YAZ PLUS TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
07-03-2017
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Active ingredient:
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM; LEVOMEFOLATE CALCIUM
Available from:
BAYER INC
ATC code:
G03AA12
INN (International Name):
DROSPIRENONE AND ESTROGEN
Dosage:
3.00MG; 0.02MG; 0.451MG; 0.451MG
Pharmaceutical form:
TABLET
Composition:
DROSPIRENONE 3.00MG; ETHINYL ESTRADIOL 0.02MG; LEVOMEFOLATE CALCIUM 0.451MG; LEVOMEFOLATE CALCIUM 0.451MG
Administration route:
ORAL
Units in package:
28
Prescription type:
Prescription
Therapeutic area:
CONTRACEPTIVES
Product summary:
Active ingredient group (AIG) number: 0453183001; AHFS:
Authorization status:
APPROVED
Authorization date:
2012-06-06
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
YAZ
®
PLUS
3.0 mg drospirenone, 0.020 mg ethinyl estradiol, 0.451 mg levomefolate
calcium tablets and
0.451 mg levomefolate calcium tablets
Oral Contraceptive
Acne Therapy
Improvement in Folate Status
Bayer Inc.
2920 Matheson Boulevard East
Mississauga, Ontario
L4W 5R6
Canada
http://www.bayer.ca
Date of Revision:
March 2, 2017
Submission Control No: 201007
©2017, Bayer Inc.
® TM see www.bayer.ca/tm-mc
_YAZ PLUS Product Monograph _
_ _
_Page 2 of 73 _
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
..................................................................................................14
DRUG INTERACTIONS
..................................................................................................20
DOSAGE AND ADMINISTRATION
..............................................................................27
OVERDOSAGE
................................................................................................................29
ACTION AND CLINICAL PHARMACOLOGY
............................................................30
STORAGE AND STABILITY
..........................................................................................36
SPECIAL HANDLING INSTRUCTIONS
.......................................................................36
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................36
PART II: SCIENTIFIC INFORMATION
................................................................................37
PHARMACEUTICAL INFORMAT
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