Annie Warnings

Not to be used in patients with thromboembolic disease or hepatic disease.
Should not be used in women with risk factors for thromboembolic disease (e.g. women with history of vasculitis, obesity, diabetes or hypertension).
Should not be used in patients known or having history of liver tumours and in patients with known or suspected of estrogen-dependent tumours (e.g. cervical cancer, breast cancer).
Use with caution in women who smoke cigarettes, especially those aged over 35 years should consult physician before use.
Consult a physician for other indications except for its contraceptive properties.
Consult a physician if the patient has any abnormal side effects.
Special Notes: ANNIE is not for use in men.
According to the present state of knowledge an association between the use of progestogen-estrogen combinations and an increased risk of venous and arterial thromboembolic diseases cannot be ruled out.
The relative risk of arterial thromboses (e.g. stroke, myocardial infarction) appears to increase further when heavy smoking, increasing age and the use of combined oral contraceptives coincide.
In rare cases benign and in even rarer cases malignant liver tumours leading in isolated cases to life-threatening intraabdominal haemorrhage have been observed after the use of hormonal substances such as those contained in ANNIE. The doctor must therefore be informed of the occurrence of unusual upper abdominal complaints which do not disappear spontaneously within a short time as it may then be necessary to withdraw the preparation.