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

Excipients: lactose monohydrate 15.00 mg, microcrystalline cellulose 20.50 mg, povidone-K25 0.75 mg, croscarmellose sodium 1.00 mg, silicon dioxide colloid 0.50 mg, magnesium stearate 2.25 mg.

Film sheath: hypromellose 6sp 1.38 mg, titanium dioxide (E171) 0.27 mg, iron dye oxide yellow (E172) 0.20 mg, macrogol-4000 0.15 mg.

for 1 tablet of 80 mg, film-coated:

Core:

Active substance: valsartan 80.00 mg;

Excipients: lactose monohydrate 30.00 mg, microcrystalline cellulose 41.00 mg, povidone-K25 1.50 mg, croscarmellose sodium 2.00 mg, silicon dioxide colloid 1.00 mg, magnesium stearate 4.50 mg.

Film sheath: hypromellose 6sr 3.00 mg, titanium dioxide (E171) 0.68 mg, iron dye red oxide (E172) 0.02 mg, macrogol-4000 0.30 mg.

for 1 tablet 160 mg, film-coated:

Core:

Active substance: valsartan 160.00 mg;

Excipients: lactose monohydrate 60.00 mg, microcrystalline cellulose 82.00 mg, povidone-K25 3.00 mg, croscarmellose sodium 4.00 mg, silicon dioxide colloid 2.00 mg, magnesium stearate 9.00 mg.

Film sheath: (E171) 1.36 mg, iron dye oxide yellow (E172) 0.50 mg, ferric iron oxide red (E172) 0.02 mg, macrogol-4000 0.60 mg

Description:

Tablets 40 mg: round, slightly biconcave tablets with a risk on one side, covered with a film coating of a brownish-yellow color. View of the fracture: a white rough mass with a film coating of a brownish-yellow color.

Tablets 80 mg: round, biconcave tablets with a risk on one side, covered with a film shell of pink color. View of the fracture: a white rough mass with a film shell of pink color.

Tablets 160 mg: oval, biconvex tablets with a risk on one side, covered with a film coating of a brownish-yellow color. View of the fracture: a white rough mass with a film coating of a brownish-yellow 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 AT₁-receptors. The consequence of the blockade AT₁-receptors is an increase in the plasma concentration of angiotensin II, which can stimulate unlocked AT₂-receptors, which balances the vasopressor effects associated with excitation AT₁receptors. Valsartan has no agonistic activity against AT₁receptors. His affinity for AT₁-receptors are approximately 20 000 times higher than for AT₂receptors.

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. The frequency of development of dry cough is lower in patients receiving angiotensin II receptor antagonists (ARA II), in comparison with patients receiving an ACE inhibitor. 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 in 4-6 hours. The antihypertensive effect of valsartan persists for 24 hours after its administration.With the constant 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 during prolonged therapy. Simultaneous use with hydrochlorothiazide allows achieving a significant additional reduction in blood pressure.

Sudden abolition of valsartan is not accompanied by a sharp increase in blood pressure or other undesirable clinical consequences (that is, the "cancellation" syndrome does not develop). In patients with AH, diabetes mellitus (DM) type 2 and nephropathy, taking valsartan in a dose of 160-320 mg / day there is a significant decrease in proteinuria (36-44%).

Application after acute myocardial infarction in patients older than 18 years

With the use of valsartan for 2 years, with the onset of admission from 12 hours to 10 days after the development of myocardial infarction (myocardial infarction (complicated by left ventricular failure and / or left ventricular systolic dysfunction), the overall mortality, cardiovascular mortality decreases and the time lengthens before the first hospitalization for exacerbation of the course of chronic heart failure (CHF), repeated MI, sudden cardiac arrest and stroke (without death).

CHF in patients older than 18 years

When valsartan was used (at an average daily dose of 254 mg) for 2 years in patients with CHF II-IV functional class by classification NYHA with a left ventricular ejection fraction (LVEF) of less than 40% and an internal diastolic diameter LV more than 2.9 cm / m², receiving standard therapy (ACE inhibitors, diuretics, digoxin, beta-blockers), there was a significant reduction in the risk of hospitalization for worsening of CHF flow, slowing of the progression of CHF, improvement of the class of CHF according to classification NYHA, increased LVEF, as well as a decrease in the severity of heart failure symptoms and an improvement in the quality of life compared with placebo.

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 patients with AH and impaired glucose tolerance. Valsartan did not influence the incidence of fatal outcomes as a result of cardiovascular events, myocardial infarction and transient ischemic attacks without a lethal outcome, the frequency of hospitalizations due to exacerbation of CHF flow or unstable angina, arterial revascularization in this category of patients differing in age,sex and race. In patients receiving valsartan, the risk of microalbuminuria was significantly lower than in patients not receiving this therapy.

The recommended initial dose of valsartan in patients with AH and impaired glucose tolerance is 80 mg once a day. If necessary, the dose may be increased to 160 mg.

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 achieved within 2 weeks and maintained at the achieved level during prolonged therapy.

Pharmacokinetics:

Suction

After taking valsartan, the maximum concentration (C_max) in the blood plasma is achieved within 2-4 hours. The average absolute bioavailability is 23%. When valsartan is used with food, the area under the concentration-time curve (AUC) and C_mOh in blood plasma are reduced by 40% and 50%, respectively. Nevertheless, 8 hours after taking the drug, plasma concentrations of valsartan taken on an empty stomach and with food are the same. Decrease AUC is not accompanied by a clinically significant decrease in the therapeutic effect of valsartan, so the drug Valsacor® can be taken regardless of the time of ingestion.

Distribution

Volume of distribution (V_d) of valsartan in the equilibrium period after intravenous administration was about 17 liters, indicating that there was no pronounced valsartan distribution in the tissues. Valsartan actively binds to blood plasma proteins (94-97%), mainly with albumin.

Metabolism

Valsartan does not undergo significant biotransformation, only about 20% of the dose taken orally is excreted as metabolites. The hydroxyl metabolite is determined in blood plasma at low concentrations (less than 10% of AUC valsartan). This metabolite has no pharmacological activity.

Excretion

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

Pharmacokinetics of special groups of patients

Patients with CHF

In patients with CHF, the time to achieve C_max and T_1/2are similar to those in healthy volunteers. Increase AUC and C_mOh is directly proportional to an increase in the dose of valsartan (from 40 mg to 160 mg twice a day). The cumulative factor is, on average, 1.7. When administered, the clearance of valsartan is about 4.5 l / h. 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, the bioavailability of valsartan was higher than that of young patients, which is not clinically relevant.

Patients with impaired renal function

Renal clearance of valsartan is only 30% of the total clearance, so there is no correlation between renal function and systemic bioavailability of valsartan. Dose adjustments in patients with impaired renal function (creatinine clearance (CK) greater than 10 ml / min) is not required. The safety of valsartan in patients with SC less than 10 ml / min and patients on hemodialysis is not established, so in these patients the drug should be used with caution.Since the degree of binding of valsartan to plasma proteins is high, its excretion in hemodialysis is unlikely.

Patients with hepatic impairment

About 70% of the absorbed dose of valsartan is excreted through the intestine, mostly unchanged. Valsartan is not significantly exposed to metabolism. In patients with mild or moderate impairment of liver function, increased bioavailabilityAUC) valsartan in 2 times in comparison with that of 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;

- xheart failure (II-IV functional class by classification NYHA) as part of complex therapy (against standard therapy) in patients not receiving ACE inhibitors;

- PIncreased survival of patients after acute myocardial infarction complicated by left ventricular failure and / or systolic dysfunction of the left ventricle (LV),in the presence of stable indicators of hemodynamics.

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;

- severe violations of the liver (more than 9 points on the scale Child-Pugh), biliary cirrhosis and cholestasis;

- simultaneous application with aliskiren in patients with diabetes mellitus or moderate and severe renal dysfunction (CC less than 60 ml / min);

- pregnancy and the period of breastfeeding;

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

- deficiency of lactase, lactose intolerance, glucose-galactose malabsorption syndrome, since the composition of the preparation Valsacor® includes lactose.

Carefully:

Hyperkalemia, concomitant use of potassium-sparing diuretics, potassium preparations, potassium-containing food additives or other drugs capable of increasing the potassium content in the blood plasma (eg, heparin), mild and moderate hepatic non-biliary disease without cholestasis, severe renal dysfunction mL / min) (no clinical data),renal dysfunction in patients 6 to 18 years of age (QC less than 30 ml / min), including those on hemodialysis, hyponatremia, compliance with a diet with restricted intake of table salt, conditions accompanied by a decrease in the volume of circulating blood (BCC) (including diarrhea, vomiting), bilateral stenosis of the renal arteries or stenosis of the single kidney artery, condition after kidney transplantation, primary hyperaldosteronism, in patients with chronic heart failure III-IV functional class (by NYNA), renal function of which depends on the state of the renin-angiotensin-aldosterone system (RAAS), stenosis of the aortic and / or mitral valve, hypertrophic obstructive cardiomyopathy (GOCMP), in patients with hereditary angioedema or angioneurotic edema on the background of previous therapy with ARA II or ACE inhibitors.

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:

The use of ARA II in the first trimester of pregnancy is not recommended. The use of ARA II 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.

When planning pregnancy, it is recommended that the patient be transferred to alternative antihypertensive therapy, taking into account the safety profile. When confirming pregnancy, the preparation Valsacor® should be canceled as soon as possible. Newborns, whose mothers received ARA II during pregnancy, need medical supervision, since there is a risk of developing arterial hypotension.

There is no data on the isolation of valsartan in breast milk. Therefore, the question of stopping breastfeeding or abolishing valsartan therapy and transferring to alternative antihypertensive therapy should be resolved taking into account the safety profile.

Dosing and Administration:

Inside, regardless of meal time.

Patients over 18 years of age

Arterial hypertension

The recommended initial dose of Valsacor® is 80 mg once a day, regardless of race, age or sex of the patient. The antihypertensive effect develops within 2 weeks and reaches its maximum after 4 weeks. In patients who can not achieve adequate BP control, the daily dose of valsartan can be gradually increased to a maximum daily dose of 320 mg.

In order to further reduce blood pressure, it is possible to use diuretics (hydrochlorothiazide), as well as the simultaneous use of other antihypertensive drugs.

Chronic heart failure

The recommended initial dose of Valsacor® is 40 mg twice a day. The dose of the drug should be gradually increased for at least 2 weeks to 80 mg 2 times a day, and with good tolerability - up to 160 mg 2 times a day. The maximum daily dose is 320 mg in two divided doses. It may be necessary to reduce the dose of concurrently taken diuretics.

Possible simultaneous use with other drugs intended for the treatment of CHF.However, simultaneous therapy with drugs of three classes: valsartan, ACE inhibitors and beta-blockers is not recommended. Assessment of patients with CHF should include monitoring of kidney function.

Application after acute myocardial infarction

Treatment should be started within 12 hours after the development of acute MI with stable hemodynamic parameters. After applying the initial dose of 20 mg twice a day (1/2 40 mg tablets), the dose of Valsacor® can be gradually increased by titration to: 40 mg, 80 mg and 160 mg twice daily for several weeks. The maximum daily dose is 320 mg in 2 divided doses. It is recommended to increase the dose to 80 mg twice a day by the end of week 2, and the maximum target dose of 160 mg 2 times a day can be achieved by the end of the third month of therapy with Valsacor®. The achievement of the target dose depends on the tolerability of valsartan during the titration period of the doses.

With the development of excessive blood pressure lowering, accompanied by clinical manifestations, or impaired renal function, the dose of the drug should be reduced. Possible simultaneous use with other drugs,including thrombolytic agents, acetylsalicylic acid as an antiplatelet agent, beta-adrenoblockers and inhibitors of HMG-CoA reductase (statins). Simultaneous use with ACE inhibitors is not recommended.

Assessment of patients after acute MI should include monitoring of kidney function.

Patients 6 to 18 years of age

Arterial hypertension

The recommended initial dose of the drug 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 exceeding 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

Chronic heart failure and suffered acute myocardial infarction

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

Elderly patients

Correction of the dose of the drug in patients over 65 years is not required.

Impaired renal function

Correction of the dose in patients with QC more than 10 ml / min is not required.The simultaneous use of the drug Valsacor® with aliskiren in patients with moderate and severe renal dysfunction (CC less than 60 ml / min) is contraindicated.

Impaired liver function

In patients with mild or moderate impairment of non-biliary liver function without the effects of cholestasis, the drug should be used with caution, the daily dose should not exceed 80 mg.

Patients with diabetes mellitus

Simultaneous application of the drug Valsakor^® with aliskirenom in patients with diabetes is contraindicated.

Side effects:

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 <1/10000

the frequency of the unknown can not be estimated from the available data.

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.

Arterial hypertension

Violations from the blood and lymphatic system:

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

Immune system disorders:

frequency is unknown: hypersensitivity reactions, including serum sickness.

Disorders from the metabolism and nutrition:

frequency is unknown: increased serum potassium, hyponatremia.

Hearing disorders and labyrinthine disturbances:

infrequently: vertigo.

Vascular disorders:

frequency unknown: vasculitis.

Disturbances from the respiratory system, chest and mediastinal organs:

infrequently: cough.

Disorders from the gastrointestinal tract:

infrequently: pain in the abdomen.

Disorders from the liver and bile ducts:

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

Disturbances from the skin and subcutaneous tissues:

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

Disturbances from the musculoskeletal and connective tissue:

frequency unknown: myalgia.

Disorders from the kidneys and urinary tract:

frequency unknown: renal dysfunction and renal failure, increased serum creatinine concentration.

General disorders and disorders at the site of administration:

infrequently: increased fatigue.

In the course of clinical studies, the following adverse events were observed in patients with AH: the cause and effect of which was not established with the use of valsartan: arthralgia, asthenia, back pain, diarrhea, dizziness, insomnia, decreased libido, nausea, peripheral edema, pharyngitis, rhinitis, sinusitis, upper respiratory tract infections.

After a recent acute myocardial infarction and / or chronic heart failure (II-IV functional class by classification NYHA)

Violations from the blood and lymphatic system:

frequency unknown: thrombocytopenia.

Immune system disorders:

frequency is unknown: hypersensitivity reactions, including serum sickness.

Disorders from the metabolism and nutrition:

infrequently: hyperkalemia;

frequency is unknown: increased serum potassium, hyponatremia.

Impaired nervous system:

often: dizziness, postural dizziness;

infrequently: faint, headache.

Hearing disorders and labyrinthine disturbances:

infrequently: vertigo.

Heart Disease:

infrequently: increased symptoms of chronic heart failure.

Vascular disorders:

often: marked decrease in blood pressure, orthostatic hypotension; frequency unknown: vasculitis.

Disturbances from the respiratory system, chest and mediastenumI:

infrequently: cough.

Disorders from the gastrointestinal tract:

infrequently: nausea, diarrhea.

Disorders from the liver and bile ducts:

frequency unknown: impaired liver function.

Disturbances from the skin and subcutaneous tissues:

infrequently: angioedema;

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

Disturbances from the musculoskeletal and connective tissue:

rarely: rhabdomyolysis;

frequency unknown: myalgia.

Disorders from the kidneys and urinary tract:

often: renal dysfunction and kidney failure;

infrequently: acute renal failure, increased serum creatinine concentration;

frequency is unknown: an increase in the urea nitrogen in the blood plasma.

General disorders and disorders at the site of administration:

infrequently: asthenia, increased fatigue.

Overdose:

Symptoms: the main expected manifestation of valsartan overdose is a marked decrease in blood pressure, which can lead to impaired consciousness, collapse and / or shock.

Treatment: symptomatic, it is recommended to induce vomiting and rinse the stomach. With the development of a pronounced reduction in blood pressure, it is necessary to transfer the patient to the "lying" position on the back with the legs raised upwards, intravenously administer a 0.9% solution of sodium chloride. It is recommended that the heart and respiratory system, bcc and the amount of urine be regularly monitored. 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 or moderate and severe 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 an increase in its toxic effect are possible. The risk of toxic manifestations associated with the use of lithium drugs may increase additionally with simultaneous use with the drug Valsakor^® and diuretics.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 dietary supplements and other medicines and substances that can cause hyperkalemia (eg, 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 the renin-angiotensin-aldosterone system

In some patients, double blockade of RAAS was accompanied by the development of arterial hypotension, syncope, hyperkalemia and impaired renal function (including acute renal failure (ARF)).

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 with valsartan, it is possible to reduce the antihypertensive effect, increase the risk of kidney dysfunction and increase the potassium content in blood plasma. Prior to the beginning of combination therapy, it is recommended to evaluate the function of the kidneys, as well as to correct the disturbances of the water electrolyte balance.

Protein-carriers

Research in vitro on liver cultures showed that valsartan is a substrate for the OATP1B1 / OATP1B3 carrier proteins and MRP2. Simultaneous application of valsartan with inhibitors of the carrier protein OATP1B1 / OATP1B3 (rifampicin, ciclosporin) or MRP2 (ritonavir) can increase the systemic exposure of valsartan (FROM_mOh and AUC). Caution should be exercised at the beginning of simultaneous use with the above drugs or after their withdrawal.

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:

Hyperkalemia

With the simultaneous use of potassium-sparing diuretics (spironolactone, eplerenone, triamterene, amiloride), potassium preparations, potassium-containing salt substitutes or other drugs capable of increasing the potassium content in the blood plasma (eg, heparin), care should be taken. It is necessary to regularly monitor the potassium content in the blood plasma.

Impaired renal function

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

The simultaneous use of valsartan with aliskiren in patients with moderate to severe renal impairment (creatinine clearance less than 60 mL / min) is contraindicated.

Impaired liver function

In patients with mild to moderate hepatic impairment without cholestasis phenomena Valsakor® drug should be used with caution.

Patients with hyponatraemia and / or dehydration

In patients with severe hyponatremia and / or dehydration, for example, as a result of taking high doses of diuretics in rare cases at the beginning of therapy with Valsakor® may develop hypotension with clinical manifestations.

Before treatment, it is recommended to restore the sodium and / or BCC content, in particular by reducing the dose of diuretics.

Stenosis of the renal artery

Use of valsartan short course in patients with renovascular hypertension, which developed secondary to renal artery stenosis only does not cause significant changes in renal hemodynamics parameters, concentrations of creatinine or urea nitrogen in blood serum. However, given that other drugs that affect the RAAS,can cause an increase in the concentration of urea and creatinine in the serum in patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney, it is necessary to regularly monitor the concentration of creatinine and residual urea nitrogen in the blood serum.

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.

The period after the transferred MI

Simultaneous use with ACE inhibitors is not recommended, since it does not have additional clinical advantages over monotherapy and increases the risk of developing unwanted phenomena.

The use of valsartan in patients after myocardial infarction often leads to a slight decrease in blood pressure, but the cessation of therapy due to hypotension is usually not required if the recommendations for dosing are followed.

Therapy with Valsacor^® should be started cautiously. Assessment of patients after acute myocardial infarction should include monitoring of kidney function.

Possible simultaneous use in acute MI with other drugs: thrombolytics, acetylsalicylic acid, beta-adrenoblockers and inhibitors of HMG-CoA reductase (statins).

Chronic heart failure

In patients with CHF, the simultaneous use of three classes of drugs is not recommended: ACE inhibitors, beta-blockers and valsartan, since this therapy did not give an additional clinical effect, and the risk of developing adverse events increased. Usage in patients with CHF is usually accompanied by a decrease in blood pressure, but with the recommendations for the selection of doses, treatment rarely requires withdrawal due to hypotension. Therapy with Valsacor® in patients with CHF should be started with caution.Due to inhibition of RAAS activity in some patients (for example, in patients with chronic heart failure III-IV functional class by classification NYNA, the function of the kidneys which depends on the state of RAAS) against the background of therapy with ACE inhibitors may change the function of the kidney: the development of oliguria and / or progressive azotemia, and in rare cases - arresting and / or lethal outcome. The drug Valsacor ® blocks the receptors of angiotensin II, so patients with CHF need regular monitoring of kidney function.

Angioedema in history

Among patients with angioneurotic edema on the background of therapy with the drug Valsakor^®, 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.

Special information on excipients

The preparation Valsacor® contains lactose, therefore it should not be used in the following conditions: lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.

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

In connection with the possibility of dizziness or weakness on the background of the use of the drug Valsakor^®care must be taken when driving vehicles and engaging in potentially hazardous activities.

Form release / dosage:

Film-coated tablets, 40 mg, 80 mg and 160 mg.

Packaging:

For 7, 10, 14 or 15 tablets in a blister (contour acrylic packaging) from the combined material PVC / PE / PVDC - aluminum foil.

By 2, 4, 8, 12, 14 or 20 blisters (contour cell packs) (7 tablets each), or 2, 3, 6 or 9 blisters (contour cell packs) (10 tablets each), or 1,2 , 4, 6, 7 or 10 blisters (contour cell packs) (14 tablets each), or 2, 4 or 6 blisters (contour cell packs) (15 tablets each) along with the instructions for use are placed in a cardboard pack.

For hospitals:

For 80 blisters (contour cell packs) (7 tablets), or 20 or 50 blisters (contour cell packs) (10 tablets each), or 40 blisters (contour cell packs) (14 tablets each) together with instructions for use put in a pack of cardboard.

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:LSR-004921/08

Date of registration:25.06.2008 / 24.11.2014

Expiration Date:Unlimited

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

Manufacturer: & nbsp

KRKA-RUS, LLC Russia

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®)