In the course of preparation of requirements to safety, efficacy of medicines based on modern scientifically grounded information about the clinical experience of monocomponent and combined drugs containing as active ingredient or one of the active substances ACE inhibitors (regardless of the dosage form), the necessity bringing the approved application instructions into compliance with the following requirements:
1. The section "Contraindications" should contain the following information:
- "Simultaneous use with aliskiren and preparations containing aliskiren, in patients with diabetes mellitus and / or moderate or severe renal dysfunction (glomerular filtration rate (GFR) of less than 60 ml / min / 1.73 m2 surface area of the body "and
- "Simultaneous use with angiotensin receptor antagonists II (APA II) in patients with diabetic nephropathy. "
2. In the section "Interaction with other drugs", information should be provided on the interactions of ACE inhibitors:
- with preparations containing co-trimoxazole (trimethoprim + sulfamethoxazole) - increased risk of hyperkalemia;
- with inhibitors mTOR (mammalian Target of Rapamycin - target rapamycin in mammalian cells), for example, tamsirolimus, sirolimus, everolimus - increased risk of angioedema development;
- with inhibitors of dipeptidyl peptidase type IV (DPP)-IV) (glyptins), for example, sitagliptin, saxagliptin, vildagliptin, linagliptin - increased risk of angioedema development;
- with racecadotril (enkephalinase inhibitor, used to treat acute diarrhea) - increased risk of angioedema development;
- with estramustine - an increased risk of angioedema.
3. In the sections "Special instructions" and / or "Interaction with other drugs" in the section on the double blockade of the renin-angiotensin-aldosterone system (RAAS), it should be indicated that A) simultaneous use of ACE inhibitors with preparations containing aliskiren, is contraindicated in patients with diabetes mellitus and / or with moderate or severe renal failure (GFR less than 60 mL / min / 1.73 m2 body surface area) and is not recommended in other patients, and B) simultaneous use of ACE inhibitors with angiotensin II receptor antagonists is contraindicated in patients with diabetic nephropathy and is not recommended in other patients.