Based on the results of the examination of the relationship between the expected benefit and the possible risk of perindopril medicines in the drug form, "film-coated tablets," it has been established that currently in the public turnover of the Russian Federation there are perindopril medicines, in the instructions for use of which there are significant differences in the sections "Indications to application "and" Method of administration and dose ".
These differences are explained by the fact, in the instruction for the use of the reference medication "Prestarium A, film-coated tablets, 2.5 mg, 5 mg, 10 mg" in 2013 - 2014. the developer made new indications for use on the basis of the results of his own clinical studies, and instructions for the use of a number of reproduced perindopril medicines have not been reviewed for a long time.
We consider it advisable to give instructions on the use of all medicines perindopril, registered in the territory of the Russian Federation, in accordance with the text of the instruction for the use of the drug Prestarium A tablets coated with a film membrane, 2.5 mg, 5 mg, 10 mg, presented in the State Register of Medicines The Russian Federation and, in particular:
1. in the section "Indications for use" give additional indications for use:
"- prevention of recurrent stroke (combination therapy with indapamide) in patients who underwent a stroke or transient cerebral circulation disorder by ischemic type" and
"- stable CHD: reduced risk of cardiovascular complications in patients with stable coronary artery disease."
2. in the section "Method of use", give instructions on the use of perindopril preparations in the edition of the corresponding section of the instruction on the use of the reference medicinal preparation "Prestarium A, film-coated tablets, 2.5 mg, 5 mg, 10 mg" (manufacturer: Laboratories Servier Industries, France, Serdix, Russia), including indications for use according to indications "Prevention of recurrent stroke ..." and "Stable IHD ...", as well as instructions for the use of the drug in specific patient groups.