DEMULEN 30 (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:

2MG; 30MCG

Pharmaceutical form:

TABLET

Composition:

ETHYNODIOL DIACETATE 2MG; ETHINYL ESTRADIOL 30MCG

Administration route:

ORAL

Units in package:

28

Prescription type:

Prescription

Therapeutic area:

CONTRACEPTIVES

Product summary:

Active ingredient group (AIG) number: 0206451001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2019-07-04

Summary of Product characteristics

PRESCRIBING INFORMATION
DEMULEN* 30
(2 mg Ethynodiol Diacetate plus 0.03 mg Ethinyl Estradiol Tablets)
ORAL CONTRACEPTIVE
Pfizer Canada Inc
Date of Preparation:
17,300 Trans-Canada Highway
November 27, 2018
Kirkland, Quebec H9J 2M5
Control No. 219451
*
TM G.D. Searle & Co.
Pfizer Canada Inc., Licensee
©
Pfizer Canada Inc. 2018
2
PRESCRIBING INFORMATION
DEMULEN* 30
(2 mg Ethynodiol Diacetate plus 0.03 mg 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, in a manner
that inhibits ovulation, which leads to contraception. Some studies
have demonstrated changes in
the endometrium and cervical mucus with the use of hormonal
contraceptives. However, further
research is required to determine, quantitatively, whether or not the
contribution of changes in
endometrium and cervical mucus, observed with combination oral
contraceptives, have a role in
the prevention of pregnancy.
INDICATIONS
Prevention of Pregnancy.
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.
3
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.
10.
Allergic reaction to ethynodiol diacetate, ethinyl estradiol or to any
other ingredients in
DEMULEN (see DOSAGE FORMS).
11.
Hereditary or acquired thrombophilias
12.
Severe dyslipoproteinemia
13.
Heavy smoking (>15 cigarettes per day) and over age 35
14.
Major surgery associated