Egipres capsules 10 + 10mg, No. 30

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BIDL3179611
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Expiration Date: 05/2027

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Эгипрес капсулы 10+10мг, №30

Egipres capsules 10 + 10mg, No. 30

Arterial hypertension (patients who are indicated for combination therapy with amlodipine and ramipril in doses, as in combination).

Inside, 1 capsule. 1 time per day, at the same time, regardless of the meal.

The dose of EgipresЃ is selected after previously titrated doses of individual components of the drug: ramipril and amlodipine in patients with hypertension. The drug EgipresЃ with fixed doses of active ingredients cannot be used for initial therapy. If patients need dose adjustment, then it should be carried out only by titrating the doses of active ingredients in monotherapy. Only after this is it possible to use EgipresЃ with fixed doses of active ingredients in the combinations below.

If there is a therapeutic need, the dose of EgipresЃ can be changed on the basis of individual titration of doses of individual components: 5 mg amlodipine + 5 mg ramipril or 5 mg amlodipine + 10 mg ramipril or 10 mg amlodipine + 5 mg ramipril or 10 mg amlodipine + 10 mg ramipril.

EgipresЃ at a dose of 10 mg amlodipine + 10 mg ramipril is the maximum daily dose of the drug, which is not recommended to be exceeded. Dosages of 10 mg amlodipine + 5 mg ramipril (for amlodipine) and 5 mg amlodipine + 10 mg ramipril (for ramipril) are the maximum daily doses.

Adult patients

In patients taking diuretics, the drug should be prescribed with caution, due to the risk of imbalance in water and electrolyte balance. In these patients, kidney function and blood potassium levels should be monitored.

Elderly patients and patients with renal insufficiency. Excretion of amlodipine and ramipril and its metabolites in elderly patients and patients with renal insufficiency is slowed down. Therefore, in such patients, it is necessary to regularly monitor the content of creatinine and potassium in the blood plasma. EgipresЃ can be prescribed to patients with creatinine Cl equal to or exceeding 60 ml / min. At Cl creatinine <60 ml / min, as well as in patients with hypertension on hemodialysis, EgipresЃ is recommended only for patients who received 5 mg of ramipril, as the optimal maintenance dose during titration of the individual dose. There is no need to titrate an individual dose of amlodipine in patients with impaired renal function. EgipresЃ is contraindicated in patients with Cl creatinine <20 ml / min / 1.73 m2.The change in the concentration of amlodipine in blood plasma does not correlate with the severity of renal failure.

Patients with hepatic impairment. Care should be taken when prescribing EgipresЃ to patients with hepatic insufficiency due to the lack of recommendations for dosing the drug in such patients. EgipresЃ is recommended only for patients who received 2.5 mg of ramipril as the optimal maintenance dose during the titration of the individual dose.

Children and adolescents

EgipresЃ should not be prescribed to children and adolescents under 18 years of age due to the lack of data on the efficacy and safety of ramipril and amlodipine in these patient groups, both as monotherapy and as combination therapy.

Capsules1 caps.
active substances:
amlodipine besilate6.95 / 6.95 / 13.9 / 13.9 mg
(corresponds to amlodipine - 5/5/10/10 mg)
ramipril5/10/5/10 mg
excipients: crospovidone - 20/40/40/40 mg; hypromellose - 1.18 / 2.36 / 2.36 / 2.36 mg; MCC - 114.82 / 229.64 / 229.64 / 229.64 mg; glyceryl dibehenate - 2.05 / 4.1 / 4.1 / 4.1 mg
Capsules, 5 mg + 5 mg; hard gelatin capsule (CONI-SNAP 3), color code for cap and base - 51072: brilliant blue dye (E133), charming red dye (E129), titanium dioxide, gelatin
Capsules, 5 mg + 10 mg; hard gelatin capsule (CONI-SNAP 0), color code for cap and base - 51072/37350: cap - titanium dioxide; dye brilliant blue (E133), dye red charming (E129); gelatin; base - titanium dioxide; iron dye red oxide (E172); gelatin
Capsules, 10 mg + 5 mg; hard gelatin capsule (CONI-SNAP 0), color code for cap and base - 33007/37350: cap - titanium dioxide; dye azorubin (E122); indigo carmine (E132); gelatin; base - titanium dioxide; iron dye red oxide (E172); gelatin
Capsules, 10 mg + 10 mg; hard gelatin capsule (CONI-SNAP 0), color code for cap and base - 33007: dye azorubin (E122), indigo carmine (E132), titanium dioxide, gelatin

Amlodipine

hypersensitivity to amlodipine and other dihydropyridine derivatives;

severe arterial hypotension (SBP less than 90 mm Hg), shock (including cardiogenic);

an obstructive process that impedes the release of blood from the left ventricle (for example, clinically significant aortic stenosis);

hemodynamically unstable heart failure after myocardial infarction;

pregnancy;

breastfeeding period;

age up to 18 years (safety and effectiveness have not been determined).

Ramipril

hypersensitivity to ramipril, other ACE inhibitors;

a history of angioedema (hereditary or idiopathic, as well as associated with previous therapy with ACE inhibitors);

hemodynamically significant renal artery stenosis (bilateral or unilateral, in the case of a single kidney);

arterial hypotension (SBP less than 90 mm Hg) or conditions with unstable hemodynamic parameters;

hemodynamically significant stenosis of the aortic or mitral valve or hypertrophic obstructive cardiomyopathy;

primary hyperaldosteronism;

severe renal failure (Cl creatinine <20 ml / min / 1.73 m2);

hemodialysis (clinical experience is insufficient);

nephropathy, which is treated with corticosteroids, NSAIDs, immunomodulators and / or other cytotoxic agents (clinical experience is insufficient);

decompensated chronic heart failure (clinical experience is insufficient);

hemodialysis or hemofiltration using certain types of membranes with a negatively charged surface, such as high-flow polyacrylonitrile membranes (risk of hypersensitivity reactions);

LDL apheresis with dextran sulfate (risk of hypersensitivity reactions);

desensitizing therapy for hypersensitivity reactions to insect poisons - bees, wasps;

acute stage of myocardial infarction in patients with diseases such as severe heart failure (NYHA functional class IV); life-threatening ventricular arrhythmias; pulmonary heart;

simultaneous use of drugs containing aliskiren in patients with impaired renal function (Cl creatinine less than 60 ml / min) and patients with diabetes mellitus;

pregnancy;

breastfeeding period;

age up to 18 years (experience of clinical use is insufficient).

Amlodipine + ramipril

hypersensitivity to excipients that make up the drug;

renal failure (Cl creatinine <20 ml / min / 1.73 m2);

pregnancy;

breastfeeding period;

age up to 18 years (experience of clinical use is insufficient).

With caution for the combination of amlodipine + ramipril: atherosclerotic lesions of the coronary and cerebral arteries (danger of excessive decrease in blood pressure); an increase in the activity of the RAAS, in which, with ACE inhibition, there is a risk of a sharp decrease in blood pressure with a deterioration in renal function; severe, especially malignant hypertension; CHF, especially severe or for which other drugs with antihypertensive action are taken; hemodynamically significant unilateral renal artery stenosis (in the presence of both kidneys); previous use of diuretics; violations of the water and electrolyte balance, a decrease in the BCC (including against the background of taking diuretics, salt-free diet, diarrhea, vomiting, profuse sweating); simultaneous use with drugs containing aliskiren (with a double blockade of the RAAS, the risk of a sharp decrease in blood pressure, hyperkalemia and deterioration of renal function increases);dysfunction of the liver (lack of experience of use: it is possible both an increase and a weakening of the effects of ramipril; if patients have cirrhosis of the liver with ascites and edema, significant activation of the RAAS is possible); impaired renal function (Cl creatinine more than 20 ml / min); condition after kidney transplantation; systemic connective tissue diseases, incl. systemic lupus erythematosus, scleroderma, concomitant therapy with drugs that can cause changes in the peripheral blood picture (including allopurinol, procainamide) - it is possible to suppress bone marrow hematopoiesis, the development of neutropenia or agranulocytosis; diabetes mellitus (risk of developing hyperkalemia); old age (risk of increased antihypertensive action); hyperkalemia; hyponatremia; CHF of nonischemic etiology of III Ц IV functional class according to NYHA classification;aortic stenosis; sick sinus syndrome; mitral stenosis; arterial hypotension; the only functioning kidney; renovascular hypertension; simultaneous use of dantrolene, estramustine, potassium-sparing diuretics and potassium preparations, potassium-containing substitutes for table salt, lithium preparations; surgery / general anesthesia; performing hemodialysis using high-flow membranes (eg AN69Ѓ).performing hemodialysis using high-flow membranes (eg AN69Ѓ).performing hemodialysis using high-flow membranes (eg AN69Ѓ).

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