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There are no data available on aldona. Following treatment with the aldosterone antagonist spironolactone side effects such as gynecomastia and impotence were observed in men and disturbances to cycle (intracyclic menstrual bleeding, amennorhea) and - although seemingly contradictory - hirsutism in women. These effects are dose-dependent and probably arise from a reduction of the 17-hydroxylase activity and an anti-androgenic partial effect. Since aldona also develops antiandrogenic properties in animal experiments, similar effects on the endocrine system should be taken into consideration in case of repeated intake of aldona. Since no experimental data are available concerning the relative efficacy of aldona in this respect,

it is not possible to make an assessment of the potentially effective dose range in humans. Other general side-effects of spironolactone during therapeutic use in adults (dose range: 50 - 400 mg/day, oral) include disturbances of the gastrointestinal tract (e.g. nausea, vomiting and cramps) changes to the metabolism (e.g. disturbance of the electrolyte metabolism, increase in the uric acid level) and liver function disturbances (cholestasis). Depending on their extent, such electrolyte changes (hyperkalemia, hyponatremia) may lead to disturbances in cardiac rhythm. In the case of existing hypotonia spironolactone can also lead to a further decrease in blood pressure. Due to its anti-aldosterone effect demonstrated in

animal experiments and its structural similarity to spironolactone, exposure to aldona can be expected to lead to the same effects.

Due to the described potential effects classification with R 48/20/21/22 according to 67/548/EEC and STOT Cat 2 according to Regulation (EC) No. 1272/2008 (CLP) is required.