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

Excipients: cellulose microcrystalline 29.75 mg / 59.5 mg, lactose monohydrate 9.0 mg / 18.0 mg, carboxymethyl starch sodium(sodium starch glycolate) 7.2 mg / 14.4 mg, povidone 2.7 mg / 5.4 mg, sodium lauryl sulfate 0.45 mg / 0.9 mg, magnesium stearate 0.9 mg / 1.8 mg;

Excipients for the shell:

- for a dosage of 40 mg: Opadry II [alcohol polyvinyl 1.2 mg, macrogol-3350 0.606 mg, talc 0.444 mg, titanium dioxide 0.604 mg, iron oxide yellow 0.141 mg, iron oxide red 0.003 mg, iron oxide black 0.002 mg];

- for a dosage of 80 mg: Opadry II [alcohol polyvinyl 2.0 mg, macrogol-3350 1,01 mg, talc 0.74 mg, titanium dioxide 1,17 mg, aluminum lacquer on the basis of a dye of charming red 0,029 mg, aluminum varnish based on azorubin dye 0,023 mg, aluminum lacquer based on dye sunset yellow 0.028 mg].

Description:

Round, biconvex tablets, coated with a film coating of brownish-yellow color (at a dosage of 40 mg) or pink (at a dosage of 80 mg). On the cross section, the inner layer is white or almost white.

Pharmacotherapeutic group:Angiotensin II receptor antagonist

ATX: & nbsp

C.09.C.A.03 Valsartan

C.09.C.A Angiotensin II antagonists

Pharmacodynamics:

Valsartan - an active specific antagonist of angiotensin receptors II. Selectively blocks AT receptor subtype₁ which are responsible for the effects of angiotensin II. The consequence of the blockade AT₁-receptors is an increase in plasma concentrations of angiotensin II, which can stimulate unlocked AT₂-receptors. Valsartan does not have any marked agonistic activity in relation to AT₁receptors. The affinity of valsartan for the receptors of the subtype AT₁approximately at 20 000 times higher than to the receptors of the AT subtype₂. Valsartan does not enter into interaction and does not block the receptors of other hormones or ion channels, having important in regulating the functions of the cardiovascular system. Probability the occurrence of cough with valsartan is very low, which is associated with from no effect on the angiotensin-converting enzyme (ACE), which is responsible for the degradation of bradykinin. Comparison of valsartan with an inhibitor ACE demonstrates, what the incidence of dry cough is significant (p < 0.05) is lower in patients taking valsartanthan the of patients taking an ACE inhibitor (2.6% vs. 7.9%, respectively). AT group of patients who had previously been treated with an inhibitor ACE developed dry cough, when treated with valsartan, this undesirable reaction is noted in 19,5% cases, and in the treatment with thiazide diuretic - in 19.0% of cases, - while at group of patients treated with an inhibitor ACE, cough is observed in 68,5% cases (p < 0,05).

Use in hypertension in patients older than 18 years

When treatment of valsartan in patients with arterial hypertension, there is a decrease in blood pressure (BP), not accompanied by a change in the heart rate (Heart rate).

After Intra-single dose administration in most patients, the onset of antihypertensive action is observed within 2 hours, and the maximum decrease HELL is reached within 4-6 hours, lasting more than 24 hours. With repeated use of valsartan, the maximum decrease HELL, regardless of the accepted dose, is usually achieved within 2-4 weeks, and is maintained at the achieved level in the course of long-term therapy. In the case of simultaneous application of valsartan with hydrochlorothiazide a significant additional reduction is achieved HELL. Sharp The discontinuation of valsartan is not accompanied by a significant increase Blood pressure or other undesirable reactions. Have patients with arterial hypertension, sugar type 2 diabetes and nephropathy, taking valsartan in a dose of 160-320 mg, noted a significant decrease in proteinuria (36-44%).

Application after acute myocardial infarction in patients older than 18 years

When the use of valsartan for 2 years in patients between 12 hours to 10 days after an acute myocardial infarction (complicated by left ventricular failure and / or left ventricular systolic dysfunction), the overall mortality, cardiovascular mortality rates decrease and the time increases before the first hospitalizations for exacerbation of the course chronic heart failure, repeated myocardial infarction, sudden cardiac arrest, and stroke (without lethal outcome). The safety profile of valsartan in patients with acute infarction the myocardium is similar to that in other conditions.

Chronic heart failure (CHF) in patients older than 18 years

When application of valsartan (in an average daily dose 254 mg) for 2-х years in patients from CHF II (62%), III (36%) and IV (2%) of the functional class according to the classification NYHA from left ventricular ejection fraction (LV) less than 40% and internal diastolic diameter LV more than 2.9 cm / m², receiving standard therapy, including inhibitors ACE (93%), diuretics (86%), digoxin (67%) and beta-adrenoblockers (36%) there was a significant decrease (by 27.5%) of the risk hospitalization in occasion of an exacerbation of a current CHF.

Patients who do not received inhibitors ACE, significant a decrease in the total mortality (by 33%), cardiovascular mortality and morbidity, related to CHF (time before the onset of the first cardiovascular event), which are estimated by the following indicators: death, sudden death with resuscitation, hospitalization for exacerbation of the course CHF, intravenous introduction of inotropes or vasodilators during 4 or more hours without hospitalization (by 44%). In the group of patients receiving inhibitors ACE (without beta-adrenoblockers), against the background of valsartan treatment is not observed reduction in the overall mortality rate, however,vascular mortality and morbidity associated with CHF on 18,3%.

AT In general, the use of valsartan leads to a decrease in the number of hospital admissions for CHF, slowing the progression of CHF, improving the functional class CHF by classification NYHA, an increase in the left ventricular ejection fraction, as well as a decrease in the signs and symptoms of heart failure and improved quality of life compared with placebo.

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

When use of valsartan and lifestyle changes, a statistically significant reduction in the risk of developing diabetes mellitus the of 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 fatalities, on hospitalization due to heart failure or unstable angina, arterial revascularization in patients with impaired tolerance to glucose and arterial hypertension, differing in age, sex and race. Have patients receiving valsartan, risk development of microalbuminuria was significantly lower than in patients not receiving this therapy.

Use in children and adolescents aged 6 to 18 years with hypertension

Children and adolescents aged 6 to 18 years valsartan provides dose-dependent, gradual decline HELL. When using valsartan, the maximum reduction AD, regardless of from the accepted dose is usually achieved within 2 weeks, and supported on achieved level during long-term therapy.

Pharmacokinetics:

Suction

After taking Inside the absorption of valsartan occurs quickly, maximum concentration (C_m_Oh) Valsartan in the blood plasma is achieved within 2-4 hours. Average absolute bioavailability of 23%. When valsartan is used with food, the area under crooked "concentration-time" (AUC) and FROM_m_Oh decrease by 40% and 50% respectively, although, starting from about On the 8th h after taking the drug, the concentration of valsartan in plasma blood in the case of taking it on an empty stomach, and in case of admission from food, the same. Decrease AUC, nevertheless, is not accompanied by clinically significant decreased therapeutic effect, so valsartan can be taken regardless of the time of ingestion.

Distribution

Volume of distribution (V_d) valsartan in the equilibrium period after intravenous administration was about 17 liters, what indicates on the lack of extensive distribution of valsartan in tissues. Valsartan at a significant degree of binding to blood serum proteins (94-97%), mainly with albumins.

Metabolism

Valsartan does not undergo a pronounced metabolism (about 20% of the dose is determined in the form of metabolites). The hydroxyl metabolite is determined in blood plasma at low concentrations (less than 10% from AUC valsartan). This metabolite is pharmacologically inactive.

Excretion

Valsartan is biphasic: a-phase from half-life (T_1/2α) less than 1 hour and β-phase with T_1/2_β - about 9 hours. Valsartan is excreted mainly unchanged through the intestine (about 83%) and kidneys (about 13%). After intravenously, 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_m_Oh and T_1/2 similar to those of healthy volunteers. Increase AUC and C_m_Oh is directly proportional to the increase in the dose of the drug (from 40 mg to 160 mg 2 times).The cumulation factor is at an average of 1.7. When administered, the clearance of valsartan was approximately 4.5 liters / hour. The age of patients with CHF did not exert influence on clearance of valsartan.

Patients over the age of 65 years

In some patients over the age of 65 years systemic bioavailability of valsartan is higher than that of patients of young age (not has clinical significance).

Patients with impaired renal function

Correlation between renal function and systemic bioavailability of valsartan is absent. In patients with impaired function kidney and creatinine clearance (CC) more than 10 ml / min correction doses no drug is required. Currently, there is no data on the use in patients on hemodialysis. Valsartan has a high degree of binding to proteins plasma blood, therefore its excretion in hemodialysis is unlikely.

Patients with hepatic impairment

In patients with mild and moderate impairment of liver function, increased bioavailabilityAUC) 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 the drug in patients with severe impairment of liver function has not been studied.

Children and adolescents aged 6 to 18 years

The pharmacokinetic properties of valsartan in children and adolescents aged 6 to 18 years do not differ from the pharmacokinetic properties of valsartan in patients older than 18 years.

Indications:

Adults

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 pharmacotherapeutic groups: diuretics, cardiac glycosides, ACE inhibitors or beta-blockers. The use of each of these drugs is not mandatory.

For increased survival of patients after acute myocardial infarction complicated by left ventricular failure and / or left ventricular systolic dysfunction, with stable hemodynamic parameters.

Children and teens

Arterial hypertension in children and adolescents aged 6 to 18 years.

Contraindications:

Hypersensitivity to valsartan or any other component of the drug.

Pregnancy and lactation.

Severe violations of the liver, biliary cirrhosis and cholestasis.

Simultaneous use with aliskiren in patients with diabetes mellitus or patients with impaired renal function (creatinine clearance less than 60 ml / min).

Age up to 6 years - according to indications arterial hypertension, up to 18 years - according to other indications.

AT the formulation of the drug includes lactose monohydrate, so the drug should not be used with lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Carefully:

The preparation Valaar should be used with caution in bilateral stenosis of the renal arteries, stenosis of the artery of a single kidney, primary hyperaldosteronism, while observing a diet with restriction of consumption of table salt; at conditions accompanied by a decrease in the volume of circulating blood (including diarrhea, vomiting); in adults with CC less than 10 ml / min, in patients from 6 to 18 years with CC less than 30 ml / min, including those on hemodialysis, with mild and moderate impairment of liver function of non-biliary origin without phenomena of cholestasis, in patients with CHF III-IV functional class for NYHA, renal function in which depends on the renin-angiotensin-aldosterone system (RAAS), in patients with mitral or aortic stenosis, hypertrophic obstructive cardiomyopathy, as well as in patients after kidney transplantation.

The drug Valaar should be used with caution in patients with hereditary angioedema or angioedema, with previous use of angiotensin II receptor antagonists (APA II) or ACE inhibitors. Care should be taken when concomitantly prescribing the drug with other agents that inhibit RAAS, such as ACE inhibitors or aliskiren-containing drugs.

It is not recommended to use the drug simultaneously with ACE inhibitors, since this combination therapy has no advantage over monotherapy with valsartan or an ACE inhibitor for all-cause mortality.

Pregnancy and lactation:

Pregnancy

Given the mechanism of action of angiotensin II receptor antagonists, one can not exclude risk for the fetus. The effect of ACE inhibitors (drugs that affect the renin-angiotensin-aldosterone system (RAAS) on the fetus,in case of their application in second and third trimester of pregnancy, can lead to its damage and death. According to the retrospective data, when using ACE inhibitors in the first trimester of pregnancy, the risk of having children with congenital defects increases. There are reports of spontaneous abortions, oligohydramnios and renal dysfunction in newborns, whose mothers during pregnancy accidentally received valsartan. The preparation Valaar, like any other drug that directly affects RAAS, should not be used during pregnancy, as well as in women planning pregnancy. With the use of funds affecting RAAS, the doctor should inform women of childbearing age of the potential risk of adverse effects of these drugs on the fetus during pregnancy. If pregnancy is diagnosed during treatment with Valaar, treatment should be discontinued as soon as possible.

Fertility

AT Preclinical studies in animals showed no effects of valsartan on fertility. There is no data on the effect of valsartan on fertility in humans.

Breastfeeding period

It is not known, whether valsartan in breast milk. Therefore, do not use the drug during lactation.

Dosing and Administration:

Inside, not liquid, regardless of food intake, washing down with enough water.

Adults

Arterial hypertension

The recommended initial dose of Valaar is 80 mg once a day, regardless of race, age or sex of the patient. Antihypertensive effect is observed in the first 2 weeks of treatment, the maximum effect develops after 4 weeks. For those patients who do not achieve an adequate therapeutic response, the daily dose of the drug can be gradually increased to a maximum daily dose of 320 mg or diuretics should be additionally applied.

Chronic heart failure

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

To improve the survival of patients after acute myocardial infarction

Treatment should be started within 12 hours after myocardial infarction. The initial dose is 20 mg (1/2tablets 40 mg) 2 times a day. The dose is increased by titration (40 mg, 80 mg, 160 mg twice daily) for several consecutive weeks, until the target dose of 160 mg twice a day is reached.

The maximum daily dose is 320 mg in 2 divided doses. Usually, it is recommended that the dose be increased to 80 mg twice a day by the end of the 2 week treatment. Attainment the maximum target dose of 160 mg 2 times a day is recommended by the end of the third month of therapy with the drug Valaar. The increase in dose depends on the tolerability of the drug during the titration period.

AT In the case of development of arterial hypotension accompanied by clinical manifestations, or renal dysfunction, a dose reduction should be considered.

Assessment of the condition of patients, in the period after a previous myocardial infarction, should include an evaluation of the kidney function.

Patients over the age of 65 years

In elderly patients older than 65 years, dose adjustment is not required.

Patients with impaired renal function

Have patients with impaired renal function, dose adjustment is not required. AT Currently there is no data on the use of the drug in patients with SC less than 10 ml / min.

Patients with hepatic impairment

Patients with mild or moderate impairment of liver function of non-biliary origin without cholestasis should be administered with caution, the daily dose should not exceed 80 mg.

Children and adolescents aged 6 to 18 years

Arterial hypertension

The recommended initial dose of the drug Valaar in children and adolescents between the ages of 6 to 18 years is 40 mg with a body weight of the child less than 35 kg and 80 mg with the body weight of the child more 35 kg. The dose is recommended to be adjusted taking into account the decrease in blood pressure. The maximum recommended doses are shown in the table below. The use of higher doses is not recommended.

Body mass	Maximum recommended daily dose
≥ 8 kg <35 kg	80 mg
≥ 35 kg <80 kg	160 mg
≥ 80 kg <160 kg	320 mg

Side effects:

Data on the dependence of the frequency of any of the undesirable reactions on the dose or duration of valsartan treatment, as well as sex, age or race, are not available. The safety profile of valsartan in children and adolescents aged 6 to 18 years with arterial hypertension does not differ from that of valsartan in adult patients.

Below the undesirable reactions that were observed during clinical trials, as well as with the use of the drug in clinical practice, are given.

Frequency development of adverse reactions is given in accordance with the classification WHO: very often (≥1 / 10 cases), often (≥1 / 100 and <1/10 cases) infrequently (≥1 / 1000 and <1/100 of cases), rarely (≥1 / 10000 and <1/1000 cases) and very rarely (<1/10000 cases, including individual messages). Within each group allocated by frequency occurrence, Unwanted reactions are distributed in decreasing order their importance.

For all the undesirable reactions revealed in clinical practice and in the analysis of laboratory parameters (the frequency of development of which can not be established) was used gradation "frequency is unknown."

Patients with hypertension

On the part of the hematopoiesis and lymphatic system: frequency unknown - decline hemoglobin, hematocrit, neutropenia, thrombocytopenia.

From the immune system: frequency is unknown - hypersensitivity reactions, including serum sickness.

Metabolic disorders: the frequency is unknown - an increase in the potassium content in the serum.

Co the sides of the hearing organ and labyrinthine disorders: infrequently - vertigo.

Co cardiovascular system: frequency is unknown - vasculitis.

From the side respiratory system: infrequently - cough.

From the side gastrointestinal tract: infrequently - pain in the abdomen.

From the hepatobiliary system: frequency unknown - function violation liver, including increase in the concentration of bilirubin in the blood plasma.

From the skin and subcutaneous tissue: very rarely - angioedema edema, skin rash, itching.

From the side musculoskeletal system: frequency is unknown - myalgia.

From the side of the kidneys: frequency unknown - renal dysfunction, increased concentrations creatinine in serum.

Other: infrequently - increased fatigue.

Also in clinical trials the patients with arterial hypertension, the following adverse events were observed, the cause-effect relationship of which from the administration of the drug has not been established: arthralgia, asthenia, back pain, diarrhea, dizziness, insomnia, decreased libido, nausea, peripheral edema, pharyngitis, rhinitis, sinusitis, upper respiratory tract infections, viral infections.

Patients receiving valsartan after an acute acute myocardial infarction and / or with CHF

Co side of the hematopoiesis and lymphatic system: frequency unknown - thrombocytopenia.

From the immune system: frequency is unknown - reactions hypersensitivity, including serum sickness.

Metabolic disorders: infrequently hyperkalemia; frequency unknown - increase of content potassium in the blood serum.

From the nervous system: often - dizziness, postural dizziness; infrequently - fainting, headache.

Co the sides of the hearing organ and labyrinthine disorders: infrequently - vertigo.

From the side of the cardiovascular system: often expressed decrease AD, orthostatic hypotension; infrequently - increased symptoms of chronic heart failure; frequency is unknown - vasculitis.

Co the respiratory system: infrequently - cough.

From the side gastrointestinal tract: infrequently - nausea, diarrhea.

From the hepatobiliary system: frequency unknown - function violation liver.

From the skin and subcutaneous tissue: very rarely - angioedema edema; frequency unknown - skin rash, itching.

From the musculoskeletal system: rarely - rhabdomyolysis; frequency unknown - myalgia.

From the side of the kidneys: often - renal dysfunction; infrequently acute renal failure, increased serum creatinine concentration blood; frequency unknown - increase in the content of urea nitrogen in the blood plasma.

Common violations: infrequently - asthenia, increased fatigue.

Also during the clinical trials in patients after acute myocardial infarction myocardium and / or CHF the following undesirable phenomena, cause-and-effect the connection of which with the administration of the drug not installed: arthralgia, pain at belly, pain in back, asthenia, insomnia, decreased libido, neutropenia, peripheral edema, pharyngitis, rhinitis, sinusitis, upper respiratory infections pathways, viral infection.

Overdose:

Symptoms. With an overdose of valsartan, the main manifestation is a marked decrease in blood pressure, which can lead to depression, collapse and / or shock.

Treatment. Symptomatic treatment, 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. If there is a marked decrease in blood pressure as a therapy, intravenous injection of 0.9% sodium chloride solution is necessary, the patient should be laid, raising his legs, for a period of time necessary for therapy, to take active measures to maintain the cardiovascular system, including regular monitoring of cardiac activity and the respiratory system, the volume of circulating blood (BCC), and the amount of urine released.

Interaction:

It is found that when monotherapy valsartan no clinically significant interactions with the following drugs: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine, glibenclamide.

Double blockade of RAAS with the use of angiotensin II receptor antagonists, ACE inhibitors or aliskiren

Simultaneous use of angiotensin receptor antagonists II, including valsartan, with other agents that affect RAAS, is associated with an increased incidence of arterial hypotension, hyperkalemia and changes in renal function by compared with monotherapy.It is recommended to monitor blood pressure, kidney function and electrolyte content in patients taking valsartan and other drugs that affect RAAS.

Non-steroidal anti-inflammatory drugs (NSAIDs), including selective inhibitors of cyclooxygenase-2

When the use of valsartan concurrently with NSAIDs, including selective inhibitors of cyclooxygenase-2, may reduce its antihypertensive effect. When angiotensin II receptor antagonists are used concomitantly with NSAIDs, kidney function may worsen and potassium levels rise in the blood plasma. If it is necessary to simultaneously use valsartan and NSAIDs before starting treatment, it is necessary to evaluate the function of the kidneys and correct the violations of the water electrolyte balance.

Protein-carriers

By the results of the study in vitro on liver cultures valsartan is a substrate for the OATP1B1 vector proteins and MRP2. Simultaneous administration of valsartan from inhibitors of the carrier protein OATP1B1 (rifampicin, ciclosporin) and with inhibitors of the carrier protein MRP2 (ritonavir) can increase the systemic exposure of valsartan (C_mOh and AUC).

Lithium preparations

With the use of ACE inhibitors simultaneously with lithium preparations, an increase in the level of lithium in the blood plasma and an increase in its toxic effect are noted. It is not recommended to apply valsartan simultaneously with lithium preparations (experience of use is limited). If it is necessary to use valsartan concomitantly with lithium preparations, it is necessary to control the lithium content in the blood plasma.

With the simultaneous use of valsartan with biologically active additives, containing potassium, potassium-sparing diuretins (incl. spironolactone, eplerenone, triamterene, amiloride), potassium-containing salt substitutes or with other drugs that can cause an increase in the content of the katya in the blood (for example, with heparin), care should be taken and regular monitoring of potassium in the blood.

Children and adolescents Arterial hypertension is often associated with impaired renal function. This category of patients is recommended with caution to take valsartan concomitantly with other drugs that affect the renin-angiotensin-aldosterone system, since this can lead to an increase in the potassium concentration at blood serum. Regular monitoring of kidney function should be performed and concentration of potassium in the blood serum of this group of patients.

Special instructions:

Kidney Transplantation

There are no data on the safety of valsartan in patients after kidney transplantation.

Deficiency in the body of sodium and / or decreased BCC

In patients with severe sodium deficiency and / or reduced bcc, for example, receiving high doses of diuretics, in rare cases, at the beginning of treatment with the drug may develop arterial hypotension accompanied by clinical manifestations. Before starting treatment with the drug should be corrected the content in the body and / or replenish the BCC, including by reducing the dose of the diuretic.

Stenosis of the renal artery

The use of the drug in a short course in patients with reninvascular hypertension, which developed secondary due to unilateral stenosis of the artery of a single kidney, does not lead to any significant change in renal hemodynamics, serum creatinine concentration, or blood urea nitrogen. However, given that other drugs that affect RAAS,can cause an increase in the concentration of urea and creatinine in the blood serum in patients with bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney, as a precautionary measure, it is recommended that these parameters be monitored.

Primary hyperaldosteronism

The drug is ineffective for the treatment of hypertension in patients with primary hyperaldosteronism, since in this category of patients there is no activation of RAAS.

CHF / period after a previous myocardial infarction

In patients with CHF or after a previous myocardial infarction, starting treatment with valsartan, there is often a slight decrease in blood pressure, and therefore it is recommended to control blood pressure at the beginning of therapy. Subject to the recommendations on the dosing regimen, there is usually no need to discontinue the drug due to hypotension. Evaluation of patients with CHF should include assessment of renal function.

Due to inhibition of RAAS in some patients, renal dysfunction may occur. In patients with CHF III-IV functional class by classification NYHA, the function of the kidneys in which it depends on the state of RAAS,treatment with ACE inhibitors and angiotensin II receptor antagonists may be accompanied by oliguria and / or augmentation of azotemia and in rare cases with the development of acute renal failure and / or death. Therefore, in these categories of patients before the use of the drug, as well as periodically during treatment, it is necessary to assess the function of the kidneys.

Combination therapy for hypertension

When hypertension Valaar preparation may be used in monotherapy as well as in conjunction with other antihypertensives, in particular diuretics. Combination therapy in the post-myocardial infarction period Valaar possible to use the drug in combination with other drugs used after myocardial infarction, namely: thrombolytics, aspirin as antiplatelet drugs, beta-blockers and inhibitors of HMG-CoA reductase inhibitors (statins). In this category of patients is not recommended Valaar drug concurrently with ACE inhibitors, since this combination therapy is not superior to monotherapy with valsartan or ACE inhibitorfor all-cause mortality.

Combination therapy with CHF

When CHF the preparation Valaar can be used both in monotherapy and simultaneously with other agents - diuretics, cardiac glycosides, as well as inhibitors ACE or beta-blockers. In this category of patients is not recommended the use of triple combination therapy with an ACE inhibitor, beta-adrenoblocker and valsartan.

Angioedema

Angioedema, including swelling of the larynx and vocal cords leading to airway obstruction, and / or swelling of the face, lips, pharynx, and / or tongue edema, occurred in patients who received valsartan, some of these patients had angioedema earlier on the background of taking other drugs, including inhibitors ACE. Taking the drug Valaar in case of angioedema development should be immediately canceled, the resumption of the drug is prohibited.

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

Since against the background of therapy with Valaar, it is possible to develop such undesirable reactions as dizziness or fainting, for patients taking the drug,Care should be taken when driving a vehicle and engaging in potentially hazardous activities.

Form release / dosage:

Tablets, film-coated, 40 mg and 80 mg.

Packaging:

By 7, 10, 14, 15, 20, 30 tablets in a planar cell packaging made of polyvinylchloride film and aluminum foil printed lacquered.

By 1, 2, 3, 4, 5, 6, 7, 8, 20, 50, 70, 80 or 100 contour mesh packages together with instructions for use in a pack of cardboard.

Storage conditions:

AT dry, protected from light, at a temperature not exceeding 25 FROM.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002423

Date of registration:07.04.2014

Expiration Date:07.04.2019

Date of cancellation:2019-04-07

The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Manufacturer: & nbsp

OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Information update date: & nbsp14.01.2017

Illustrated instructions

Instructions

Valaar (Valaar)