Annie

1 tablet of ANNIE contains 2 mg cyproterone acetate and 0.035 mg ethinyl estradiol.

For the treatment of signs of androgenization in women and contraception in women with these symptoms.
ANNIE is an oral contraceptive pill. To inhibit the influence of the androgens which are also produced in females that may cause acne in women.

Before starting ANNIE, a thorough general physical and gynaecological examination should be carried out and pregnancy must be excluded.
As a precaution, control examinations should be conducted at intervals of about 6 months during long-term treatment with the tablets.
START OF TREATMENT: Wait for the next period to occur. Start taking the tablets on the 1^st day of the cycle (1^st day of bleeding = 1^st day of the cycle).
USE OF THE MEMO-PACK: Take the first tablet from the memo-pack out of the section marked with the corresponding day of the (for example "Mon" for Monday), press it through the aluminium foil, and swallow it whole with some liquid. It does not matter at what time of the day the patient takes the tablet, but once the patient has selected a particular time - preferably after breakfast or evening meal - the patient should keep to it every day.
1 TABLET DAILY FOR 21 DAYS: From now on the patient must take a tablet every day in the direction indicated by the arrows on the pack until the pack is empty. If, at any time, the patient is not sure whether she has taken the tablet for that day not, a glance at the memo-pack will tell.
TABLET-FREE INTERVAL OF 7 DAYS: After all 21 tablets have been taken, a tablet-free interval of 7 days follows during which time a menstruation-like bleeding will occur.
CONTINUATION OF TREATMENT: After this 7-days interval, tablet-taking is resumed from the next pack - regardless of whether a bleeding has already ceased (which it usually has) or is still continuing.
Thus, the patient will be following a simple scheme of 3 weeks tablet-taking, 1 week off, and each new pack will start on the same day of the week as the previous one.
NOTE: Irregular tablet-taking, vomiting or intestinal affections with diarrhoea, very rare individual metabolic disturbances or prolonged simultaneous use of certain medical preparations (see Precautions) can affect the contraceptive action (possible first symptom: intermenstrual bleeding). Mild laxatives do not impair the action of the tablets.
LENGTH OF USE: The length of use depends on the severity of the clinical picture; in general, treatment should be carried out over several months.
It is recommended to take ANNIE for at least another 3 to 4 cycles after the signs have subsided. Should there be a recurrence, weeks or months after discontinuation of tablet-taking treatment with ANNIE may be resumed.
IF INTERMENSTRUAL BLEEDING OCCURS during 3 weeks in which ANNIE is being taken, tablet-taking should not be interrupted. Slight bleeding will usually stop spontaneously. However, if the bleeding is heavy, similar to menstrual bleeding, the patient should consult the doctor.
IF A PERIOD IS MISSED: If, in exceptional cases, bleeding fails to occur during the tablet-free interval, tablet-taking is provisionally not to be resumed (no new pack) and the doctor must be consulted.
WHAT TO DO IN CASE OF IRREGULAR TABLET-TAKING (if the patient forgets to take the daily tablet): If the patient forgets to take the tablet at the usual time, the patient must take it within the next 12 hours at the latest. If more than 12 hours elapse from the time that the patient normally take the tablet and also in case of vomiting or diarrhoea the patient must continue to take the other tablets in the pack at the usual time in order to avoid a premature withdrawal bleeding during this cycle. At the same time, however, a non-hormonal method of contraception (with the exception of the rhythm and temperature methods) must be employed additionally in order to prevent a pregnancy which would be a compelling reason for the discontinuation of ANNIE treatment.
After the pack has been used up, the usual 7-day tablet-free interval follows during which a bleeding normally occurs.
If bleeding fails to occur the doctor must be consulted before tablet-taking is resumed.

Severe disturbances of liver function, Dubin-Johnson syndrome, Rotor syndrome previous or existing liver tumours, existing or previous thromboembolic processes (e.g. stroke, myocardial infarction), sickle-cell anaemia, existing or treated cancer of the breast or the endometrium, severe diabetes with vascular changes, disturbances of lipometabolism.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.

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.

Inform the doctor if the patient suffers from any of the following disorders: diabetes, high blood pressure, varicose veins, otosclerosis, multiple sclerosis, epilepsy, porphyria, tetany, chorea minor. In all these cases, and also where there is a history of phlebitis, or a tendency to diabetes, ANNIE may only be taken under strict medical supervision.
If the patient is taking other medical preparations regularly (for example, barbiturates, phenylbutazone, hydantoins, rifampicin, ampicillin), since they can impair the action of ANNIE. Insulin and antidiabetic requirements may change.
Reasons for Immediate Discontinuation of Annie: Occurrence for the first time of migrainous headaches or more frequent occurrence of unusually severe headaches, sudden perceptual disorders (e.g. disturbances of vision or hearing), first signs of thrombophlebitis or thromboembolic symptoms (for example, unusual pains in or swelling of the legs, stabbing pains on breathing or coughing for no apparent reason), a feeling of pain and tightness in the chest, pending operations (six weeks before hand), immobilization (for instance, following accidents). In all these cases there may be an increased risk of thrombosis. Further reasons for discontinuation are: onset of jaundice, onset of hepatitis, itching of the whole body, increase in epileptic seizures, significant rise in blood pressure, pregnancy.

Contraindicated in pregnancy, lactation, jaundice or persistent itching during a previous pregnancy, a history of herpes of pregnancy, otosclerosis with deterioration during pregnancy.

In some cases, headaches, gastric upsets, nausea, a feeling of tension in the breasts, changes in body weight and libido, or depressive moods can occur. In predisposed women, long-term use of the tablets can sometimes cause brownish patches on the face which are made worse by long exposure to the sun. Women who have this tendency should therefore avoid exposure to the sunlight.
Consult a doctor if the patient has any persistent problem.

Store below 30°C.

Oral Contraceptives / Acne Treatment Preparations

G03HB01 - cyproterone and estrogen ; Belongs to the class of antiandrogen preparations in combination with estrogens. Used to counter androgenic activities.

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