LOESTRIN 1.5/30 TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

NORETHINDRONE ACETATE; ETHINYL ESTRADIOL

Available from:

ALLERGAN INC

ATC code:

G03AA05

INN (International Name):

NORETHISTERONE AND ESTROGEN

Dosage:

1.5MG; 30MCG

Pharmaceutical form:

TABLET

Composition:

NORETHINDRONE ACETATE 1.5MG; ETHINYL ESTRADIOL 30MCG

Administration route:

ORAL

Units in package:

5X21

Prescription type:

Prescription

Therapeutic area:

CONTRACEPTIVES

Product summary:

Active ingredient group (AIG) number: 0206375001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2022-04-22

Summary of Product characteristics

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_Page 1 of 44_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
LOESTRIN
 1.5/30
(NORETHINDRONE ACETATE [NA] AND ETHINYL ESTRADIOL [EE] TABLETS, USP)
1.5 MG NA AND 30 MCG EE TABLETS
ORAL CONTRACEPTIVE
Allergan Inc.
85 Enterprise Blvd., Suite 500
Markham, Ontario
L6G 0B5
www.allergan.ca
Date of Initial Approval:
December 31, 1974
Date of Revision:
December 3, 2019
Submission Control No: 230515
_ _
_LOESTRIN_
_®_
_ 1.5/ 30 Product Monograph _
_Page 2 of 44_
RECENT MAJOR LABEL CHANGES
CONTRAINDICATIONS (2) 12-2019
WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic (7) 12-2019
DRUG INTERACTIONS, Drug-Drug Interactions (9.2)
12-2019
PATIENT MEDICATION INFORMATION 12-2019
_ _
_LOESTRIN_
®
_ 1.5/ 30 Product Monograph _
_Page 3 of 44_
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
........................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 4
1
INDICATIONS
.................................................................................................................
4
1.1
Pediatrics
...............................................................................................................
4
1.2
Geriatrics
...............................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Recommended Dose and Dosage Adjustment
....................................................... 5
4.2
Missed Dose
..........................................................................................................
5
5
OVERDOSAGE
......................................................................................