Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Schering
E-GEN-C TABLETS SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form): E-GEN-C TABLETS Emergency postcoital contraceptive COMPOSITION 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. PHARMACOLOGICAL CLASSIFICATION A. 21.8.2 Progesterones with or without estrogens. PHARMACOLOGICAL ACTION E-Gen-C acts as a contraceptive by preventing the nidation of a fertilised ovum in the uterine mucosa. INDICATIONS 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. CONTRA-INDICATIONS 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 durin Read the complete document