ANGELIQ TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
08-03-2016
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Active ingredient:
DROSPIRENONE; ESTRADIOL
Available from:
BAYER INC
ATC code:
G03FA17
INN (International Name):
DROSPIRENONE AND ESTROGEN
Dosage:
1.0MG; 1.0MG
Pharmaceutical form:
TABLET
Composition:
DROSPIRENONE 1.0MG; ESTRADIOL 1.0MG
Administration route:
ORAL
Units in package:
28
Prescription type:
Prescription
Therapeutic area:
PROGESTINS
Product summary:
Active ingredient group (AIG) number: 0251181001; AHFS:
Authorization status:
APPROVED
Authorization date:
2005-07-08
Summary of Product characteristics
_ _
_Page 1 of 47 _
PRODUCT MONOGRAPH
PR
ANGELIQ
®
Drospirenone and Estradiol-17β tablet
1/1 mg
Progestin – Estrogen
Bayer Inc.
2920 Matheson Boulevard East
Mississauga, Ontario
L4W 5R6
http://www.bayer.ca
Date of Revision:
February 17, 2016
Submission Control No: 189314
© 2016, Bayer Inc.
® TM see www.bayer.ca/tm-mc
_ _
_Page 2 of 47 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................21
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................27
PART II: SCIENTIFIC INFORMATION
................................................................................28
PHARMACEUTICAL INFORMATION
..........................................................................28
CLINICAL TRIALS
..........................................................................................................30
DETAILED PHARMACOLOGY
..........
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