(and dosage form):
Emergency postcoital contraceptive
4 Tablets each containing levonorgestrel (d-13-ethyl-17alpha-ethinyl-17beta-hydroxy-4-gonen-3-one) 0,25 mg and ethinylestradiol (17alpha-ethinyl-estra-1,3,5(10)-triene-3,17beta-diol) 0,05 mg.
A. 21.8.2 Progesterones with or without estrogens.
E-Gen-C acts as a contraceptive by preventing the nidation of a fertilised ovum in the uterine mucosa.
For the prevention of pregnancy within 72 hours of unprotected sexual intercourse or the recognisable failure of mechanical methods.
E-Gen-C is intended for emergencies only and is completely unsuitable for regular contraception. Its reliability is not as high as that of the familiar pill, which is taken for at least 21 days of the menstrual cycle.
Pregnancy; existing or previous thromboembolic processes in arteries and veins and states which predispose to such diseases (eg disturbances of the clotting system with a tendency towards thrombosis, certain heart diseases); previous or existing liver tumours; existing or treated cancer of the breast or the endometrium and a history of herpes of pregnancy.
E-Gen-C is not to be used if there is a possibility that pregnancy already exists, eg if unprotected sexual intercourse has already taken place in the same cycle or if the last menstrual period failed to occur.
The repeated use of E-Gen-C within a single monthly cycle is to be avoided, since it constitutes undesirable hormonal stress and may result in severe cycle disturbances.
The benefit-risk ratio must be carefully considered in the following diseases: severe disturbances of liver function, jaundice or persistent itching during a previous pregnancy, Dubin-Johnson syndrome, Rotor syndrome, existing thrombophlebitis, sickle-cell anaemia.
Patients who become pregnant despite post coital contraception should be carefully evaluated for possible ectopic pregnancy since E-Gen-C appears to affect only endometrial implantation.
The effect of E-Gen-C on the conceptus in the event of failure to prevent conception is not definitely known.
DOSAGE AND DIRECTIONS FOR USE
Commencement of treatment
The first two tablets are to be taken as soon as possible after sexual intercourse - up to 72 hours later at the most. The other two tablets are to be taken twelve hours later.
The earlier E-Gen-C is used, the more effective it is. Even extremely high doses of hormone can no longer prevent pregnancy once a fertilised ovum has become implanted in the uterine mucosa.
All further unprotected sexual intercourse must be avoided until the next menstrual period; till then, only local mechanical and/or chemical methods (condom, pessary, foam) of contraception may be used.
SIDE EFFECTS AND SPECIAL PRECAUTIONS
Tension in the breasts and vomiting.
The simultaneous use of an antiemetic helps to ward off nausea. Should vomiting occur within two hours of taking E-Gen-C, it may be advisable to repeat the dose.
The next menstrual period may occur earlier or later than usual. At all events, you should visit your doctor 3 weeks after taking E-Gen-C regardless of whether bleeding has occurred or not.
Intestinal disorders with diarrhoea can effect the contraceptive affect.
Interaction with other medicines and efficacy
The regular use of other drugs (eg barbiturates, phenylbutazone, hydantoins, rifampicin, ampicillin) may impair the contraceptive effect of E-Gen-C. It is therefore necessary to inform the prescriber about such medication.
The requirement for oral antidiabetics or insulin can temporarily change.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Unknown till now. Symptomatic treatment according to conventional methods.
4 Round light brown coated tablets.
Blister pack containing 4 tablets.
Store below 30°C. Keep out of reach of children.
NAME AND BUSINESS ADDRESS OF THE APPLICANT
Schering (Pty) Ltd
(Reg No: 1964/009072/07)
106 Sixteenth Road
P O Box 5278
Halfway House 1685
DATE OF PUBLICATION OF THIS PACKAGE INSERT
10 June 1997
SCHERING (PTY) LTD
(Reg No: 1964/009072/07)
Schering AG Germany
Updated on this site: April 2003
Current: January 2005
Source: Pharmaceutical Industry
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