YASMIN PLUS TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DROSPIRENONE; LEVOMEFOLATE CALCIUM; LEVOMEFOLATE CALCIUM; ETHINYL ESTRADIOL

Available from:

BAYER INC

ATC code:

G03AA12

INN (International Name):

DROSPIRENONE AND ESTROGEN

Dosage:

3.0MG; 0.451MG; 0.451MG; 0.03MG

Pharmaceutical form:

TABLET

Composition:

DROSPIRENONE 3.0MG; LEVOMEFOLATE CALCIUM 0.451MG; LEVOMEFOLATE CALCIUM 0.451MG; ETHINYL ESTRADIOL 0.03MG

Administration route:

ORAL

Units in package:

28

Prescription type:

Prescription

Therapeutic area:

CONTRACEPTIVES

Product summary:

Active ingredient group (AIG) number: 0453183002; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-06-18

Summary of Product characteristics

_ _
_YASMIN PLUS Product Monograph _
_ _
_Page 1 of 70 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
YASMIN
® PLUS
3.0 mg drospirenone, 0.030 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
http://www.bayer.ca
Date of Revision:
March 2, 2017
Submission Control No: 200982
© 2017, Bayer Inc.
® TM see www.bayer.ca/tm-mc
_ _
_YASMIN PLUS Product Monograph _
_ _
_Page 2 of 70 _
_ _
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
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................19
DOSAGE AND ADMINISTRATION
..............................................................................26
OVERDOSAGE
................................................................................................................29
ACTION AND CLINICAL PHARMACOLOGY
............................................................29
STORAGE AND STABILITY
..........................................................................................36
SPECIAL HANDLING INSTRUCTIONS
.......................................................................36
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................36
PART II: SCIENTIFIC INFORMAT