INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo FEMULEN® TABLETS

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

FEMULEN® TABLETS

COMPOSITION:
Each tablet contains
ethynodiol diacetate B.P. 0,5 mg.

PHARMACOLOGICAL CLASSIFICATION:
A 18.7 Contraceptive preparations

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.

INDICATIONS:
Oral contraception.

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.

PRESENTATION:
Pack of 28 tablets. Full instructions for the patient are contained in each pack.

STORAGE INSTRUCTIONS:
Store in a dry place, below 30 °C. Keep out of reach of children.

REGISTRATION NUMBER:
E/18.7/57

NAME AND BUSINESS ADDRESS OF APPLICANT:
G.D. Searle (South Africa) (Pty) Ltd.
14 Mandy Road
Reuven
Johannesburg 2091

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
9 April 1985

® 1994, G.D. Searle (South Africa) (Pty) Ltd.

CODE 4150-4-6/94

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