Walsakor - instructions for use, dose, side effects, contraindications

Excipients: lactose monohydrate 120.00 mg, cellulose microcrystalline 164,00 mg, povidone 6.00 mg, 8.00 mg of croscarmellose sodium, colloidal silicon dioxide 4.00 mg magnesium stearate 18.00 mg.

SHELL:

Hypromellose 11.20 mg, titanium dioxide (E171) 2.40 mg, ferric iron oxide yellow (E172) 1.00 mg, iron oxide red oxide (E172) 0.20 mg, macrogol-4000 1.20 mg.

Description:

Oval, biconvex tablets with a risk on one side, covered with a film coating of light brown color.

Pharmacotherapeutic group:Angiotensin II receptor antagonist

ATX: & nbsp

C.09.C.A.03 Valsartan

C.09.C.A Angiotensin II antagonists

Pharmacodynamics:

Valsartan is a selective angiotensin II receptor antagonist (type AT₁) for oral administration, non-protein nature.

Selectively blocks AT receptor subtype₁. The consequence of the blockade AT₁-receptors is an increase in the plasma concentration of angiotensin II, which can stimulate the unblocked receptors of the subtype AT₂, which presumably regulates the effects of AT₁receptors. Valsartan has no agonistic activity against AT₁receptors. Its affinity for AT subtype receptors₁ approximately 20,000 times greater than to the AT subtype receptors₂.

Valsartan does not inhibit angiotensin-converting enzyme (ACE), also known as kininase II, which converts angiotensin I into angiotensin II and breaks down bradykinin. Due to the lack of influence on ACE, the effects of bradykinin and substance P are not potentiated, therefore, when dry angiotensin II receptor antagonists (ARA II) are administered, dry cough is unlikely to develop. Valsartan does not interact and does not block the receptors of other hormones or ion channels involved in the regulation of the functions of the cardiovascular system.

Use in hypertension in patients older than 18 years

In the treatment of hypertension (AH) valsartan lowers blood pressure (BP), without affecting the heart rate (heart rate).

After ingestion of a single dose of valsartan, the antihypertensive effect develops within 2 hours, and the maximum decrease in blood pressure is achieved within 4-6 hours. The antihypertensive effect of valsartan persists for 24 hours after its administration. With repeated use of valsartan, the maximum decrease in blood pressure, regardless of dose, is achieved after 2-4 weeks and is maintained at the achieved level with prolongedtherapy. Simultaneous use with hydrochlorothiazide allows achieving a significant additional reduction in blood pressure.

The sudden discontinuation of valsartan is not accompanied by a significant increase in blood pressure or other undesirable events.

In patients with AH, type 2 diabetes and nephropathy, valsartan in a dose of 160-320 mg, there is a clinically significant decrease in proteinuria (excretion of albumin) (36-44%).

Application after acute myocardial infarction in patients older than 18 years

The use of valsartan in patients after 12 hours to 10 days after the development of acute myocardial infarction complicated by left ventricular failure and / or left ventricular systolic dysfunction (LV) for 2 years reduces the overall mortality, cardiovascular mortality and lengthens the time before the first hospitalization for worsening of the course of chronic heart failure (CHF), repeated myocardial infarction, sudden cardiac arrest and stroke (without a lethal outcome).

The safety profile of valsartan in patients with acute myocardial infarction is similar to that in other conditions.

CHF in patients older than 18 years

When valsartan is used against standard therapy (ACE inhibitors and / or diuretics and / or digoxin and / or beta-blockers) for 2 years in patients with CHF II-IV functional class (FC) by classification NYHA with a left ventricular ejection fraction (LVEF) of less than 40% and an internal end-diastolic size of the left ventricle (LVD) more than 2.9 cm / m² there is a significant reduction in the risk of primary hospitalization for worsening of the course of CHF.

In patients who do not receive ACE inhibitors, overall mortality, cardiovascular mortality and incidence associated with CHF are significantly reduced with valsartan treatment. With the use of ACE inhibitors without a beta-adrenoblocker, the cardiovascular mortality and morbidity associated with CHF are reduced. Treatment with valsartan leads to a significant decrease in FC of CHF according to the classification NYHA (including dyspnea, fatigue, edema and "wet" wheezing in the lungs), significantly improves the quality of life (the Minnesota questionnaire for assessing the quality of life of patients with CHF), increases LVEF and significantly reduces LV CRD.

Use in patients over 18 years with AH and impaired glucose tolerance

With the use of valsartan and lifestyle changes, there was a statistically significant reduction in the risk of developing diabetes in this category of patients. Valsartan did not influence the incidence of fatal outcomes as a result of cardiovascular events, myocardial infarction and ischemic attacks without a lethal outcome, the frequency of hospitalizations due to exacerbation of CHF or unstable angina, arterial revascularization in patients with impaired glucose tolerance and AH, differing in age , sex and race.

Application in children and adolescents from 6 to 18 years with AH

Children and adolescents from 6 to 18 years valsartan provides a dose-dependent, smooth decrease in blood pressure. With valsartan, the maximum reduction in blood pressure, regardless of the dose taken internally, is usually achieved within 2 weeks and maintained at the achieved level during prolonged therapy.

Pharmacokinetics:

Valsartan is rapidly absorbed after oral administration, the maximum concentration (C_mOh) in the blood plasma is achieved in 2-4 hours.

The average absolute bioavailability of valsartan is 23%.

When valsartan is used with food, the area under the concentration-time curve (AUC) decreases by 48%, although starting from about the 8th hour after taking valsartan, its concentration in the blood plasma as in the case of fasting, and in the case of food intake, are the same. Decrease AUC, nevertheless, is not accompanied by a clinically significant decrease in the therapeutic effect, therefore valsartan can be taken regardless of the time of ingestion.

Valsartan largely binds to blood serum proteins (94-97%), mainly with albumin. The equilibrium volume of the distribution of valsartan is small, about 17 liters. Valsartan is not exposed to the expressed metabolism (about 20% of the accepted dose is defined in the form of metabolites). The hydroxyl metabolite is determined in blood plasma at low concentrations (less than 10% of AUC valsartan). This metabolite is pharmacologically inactive.

Valsartan is biphasic: α-phase with half-life (T_1/2α) for less than 1 hour and the β-phase with T_1/2- about 9 hours. Valsartan is excreted mostly unchanged with bile through the intestine (about 83%) and kidneys (about 13%).After intravenous administration, the plasma clearance of valsartan is about 2 l / h and its renal clearance is 0.62 l / h (about 30% of the total clearance). T_1/2valsartan is 6 hours.

Pharmacokinetics in selected patient groups

Patients with CHF

In this category of patients, the time to reach C_max and T_1/2 similar to those of healthy volunteers. Increase AUC and C_mOh is directly proportional to an increase in the dose of valsartan (from 40 mg to 160 mg 2 times). The cumulation factor averages 1.7. When administered, the clearance of valsartan was approximately 4.5 liters / hour. The age of patients with CHF did not affect the clearance of valsartan.

Patients of advanced age (over 65 years)

In some patients over the age of 65, systemic bioavailability of valsartan is higher than that of young patients, however, the clinical significance of this is absent.

Patients with impaired renal function

Correlation between renal function and systemic bioavailability of valsartan is absent. In patients with impaired renal function and creatinine clearance (CK) of more than 10 ml / min, dose adjustment is not required. Currently, there is no data on the use in patients on hemodialysis. Valsartan has a high degree of binding to blood plasma proteins, so its elimination in hemodialysis is unlikely.

Patients with impaired hepatic function

Increased bioavailability is noted in patients with mild and moderate impairment of liver function (by value AUC) valsartan in 2 times in comparison with healthy volunteers. However, there is no correlation of the values AUC Valsartan with a degree of impaired liver function. The use of valsartan in patients with severe impairment of liver function has not been studied.

Patients 6 to 18 years of age

The pharmacokinetics of valsartan in children and adolescents 6 to 18 years old does not differ from the pharmacokinetics of valsartan in patients older than 18 years.

Indications:

Patients over 18 years of age

- Arterial hypertension.

- Chronic heart failure (II-IV functional class by classification NYHA) in patients receiving standard therapy with one or more drugs from the following groups: diuretics, cardiac glycosides, as well as ACE inhibitors or beta-blockers. The use of each of these drugs is not mandatory.

- Increased survival of patients with acute myocardial infarction,complicated with left ventricular failure and / or systolic dysfunction of the left ventricle, with stable hemodynamic parameters.

Patients 6 to 18 years of age

- Arterial hypertension in children and adolescents from 6 to 18 years.

Contraindications:

- Hypersensitivity to valsartan or other components of the drug;

- batiming and period of breastfeeding;

- aboutsimultaneous use with aliskiren in patients with diabetes mellitus or renal dysfunction (CC less than 60 ml / min);

- atozrast to 6 years - according to indications arterial hypertension, up to 18 years - according to other indications;

- dlactase inhibitor, lactose intolerance, glucose-galactose malabsorption syndrome;

- thepatic impairment of liver function (more than 9 on the Child-Pugh scale), biliary cirrhosis and cholestasis.

Carefully:

Severe renal impairment in patients older than 18 years (CC less than 10 ml / min) (no clinical data), impaired kidney function in patients between 6 and 18 years (CC less than 30 ml / min), including hemodialysis, aortic stenosis and / or mitral valve, hypertrophic obstructive cardiomyopathy (GOKMP), chronic heart failure (II - IV functional class classification NYHA), a condition after kidney transplantation, hemodialysis, hyponatremia, a diet with restricted intake of table salt, bilateral stenosis of the renal arteries or stenosis of the single kidney, hyperkalemia, primary hyperaldosteronism, conditions accompanied by a decrease in the volume of circulating blood (bcc) (including diarrhea, vomiting ), in patients with hereditary angioedema, or edema on the background of previous therapy with ARA II or ACE inhibitors, lungs (5-6 on the Child-Pugh scale) and moderate (7-9 on the Child-Pi scale ) Human liver nebiliarnogo genesis without signs of cholestasis (maximum daily dose of valsartan should not exceed 80 mg), the simultaneous use of ARA II with other drugs that inhibit the renin-angiotensin-aldosterone system (RAAS), such as ACE inhibitors and drugs containing aliskiren.

It is not recommended to use ARA II, including valsartan, concomitantly with ACE inhibitors, since their concomitant use has no advantage over monotherapy with valsartan or an ACE inhibitor in terms of overall mortality.

Pregnancy and lactation:

Given the mechanism of action of angiotensin II receptor antagonists, the risk to the fetus can not be ruled out. The drug is contraindicated in II-III trimester of pregnancy, because the use of II-III trimester of pregnancy can cause fetotoxic effects (decreased kidney function, low blood pressure, slowing ossification of the fetal bones) and neonatal toxic effects (renal failure, arterial hypotension, hyperkalemia). If nevertheless used the drug in II-III trimesters of pregnancy, it is necessary to conduct ultrasound examination of the kidneys and bones of the fetal skull.

The drug Valsacor ®, like any other drug that directly affects RAAS, should not be used during pregnancy, as well as in women planning pregnancy. When planning pregnancy, it is recommended that the patient be transferred to alternative antihypertensive therapy, taking into account the safety profile. When using agents that affect RAAS, it is necessary to inform women of childbearing age of the potential risk of adverse effects of these drugs on the fetus during pregnancy.When confirming pregnancy, the preparation Valsacor® should be canceled as soon as possible.

It is not known whether valsartan in breast milk. If you need to use Valsacor® during lactation, breastfeeding should be discontinued. The use of valsartan did not adversely affect reproductive function in males and female rats at doses up to 200 mg / kg / day when ingestion. This dose is 6 times higher than the maximum recommended daily human dose in terms of mg / m² (calculations were made at the rate of 320 mg / day for ingestion and body weight of the patient 60 kg).

Dosing and Administration:

Inside, regardless of the time of ingestion, not chewing, once a day.

Patients over 18 years of age

Arterial hypertension

The use of the drug Valsacor ® is possible in a dose of 40 mg, 80 mg, 160 mg, 320 mg. The recommended initial dose is 80 mg once a day, regardless of race, age and sex of the patient. The antihypertensive effect develops within 2 weeks of therapy and reaches its maximum after 4 weeks. In patients who can not achieve optimal BP control, the daily dose of Valsacor® can be gradually increased to a maximum daily dose of 320 mg.Simultaneous use of diuretics, for example hydrochlorothiazide, allows achieving a significant additional reduction in blood pressure.

Chronic heart failure (II-IV FC by classification NYHA)

The recommended initial dose of Valsacor® is 40 mg twice a day. The dose of the drug should be increased gradually for at least two weeks to 80 mg twice a day, and with good tolerability - up to 160 mg 2 times a day. The maximum daily dose of 320 mg in two divided doses. With the simultaneous administration of diuretics, the dose should be reduced. It may be used concomitantly with other drugs intended for the treatment of CHF. However, the combination of an ACE inhibitor, a beta-blocker and valsartan is not recommended. Patients with CHF should always evaluate the kidney function.

Increased survival of patients with acute myocardial infarction

In patients with stable hemodynamics, treatment should be started within 12 hours after myocardial infarction. The initial dose is 20 mg (1/2 tablet 40 mg of the preparation Valsacor ®) 2 times a day, then the dose is increased by titration up to 40 mg, 80 mg twice a day for several weeks, until the target dose of 160 mg 2 times per day. The maximum daily dose is 320 mg in 2 divided doses.

As a rule, taking into account the tolerability of therapy, it is recommended to increase the dose to 80 mg twice a day by the end of the second week of treatment and to the maximum target dose of 160 mg twice a day - by the end of the third month of therapy. In the case of symptomatic arterial hypotension or renal dysfunction, it is advisable to consider the question of dose reduction.

The drug Valsacor ® can be used in patients after myocardial infarction against the background of therapy with other drugs, including thrombolytics, acetylsalicylic acid as antiplatelet agents, beta-blockers, HMG-CoA reductase inhibitors (statins) and diuretics. Use the drug Valsacor⁸ simultaneously with ACE inhibitors and other drugs that inhibit RAAS, is not recommended.

In patients with myocardial infarction, renal function should always be evaluated.

Special patient groups

Patients of advanced age (over 65 years)

For elderly patients, dose adjustment is not required.

Impaired renal function

Patients with impaired renal function are not required to adjust the dose.

Impaired liver function

Patients with lungs (5-6 points on the Child-Pugh scale) or moderate (7-9 points on the Child-Pugh scale) with violations of the liver function of non-biliary origin without the phenomena of cholestasis, the preparation Valsacor® in a dosage of 320 mg is contraindicated, since the maximum daily dose is not should exceed 80 mg.

Patients 6 to 18 years of age

Arterial hypertension

The recommended initial dose of the drug is Valsacor^® in children and adolescents from 6 to 18 years is 40 mg with a body weight of the child less than 35 kg and 80 mg with a body weight of the child more than 35 kg. It is recommended to adjust the dose taking into account the decrease in blood pressure. The maximum recommended daily doses are shown in the table below. The use of higher doses is not recommended.

Body mass	The maximum recommended daily dose
≥ 8 kg <35 kg	80 mg
≥ 35 kg <80 kg	160 mg
≥ 80 kg ≤ 160 kg	320 mg

CHF and transferred acute myocardial infarction

Valsacor® is not recommended for the treatment of CHF and acute myocardial infarction in patients under 18 years of age.

Special patient groups

Impaired renal function

The safety of valsartan in children 6 to 18 years of age with a QC of less than 30 ml / min or those on hemodialysis has not been studied. Therefore, the use of Valsacor® in these patients is not recommended.Children from 6 to 18 years with a QC greater than 30 ml / min dose adjustment of Valsacor® is not required. Kidney function and serum potassium content should be carefully monitored.

Impaired liver function

Preparation Valsacor^® contraindicated for children 6 to 18 years with severe impaired liver function (more than 9 on the Child-Pugh scale), biliary cirrhosis or cholestasis. The clinical experience of using valsartan in children with a lung (5-6 points on the Child-Pugh scale) and moderate (7-9 on the Child-Pugh scale) is a violation of the liver function of non-biliary genesis without the phenomena of cholestasis. The maximum daily dose of valsartan in such patients should not exceed 80 mg.

Side effects:

The incidence of adverse events (AEs) is comparable to placebo. There is no data on the dependence of the incidence of AE on the dose or duration of treatment, as well as the age, sex or race of patients. The safety profile of valsartan in patients with AH at the age of 6 to 18 years does not differ from the safety profile of valsartan in patients with AH older than 18 years.

Classification of the frequency of development of side effects of the World Health Organization (WHO):

very often - ≥1 / 10

often from ≥ 1/100 to <1/10

infrequently - from ≥ 1/1000 to <1/100

rarely from ≥ 1/10000 to <1/1000

very rarely - from <1/10000

frequency is unknown - can not be estimated from the available data.

All AE valsartan, identified in clinical practice and in the analysis of laboratory indicators can not be attributed to any frequency of occurrence, so they are referred to the group "frequency is unknown."

Arterial hypertension

From the hematopoiesis:

frequency is unknown: a decrease in hemoglobin, hematocrit, neutropenia, thrombocytopenia.

From the immune system:

frequency is unknown: hypersensitivity reactions, including serum sickness.

From the side of metabolism:

frequency is unknown: increased serum potassium, hyponatremia.

From the sense organs:

infrequently: vertigo.

From the cardiovascular system:

frequency unknown: vasculitis.

From the respiratory system:

infrequently: cough.

From the digestive system:

infrequently: abdominal pain;

the frequency is unknown: a violation of the liver, including an increase in the concentration of bilirubin in the blood plasma.

From the skin:

very rarely: angioedema, skin rash, itching;

frequency unknown: bullous dermatitis.

From the musculoskeletal system:

frequency unknown: myalgia.

From the genitourinary system:

frequency unknown: impaired renal function, increased serum creatinine concentration.

Other:

infrequently: increased fatigue.

In the course of clinical trials, the following AEs were also observed in patients with AH (cause-and-effect relationship with the drug was not established): arthralgia, asthenia, back pain, diarrhea, dizziness, insomnia, decreased libido, nausea, peripheral edema, pharyngitis, rhinitis, sinusitis, upper respiratory tract infections, viral infections.

In adults with acute myocardial infarction and / or CHF, the safety profile in clinical trials differs somewhat from that in patients with AH. This may be due to the disease itself.

Chronic heart failure (II-IV FC by classification NYHA) and survival of patients with acute myocardial infarction

From the hematopoiesis:

frequency unknown: thrombocytopenia.

From the immune system:

frequency is unknown: hypersensitivity reactions, including serum sickness.

From the side of metabolism:

infrequently: hyperkalemia;

frequency is unknown: increased serum potassium, hyponatremia.

From the nervous system:

often: dizziness, orthostatic (postural) dizziness; infrequently: faint, headache.

From the sense organs:

infrequently: vertigo.

From the cardiovascular system:

often: marked decrease in blood pressure, orthostatic hypotension;

infrequently: increased symptoms of heart failure;

frequency unknown: vasculitis.

From the respiratory system:

infrequently: cough.

From the digestive system:

infrequently: nausea, diarrhea;

frequency unknown: impaired liver function.

From the skin and subcutaneous tissue:

very rarely: angioedema;

frequency unknown: skin rash, skin itching, bullous dermatitis.

From the musculoskeletal system:

very rarely: rhabdomyolysis;

frequency unknown: myalgia.

From the genitourinary system:

often: impaired renal function;

infrequently: acute renal failure, increased serum creatinine concentration;

frequency is unknown: increase in the concentration of residual urea nitrogen in the blood serum.

Other:

infrequently: asthenia, increased fatigue.

Also, in the course of clinical studies, the following AEs were observed in patients after acute myocardial infarction and / or CHF (causal relationship with valsartan was not established): arthralgia, abdominal pain, back pain, asthenia, insomnia, decreased libido, neutropenia , peripheral edema, pharyngitis, rhinitis, sinusitis, upper respiratory tract infections, viral infections.

Overdose:

Symptoms: a marked decrease in blood pressure, which can lead to impaired consciousness, collapse and / or shock.

Treatment: Symptomatic, the nature of which depends on the time elapsed since the time of taking the drug, and on the severity of the symptoms. In case of an accidental overdose, you should induce vomiting (if the drug was taken recently) or to wash the stomach.

With a pronounced decrease in blood pressure, it is necessary to transfer the patient to the "lying" position on the back with the legs raised upwards; further, it is necessary to carry out activities aimed at maintaining the functions of the cardiovascular and respiratory systems, BCC (introduction 0.9% solution of sodium chloride intravenously) and daily diuresis control.

Hemodialysis is ineffective.

Interaction:

Simultaneous use is contraindicated

The simultaneous use of ARA II, including valsartan, or ACE inhibitors with aliskiren is contraindicated in patients with diabetes mellitus or renal dysfunction (CC less than 60 ml / min).

Simultaneous use is not recommended

Lithium

Simultaneous use with lithium preparations is not recommended, since a reversible increase in the concentration of lithium in the blood plasma and the development of intoxication are possible. The simultaneous use of valsartan with diuretics and lithium preparations may further increase the concentration of lithium and increase the risk of intoxication. If it is necessary to simultaneously apply with lithium preparations, the concentration of lithium in the blood plasma should be carefully monitored.

Potassium-sparing diuretics (spironolactone, eplerenone, triamterene, amiloride), potassium preparations, potassium-containing food additives and other medicines and substances that can increase serum potassium (for example, heparin)

If it is necessary to simultaneously apply with drugs that affect the potassium content, it is recommended to monitor the potassium content in the blood plasma.

Use with caution at the same time

Double blockade of RAAS

In some patients, double blockade of RAAS was accompanied by the development of arterial hypotension, syncope, hyperkalemia, and renal dysfunction (including acute renal failure). Care must be taken when using ARA II simultaneously, including valsartan with drugs that affect RAAS, such as ACE inhibitors or aliskiren.

Non-steroidal anti-inflammatory drugs (NSAIDs), including selective inhibitors of cyclooxygenase-2 (COX-2), acetylsalicylic acid in a dose of more than 3 g / day and nonselective NSAIDs

With simultaneous use, it is possible to weaken the antihypertensive effect, increase the risk of kidney dysfunction and increase the potassium content in the blood plasma. At the beginning of therapy it is recommended to evaluate the function of the kidneys, and also to correct the disturbances of the water-electrolyte balance.

Protein Transfer Inhibitors

By the results of the study in vitro Valsartan is a substrate for the hepatic carrier proteins OATP1B1 / OATP1B3 and MRP2. The clinical significance of this fact is unknown.Simultaneous application of inhibitors of protein-transporter proteins OATP1B1 / OATP1B3 (for example, rifampicin, ciclosporin) and MRP2 (e.g., ritonavir) can increase the systemic exposure of valsartan (C_mOh and AUC). This should be taken into account at the beginning and at the end of the simultaneous therapy.

Lack of drug interaction

There were no clinically significant interactions with the following drugs: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine and glibenclamide.

Patients 6 to 18 years of age

In children and adolescents, AH is often associated with impaired renal function. The simultaneous use of valsartan with other drugs that affect RAAS can cause an increase in the potassium content in the blood plasma in such patients. Care should be taken when applying the above combination at the same time and regularly monitoring the kidney function and the potassium content of the blood plasma in this group of patients.

Special instructions:

When using Valsacor® in patients with AH, regular monitoring of laboratory parameters is not required.

Hyponatremia and / or dehydration

In patients with severe hyponatraemia and / or dehydration, for example, due to the administration of large doses of diuretics, in rare cases at the beginning of therapy with Valsacor®, hypotension with clinical manifestations may develop. Before the start of treatment, it is recommended to restore the sodium content and / or replenish the BCC, in particular by reducing the dose of diuretics.

With the development of arterial hypotension with clinical manifestations: the patient should be given a horizontal position and, if necessary, intravenously enter a 0.9% solution of sodium chloride. Therapy with Valsacor® can be continued only after the hemodynamic parameters are stabilized.

Hyperkalemia

Simultaneous use of potassium-sparing diuretics (spironolactone, eplerenone, triamterene, amiloride), potassium preparations, potassium-containing food additives or other drugs capable of increasing the serum potassium content (eg, heparin) is not recommended. It is necessary to monitor the potassium content in the blood plasma.

Stenosis of the renal artery

The short-term use of valsartan in patients with reno- vascular hypertension,which developed secondary due to unilateral stenosis of the artery of a single kidney, was not accompanied by significant changes in renal hemodynamics, creatinine or urea nitrogen in the blood serum. Since other drugs that affect RAAS are capable of increasing serum urea and creatinine concentrations in patients with bilateral renal artery stenosis or arterial stenosis of a single kidney, it is recommended to monitor these parameters as a precautionary measure.

Condition after kidney transplantation

The safety of Valsacor® in patients who have recently undergone kidney transplantation has not been established.

Primary hyperaldosteronism

Patients with primary hyperaldosteronism are resistant to antihypertensive drugs that affect RAAS; therefore, such patients are not recommended for using Valsacor®.

Stenosis of aortic and / or mitral valves, GOKMP

The drug Valsacor® should be used with caution in patients with hemodynamically significant stenosis of the aortic and / or mitral valves or with GOKMP.

Impaired renal function

Patients with impaired renal function do not need to change the dose of the drug. Because there is no data on the use of the drug in severe renal failure (CC less than 10 ml / min or 0.167 ml / s) and in patients on hemodialysis, in such cases, the drug is recommended to use with caution.

The simultaneous use of ARA II, including valsartan, or ACE inhibitors with aliskirenom is contraindicated in patients with impaired renal function (CC less than 60 ml / min).

Impaired liver function

Patients with mild or moderate impairment of the non-biliary liver function without the phenomena of cholestasis, the preparation Valsacor® at a dosage of 320 mg is contraindicated, since the maximum daily dose should not exceed 80 mg.

Angioedema in history

Among patients with angioneurotic edema (edema of the larynx and vocal cords causing airway obstruction and / or swelling of the face, lips, pharynx and / or tongue) against the background of therapy with Valsacor®, there have been cases of angioedema development in the anamnesis, including ACE inhibitors. When developing angioedema, immediately discontinue the drug and exclude the possibility of repeated use.

Arterial hypertension

With AH, the preparation Valsacor® can be used in monotherapy or simultaneously with other antihypertensive drugs, in particular with diuretics.

CHF / survival of patients with acute myocardial infarction

It is possible to use the drug Valsacor ® in combination with other drugs used in acute myocardial infarction (thrombolytics, acetylsalicylic acid as an antiplatelet agent, beta-blockers and inhibitors of HMG-CoA reductase (statins)). Simultaneous use of the preparation Valsacor® and ACE inhibitors in this category of patients is not recommended, since this combination therapy does not lead to an additional clinical effect and is accompanied by an increased risk of developing adverse events compared with therapy with two drugs alone.

In patients with CHF, triple combination therapy: the preparation Valsacor®, ACE inhibitor and beta-blocker is not recommended, since it does not lead to an additional clinical effect and is accompanied by an increased risk of developing adverse events.

The use of Valsacor® in patients with heart failure or acute myocardial infarction often results in a slight decrease in blood pressure, usually without withdrawal of the drug when the dosage instruction is followed.

Patients whose renal function may be affected by RAAS activity (eg in patients with CHF II-IV FC by classification NYNA), therapy with ACE inhibitors and APA II is accompanied by oliguria and / or augmentation of azotemia, and in rare cases acute renal failure and / or lethal outcome. Because the valsartan is ARA II, one can not exclude the possibility of impaired renal function when it is applied.

Initiate therapy in patients with heart failure or acute myocardial infarction should be cautious. When examining patients, kidney function should always be evaluated.

Special information on excipients

The drug Valsacor® contains lactose, therefore the drug is contraindicated in patients with lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome.

Effect on the ability to drive transp. cf. and fur:

Care must be taken when driving vehicles and engaging in potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions, since it is possible to develop dizziness or weakness on the background of arterial hypotension.

Form release / dosage:

Film-coated tablets, 320 mg.

Packaging:

For 10, 14 or 15 tablets in a blister of the combined material PVC / PE / PVDC - aluminum foil.

For 2, 3 or 14 blisters (10 tablets), or 1, 2, 4, 7 or 10 blisters (14 tablets), or 2 blisters (15 tablets) together with the instructions for use are put in a cardboard box.

For 20, 50 or 56 blisters (10 tablets each), or 40 blisters (14 tablets) together with instructions for use are put in a cardboard box (for hospitals).

Storage conditions:

At a temperature of no higher than 25 ° C, in the original packaging.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002303

Date of registration:08.11.2013 / 27.06.2014

Expiration Date:08.11.2018

The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Manufacturer: & nbsp

KRKA, d.d. Slovenia

Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Information update date: & nbsp20.01.2017

Illustrated instructions

Instructions

Valsacor® (Valsacor® )