|
Product
Anti-asthmatic Products (Aerocort Inhaler)
|
Ginette 35
|
|
| |
|
Ginette 35
Cyproterone acetate and Ethinyl estradiol tablets
COMPOSITION
Each film coated tablet contains
Ethinyl estradiol ………. 0.035 mg
Cyproterone acetate BP … 2 mg
INDICATIONS
Ginette 35 is indicated for:
• Androgen-dependent acne, especially those forms that are accompanied by seborrhoea or by inflammation or formation of nodes (acne papulopustulosa, acne nodulocystica)
• Androgen-dependent alopecia
• Mild forms of hirsutism
• Oral contraception in women requiring anti-androgen therapy
|
DOSAGE AND ADMINISTRATION
Ginette 35 must be taken exactly as directed at intervals not exceeding 24 hours. Ginette 35 consists of 21 tablets of a monophasic combined hormonal preparation.
The dosage of Ginette 35 is one tablet daily for 21 consecutive days followed by 7 pill-free days.
Starting Ginette 35
A patient should begin to take Ginette 35 on the first day (Day 1) of her menstrual period (the first day of the menstrual bleeding is counted as day 1 of the cycle). During the first cycle of Ginette 35 use, the patient should be instructed to take one tablet daily, beginning on day 1 of her menstrual cycle, for 21 consecutive days in the direction shown by the arrows until the pack is empty. This is followed by 7 pill-free days. Withdrawal bleeding could occur during this period.
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.
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 will 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 treatment cycle.
Subsequent courses
The patient should begin a new pack of Ginette 35 , taking her tablets on the next day after 7 pill-free days, regardless of whether the menstrual period is still in progress.
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 Ginette 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 Ginette 35 may be resumed.
Missed dose
If the patient forgets to take a tablet at the usual time, the tablet may be taken within the next 12 hours.
If more than 12 hours have elapsed from the time of usual administration, the patient must discard the missed tablet and continue to take the remaining tablets in the pack at the usual time in order to avoid premature withdrawal bleeding during this cycle. A supplementary nonhormonal method of contraception must be employed for the next 7 days to prevent pregnancy, which would necessitate immediate discontinuation of Ginette 35 treatment.
CONTRAINDICATIONS
Pregnancy; lactation; severe disturbances of liver function; recurrent cholestatic jaundice; jaundice or persistent itching during a previous pregnancy; Dubin-Johnson syndrome; Rotor syndrome; previous or existing liver tumours; 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); severe migraine or cerebrovascular insufficiency; sickle-cell anaemia; existing or treated cancer of the breast or the endometrium; undiagnosed vaginal bleeding; severe diabetes with vascular changes; disturbances of lipometabolism; a history of herpes of pregnancy; otosclerosis with deterioration in previous pregnancies.
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 Ginette 35
Occurrence for the first time of migraine 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 (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), 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, significant rise in blood pressure, pregnancy.
PACKAGING INFORMATION
GINETTE 35 is available in a blister strip of 21 tablets.
|
|
