Adverse reactions : תופעות לוואי

4.8     Undesirable effects

The most commonly reported adverse drug reactions, (ADRs) in patients taking Androcur 10 mg are intermenstrual bleeding, weight gain and depression.

The most serious adverse drug reactions involved benign and malignant liver tumours, which may cause intra-abdominal haemorrhage.

The following table lists the adverse drug reactions, which have been reported in connection with Androcur 10 mg. They are based on post-marketing data and experience gained with Androcur, for which frequency cannot be estimated.


The best suited MedDRA terminology was used to describe any certain reaction, and its synonyms and associated diseases.


System Organ Class         Rare                   Frequency not known MedDRA                                            (cannot be estimated from the available data) 
Neoplasms Benign,          Meningioma             Benign and malignant liver tumours* Malignant and
Unspecified (incl. cysts and polyps)

Immune system                                     Hypersensitivity reactions disorders

Metabolism and nutrition                          Weight gain disorders
Weight loss

Rise in blood sugar in diabetics
Hepatobiliary disorders                            Abnormal hepatic function 
Jaundice*

Hepatitis*
Psychiatric disorders                              Depression

Decrease in libido

Increase in libido
Gastrointestinal disorders                         Intra-abdominal haemorrhage 
Skin and subcutaneous                              Skin reactions tissue disorders

Reproductive system and                            Pain, breast tenderness or breast enlargement, breast disorders                                   in particular at the start of treatment 
Irregular or absent menstrual bleeding

Spotting*
*   For more information see section 4.4.
The occurrence of meningiomas (single and multiple) has been reported in connection with the use of cyproterone acetate (see section 4.4).

Stomach complaints and nausea have been commonly reported in connection with medicinal products, which contain cyproterone acetate as their active ingredient.

Furthermore, due to the concomitant administration of a suitable oestrogen or a suitable progestogen-oestrogen combination (oral contraceptive, ‘pill’), the information, contained in the section, Undesirable effects, of the pertinent summary of product characteristics and package leaflet, has to be additionally observed.

Although cyproterone acetate also has a contraceptive effect in combination with an oestrogen or a suitable cyproterone acetate-oestrogen combination contraceptive, it should not be used exclusively for contraception but only used in women who have to be treated for their androgen-dependent skin disorders (see section 4.1). Women who are being treated with CPA in combination with an oestrogen and/or with a suitable oestrogen- progestogen combination, should not take any additional oral contraceptive during this treatment. Regular intake has to be observed in order to achieve contraceptive protection.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il