HYDROCORTISONE ROUSSEL

Glucocorticoid replacement treatment during adrenal insufficiency:

· primary adrenal insufficiency: Addison's disease, adrenalectomy,

· pituitary-origin adrenal insufficiency: Sheehan syndrome, pituitary insufficiencies of various causes,

· congenital adrenal hyperplasia with or without salt-wasting syndrome (Debré-Fibiger syndrome).

HYDROCORTISONE ARROW has a major influence on the ability to drive vehicles and use machines. Adverse effects, such as dizziness and convulsions, are possible after corticosteroid treatment. If these effects appear, patients must not drive or use machines.

The adverse effects reported during clinical trials and from post-marketing experience through spontaneously reported cases or cases reported in the literature are presented below. Frequencies have been defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), frequency not determined (cannot be estimated from the available data). Within each frequency group, adverse effects must be presented in descending order of severity.

In case of underdosage, the following may be observed: asthenia, orthostatic hypotension, hyperkalaemia.

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. Healthcare professionals report any suspected adverse reaction via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/ .