Gale Dosage/Direction for Use

For oral administration only.
Control of libido in severe hypersexuality and/or sexual deviation: Adults and the elderly: The usual dose is started with one Cyproterone Acetate 50 mg Tablet twice daily. The duration of cyproterone acetate treatment should be defined on an individual basis. When a satisfactory result has been achieved, the therapeutic effect should be maintained with the lowest possible dose. When changing the dose or when discontinuing cyproterone acetate, this should be done gradually.
The daily dose should be divided and taken after the morning and evening meals.
The management of patients with prostatic cancer: The maximum daily dose is 300 mg.
Adults and the elderly: To suppress "flare" with initial LHRH Analogue therapy: Initially 2 tablets of Cyproterone Acetate 50 mg Tablets twice daily (200 mg) alone for 5-7 days, followed by 2 tablets of Cyproterone Acetate 50 mg Tablets twice daily (200 mg) for 3-4 weeks together with the LHRH analogue therapy in the dosage recommended by the marketing authorization holder (see SmPC of LHRH analogue).
In long term palliative treatment where LHRH analogues or surgery are contraindicated, not tolerated, or when oral therapy is preferred: 200-300 mg/day.
For the previously mentioned two indications the dosage should be divided into 2-3 doses per day and taken after meals.
In the treatment of hot flushes in patients under treatment with LHRH analogues or who have had an orchidectomy: 50 mg starting dose with upward titration, if necessary, within the range 50-150 mg/day. For this indication, the dosage should be divided into 1-3 doses per day and taken after meals.
Additional information on special population (applies to all indications): Children and adolescents: Cyproterone acetate is not recommended for use in male children and adolescents below 18 years of age due to lack of data on safety and efficacy.
Cyproterone acetate must not be given before the conclusion of puberty since an unfavourable influence on longitudinal growth and still unstabilised axes of endocrine function cannot be ruled out.
Elderly patients: There are no data suggesting the need for a dosage adjustment in elderly patients.
Patients with hepatic impairment: The use of cyproterone acetate is contraindicated in patients with liver diseases (see Precautions and Adverse Reactions).
Patients with renal impairment: The use of cyproterone acetate in patients with renal impairment has not been investigated. There are no data suggesting the need for dosage adjustment in patients with renal impairment (see Pharmacology: Pharmacokinetics under Actions).