ACTONEL PLUS CA & D TABLET 35MG AND 500MG/400 IU F
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
14-05-2024
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Active ingredient:
RISEDRONATE SODIUM CALCIUM CARBONATE CHOLECALCIFEROL CONCENTRATE
Available from:
Warner Chilcott UK Limited
Dosage:
35/500/400 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2010-04-30
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actonel Plus Ca & D Tablet 35mg and 500mg/400 IU film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Actonel Plus Ca & D Tablet is composed of Actonel 35 mg tablets (light-orange tablets) and calcium/vitamin D3
tablets (white tablets).
Light-orange tablets
Each film-coated tablet contains 35 mg risedronate sodium (equivalent to 32.5 mg risedronic acid).
White tablets
Each film-coated tablet contains 1250 mg calcium carbonate equivalent to 500 mg calcium and 10 micrograms (400
IU) colecalciferol (vitamin D ).
Excipients:
Each light-orange tablet contains lactose.
Each white tablet contains sucrose.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Risedronate sodium tablet:_
Oval, light-orange, film-coated tablet with RSN on one side and 35 mg on the other.
_Calcium/vitamin D tablet:_
Capsule-shaped, white, film-coated tablet with “CA+D ” on one side and blank on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures.
Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures (see section 5.1).
Actonel Plus Ca & D Tablet is only intended for use in assessed patients for whom the amount of calcium and vitamin
D included is considered to provide adequate supplementation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
A weekly unit of Actonel Plus Ca & D Tablet, consists of 1 Actonel 35 mg film-coated tablet and 12 calcium/vitamin
D tablets packaged in a blister card.
The recommended dose in adults is 1 Actonel 35 mg tablet on the first day followed on the next day by 1
calcium/vitamin D tablet twice daily for 6 days. This 7-day sequence is
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