DIANE-35 TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-03-2017
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Active ingredient:
CYPROTERONE ACETATE; ETHINYL ESTRADIOL
Available from:
BAYER INC
ATC code:
G03HB01
INN (International Name):
CYPROTERONE AND ESTROGEN
Dosage:
2MG; 35MCG
Pharmaceutical form:
TABLET
Composition:
CYPROTERONE ACETATE 2MG; ETHINYL ESTRADIOL 35MCG
Administration route:
ORAL
Units in package:
21
Prescription type:
Prescription
Therapeutic area:
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0232337001; AHFS:
Authorization status:
APPROVED
Authorization date:
1997-09-17
Summary of Product characteristics
_DIANE-35 Product Monograph_
Page 1 of 44
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DIANE
®
-35
cyproterone acetate and ethinyl estradiol tablets
2 mg cyproterone acetate and 0.035 mg ethinyl estradiol tablets
Acne Therapy
Bayer Inc.
Date of Revision:
2920 Matheson Boulevard East
March 16, 2017
Mississauga, Ontario
L4W 5R6
www.bayer.ca
Submission Control No.: 201157
© 2017, Bayer Inc.
® TM see www.bayer.ca/tm-mc
_DIANE-35 Product Monograph_
Page 2 of 44
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
.....................................................................................
20
OVERDOSAGE
........................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
22
STORAGE AND STABILITY
.................................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 23
PART
II:
SCIENTIFIC
INFORMATION
.....
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