Each pack contains
a) 21 Yellow coloured active tablets
Each film coated tablet contains Ethinylestradiol 0.035 mg, Cyproterone acetate BP 2 mg,
b) 7 White Placebo tablets Colours: Quinoline Yellow and Titanium Dioxide
Androgen-dependent acne, especially those forms which are accompanied by seborrhea or by inflammation or formation of nodes (acne papulopustulosa, acne nodulocystica), androgen-dependent alopecia and mild forms of hirsutism.
Oral contraception in women requiring anti-androgen therapy and for treatment of symptoms of PCOS.
Cyproterone is contraindicated if you have any of the following conditions:
- A history of herpes of pregnancy;
- Disturbances of lipometabolism;
- Dubin-johnson syndrome;
- Existing or previous thromboembolic processes in arteries or veins and states which predispose to such diseases (e.g. disturbances of the clotting system with a tendency towards thrombosis, certain heart diseases);
- Existing or treated cancer of the breast or the endometrium;
- Jaundice or persistent itching during a previous pregnancy;
- Otosclerosis with deterioration in previous pregnancies;
- Previous or existing liver tumours;
- Recurrent cholestatic jaundice;
- Rotor syndrome;
- Severe diabetes with vascular changes;
- Severe disturbances of liver function;
- Severe migraine or cerebrovascular insufficiency;
- Sickle-cell anaemia;
- Undiagnosed vaginal bleeding;
Strict medical supervision is required in patients with diabetes or a tendency to diabetes, high blood pressure, varicose veins, a history of phlebitis, otosclerosis, multiple sclerosis, epilepsy, prophyria, tetany, chorea minor; asthma, depression, or states in which fluid retention occurs.
Reasons for immediate discontinuation of Cyproterone 35 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 healing), first signs of thrombophlebitis or thromboembolic symptoms (for e.g. 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 beforehand), immobilisationn (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, significant rise in blood pressure, pregnancy.
Cyproterone 35 is not for use in men and should not be prescribed in children.
Before starting Cyproterone 35, a thorough gynaecological examination (including the breasts and a cytological smear of the cervix) should be carried out and the family case history carefully noted.
In addition, disturbances of the clotting system must be ruled out if any members of the family have suffered from thromboembotic diseases (eg. Deep vein thrombosis, stroke myocardial infarction) already at a young age.
Pregnancy must be excluded.
If the hirsutism has only recently appeared or has lately intensified to a considerable extent, an androgen-producing tumour or an adrenal enzyme defect must be excluded in the differential diagnosis.
The first course of Cyproterone 35 is started on the first day of the cycle (the first day of the menstrual bleeding is counted as day 1 of the cycle).
The first tablet should be taken from the starter section of the calendar pack by selecting the appropriate tablet for that day of the week (eg. "Mon" for Monday).
The tablet is swallowed whole with a little liquid. It does not matter at what time of the day the tablet is taken, but once the patient has selected a particular time, the tablet should be taken as near as possible at the same time each day.
A tablet is then taken every day in the direction shown by the arrows until the pack is empty.
If the patient is using hormonal contraceptives, the doctor should decide when she should start treatment.
The same applies to patients who have just had a delivery or an abortion.
The first cycle may be somewhat shorter than usual, whereas all following cycles with last four weeks.
An additional, non-hormonal method of contraception (with the exception of the rhythm and temperature methods) should be employed during the first 14 days of the first treated cycle.
After the last tablet has been taken from the first pack, tablet-taking is continued from a new pack on the very next day.
The first tablet must again be taken from the starter section of the calendar pack marked with the appropriate day of the week.
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 that Cyproterone 35 be taken 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 Cyproterone 35 may be resumed.
Carton containing a blister strip containing 21 yellow film-coated biconvex tablets and 7 white film-coated biconvex tablets (calendar pack).