RECLIPSEN 28 TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
19-06-2015
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Active ingredient:
DESOGESTREL; ETHINYL ESTRADIOL
Available from:
ACTAVIS PHARMA COMPANY
ATC code:
G03AA09
INN (International Name):
DESOGESTREL AND ESTROGEN
Dosage:
0.15MG; 0.03MG
Pharmaceutical form:
TABLET
Composition:
DESOGESTREL 0.15MG; ETHINYL ESTRADIOL 0.03MG
Administration route:
ORAL
Units in package:
28 (21 DRUG-7 PLACEBO)
Prescription type:
Prescription
Therapeutic area:
CONTRACEPTIVES
Product summary:
Active ingredient group (AIG) number: 0224591001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-04-27
Summary of Product characteristics
_RECLIPSEN_
_TM_
_ Product Monograph _
_Page 1 of 54 _
PRODUCT MONOGRAPH
PR
RECLIPSEN
TM 21 AND
PR
RECLIPSEN
TM 28
Desogestrel and Ethinyl Estradiol Tablets, USP
(0.15 mg desogestrel and 0.03 mg ethinyl estradiol)
Oral Contraceptive
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
Canada, L5N 6J5
Date of Revision:
May 20, 2015
Submission Control No: 184338
_RECLIPSEN_
_TM_
_ Product Monograph _
_Page 2 of 54 _
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
.................................................................................................
17
DOSAGE AND ADMINISTRATION
.............................................................................
22
OVERDOSAGE
...............................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 26
STORAGE AND STABILITY
.........................................................................................
28
SPECIAL HANDLING INSTRUCTIONS
......................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 28
PART II: SCIENTIFIC INFORMATION
...............................................................................
30
PHARMACEUTICAL INFORMATION
.........................................................................
30
CLINICAL TRIAL
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