ACTONEL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-08-2017
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Active ingredient:
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)
Available from:
ALLERGAN PHARMA CO.
ATC code:
M05BA07
INN (International Name):
RISEDRONIC ACID
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 5MG
Administration route:
ORAL
Units in package:
28
Prescription type:
Prescription
Therapeutic area:
BONE RESORPTION INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0135301002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2019-01-04
Summary of Product characteristics
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ACTONEL
®
Risedronate Sodium (as the hemi-pentahydrate) Tablets, USP
5 mg, 30 mg, 35 mg, and 150 mg
Pr
ACTONEL DR
®
Risedronate Sodium (as the hemi-pentahydrate) Delayed-Release Tablets
35 mg
Bisphosphonates
Allergan Pharma Co.
Markham, Ontario
L6G 0B5
Date of Preparation:
August 3, 2017
Submission Control No: 205107
2
TABLE OF CONTENTS
PAGE
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
............................................................................3
INDICATIONS AND CLINICAL USE
..................................................................................3
CONTRAINDICATIONS
.......................................................................................................4
WARNINGS AND PRECAUTIONS
......................................................................................4
ADVERSE REACTIONS
........................................................................................................7
DRUG INTERACTIONS
......................................................................................................13
DOSAGE AND ADMINISTRATION
..................................................................................16
OVERDOSAGE
.....................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
................................................................18
STORAGE AND STABILITY
..............................................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................24
PART II: SCIENTIFIC INFORMATION
................................................................................26
PHARMACEUTICAL INFORMATION
..............................................................................26
CLINICAL TRIALS
...............................................
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