CO-DALNEVA PILLS 10MG + 2.5MG + 8MG

1 pill 5 mg + 0.625 mg + 2 mg contains:

Active ingredients:

Amlodipine besylate (amlodipine besylate) 6.935 mg, which is equivalent to Amlodipine 5 mg Indapamide 0.625 mg

Perindopril erbumin B substance-granules 10,206 mg

[The active substance of the substance-granules: Perindopril erbumin 2,000 mg

1 pill 5 mg + 1.25 mg + 4 mg contains:

Active ingredients:

Amlodipine besylate (amlodipine besylate) 6.935 mg, equivalent to amlodipine 5 mg Indapamide 1.250 mg

Perindopril erbumin B substance-granules 20.412 mg

[The active substance of the substance-granules: perindopril erbumin 4,000 mg

1 pill 10 mg + 1.25 mg + 4 mg contains:

Active ingredients:

Amlodipine besylate (amlodipine besylate) 13.870 mg, equivalent to amlodipine 10 mg

Indapamide 1,250 mg

Perindopril erbumin B substance-granules 20.412 mg

[The active substance of the substance-granules: perindopril erbumin 4,000 mg

1 pill 5 mg + 2.5 mg + 8 mg contains:

Active ingredients:

Amlodipine besylate (amlodipine besylate) 6.935 mg, equivalent to amlodipine 5 mg Indapamide 2,500 mg

Perindopril erbumin B substance-granules 40,824 mg

[The active substance of the substance-granules: perindopril erbumin 8,000 mg

1 pill 10 mg + 2.5 mg + 8 mg contains:

Active ingredients:

Amlodipine besylate (amlodipine besylate) 13.870 mg, equivalent to amlodipine 10 mg

Indapamide 2,500 mg

Perindopril erbumin B substance-granules 40,824 mg

[The active substance of the substance-granules: perindopril erbumin 8,000 mg

Therapeutic indications

Arterial hypertension (if necessary, simultaneous therapy with amlodipine, indapamide and perindopril in doses used in the monotherapy of individual components).

Dosage and administration

Inside, on 1 pill once a day, preferably in the morning, before meals.

The dose of Ko-Dalneva® is selected after a previous titration of doses of individual active ingredients of the drug.

The maximum daily dose of Co-Dalnev® is 10 mg of amlodipine + 2.5 mg of indapamide + 8 mg of perindopril.

Elderly patients and patients with impaired renal function

Co-Dalneva® is contraindicated for use in patients with severe renal dysfunction (CC less than 30 ml / min) (see section “Contraindications”). Co-Dalneva® can be used in patients with moderate renal dysfunction (CC 30-60 ml / min). Such patients are recommended individual selection of doses of amlodipine, indapamide, perindopril.

For patients with impaired renal function (CC is 60 ml / min or more) dose adjustment is not required. Amlodipine, used in equivalent doses, is equally well tolerated by patients of both elderly and younger age. It is not necessary to change the dosing regimen in elderly patients, but the dose should be increased with caution, which is associated with age-related changes and T1 / 2 lengthening.Changes in the concentration of amlodipine in the blood plasma do not correlate with the severity of renal failure. Amlodipine is not dialyzed.

The elimination of perindoprilat in elderly patients and patients with renal insufficiency is slow. Therefore, in such patients it is necessary to regularly monitor the concentration of creatinine and the content of potassium in the blood plasma.

Patients with impaired liver function

Co-Dalneva® is contraindicated in patients with severe hepatic insufficiency (see section “Contraindications”).

Caution must be exercised when using the drug in patients with mild and moderate liver dysfunction.

Contraindications

• Hypersensitivity to amlodipine and other dihydropyridine derivatives, indapamide and other sulfonamide derivatives, perindopril and other ACE inhibitors, as well as to the excipients that make up the drug.
• Angioedema (angioedema) in history, associated with taking ACE inhibitors.
• Hereditary / idiopathic angioedema.
• Severe arterial hypotension (systolic blood pressure less than 90 mm Hg. Art.).
• Shock, including cardiogenic shock.
• Obstruction of the output tract of the left ventricle (for example, clinically significant aortic stenosis).
• Hemodynamically unstable heart failure after acute myocardial infarction.
• Severe renal failure (CC less than 30 ml / min).
• Severe hepatic impairment, including hepatic encephalopathy.
• Refractory hypokalemia.
• Simultaneous use with aliskiren or drugs containing aliskiren in patients with diabetes and / or moderate or severe renal impairment (glomerular filtration rate (GFR) of less than 60 ml / min / 1.73 m2 of body surface area).
• Concurrent use with angiotensin II receptor antagonists (ARA II) in patients with diabetic nephropathy.
• Pregnancy and breastfeeding period (see section “Use during pregnancy and during breastfeeding”).
• Age up to 18 years (efficacy and safety have not been established).

Given the lack of sufficient clinical experience, should not be used in patients on hemodialysis, as well as in patients with untreated heart failure in the stage of decompensation.

Carefully

Hepatic failure mild to moderate severity, moderately severe renal failure (CC 30-60 ml / min), systemic connective tissue diseases (including systemic lupus erythematosus, scleroderma), bilateral renal artery stenosis, single kidney stenosis, immunosuppressant therapy, Allopurinol, procainamide (risk of developing neutropenia and agranulocytosis), simultaneous use with drugs that can cause polymorphic ventricular tachycardia such as "pirouette",simultaneous use with potassium-sparing diuretics, potassium and lithium preparations, simultaneous use of drugs extending the QT interval, hyperkalemia, suppression of bone marrow hematopoiesis, reduced volume of circulating blood unstable angina (with the exception of Prinzmetal stenocardia), atherosclerosis, cerebrovascular diseases, renovascular hypertension, diabetes mellitus, chronic heart failure tolerance (III-IV functional class according to the NYHA classification), acute myocardial infarction (within 1 month after myocardial infarction), sick sinus syndrome combination with gout and urate nephrolithiasis), hyperparathyroidism, simultaneous use of dantrolen, estramustine, simultaneous use with inducers and / or inhibitors of the isoenzyme CYP3A4, surgery / general anesthesia, blood lability, check hemodialysis using high-flow membranes (for example, AN69®), before the procedure of low density lipoprotein apheresis (LDL) using dextran sulfate, simultaneous desensitization therapy with allergens (eg, hymenoptera), a condition after kidney transplantation, aortic stenosis, mitral stenosis,hypertrophic obstructive cardiomyopathy (GOKMP), congenital deficiency of glucose-6-phosphate dehydrogenase, use in elderly patients and in patients of the Negroid race.

Special instructions and precautionary measures

Co-Dalneva®

Renal dysfunction

Co-Dalneva® is contraindicated in patients with severe renal impairment (CC less than 30 ml / min).

Co-Dalneva® can be used in patients with moderate renal dysfunction (CC 30-60 ml / min). Such patients are recommended individual selection of doses of amlodipine, indapamide, perindopril.

In some patients with hypertension without previous obvious renal dysfunction during therapy, laboratory signs of functional renal failure may appear. In this case, drug treatment should be discontinued. In the future, you can resume combination therapy using low doses of a combination of perindopril and indapamide, or use these drugs separately. Such patients require regular monitoring of the potassium content and serum creatinine concentration 2 weeks after the start of therapy and every 2 months thereafter.

In patients with bilateral renal artery stenosis or arterial stenosis of the only functioning kidney during therapy with ACE inhibitors, it is possible to increase the concentration of urea and creatinine in the blood serum, usually taking place when therapy is canceled.

The development of renal failure occurs more often in patients with severe CHF or an initial impairment of renal function, including renal artery stenosis.

Hypotension and impaired water-electrolyte balance

Patients with hyponatremia (especially with renal artery stenosis, including bilateral) have a risk of sudden development of arterial hypotension. Therefore, one should pay attention to possible symptoms of dehydration and reduction of electrolytes in the blood plasma, for example, after diarrhea or vomiting. The use of ACE inhibitors causes a blockage of the RAAS and therefore may be accompanied by a sharp decrease in blood pressure and / or an increase in plasma creatinine, which indicates the development of functional renal failure. These phenomena are more often observed when taking the first dose of the drug or during the first two weeks of therapy and sometimes develop acutely. Such patients require regular monitoring of the plasma electrolyte content. In severe hypotension, intravenous administration of 0.9% sodium chloride solution may be required. Transient arterial hypotension is not a contraindication for continued therapy. After the restoration of circulating blood volume (BCC) and blood pressure, treatment can be resumed using low doses of perindopril and indapamide, or used separately.

Elderly patients

Before you start taking Co-Dalnev®, it is necessary to evaluate the functional activity of the kidneys and the content of potassium in the blood plasma. At the beginning of therapy, the dose of the drug is selected, taking into account the degree of decrease in blood pressure, especially in the case of a decrease in BCC and loss of electrolytes, thus avoiding a sharp decrease in blood pressure.

Atherosclerosis

The risk of developing hypotension exists in all patients, however, special care should be taken in patients with coronary heart disease (CHD) and cerebrovascular diseases. In these patients, treatment begins with low doses of the drug.

Children

Co-Dalneva® is contraindicated for use in children under 18 years of age due to the lack of data on efficacy and safety in this age group.

Amlodipine

During the period of treatment with amlodipine, it is necessary to control body weight and sodium intake, the appointment of an appropriate diet. It is necessary to maintain dental hygiene and observation at the dentist (to prevent pain, bleeding and gum hyperplasia).

Patients with low body mass, patients of short stature and patients with severe liver dysfunction may require a lower dose.

CHF

In patients with CHF (III and IV functional class according to the NYHA classification), treatment is carried out with caution, due to the possibility of pulmonary edema. BMCC, including amlodipine, should be used with caution in patients with CHF, due to the possible increased risk of cardiovascular events and mortality.

Liver dysfunction

In patients with impaired liver function T1/2 and amlodipine AUC increases. Reception of an amlodipin should be begun with the lowest doses and to be careful both at the beginning of therapy, and at an increase in a dose of an amlodipin.Patients with severe impaired liver function should be gradually increased, careful monitoring of the clinical condition is necessary.

Elderly patients

Elderly patients may increase T1/2 and decrease clearance of amlodipine. Dose adjustment is not required, but careful monitoring of patients is necessary.

Indapamide

In the presence of abnormal liver function, the administration of thiazide and thiazide-like diuretics can lead to the development of hepatic encephalopathy. In this case, you should immediately stop taking the drug.

Photosensitivity

While receiving thiazide and thiazide-like diuretics, photosensitivity reactions have been reported. In the event of a photosensitivity reaction, treatment should be discontinued. If you need to continue diuretic therapy, it is recommended to protect the skin from exposure to sunlight or artificial UV rays.

Water and electrolyte balance

Sodium content in blood plasma

Prior to treatment, it is necessary to determine the sodium content in the blood plasma. While taking the drug, this indicator should be regularly monitored. All diuretics can cause hyponatremia, which sometimes leads to serious complications. At the initial stage of therapy, a decrease in sodium content in the blood plasma may be asymptomatic, therefore regular laboratory monitoring is necessary.Elderly patients show more frequent monitoring contained