Hyposart tablets 32mg, No. 28

Arterial hypertension.
Chronic heart failure and impaired systolic function of the left ventricle (LVEF ? 40%) - as an adjunctive therapy to ACE inhibitors or in case of intolerance to ACE inhibitors.

Inside, 1 time per day, regardless of the time of the meal.

Arterial hypertension The
recommended initial and maintenance dose of Hyposart is 8 mg 1 time / day.
If necessary, the dose can be increased to 16 mg 1 time / day.
The maximum antihypertensive effect is achieved within 4 weeks of therapy.
The maximum daily dose is 32 mg 1 time / day.
If, against the background of the maximum daily dose, adequate control of blood pressure is not achieved, it is recommended to add a thiazide diuretic to therapy.
Patients with reduced BCC
In patients at risk of developing arterial hypotension, therapy is recommended to start with an initial dose of 4 mg.
Patients with impaired renal function
In patients with mild or moderate renal impairment (CC 30-80 ml / min / 1.73 m2 body surface area), including patients on hemodialysis, the initial dose of the drug is 4 mg. The dose is titrated depending on the therapeutic effect. Clinical experience of using the drug in patients with severely impaired renal function or end-stage renal failure (CC less than 15 ml / min) is limited (see section 'Special instructions'.)
Patients with impaired liver function The
initial daily dose of the drug in patients with mild liver disease and moderate severity is 4 mg. The dose may be increased if necessary.
There is no clinical experience with the drug in patients with severe hepatic impairment and / or cholestasis (see section on Contraindications).
Concomitant therapy
The use of the drug Hyposart simultaneously with thiazide diuretics (for example, hydrochlorothiazide) may enhance the antihypertensive effect of the drug.

Chronic heart failure The
recommended initial dose of Hyposart is 4 mg 1 time / day. An increase to the maximum daily dose of 32 mg 1 time / day or to the maximum tolerated dose is carried out by doubling the dose with an interval of at least 2 weeks.
Special groups of patients
Elderly patients and patients with impaired renal or hepatic function do not require adjustment of the initial dose of the drug.
Use in children and adolescents The
safety and efficacy of the drug Giposart in children and adolescents under the age of 18 have not been established.
Concomitant therapy
The drug Giposart can be used simultaneously with other drugs for the treatment of CHF, including ACE inhibitors, beta-blockers, diuretics, cardiac glycosides, or combinations of these drugs.

1 tablet (32 mg) contains:
Active ingredient: candesartan cilexetil - 32.00 mg.
Excipients: lactose monohydrate - 174.00 mg, corn starch - 40.00 mg, hyprolose - 4.00 mg, hyprolose * - 4.00 mg, macrogol 6000 - 5.20 mg, magnesium stearate - 0.80 mg.

* Viscosity, water, 25 ? — (5%) 75 - 150 cps
** Viscosity, water, 25 ? — (5%) 1500 - 3000 cps

Hypersensitivity to candesartan or other components of the drug.
Lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.
Pregnancy and the period of breastfeeding.
Children and adolescents under 18 years of age (efficacy and safety have not been established).
Severe liver dysfunction and / or cholestasis.
Simultaneous use with aliskiren and aliskiren-containing drugs, in patients with diabetes mellitus or impaired renal function (glomerular filtration rate less than 60 ml / min).

Carefully

Severe renal dysfunction (creatinine clearance (CC) less than 30 ml / min), hemodialysis, bilateral renal artery stenosis or stenosis of a solitary kidney artery, hemodynamically significant stenosis of the aortic and / or mitral valve, hypertrophic obstructive cardiomyopathy (GOKM), condition after kidney transplantation , cerebrovascular disorders of ischemic origin and coronary heart disease (IHD), hyperkalemia in patients with reduced circulating blood volume (BCC), general anesthesia and surgical interventions (risk of arterial hypotension due to RAAS blockade), primary hyperaldosteronism.

Tradename:

Hyposart

International non-proprietary name:

Candesartan

Dosage form:

pills

Composition:

1 tablet (4 mg) contains:
Active ingredient: candesartan cilexetil - 4.00 mg.
Excipients: lactose monohydrate - 98.95 mg, corn starch - 20.00 mg, hyprolose - 2.00 mg, hyprolose * - 2.00 mg, macrogol 6000 - 2.60 mg, magnesium stearate - 0.40 mg, iron dye red oxide E 172 - 0.05 mg.
1 tablet (8 mg) contains:
Active ingredient: candesartan cilexetil - 8.00 mg.
Excipients: lactose monohydrate - 197.90 mg, corn starch - 40.00 mg, hyprolose - 4.00 mg, hyprolosis * - 4.00 mg, macrogol 6000 - 5.20 mg, magnesium stearate - 0.80 mg, iron dye red oxide E 172 - 0.10 mg.
1 tablet (16 mg) contains:
Active ingredient: candesartan cilexetil - 16.00 mg. Excipients: lactose monohydrate - 87.00 mg, corn starch - 20.00 mg, hyprolose - 2.00 mg, hyprolosis * - 2.00 mg, macrogol 6000 - 2.60 mg, magnesium stearate - 0.40 mg.
1 tablet (32 mg) contains:
Active ingredient: candesartan cilexetil - 32.00 mg.
Excipients: lactose monohydrate - 174.00 mg, corn starch - 40.00 mg, hyprolose - 4.00 mg, hyprolose * - 4.00 mg, macrogol 6000 - 5.20 mg, magnesium stearate - 0.80 mg.

* Viscosity, water, 25 ? — (5%) 75 - 150 cps
** Viscosity, water, 25 ? — (5%) 1500 - 3000 cps

Description:

For 4 mg tablets:
Round, flat, scored on one side, light pink in color.
For 8 mg tablets:
Round, biconvex, scalloped tablets on one side and engraved '8' on the other, light pink in color.
For 16 mg tablets:
White, round, biconvex, scored tablets on one side.
For 32 mg tablets:
Round flat tablets with a score line on one side and engraved '32' on the other, white.

Pharmacotherapeutic group:

angiotensin II receptor antagonist

ATX code:

C09CA06

Pharmacological properties

Pharmacodynamics
Angiotensin II is the main enzyme of the renin-angiotensin-aldosterone system (RAAS), which is involved in the pathogenesis of arterial hypertension (AH), heart failure and other cardiovascular diseases.
Candesartan is a selective antagonist of angiotensin II receptors, subtype 1 (AT1 receptors). Does not exhibit agonist properties (does not affect the angiotensin-converting enzyme (ACE) and does not lead to the accumulation of bradykinin or substance P, does not bind to receptors of other hormones, does not affect the state of ion channels involved in the regulation of the cardiovascular system). As a result of blocking the AT1 receptors of angiotensin II, there is a compensatory dose-dependent increase in renin activity, the concentration of angiotensin I, angiotensin II and a decrease in the concentration of aldosterone in the blood plasma.
Arterial hypertension
Taking candesartan orally provides a dose-dependent, gradual decrease in blood pressure (BP) due to a decrease in total peripheral vascular resistance (OPSR) without a reflex increase in heart rate (HR). There is no data on the development of severe arterial hypotension after taking the first dose or on the development of a withdrawal syndrome after discontinuation of therapy.
The onset of antihypertensive action after taking the first dose of the drug usually develops within 2 hours, the duration of the effect is 24 hours. Against the background of continued therapy with candesartan in a fixed dose, the maximum decrease in blood pressure is usually achieved within 4 weeks and lasts throughout the entire treatment. The addition of the thiazide diuretic hydrochlorothiazide to candesartan enhances its antihypertensive effect.
The age and gender of the patient does not affect the effectiveness of the drug. Candesartan increases renal blood flow and does not alter or increase the glomerular filtration rate, while renal vascular resistance and filtration fraction are reduced.
Candesartan has a less pronounced antihypertensive effect in black patients (a population with predominantly low plasma renin activity).
There are no data on the effect of candesartan on the progression of diabetic nephropathy.
In patients with arterial hypertension and type 2 diabetes mellitus, candesartan does not adversely affect blood glucose concentration and lipid profile.
Heart failure
Candesartan therapy reduces the mortality rate and hospitalization rate in patients with chronic heart failure (CHF), regardless of age, gender and concomitant therapy, and leads to a decrease in the functional class of CHF according to the NYHA classification.
Candesartan is effective in patients taking beta-blockers concomitantly in combination with ACE inhibitors; while its effectiveness does not depend on the dose of the ACE inhibitor.
In patients with CHF and reduced systolic function of the left ventricle (left ventricular ejection fraction (LVEF) less than 40%), candesartan reduces systemic vascular resistance and wedge pressure in the pulmonary capillaries.

Pharmacokinetics of
Candesartan cilexetil is a prodrug. Candesartan cilexetil, after oral administration, is rapidly converted into the active substance, candesartan, through ether hydrolysis.
When absorbed from the digestive tract, it strongly binds to ATI receptors and slowly dissociates, has no agonist properties.
Absorption and distribution The
absolute bioavailability of candesartan is approximately 40% after oral administration. The relative bioavailability is approximately 34%.
The maximum concentration (Cmax) in the blood serum is reached 3-4 hours after ingestion. Plasma concentration increases linearly with increasing dose in the therapeutic range (up to 32 mg). The connection with blood plasma proteins is high (more than 99%). The volume of distribution of candesartan is 0.13 L / kg. The pharmacokinetic parameters of candesartan do not depend on the age, gender of the patient and the time of meal.
Metabolism and excretion
Candesartan is mainly excreted from the body by the kidneys and through the intestines unchanged. It is slightly metabolized in the liver (20-30%) with the participation of the isoenzyme CYP2C9 with the formation of an inactive derivative.
The half-life (T1 / 2) of candesartan is approximately 9 hours. Does not cumulate. The total clearance is about 0.37 ml / min / kg, while the renal clearance of the drug is 0.19 ml / min / kg. After oral administration of 14C-labeled candesartan cilexetil, 26% of the dose was excreted by the kidneys in the form of candesartan and 7% in the form of an inactive metabolite, while 56% of the dose is excreted through the intestine with bile in the form of candesartan and 10% in the form of an inactive metabolite. After a single oral administration within 72 hours, more than 90% of the dose is excreted.

Special patient groups

In elderly patients (over 65 years of age), the Cmax and the area under the concentration-time curve (AUC) of candesartan increase in comparison with young patients by about 50% and 80%, respectively. However, the reaction from blood pressure and possible side effects when using candesartan do not depend on the age of the patients.
In patients with mild or moderate renal impairment, the Cmax and AUC of candesartan increase by about 50% and 70%, respectively, while T1 / 2 does not change compared with patients with preserved renal function.
Pharmacokinetics in hemodialysis patients are similar to those in patients with severe renal impairment.
In patients with severely impaired renal functionCmax and AUC increase by 50% and 110%, respectively, and T1 / 2 of the drug increases by 2 times.
In patients with mild to moderate hepatic impairment, the mean AUC of candesartan increases by about 20% in one study and 80% in another study.
No experience of use in patients with severely impaired liver function.

Indications for use

Arterial hypertension.
Chronic heart failure and impaired systolic function of the left ventricle (LVEF ? 40%) - as an adjunctive therapy to ACE inhibitors or in case of intolerance to ACE inhibitors.

Contraindications

Hypersensitivity to candesartan or other components of the drug.
Lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.
Pregnancy and the period of breastfeeding.
Children and adolescents under 18 years of age (efficacy and safety have not been established).
Severe liver dysfunction and / or cholestasis.
Simultaneous use with aliskiren and aliskiren-containing drugs, in patients with diabetes mellitus or impaired renal function (glomerular filtration rate less than 60 ml / min).

Carefully

Severe renal dysfunction (creatinine clearance (CC) less than 30 ml / min), hemodialysis, bilateral renal artery stenosis or stenosis of a solitary kidney artery, hemodynamically significant stenosis of the aortic and / or mitral valve, hypertrophic obstructive cardiomyopathy (GOKM), condition after kidney transplantation , cerebrovascular disorders of ischemic origin and coronary heart disease (IHD), hyperkalemia in patients with reduced circulating blood volume (BCC), general anesthesia and surgical interventions (risk of arterial hypotension due to RAAS blockade), primary hyperaldosteronism.

Application during pregnancy and during breastfeeding

Pregnancy
The drug Hyposart is contraindicated for use during pregnancy, because it has a direct effect on the RAAS and can cause fetal developmental disorders (especially in the second and third trimesters of pregnancy) or have a negative effect on the newborn, up to death, if the drug was used during pregnancy.
It is known that therapy with angiotensin II receptor antagonists (ARAM) can cause fetal development disorders (impaired renal function, oligohydramnios, slowed ossification of the skull bones) and the development of complications in the newborn (renal failure, arterial hypotension, hyperkalemia).
When establishing the fact of pregnancy, the drug Hyposart must be canceled as soon as possible. When planning a pregnancy, it is necessary to transfer the patient to an adequate alternative therapy.
Breastfeeding
It is not known whether candesartan passes into breast milk, but it is known to pass into the milk of lactating rats.
During treatment with Hyposart, breastfeeding should be discontinued. Newborns whose mothers took Hyposart during pregnancy should be under close medical supervision because of the likelihood of developing arterial hypotension.

Method of administration and dosage

Inside, 1 time per day, regardless of the time of the meal.

Arterial hypertension The
recommended initial and maintenance dose of Hyposart is 8 mg 1 time / day.
If necessary, the dose can be increased to 16 mg 1 time / day.
The maximum antihypertensive effect is achieved within 4 weeks of therapy.
The maximum daily dose is 32 mg 1 time / day.
If, against the background of the maximum daily dose, adequate control of blood pressure is not achieved, it is recommended to add a thiazide diuretic to therapy.
Patients with reduced BCC
In patients at risk of developing arterial hypotension, therapy is recommended to start with an initial dose of 4 mg.
Patients with impaired renal function
In patients with mild or moderate renal impairment (CC 30-80 ml / min / 1.73 m2 body surface area), including patients on hemodialysis, the initial dose of the drug is 4 mg. The dose is titrated depending on the therapeutic effect. Clinical experience of using the drug in patients with severely impaired renal function or end-stage renal failure (CC less than 15 ml / min) is limited (see section 'Special instructions'.)
Patients with impaired liver function The
initial daily dose of the drug in patients with mild liver disease and moderate severity is 4 mg. The dose may be increased if necessary.
There is no clinical experience with the drug in patients with severe hepatic impairment and / or cholestasis (see section on Contraindications).
Concomitant therapy
The use of the drug Hyposart simultaneously with thiazide diuretics (for example, hydrochlorothiazide) may enhance the antihypertensive effect of the drug.

Chronic heart failure The
recommended initial dose of Hyposart is 4 mg 1 time / day. An increase to the maximum daily dose of 32 mg 1 time / day or to the maximum tolerated dose is carried out by doubling the dose with an interval of at least 2 weeks.
Special groups of patients
Elderly patients and patients with impaired renal or hepatic function do not require adjustment of the initial dose of the drug.
Use in children and adolescents The
safety and efficacy of the drug Giposart in children and adolescents under the age of 18 have not been established.
Concomitant therapy
The drug Giposart can be used simultaneously with other drugs for the treatment of CHF, including ACE inhibitors, beta-blockers, diuretics, cardiac glycosides, or combinations of these drugs.

Side effect

Classification of the incidence of side effects of the World Health Organization (WHO): very often (? 1/10); often (? 1/100, <1/10); infrequently (? 1/1000, <1/100); rarely (? 1/10000, <1/1000); very rare (<1/10000), including isolated messages.
The side effects of candesartan are mild and transient. The frequency of side effects does not depend on the dose of the drug and the age of the patient.
From the nervous system: often - dizziness, headache, weakness.
From the respiratory system: often - respiratory infections, pharyngitis, rhinitis, cough.
From the side of the cardiovascular system: often - a pronounced decrease in blood pressure.
From the genitourinary system:often - impaired renal function, including renal failure in predisposed patients.
From the hematopoietic and lymphatic system: very rarely - leukopenia, neutropenia, thrombocytopenia and agranulocytosis.
From the digestive system: very rarely - nausea.
On the part of the hepatobiliary system: very rarely - an increase in the activity of 'hepatic' transaminases, impaired liver function or hepatitis.
From the side of the musculoskeletal system: very rarely - back pain, arthralgia, myalgia.
Laboratory indicators: very rarely - hyperkalemia, hyponatremia, an increase in the concentration of creatinine in the blood, hyperuricemia, a slight decrease in hemoglobin.
Allergic reactions:very rarely - angioedema, skin rash, itching, urticaria.
Others: exacerbation of the course of gout, 'hot flushes' of blood to the skin of the face.

Overdose

Symptoms: marked decrease in blood pressure, dizziness, tachycardia. Individual cases of drug overdose (up to 672 mg of candesartan cilexetil), which ended in the recovery of patients without serious consequences, are described.
Treatment: with a pronounced decrease in blood pressure, transfer the patient to the 'lying' position on his back, raise his legs; further, measures should be taken to increase the BCC (administration of 0.9% sodium chloride solution intravenously).
If necessary, sympathomimetic drugs can be prescribed.
Symptomatic therapy under the control of vital body functions.
Hemodialysis is ineffective.

¬заимодействие с другими лекарственными средствами

ѕрименение кандесартана одновременно с препаратами, содержащими алискирен, противопоказано пациентам с сахарным диабетом или умеренной или т¤желой почечной недостаточностью (— ‘ менее 60 мл/мин/1,73 м?) (см. раздел Ђѕротивопоказани¤ї).
»зучено одновременное применение кандесартана с гидрохлоротиазидом, варфарином, дигоксином, пероральными контрацептивами (этинилэстрадиол/левоноргестрел), глибенкламидом, нифедипином и эналаприлом; клинически значимого фармакокинетического взаимодействи¤ не отмечено.  андесартан в незначительной степени метаболизируетс¤ в печени (с помощью изофермента CYP2C9). Ќе вы¤влено вли¤ни¤ на изоферменты CYP2C9 и CYP3A4; эффект в отношении других изоферментов цитохрома P450 в насто¤щее врем¤ неизвестен.
vипотензивные средства потенцируют антигипертензивный эффект кандесартана. ќпыт применени¤ других лекарственных средств, действующих на –јј—, показывает, что одновременное применение препарата и калийсберегающих диуретиков (спиронолактон, эплеренон, триамтерен, амилорид), препаратов кали¤, заменителей соли, содержащих калий, или других средств, способных повышать содержание кали¤ в сыворотке крови (например, гепарин), может привести к развитию гиперкалиемии. ѕри одновременном применении препаратов лити¤ и ингибиторов јѕ‘ были отмечены случаи транзиторного повышени¤ концентрации лити¤ в сыворотке крови и развитии токсических эффектов. јналогичный эффект возможен при одновременном применении препаратов лити¤ и антагонистов рецепторов ангиотензина II, что требует периодического контрол¤ концентрации лити¤ в сыворотке крови при комбинированном применении этих препаратов.
ѕри одновременном применении ј–јћ и нестероидных противовоспалительных препаратов (Ќѕ¬ѕ), включа¤ селективные ингибиторы циклооксигеназы-2 (?ќv-2) и неселективные Ќѕ¬ѕ, например, ацетилсалицилова¤ кислота более 3 г/сут, может уменьшатьс¤ антигипертензивное действие кандесартана.

?война¤ блокада –јј—
 ак и в случае с ингибиторами јѕ‘, одновременное применение ј–јII и Ќѕ¬ѕ повышает риск снижени¤ функции почек, вплоть до развити¤ почечной недостаточности, что приводит к гиперкалиемии у пациентов с нарушением функции почек. Ёта комбинаци¤ должна примен¤тьс¤ с осторожностью, особенно у пациентов пожилого возраста. ¬се пациенты должны получать достаточное количество жидкости; необходимо контролировать функцию почек в начале терапии и в дальнейшем.

ќсобые указани¤

Ётнические особенности
јнтигипертензивный эффект кандесартана у пациентов негроидной расы менее выражен по сравнению с пациентами других рас, в св¤зи с чем, чаще требуетс¤ увеличение дозы препарата vипосарт, а также сочетание с другими гипотензивными препаратами.
Ќарушение функции почек
ќпыт применени¤ препарата у пациентов с т¤желой почечной недостаточностью или наход¤щихс¤ в терминальной стадии почечной недостаточности (   менее 15 мл/мин) ограничен. ” таких пациентов необходим строгий подбор дозы препарата vипосарт под тщательным контролем ј?.
” пациентов с ’—Ќ, особенно старше 75 лет, и у пациентов с нарушени¤ми функции почек необходимо периодически контролировать функцию почек. ¬ период подбора дозы препарата vипосарт рекомендуетс¤ контролировать концентрацию креатинина и кали¤ в сыворотке крови.
 омбинированна¤ терапи¤ с ингибитором јѕ‘ при ’—Ќ
ѕри применении препарата vипосарт в комбинации с ингибитором јѕ‘ может возрастать риск развити¤ побочных эффектов: нарушение функции почек и гиперкалиеми¤. ¬ этих случа¤х необходимо тщательное наблюдение и контроль соответствующих лабораторных показателей.
vемодиализ
¬о врем¤ проведени¤ гемодиализа ј? может быть особенно чувствительно к блокаде AT1-рецепторов в результате уменьшени¤ ќ?  и активации –јј—. ѕоэтому пациентам, наход¤щимс¤ на гемодиализе, необходим контроль ј? и индивидуальный подбор дозы препарата vипосарт.
—теноз почечной артерии
ѕрепараты, оказывающие вли¤ние на –јј—, например, ингибиторы јѕ‘, могут вызывать гиперурикемию и гиперкреатининемию у пациентов с двусторонним стенозом почечных артерий или стенозом артерии единственной почки. јналогичный эффект может развитьс¤ при применении ј–јћ.
“рансплантаци¤ почки
ќпыт применени¤ препарата у пациентов, недавно перенесших трансплантацию почки, отсутствует.
јртериальна¤ гипотензи¤
” пациентов с ’—Ќ, получающих препарат vипосарт, может развитьс¤ артериальна¤ гипотензи¤.
“акже возможно развитие артериальной гипотензии у пациентов со сниженным ќ? , например, получающих большие дозы диуретиков. ¬ начале терапии необходимо соблюдать осторожность и при необходимости компенсировать ќ? .
ќбща¤ анестези¤/хирургические вмешательства
ѕри проведении хирургических вмешательств под общей анестезией у пациентов, принимающих ј–јћ, может развитьс¤ артериальна¤ гипотензи¤ вследствие блокады –јј—. ќчень редко артериальна¤ гипотензи¤ может быть выраженной и потребовать внутривенного введени¤ жидкости и/или вазопрессоров.
—теноз аортального и/или митрального клапанов, vќ ћѕ
ѕрепарат vипосарт необходимо с осторожностью примен¤ть у пациентов с гемодинамически значимым стенозом аортального и/или митрального клапанов или с vќ ћѕ.
ѕервичный гиперальдостеронизм
ѕациенты с первичным гиперальдостеронизмом резистентны к гипотензивным препаратам, вли¤ющим на –јј—, поэтому таким пациентам применение препарата vипосарт не рекомендуетс¤.
vиперкалиеми¤
ќдновременное применение препарата vипосарт и калийсберегающих диуретиков, препаратов кали¤, заменителей соли, содержащих калий, или других средств, способных повышать содержание кали¤ в сыворотке (например, гепарин), может привести к развитию гиперкалиемии у пациентов с артериальной гипертензией.
vиперкалиеми¤ может развитьс¤ и у пациентов с ’—Ќ, принимающих vипосарт. Ќа фоне терапии препаратом vипосарт у пациентов с ’—Ќ рекомендуетс¤ проводить периодический контроль содержани¤ кали¤ в сыворотке крови, особенно при одновременном применении ингибиторов јѕ‘ и калийсберегающих диуретиков (спиронолактон, эплеренон, триамтерен, амилорид).
ќбщие
ѕациенты, у которых сосудистый тонус и функци¤ почек преимущественно завис¤т от активности –јј— (например, пациенты с т¤желой декомпенсированной ’—Ќ или сопутствующим заболеванием почек, в т.ч. односторонний стеноз почечной артерии), терапи¤ другими препаратами, вли¤ющими через –јј—, может сопровождатьс¤ развитием артериальной гипотензии, азотемией, олигурией и реже Ц острой почечной недостаточностью. Ёто нельз¤ исключить и дл¤ антагонистов рецепторов ангиотензина II. „резмерное снижение ј? у пациентов с ишемической болезнью сердца или цереброваскул¤рными заболевани¤ми ишемического генеза может привести к развитию инфаркта миокарда или инсульта.
?война¤ блокада –јј— при применении препаратов, содержащих алискирен
Ќе рекомендуетс¤ двойна¤ блокада –јј— путем одновременного применени¤ кандесартана и алискирена, ввиду увеличени¤ риска развити¤ артериальной гипотензии, гиперкалиемии и нарушени¤ функции почек.
ѕрименение препарата одновременно с алискиреном и алискиренсодержащими препаратами у пациентов с сахарным диабетом или нарушением функции почек (— ‘ менее 60 мл/мин/1,73 м?) (см. раздел Ђѕротивопоказани¤ї).

¬ли¤ние на способность управлени¤ автотранспортом и работу со сложными механизмами

¬ли¤ние препарата vипосарт на управление автотранспортом и работу со сложными механизмами не изучалось, но фармакодинамические свойства препарата указывают на то, что подобное вли¤ние отсутствует.
Ќеобходимо соблюдать осторожность при управлении автотранспортом и зан¤ти¤ми потенциально опасными видами де¤тельности, требующими повышенной концентрации внимани¤ и быстроты психомоторных реакций в св¤зи с риском развити¤ головокружени¤.

‘орма выпуска

“аблетки 4 мг, 8 мг, 16 мг, 32 мг.
ѕо 14 таблеток в блистер из фольги Al/PVC/PVDC.
1, 2 или 4 блистера вместе с инструкцией по применению помещают в картонную пачку.

”слови¤ хранени¤

ѕри температуре не выше 25 ?—.
’ранить в недоступном дл¤ детей месте.

—рок годности

2 years.
Do not use the drug after the expiration date.

Vacation conditions

On prescription.