The need to update instructions on the use of appropriate drugs has been identified.
International nonproprietary name (hereinafter referred to as INN) Perindopril unites several salts of perindopril: arginate, tosylate, erbuminate. These salts of perindopril completely dissociate in the stomach, regardless of pH. The bioequivalence of all Perindopril salts is determined by the active component (cation), namely, perindopril metabolite - perindoprilat.
A number of instructions for the use of medicinal products for medical use contain a modified INN with the indication of Perindopril salt.
The expert institution deems it necessary, in the instructions for medical use, to indicate the INN recommended by the World Health Organization (WHO) Perindopril.
In addition, it is necessary to give instructions for the use of all medicines perindopril, registered on territory of the Russian Federation in accordance with modern scientifically grounded information about the experience of clinical use drugs containing as active ingredient Perindopril:
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 according to the ischemic type;
- stable IHD: reduced risk of cardiovascular complications in patients with stable coronary artery disease;
2) in the section "Method of application", give instructions on the use of perindopril preparations in the edition of the corresponding section on the use of the reference medication for use according to the indications "Prevention of recurrent stroke ..." and "Stable IHD ...", as well as instructions for the use of the drug in special groups of patients;
3) in the section "Contraindications" give an additional contraindication "- simultaneous use with aniseren and aliskirenoderzhaschimi drugs in patients with diabetes mellitus or impaired renal function (GFR <60 ml / min / 1.73 m2 surface area of the body). "