Oral Contraceptive.
Each tablet contains ethynodiol
diacetate B.P. 0,5 mg.
PHARMACOLOGICAL ACTION:
The exact mode of action of FEMULEN is not clear, but progestogen-only oral
contraceptives are believed to alter Fallopian tube motility, endometrial development and
cervical mucus viscosity. Ovulation is not necessarily prevented by FEMULEN.
CONTRA-INDICATIONS:
Hormone dependent cancer. A previous history of thromboembolic disorders, including
cerebral vascular disorders, should normally be regarded as a contra-indication. However,
these reactions are usually thought to be oestrogenic in origin and their incidence is
probably less with progestogen-only minipills.
WARNINGS:
Caution should be exercised where there is the possibility of an interaction between a
pre-existing disorder and a known or suspected side-effect. These may include hypertension
and impaired lipid metabolism. Caution should also be observed in young patients in whom
the growth period has not ended.
DOSAGE AND DIRECTIONS FOR USE:
The first tablet should be taken on the first day of bleeding of a menstrual cycle.
One tablet should be taken daily until the pack of 28 is finished. The first tablet of a
new pack should be taken the day following the last tablet of the previous pack. There
should be no break in medication.
If FEMULEN is being taken for the first time, additional contraceptive precautions should
be taken for the first two weeks of the first pack.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Patients taking FEMULEN may experience menstrual irregularity. This should decrease
with time. Other known or suspected side effects include: various gastro-intestinal
symptoms, irregular bleeding, amenorrhoea, skin pigmentation or other disorders, weight
changes and breast discomfort. The result of certain laboratory tests may be altered, and
the pathologist should be informed.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Fatal overdosage has not been reported. Overdosage may be manifested by nausea,
vomiting, breast engorgement and vaginal bleeding. Gastric lavage may not be necessary but
demulcents such as milk, egg white or bismuth hydroxide can be helpful.
IDENTIFICATION:
White, unscored tablets stamped ‘SEARLE’on both sides.
STORAGE INSTRUCTIONS:
Store in a dry place, below 30 °C. Keep out of reach of children.
