In the course of preparation of requirements to safety, effectiveness of medicines based on modern scientifically grounded information on the clinical experience of monocomponent and combined drugs containing as an active substance or one of the active substances antagonists of angiotensin II receptors (APA II) regardless of the dosage form , it was found necessary to bring the approved instructions for medical use into compliance with the following requirements:
1. The section "Contraindications" should contain the following information:
- "Simultaneous use with aniseren 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 ACE inhibitors in patients with diabetic nephropathy."
2. Sections "Specific guidance" and / or "interaction with other drugs" in the subsection on dual blockade of the renin-angiotensin-aldosterone system (RAAS) should be specified that a) the simultaneous use of the angiotensin II receptor antagonist 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 are not recommended for other patients, and B) the simultaneous use of angiotensin receptor antagonists II with ACE inhibitors is contraindicated in patients with diabetic nephropathy and is not recommended in other patients.