine clearance 30 to 60 mL/minute). Actonel is not recommended in patients with severe renal impairment (creatinine clearance < 30 mL/minute) due to limited clinical data. _Children:_ Safety and efficacy of Actonel has not been established in patients under 18 years of age. _Men:_ No dose adjustment is necessary. Compatibility with other Drugs Calcium, antacids, aluminium and some oral medications will interfere with the absorption of Actonel and therefore should be taken at a different time of the day.
ORAL
Medical Information
**INDICATIONS** - Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures. - Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis. - To maintain or increase bone mass in postmenopausal women undergoing long-term (more than 3 months), systemic corticosteroid treatment at doses > 7.5mg/day prednisone or equivalent. - Treatment to increase bone mass in men with osteoporosis. The optimal duration of use of bisphosphates for the treatment of osteoporosis has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.
**CONTRAINDICATIONS** - Known hypersensitivity to the drug or any of the ingredients. - Hypocalcaemia (see Precautions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - Inability to stand or sit upright for at least 30 minutes. - Pregnancy & lactation - Severe renal impairment (creatinine clearance <30ml/min)
M05BA07
risedronic acid
Manufacturer Information
ZUELLIG PHARMA PTE. LTD.
Balkanpharma-Dupnitsa AD
Active Ingredients
Documents
Package Inserts
Actonel once-a-week Tablet PI.pdf
Approved: October 17, 2019