|1.||The incidence of diseases of the circulatory system in women using combined oral contraceptives is significantly greater than those of controls, and the mortality is slightly increased. Coronary thrombosis, cerebrovascular accidents and venous thrombosis, are more likely to occur in women aged 35 years or over, particularly if they have used the contraceptive for longer than five years, if they smoke, if they are obese or if they are hypertensive. Additional risk factors are diabetes, hypercholesterolaemia and familial hyperlipoproteinaemia. However, the risk of mortality due to oral contraceptives in women under 35 who are in the high-risk group is in general far less than the risk of mortality due to pregnancy.|
|2.||Hypertension may occur in association with the use of oral contraceptives. Regular blood pressure checks, including a pretreatment level, are advisable.|
|3.||Prolonged amenorrhoea following the use of oral contraceptives may occur. The incidence is in the order of 1% of users. Caution is advised where oligomenorrhoea or amenorrhoea have occurred in the past.|
|4.||Mood changes, mass gain, skin pigmentation, vaginal candidiasis, gall bladder disease, gastrointestinal irritation and fluid retention may occur.|
|5.||Case reports have been published of benign hepatic tumours in women on oral contraceptives for a prolonged time, but a causal relationship has not been established. The preparation should be discontinued if persistent upper abdominal pain develops.|
|6.||Interactions with other medicines and efficacy:|
The efficacy of the contraceptive pill may be decreased when it is administered concomitantly with other medicines such as the anti-epileptic agents, rifampicin, phenylbutazone and ampicillin. With vomiting and diarrhoea, the absorption of oral contraceptives may be diminished and women should be advised to use additional methods of contraception at the time of such disorders.
|7.||Effects on laboratory tests:|
Oral contraceptives may interfere with some laboratory estimations, in particular hormones, glucose tolerance, thyroid function, blood coagulation, serum triglycerides and liver function tests.
|8.||Surgery is more likely to be associated with an increased incidence of thrombotic side effects. Adequate precaution should be taken.|
|20 August 1986||NDC 8-6045-B||012-534|