Generic drug of the therapeutic class: Endocrinology
Active ingredients: Androstanolone
laboratory: Besins International
Gel for local application
80g graduated tube
· In general treatment in humans: general and permanent and transient androgenic deficits, in particular: organic and functional hypogonadism.
· In local treatment:
o in humans: sclero-atrophic lichen, gynecomastia,
o in women: sclero-atrophic vulvar lichen.
Dosage ANDRACTIM 2.5% Gel for local application 80 g graduated tube
· General treatment in humans: daily administration on the chest and / or abdomen of 5 to 10 grams of gel per day, avoiding washing the area for six hours after administration.
· In local application (man and woman): 2.5 g every other day on the diseased area, avoiding the application on mucous areas.
This medicine is contraindicated in the following situations:
Hypersensitivity to the active substance or to any of the excipients (see section Composition ),
· In men: prostate cancer,
· In women: the use of ANDRACTIM is formally prohibited in the context of a general androgen therapy, because of the risk of virilization.
Side effects Andractim
Those of androgenic hyperactivity in the androgen-dependent tissues, controllable by a reduction of the dosage.
Reporting of suspected adverse reactions
The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr