ACTONEL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

Available from:

ABBVIE CORPORATION

ATC code:

M05BA07

INN (International Name):

RISEDRONIC ACID

Dosage:

150MG

Pharmaceutical form:

TABLET

Composition:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 150MG

Administration route:

ORAL

Units in package:

1

Prescription type:

Prescription

Therapeutic area:

BONE RESORPTION INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0135301005; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-08-03

Summary of Product characteristics

_ACTONEL/ACTONEL DR (risedronate sodium) _
_Page 1 of 63_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR ACTONEL®
risedronate sodium tablets
Tablets, 35 mg and 150 mg (as the hemi-pentahydrate), for oral use
USP
PR ACTONEL DR®
risedronate sodium delayed-release tablets
Delayed-release tablets, 35 mg (as the hemi-pentahydrate), for oral
use
Bisphosphonates (ATC Code: M05BA07)
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, QC H4S 1Z1
Date of Initial Authorization:
AUG 18, 1999
Date of Revision:
NOV 3, 2022
Submission Control Number: 267898
_ _
_ACTONEL/ACTONEL DR (risedronate sodium) _
_Page 2 of 63_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
07/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
07/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
07/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 5
1
INDICATIONS
.............................................................................................................
5
1.1
Pediatrics
..................................................................................................................
6
1.2
Geriatrics
..................................................................................................................
6
2
CONTRAINDICATIONS
................................................................................................
6
4
DOSAGE AND ADMINISTRATION
................................................................................
6
4.1
Dosing Considerations
.............................................................................................
6
4.2
Recomme