Valsacor, pills 160mg, 90pcs

Composition

(per 1 film-coated tablet,40 mg):

Core:

Active ingredient:

Valsartan 40.00 mg

Excipients: lactose monohydrate, microcrystalline cellulose, povidone-K25, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate

Film coating: hypromellose 6sr, titanium dioxide (E 171), iron oxide yellow dye (E 172), macrogol-4000

(per 1 film-coated tablet,80 mg):

Core:

Active ingredient:

Valsartan 80.00 mg

Excipients: lactose monohydrate, microcrystalline cellulose, povidone-K25, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate

Film coating: hypromellose 6sr, titanium dioxide (E 171), iron oxide red dye (E 172), macrogol-4000

(per 1 film-coated tablet,160 mg):

Core:

Active ingredient:

Valsartan 160.00 mg

Excipients: lactose monohydrate, microcrystalline cellulose, povidone-K25, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate

Film coating: hypromellose 6sr, titanium dioxide (E 171), iron oxide yellow dye (E 172), iron oxide red dye (E 172), macrogol-4000

Pharmacological action

of angiotensin II receptor antagonist

Clinical Pharmacology

Pharmacodynamics

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

Selectively blocks AT_-1receptors. The consequence of AT1-receptor blockadeis an increase in the plasma concentration of angiotensin II, which can stimulate unblocked AT2-receptors, which balances the vasopressor effects associated with the excitation_ofAT1-receptors. Valsartan has no agonistic activity against AT1receptors. Its affinityfor AT1 receptors is approximately 20,000 times higher than for AT2 receptors.

Valsartan does not inhibit the angiotensin-converting enzyme (ACE), also known as kininase II, which converts angiotensin I to angiotensin II and destroys bradykinin. Due to the lack of effect on ACE, the effects of bradykinin and substance P are not potentiated. The incidence of dry cough is lower in patients treated with angiotensin II receptor antagonists (ARA II) compared to patients treated with an ACE inhibitor. Valsartan does not interact with or block the receptors of other hormones or ion channels involved in regulating the functions of the cardiovascular system.

Use in arterial hypertension in patients over 18 years of age

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

After ingestion of a single dose of valsartan, the antihypertensive effect develops within 2 hours, and the maximum decrease in blood pressure is achieved after 4-6 hours. The antihypertensive effect of valsartan persists for 24 hours after its use. With continuous use of valsartan, the maximum reduction in blood pressure, regardless of the dose, is achieved after 2-4 weeks and is maintained at the achieved level during long-term therapy. Concomitant use with hydrochlorothiazide can achieve a significant additional reduction in blood pressure.

Sudden withdrawal of valsartan is not accompanied by a sharp increase in blood pressure or other undesirable clinical consequences (that is, the “withdrawal” syndrome does not develop). Patients with hypertension, type 2 diabetes mellitus (DM) and nephropathy taking valsartan at a dose of 160-320 mg/day showed a significant decrease in proteinuria (36-44%).

Use after acute myocardial infarction in patients over 18 years of age

When using valsartan for 2 years, starting from 12 hours to 10 days after the development of myocardial infarction (MI) (complicated by left ventricular failure and/or left ventricular systolic dysfunction), the overall mortality rate and cardiovascular mortality are reduced and the time to first hospitalization for exacerbation of chronic heart failure (CHF), recurrent MI, sudden cardiac arrest and stroke (without fatal outcome) is extended.

CHF in patients over 18 years of age

When using valsartan (at an average daily dose of 254 mg) for 2 years in patients with CHF of NYHA functional class II-IV with a left ventricular ejection fraction (LVEF) of less than 40% and an internal LV diastolic diameter of 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 exacerbation of CHF, heart failure progression, improved NYHA functional class of CHF, increased LVEF, and reduced severity of heart failure symptoms and improved quality of life compared to placebo.

Use in patients over 18 years of age with hypertension and impaired glucose tolerance

When using valsartan and lifestyle changes, there was a statistically significant reduction in the risk of developing diabetes in patients with hypertension and impaired glucose tolerance. Valsartan had no effect on the frequency of deaths due to cardiovascular events, MI and transient ischemic attacks without a fatal outcome, on the frequency of hospitalizations due to exacerbation of CHF or unstable angina, arterial revascularization in this category of patients who differ in age, gender and race. Patients receiving valsartan had a significantly lower risk of developing microalbuminuria than those not receiving valsartan.

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

Use in children and adolescents from 6 to 18 years of age with hypertension

In children and adolescents from 6 to 18 years of age, valsartan provides a dose-dependent smooth decrease in blood pressure. When using valsartan, the maximum reduction in blood pressure, regardless of the dose taken orally, is achieved within 2 weeks and maintained at the achieved level during long-term therapy.

Pharmacokinetics

Suction

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

Distribution

The volume of distribution₍vd) of valsartan at steady state after intravenous use was about 17 liters, which indicates that there is no pronounced distribution of valsartan in tissues. Valsartan actively binds to plasma proteins (94-97%), mainly albumin.

Metabolism

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

Deduction

Valsartan is excreted in two phases: a-phase with a half-life (T_1/2a) of less than 1 hour and b-phase with T_1/2b-about 9 hours. Valsartan is mainly excreted unchanged through the intestines (about 83%) and kidneys (about 13%). After intravenous use, 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_1/2 of valsartan is 6 hours.

Pharmacokinetics in special patient groups

Patients with CHF

In patients with CHF, the time to reach C_max and T_1/2 is similar to that in healthy volunteers. The increase in AUC and_cmax is directly proportional to the increase in the dose of valsartan (from 40 mg to 160 mg 2 times a day). The cumulative factor averages 1.7. When taken orally, the clearance of valsartan is about 4.5 liters/hour. The age of patients with CHF did not affect the clearance of valsartan.

Elderly patients (over 65 years of age)

In some patients over the age of 65, the bioavailability of valsartan was higher than in young patients, which is not clinically relevant.

Patients with impaired renal function

The renal clearance of valsartan is only 30% of the total clearance, so there is no correlation between renal function and the systemic bioavailability of valsartan. No dose adjustment is required in patients with impaired renal function (creatinine clearance greater than 10 ml / min). The safety of valsartan in patients with creatinine clearance less than 10 ml/min and patients undergoing hemodialysis has not been established, so the drug should be used with caution in such patients. Since the degree of binding of valsartan to plasma proteins is high, its elimination during hemodialysis is unlikely.

Patients with impaired liver function

About 70% of the absorbed dose of valsartan is excreted through the intestine, mainly in unchanged form. Valsartan is not significantly metabolized. In patients with mild or moderate hepatic impairment, the bioavailability (AUC) of valsartan increased by 2 times compared to that in healthy volunteers. However, there is no correlation between valsartan AUC values and the degree of hepatic impairment. The use of valsartan in patients with severe hepatic impairment has not been studied.

Patients from 6 to 18 years

of age The pharmacokinetics of valsartan in children and adolescents from 6 to 18 years of age do not differ from the pharmacokinetics of valsartan in patients over 18 years of age.

Indications

Patients over 18 years of age

• Arterial hypertension.
• Chronic heart failure (NYHA functional class II-IV) as part of complex therapy (against the background of standard therapy) in patients not receiving ACE inhibitors.
• Improving the survival rate of patients after acute MI complicated by left ventricular failure and / or left ventricular systolic dysfunction, in the presence of stable hemodynamic parameters.

Patients from 6 to 18 years of age

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

Use during 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 the II-III trimesters of pregnancy, since use in the II-III trimesters of pregnancy can cause fetotoxic effects (decreased renal function, lack of water, slowing ossification of the fetal skull bones) and neonatal toxic effects (renal failure, hypotension, hyperkalemia). If the drug was still used in the II-III trimesters of pregnancy, then it is necessary to conduct an ultrasound examination of the kidneys and skull bones of the fetus.

When planning pregnancy, it is recommended to transfer the patient to alternative antihypertensive therapy, taking into account the safety profile. If pregnancy is confirmed, Valsacor should be discontinued as soon as possible.

Newborns whose mothers received ARA II during pregnancy need medical supervision, as there is a risk of developing arterial hypotension. There are no data on the excretion of valsartan in breast milk. Therefore, discontinuation of breast-feeding or discontinuation of valsartan therapy and transfer to alternative antihypertensive therapy should be considered, taking into account the safety profile.

Contraindications

• Hypersensitivity to valsartan or other components of the drug.
• Severe liver dysfunction (more than 9 points on the Child-Pugh scale), biliary cirrhosis and cholestasis.
• Concomitant use with aliskiren and drugs containing aliskiren in patients with diabetes mellitus and/or moderate to severe renal impairment (glomerular filtration rate (GFR) less than 60 ml/min/1.73 m2 of body surface area).
• Concomitant use with ACE inhibitors in patients with diabetic nephropathy.

• Pregnancy and breast-feeding period.
• Age up to 6 years – according to the indication of arterial hypertension, up to 18 years – according to other indications.
• Lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome, as Valsacor® contains lactose.

Side effects

World Health Organization (WHO)classification of the incidence of side effects:

very common ≥ 1/10

common ≥ 1/100 to < 1/10

uncommon ≥ 1/1000 to < 1/100

rare ≥ 1/10000 to < 1/1000

very rare < 1/10000

frequency unknown cannot be estimated based on available data.

The safety profile of valsartan in patients with hypertension aged 6-18 years does not differ from the safety profile of valsartan in patients with hypertension older than 18 years.

Arterial hypertension

Disorders of the blood and lymphatic system:

frequency unknown: decreased hemoglobin, decreased hematocrit, neutropenia, thrombocytopenia.

Immune system disorders:

frequency unknown: hypersensitivity reactions, including serum sickness.

Metabolic and nutritional disorders:

frequency unknown: increased serum potassium, hyponatremia;

Hearing disorders and labyrinth disorders:

infrequently: vertigo.

Vascular disorders:

frequency unknown: vasculitis.

Respiratory, thoracic and mediastinal disorders:

infrequently: cough.

Disorders of the gastrointestinal tract:

infrequently: abdominal pain.

Liver and biliary tract disorders:

frequency unknown: impaired liver function, including increased plasma bilirubin concentrations.

Skin and subcutaneous tissue disorders:

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

Musculoskeletal and connective tissue disorders:

frequency unknown: myalgia.

Kidney and urinary tract disorders:

frequency unknown: impaired renal function and renal failure, increased serum creatinine.

General disorders and disorders at the injection site:

infrequently: increased fatigue.

In clinical studies, the following adverse events were observed in patients with hypertension, the causal relationship of which with the use of valsartan has not been established: arthralgia, asthenia, back pain, diarrhea, dizziness, insomnia, decreased libido, nausea, peripheral edema, pharyngitis, rhinitis, sinusitis, upper respiratory tract infections.

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

Disorders of the blood and lymphatic system:

frequency unknown: thrombocytopenia.

Immune system disorders:

frequency unknown: hypersensitivity reactions, including serum sickness.

Metabolic and nutritional disorders:

infrequently: hyperkalemia;

frequency unknown: increased serum potassium, hyponatremia.

Nervous system disorders:

common: dizziness, postural vertigo;

uncommon: fainting, headache.

Hearing disorders and labyrinth disorders:

infrequently: vertigo.

Cardiac disorders:

infrequently: increased symptoms of CHF.

Vascular disorders:

common: marked decrease in blood pressure, orthostatic hypotension;

frequency unknown: vasculitis.

Respiratory, thoracic and mediastinal disorders:

infrequently: cough.

Disorders of the gastrointestinal tract:

infrequently: nausea, diarrhea.

Liver and biliary tract disorders:

frequency unknown: impaired liver function.

Skin and subcutaneous tissue disorders:

infrequently: angioedema;

frequency unknown: skin rash, pruritus, bullous dermatitis.

Musculoskeletal and connective tissue disorders:

rare: rhabdomyolysis;

frequency unknown: myalgia.

Kidney and urinary tract disorders:

frequently: impaired renal function and renal failure;

infrequently: acute renal failure( acute renal failure), increased serum creatinine;

frequency unknown: increased plasma urea nitrogen concentration.

General disorders and disorders at the injection site:

infrequently: asthenia, increased fatigue.

Interaction

Double blockade of the renin-angiotensin-aldosterone system

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

Concomitant use of ARA II, including valsartan, with drugs that affect the RAAS, such as ACE inhibitors or aliskiren, is not recommended; if necessary, such therapy should carefully monitor blood pressure, renal function, and plasma electrolyte levels.

Concomitant use of valsartan with aliskiren and drugs containing aliskiren is contraindicated in patients with diabetes mellitus and/or moderate to severe renal impairment (GFR less than 60 ml/min / 1.73 m2 of body surface area) and is not recommended in other patients.

Concomitant use of ARA II with ACE inhibitors is contraindicated in patients with diabetic nephropathy and is not recommended in other patients.

Simultaneous use is not recommended

Lithium

Concomitant use with lithium preparations is not recommended, as a reversible increase in the concentration of lithium in blood plasma and an increase in its toxic effect is possible. The risk of toxic effects associated with the use of lithium preparations may further increase when used concomitantly with Valsacor® and diuretics. If concomitant use with lithium preparations is necessary, 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 drugs and substances that may cause hyperkalemia (for example, heparin)

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

Concomitant use with caution

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

When used concomitantly with valsartan, it is possible to reduce the antihypertensive effect, increase the risk of developing impaired renal function, and increase the potassium content in blood plasma. Before starting combination therapy, it is recommended to evaluate kidney function, as well as correct violations of the water-electrolyte balance.

Carrier proteins

In vitro studies on liver cell cultures have shown that valsartan is a substrate for the OATP1B1/OATP1B3 and MRP2 transporter proteins. Concomitant use of valsartan with OATP1B1/OATP1B3 transporter protein inhibitors (rifampicin, cyclosporin) or MRP2 (ritonavir) may increase systemic exposure to valsartan (_cmax and AUC). Caution should be exercised at the beginning of concomitant use with the above drugs or after their withdrawal.

No drug interaction

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

Patients from 6 to 18 years of age

In children and adolescents, hypertension is often associated with impaired renal function. Concomitant use of valsartan with other drugs that affect the RAAS may cause an increase in the level of potassium in the blood plasma in such patients. Caution should be exercised when concomitantly using the above combination and regularly monitor renal function and blood potassium levels in this group of patients.

How to take, course of use and dosage

Inside, regardless of the meal time.

Patients over 18 years of age

Arterial hypertension

The recommended starting dose of Valsacor® is 80 mg once a day, regardless of the patient’s race, age, or gender. The antihypertensive effect develops within 2 weeks and reaches its maximum after 4 weeks. In patients who fail to achieve adequate blood pressure control, the daily dose of valsartan may 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 agents.

Chronic heart failure

The recommended starting dose of Valsacor is 40 mg twice daily. 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 – to 160 mg 2 times a day. The maximum daily dose is 320 mg in 2 divided doses. In this case, it may be necessary to reduce the dose of simultaneously taken diuretics.

Concomitant use with other medications intended for the treatment of CHF is possible. However, concomitant therapy with three classes of drugs: valsartan, ACE inhibitors and beta-blockers is not recommended.

Assessment of patients with CHF should include monitoring of renal function.

Use after acute myocardial infarction

Treatment should begin as early as 12 hours after the development of acute MI in the presence of stable hemodynamic parameters. After applying an initial dose of 20 mg 2 times a day (½ tablet 40 mg), the dose of Valsacor® can be gradually increased by titration to: 40 mg,80 mg and 160 mg 2 times a day 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 daily by the end of the 2nd week, and the maximum target dose of 160 mg twice daily can be reached by the end of the 3rd month of therapy with Valsacor®. Achieving the target dose depends on the tolerability of valsartan during the titration period.

If an excessive decrease in blood pressure develops, accompanied by clinical manifestations or impaired renal function, the dose of the drug should be reduced.

It can be used simultaneously with other medications, including thrombolytic agents, acetylsalicylic acid as an antiplatelet agent, beta-blockers and HMG-CoA reductase inhibitors (statins). Concomitant use with ACE inhibitors is not recommended.

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

Patients from 6 to 18 years of age

Arterial hypertension

The recommended starting dose of Valsacor® in children and adolescents from 6 to 18 years of age is 40 mg with a child’s body weight of less than 35 kg and 80 mg with a child’s body weight of more than 35 kg. It is recommended to adjust the dose to reduce blood pressure. The maximum recommended daily doses are shown in the table below. Higher doses are not recommended.

Body weight	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 previous myocardial infarction

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

Elderly patients

No dose adjustment is required in patients over 65 years of age.

Impaired renal function

No dose adjustment is required in patients with creatinine clearance greater than 10 ml / min. Concomitant use of Valsacor 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 or moderate hepatic impairment of non-biliary origin without cholestasis, the drug should be used with caution, the daily dose should not exceed 80 mg.

Patients with diabetes mellitus

Concomitant use of Valsacor with aliskiren in patients with DM is contraindicated.

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 flush the stomach. With the development of a pronounced decrease in blood pressure: it is necessary to transfer the patient to the “lying” position on his back with his legs raised up, inject 0.9% sodium chloride solution intravenously. Regular monitoring of the activity of the heart and respiratory system, BCC and the amount of urine released is recommended. Hemodialysis is ineffective.

Description

Tablets 40 mg: round, slightly biconvex tablets with a risk on one side, covered with a film-coated brownish-yellow color.

View at the break: white rough mass with a film shell of brownish-yellow color.

Tablets 80 mg: round, biconvex tablets with a risk on one side, covered with a film-coated pink color.

View at the break: white rough mass with a pink film shell.

Tablets 160 mg: oval, biconvex tablets with a risk on one side, covered with a film-coated brownish-yellow color.

View at the break: white rough mass with a film shell of brownish-yellow color.

Special instructions

Hyperkalemia, the simultaneous use of potassium-sparing diuretics, potassium supplements, potassium-containing supplements or other drugs capable of increasing the potassium content in the blood plasma (e. g., heparin), light and moderate liver namilyango Genesis without signs of cholestasis, severe renal dysfunction (CC less than 10 ml/min) (no clinical data), disturbances of kidney function in patients from 6 to 18 years (KK less than 30 ml/min), including hemodialysis, hyponatremia, a diet with restriction of salt consumption, status accompanied by a decrease in the volume of circulating blood (BCC) (including diarrhea, vomiting), bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, condition after kidney transplantation, primary aldosteronism in patients with chronic heart failure III-IV NYHA functional class, renal function which depends on the state of the renin-angiotensin-aldosterone system (RAAS), stenosis of aortic and/or mitral valve disease, hypertrophic obstructive cardiomyopathy (GOCE) in patients with hereditary angioedema or angioedema in the background of previous therapy with ARA II or ACE inhibitors.

It is not recommended to use ARA II, including valsartan, simultaneously with ACE inhibitors, since their simultaneous use does not have advantages over monotherapy with valsartan or an ACE inhibitor in terms of overall mortality.

Contraindicated in children under 6 years of age-for indications of arterial hypertension, under 18 years of age-for other indications.

Patients from 6 to 18 years of age

Arterial hypertension

The recommended starting dose of Valsacor® in children and adolescents from 6 to 18 years of age is 40 mg with a child’s body weight of less than 35 kg and 80 mg with a child’s body weight of more than 35 kg. It is recommended to adjust the dose to reduce blood pressure. The maximum recommended daily doses are shown in the table below. Higher doses are not recommended.

Body weight	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 previous myocardial infarction

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

Elderly patients

No dose adjustment is required in patients over 65 years of age.

Impaired renal function

No dose adjustment is required in patients with creatinine clearance greater than 10 ml / min. Concomitant use of Valsacor 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 or moderate hepatic impairment of non-biliary origin without cholestasis, the drug should be used with caution, the daily dose should not exceed 80 mg.

Patients with diabetes mellitus

Concomitant use of Valsacor with aliskiren in patients with DM is contraindicated.

Hyperkalemia

Caution should be exercised when concomitantly using potassium-sparing diuretics (spironolactone, eplerenone, triamterene, amiloride), potassium preparations, potassium-containing salt substitutes, or other drugs that can increase the potassium content in blood plasma (for example, heparin). It is necessary to regularly monitor the content of potassium in the blood plasma.

Impaired renal function

No dose changes are required in patients with impaired renal function. Since there are no data on the use of the drug in severe renal insufficiency (creatinine clearance less than 10 ml/min or 0.167 ml/s) and in patients undergoing hemodialysis, in such cases, the drug is recommended to be used with caution.

Concomitant 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

Valsacor should be used with caution in patients with mild to moderate hepatic impairment without cholestasis.

Patients with hyponatremia and / or dehydration

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

Renal artery stenosis

The use of valsartan in a short course in patients with renovascular hypertension, which developed a second time due to stenosis of the artery of a single kidney, does not cause significant changes in renal hemodynamics, serum creatinine or urea nitrogen concentrations. However, given that other drugs that affect the RAAS may cause an increase in serum urea and creatinine concentrations in patients with bilateral renal artery stenosis or stenosis of the artery to a single kidney, it is necessary to regularly monitor serum creatinine and residual urea nitrogen concentrations.

Condition after undergoing a kidney transplant

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

Primary hyperaldosteronism

Patients with primary hyperaldosteronism are resistant to antihypertensive drugs that affect the RAAS, so the use of Valsacor® is not recommended for such patients.

Aortic and/or mitral valve stenosis, HOCMP

Valsacor® should be used with caution in patients with hemodynamically significant aortic and/or mitral valve stenosis or with HOCMP.

Period after the previous MI

Concomitant use with ACE inhibitors is not recommended, as it has no additional clinical advantages over monotherapy and increases the risk of adverse events.

The use of valsartan in patients after MI often leads to a slight decrease in blood pressure, but discontinuation of therapy due to hypotension is usually not necessary if the dosage recommendations of the drug are followed.

Valsacor® therapy should be initiated cautiously. Assessment of patients after acute MI should include monitoring of renal function.

Concomitant use in acute MI is possible with other medications: thrombolytics, acetylsalicylic acid, beta-blockers and HMG-CoA reductase inhibitors (statins).

Chronic heart failure

Concomitant use of three classes of drugs: ACE inhibitors, beta-blockers and valsartan is not recommended in patients with CHF, as this therapy did not give an additional clinical effect, while the risk of adverse events increased. Use in patients with CHF is usually accompanied by a decrease in blood pressure, but if the recommendations for dose selection are followed, treatment rarely requires discontinuation due to arterial hypotension. Valsacor therapy should be initiated with caution in patients with CHF. Due to the suppression of RAAS activity in some patients (for example, in patients with CHF of NYHA functional class III-IV, whose renal function depends on the state of RAAS), against the background of therapy with ACE inhibitors, renal function may change: the development of oliguria and/or progressive azotemia, and in rare cases – acute renal failure and/or death. Valsacor ® blocks angiotensin II receptors, so regular monitoring of renal function is necessary in patients with CHF.

History of angioedema

Patients with angioedema treated with Valsacor have had a history of angioedema, including those treated with ACE inhibitors. If angioedema develops, the drug should be discontinued immediately and the possibility of repeated use should be excluded.

Special information on excipients

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

Due to the possibility of dizziness or weakness associated with the use of Valsacor®, caution should be exercised when driving vehicles and engaging in potentially dangerous activities.

Form of production

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

7,10,14 or 15 tablets in a blister (contour cell package) made of a combined PVC/PE/PVDC material-aluminum foil.

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

For hospitals:

80 blisters (contour cell packages) (7 tablets each), or 20 or 50 blisters (contour cell packages) (10 tablets each), or 40 blisters (contour cell packages) (14 tablets each) together with instructions for use are placed in a cardboard pack.

Storage conditions

At a temperature not exceeding 25 °C, in the original packaging.

Keep out of reach of children.

Shelf

life is 5 years.

Do not use the drug after the expiration date.

Active ingredient

Valsartan

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

Children over 6 years of age, Children as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Heart Failure, Hypertension, Myocardial Infarction