Country: Canada
Language: English
Source: Health Canada
DROSPIRENONE; ETHINYL ESTRADIOL
MYLAN PHARMACEUTICALS ULC
G03AA12
DROSPIRENONE AND ESTROGEN
3MG; 0.03MG
TABLET
DROSPIRENONE 3MG; ETHINYL ESTRADIOL 0.03MG
ORAL
28
Prescription
CONTRACEPTIVES
Active ingredient group (AIG) number: 0250430001; AHFS:
APPROVED
2018-01-04
_Drospirenone and Ethinyl Estradiol Tablets 21 / 28 Product Monograph _ _ _ 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 _ _ _ 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 Read the complete document