DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS 28
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
03-01-2018
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Active ingredient:
DROSPIRENONE; ETHINYL ESTRADIOL
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
G03AA12
INN (International Name):
DROSPIRENONE AND ESTROGEN
Dosage:
3MG; 0.03MG
Pharmaceutical form:
TABLET
Composition:
DROSPIRENONE 3MG; ETHINYL ESTRADIOL 0.03MG
Administration route:
ORAL
Units in package:
28
Prescription type:
Prescription
Therapeutic area:
CONTRACEPTIVES
Product summary:
Active ingredient group (AIG) number: 0250430001; AHFS:
Authorization status:
APPROVED
Authorization date:
2018-01-04
Summary of Product characteristics
_Drospirenone and Ethinyl Estradiol Tablets 21 / 28 Product Monograph
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Page 1 of 66
PRODUCT MONOGRAPH
PR
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS 21
PR
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS 28
3 mg drospirenone and 0.03 mg ethinyl estradiol tablets
In-house standard
Oral Contraceptive
Acne Therapy
Mylan Pharmaceuticals ULC Date of Preparation:
85 Advance Road January 03, 2018
Etobicoke, ON
M8Z 2S6
Submission Control No.: 211719
_Drospirenone and Ethinyl Estradiol Tablets 21 / 28 Product Monograph
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Page 2 of 66
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT
INFORMATION................................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
3
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
15
DRUG INTERACTIONS
.........................................................................................................
19
DOSAGE AND ADMINISTRATION
.....................................................................................
27
OVERDOSAGE
........................................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
30
STORAGE AND STABILITY
.................................................................................................
35
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
35
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 35
P
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