Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Control of libido in severe hypersexuality and/or sexual deviation in the adult male.
For reduction of drive in sexual deviations in men, cyproterone acetate 50 mg can be used when other interventions are considered inappropriate.
Generally, treatment is started with 1 tablet Androcur 50 mg twice daily, after the morning and evening meals. 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.
Androcur is not recommended for use in male children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Androcur must not be given before the conclusion of puberty since an unfavourable influence on longitudinal growth and the still unstabilised axes of endocrine function cannot be ruled out.
There are no data suggesting the need for a dosage adjustment in elderly patients.
The use of Androcur is contraindicated in patients with liver diseases (see section 4.4 and 4.8).
The use of Androcur 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 section 5.2).
The tablets are to be taken with some liquid after meals.
For oral administration.
There have been no reports of ill-effects from overdosage, which it is, therefore, generally unnecessary to treat. There are no specific antidotes and if treatment is required it should be symptomatic.
5 years.
No special precautions for storage.
PVC/Aluminium blister pack.
Pack size: 60 tablets.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
