Belara Warnings

Serious effects on health may occur due to thromboembolic events (see Side Effects). Therefore, predisposing factors (eg, varicose veins, previous inflammation of the veins, thrombosis, heart disease, considerable overweight, blood-clotting disorders) and thromboembolism of the veins occurring in close relatives at an early age should be determined and taken into account when deciding whether to use Belara.
Smokers taking hormone preparations for contraception are at an increased risk of suffering from, in some cases, serious consequences of changes in the vessels (eg, heart attack, stroke). The risk increases with age and rising cigarette consumption.
In particular, women >30 years should therefore refrain from smoking when taking hormone preparations for contraception. If smoking cannot be stopped, other methods of contraception should be used. Surveillance studies have shown that the incidence of thromboembolic diseases may decrease when taking preparations with low oestrogen dosage (≤0.05 mg), which led to the development of contraceptives containing smaller amounts of hormones. It is still not certain that women taking such low-dose preparations will in fact suffer less frequently from thrombotic or thromboembolic blockage of the vessels.
Therefore, even when taking low-dose hormonal contraceptives, patients should be examined for factors promoting the formation of blood clots and the risks should be weighed against the potential benefits of this method of contraception.
The occurrence of thromboembolic diseases in relatives at an early age may be evidence of disorder of the blood clotting system. Such diseases include deep vein thrombosis, pulmonary embolism, stroke, sudden disorders of sensation and perception, speech and motion disorders, in particular paralysis, heart attack and angina pectoris. If there is a family history of such diseases, blood clotting must be examined carefully before prescribing Belara (including eg, ATIII, protein C and S).
Women >40 years require special supervision because the tendency towards thrombosis increases with age.
The risk of thromboembolism is higher with combined oral contraceptives (COC). The additional risk is highest during the first year of first taking a COC. This increased risk on the use of a COC is lower than the risk of thrombosis during pregnancy which is estimated to be 60 cases/100,000 pregnancies. In 1-2% of the cases, thromboembolism is fatal.
Consult a doctor as soon as symptoms of thrombosis or pulmonary embolism eg, pain and swelling in the arms and/or legs, shortness of breath and stabbing pain in the chest occur. The effect of Belara on the risk of thromboembolism, in comparison with other COCs, is not known.