DEMULEN 50 (28 DAY PACK) TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ETHYNODIOL DIACETATE; ETHINYL ESTRADIOL

Available from:

PFIZER CANADA ULC

ATC code:

G03AA01

INN (International Name):

ETYNODIOL AND ESTROGEN

Dosage:

1MG; 50MCG

Pharmaceutical form:

TABLET

Composition:

ETHYNODIOL DIACETATE 1MG; ETHINYL ESTRADIOL 50MCG

Administration route:

ORAL

Units in package:

28

Prescription type:

Prescription

Therapeutic area:

CONTRACEPTIVES

Product summary:

Active ingredient group (AIG) number: 0206451002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2005-04-01

Summary of Product characteristics

PRODUCT MONOGRAPH
DEMULEN* 30
DEMULEN* 50
(Ethynodiol Diacetate plus Ethinyl Estradiol Tablets)
ORAL CONTRACEPTIVE
Pfizer Canada Inc
Date of Preparation:
17,300 Trans-Canada Highway
24 September 2003
Kirkland, Quebec H9J 2M5
Control No. 086794
* TM G.D. Searle LLC
Pfizer Canada Inc, Licensee
© Pfizer Canada Inc 2003
2
PRESCRIBING INFORMATION
DEMULEN* 30
DEMULEN* 50
(Ethynodiol Diacetate plus Ethinyl Estradiol Tablets)
THERAPEUTIC CLASSIFICATION
Oral Contraceptive
ACTION
Estrogen-progestogen combinations act primarily through the mechanism
of
gonadotropin suppression due to the estrogenic and progestational
activity of their
components. Although the primary mechanism of action is inhibition of
ovulation,
alterations in the cervical mucus and the endometrium may also
contribute to
effectiveness.
INDICATIONS
DEMULEN 30
Prevention of Pregnancy.
3
DEMULEN 50
For conception control in circumstances where low-dose estrogen
formulations prove to
be unacceptable.
CONTRAINDICATIONS
1.
History of or actual thrombophlebitis or thromboembolic disorders.
2.
History of or actual cerebrovascular disorders.
3.
History of or actual myocardial infarction or coronary arterial
disease.
4.
Active liver disease or history of or actual benign or malignant liver
tumours.
5.
History of or known or suspected carcinoma of the breast.
6.
History of or known or suspected estrogen-dependent neoplasia.
7.
Undiagnosed abnormal vaginal bleeding.
8.
Any ocular lesion arising from ophthalmic vascular disease, such as
partial or
complete loss of vision or defect in visual fields.
9.
When pregnancy is suspected or diagnosed.
WARNINGS
4
1.
Predisposing Factors for Coronary Artery Disease
Cigarette smoking increases the risk of serious cardiovascular side
effects
and mortality. Birth control pills increase this risk, especially with
increasing age. Convincing data are available to support an upper age
limit of 35 years for oral contraceptive use by women who smoke.
Other women who are independently at high risk for cardiovascular
disease include those