Aprovask tablets 10 + 150mg, No. 28

Arterial hypertension (with the ineffectiveness of monotherapy with irbesartan or amlodipine).

Inside. The tablet is swallowed with water. The drug AprovaskЃ can be taken both simultaneously with a meal and on an empty stomach (i.e., regardless of the meal time).

Adults. Usually, the initial and maintenance dose of AprovaskЃ is 1 tablet / day. AprovaskЃ should be used in patients who fail to achieve target blood pressure values ??with irbesartan monotherapy or amlodipine monotherapy, or to continue treatment in patients who are already taking irbesartan and amlodipine as separate tablets. Doses should be selected individually, first with the use of separate preparations of irbesartan and amlodipine. Doses are selected depending on the response of blood pressure to the therapy and the target blood pressure. The maximum recommended dose of AprovaskЃ is 10 + 150 or 10 + 300 mg / day (due to the fact that the maximum daily dose of amlodipine is 10 mg).

Children. The safety and efficacy of AprovaskЃ have not been established.

Elderly patients and impaired renal function. Usually there is no need to reduce doses in elderly patients (see 'Pharmacodynamics') and patients with impaired renal function.

Liver dysfunction. The drug AprovaskЃ should be used with caution, due to the presence of amlodipine in the drug (see 'Contraindications', With caution and 'Special instructions').

hypersensitivity to irbesartan, amlodipine and other dihydropyridine derivatives, as well as excipients of the drug;

cardiogenic shock;

clinically significant aortic stenosis;

unstable angina (with the exception of Prinzmetal's angina);

simultaneous use with drugs containing aliskiren in patients with diabetes mellitus or with moderate to severe renal failure (glomerular filtration rate (GFR) <60 ml / min / 1.73 m2 of body surface) (see 'Interaction' and Special instructions');

simultaneous use with ACE inhibitors in patients with diabetic nephropathy (see 'Interaction' and 'Special instructions');

pregnancy;

breastfeeding period;

age up to 18 years (efficacy and safety have not been established).

With care: hypovolemia and hyponatremia, arising, for example, with intensive treatment with diuretics, hemodialysis, adherence to a diet with limited salt intake, diarrhea, vomiting (danger of excessive decrease in blood pressure, see 'Special instructions'); patients whose renal function depends on the activity of the RAAS (including with arterial hypertension with renal artery stenosis of one or both kidneys, chronic heart failure III-IV functional class according to the NYHA classification), treatment with drugs affecting the RAAS was associated with the development of oliguria and / or progressive azotemia and rarely - acute renal failure and / or death, the risk of which cannot be excluded when taking ARAII, including irbesartan) (see 'Special instructions');chronic heart failure II-IV functional class according to the NYHA classification of non-ischemic etiology (due to the content of amlodipine in the composition of the drug, the use of which in such patients was associated with an increase in reports of the development of pulmonary edema compared with placebo, despite the absence of differences in the rate of progression of cardiac insufficiency) (see 'Special instructions'); liver failure (risk of increased T1 / 2 of amlodipine - see 'Special instructions'); renal failure and after kidney transplantation (due to the content of irbesartan in the drug, it is recommended to control the potassium content and the concentration of creatinine in the blood); after a recent kidney transplant (lack of experience with the clinical use of irbesartan);aortic or mitral valve stenosis or hypertrophic obstructive cardiomyopathy; ischemic heart disease and / or clinically significant atherosclerosis of the cerebral vessels (with an excessive decrease in blood pressure, there is a risk of increased ischemic disorders, up to the development of acute myocardial infarction and stroke); sick sinus syndrome (due to the content of amlodipine in the drug).