Prestilol tablets p/o 5mg/10mg №30

Name:
Prestilol tab. plen.ob. 5mg10mg per cont. No. 30 in the pack. №1
Description:
An antihypertensive drug, which is a combination of a selective beta1-blocker and an angiotensin-converting enzyme (ACE) inhibitor. The main active ingredient Perindopril + bisoprolol Release form Tablets Dosage 5 mg 10 mg Special instructions When prescribing Prestilol, the mechanism of action of each of the active substances of the drug and possible adverse events due to concomitant pathologies and interactions with other drugs should be taken into account. Being an ACE inhibitor, perindopril can cause a sharp decrease in blood pressure. Patients with reduced blood volume, which may occur as a result of diarrhea / vomiting, while taking diuretics, following a strict salt-free diet, undergoing hemodialysis, or patients with severe arterial hypertension with high renin activity, are at a higher risk of excessive reduction in blood pressure. In patients with clinical manifestations of heart failure, the occurrence of severe arterial hypotension can be observed both against the background of renal failure and without it. In addition, an excessive decrease in blood pressure in cerebrovascular diseases and coronary artery disease can cause the development of myocardial infarction or acute cerebrovascular accident. In this regard, in patients with an increased risk of developing symptomatic arterial hypotension, it is recommended to start treatment and make dose adjustments under close medical supervision. In the event of arterial hypotension, the patient should take a horizontal position. To replenish the volume of fluid in the body, an intravenous infusion of 0.9% sodium chloride solution is indicated. After replenishing the volume of circulating blood and increasing blood pressure, Prestilol can be continued. In some cases, with CHF in patients with normal or low blood pressure, it is advisable to prescribe individual components of the drug as monotherapy. It should be borne in mind that the risk of developing angioedema while taking an ACE inhibitor increases with the simultaneous use of sirolimus, temsirolimus, everolimus, or if there are indications of angioedema of any origin in the patient’s history. It has been established that angioedema occurs more often in patients of the Negroid race. In addition, in this category of patients, the therapeutic efficacy of perindopril is low. When conducting a differential diagnosis of dry persistent cough, it should also be taken into account as a possible side effect of Prestilol. Factors that increase the risk of developing hyperkalemia are: renal failure, impaired liver function, diabetes mellitus, age over 70 years, dehydration, metabolic acidosis, acute cardiac decompensation, concomitant use of drugs that increase the level of potassium in the blood serum (for example, heparin), potassium supplements, potassium-sparing diuretics (including spironolactone, triamterene, amiloride, eplerenone), salt substitutes, or dietary supplements containing potassium. Cardiac arrhythmias caused by hyperkalemia can be fatal. In this regard, if necessary, the combination of Prestilol with the above means should regularly monitor the content of potassium in the blood serum. With caution, only in case of absolute necessity, the simultaneous use of perindopril with angiotensin II receptor blockers or aliskiren is allowed. This combination is not recommended because of the increased risk of arterial hypotension, impaired renal function and hyperkalemia. Abrupt withdrawal of Prestilol, especially in patients with coronary artery disease, can cause a temporary deterioration in cardiac activity. If it is necessary to stop treatment, the dose should be reduced gradually (within 14 days or more), using separate components, and replacement therapy should be started in parallel. If against the background of the use of Prestilol in a patient at rest, there is a decrease in heart rate to 50-55 beats per minute or less, causing the development of symptoms associated with bradycardia, it is necessary to consider lowering the dose of the drug, while maintaining an acceptable dose of bisoprolol. Carrying out hemodialysis using high-flow membranes while taking an ACE inhibitor is associated with the risk of developing anaphylactoid reactions, so it is recommended to use a different type of dialysis membrane.? There is a risk of thrombocytopenia, anemia, neutropenia, or agranulocytosis. In patients with normal renal function and in the absence of aggravating factors, neutropenia rarely develops. The use of perindopril in patients who have had severe infections is recommended to be accompanied by periodic monitoring of the content of leukocytes in the blood. In patients with bronchial asthma and other chronic obstructive pulmonary pathologies, the use of beta-blockers may increase airway resistance, in these cases, an increase in the dose of beta2-agonists is required. Patients with diabetes should be aware that the effects of beta-blockers may mask the symptoms of hypoglycemia. Patients with psoriasis (including history) should be prescribed beta-blockers after a careful assessment of the balance of benefits of therapy and the potential risks associated with it. With pheochromocytoma (or suspicion of it), the use of bisoprolol is indicated only in combination with an alpha-adrenergic blocker. Bisoprolol may mask the symptoms of hyperthyroidism. Before carrying out extensive operations involving the use of anesthetics, it is necessary to inform the anesthetist about taking Prestilol. This will avoid drug interactions that can cause bradyarrhythmia, decreased reflex tachycardia, and decreased reflex ability to compensate for blood loss-related effects. The use of the drug must be stopped 48 hours before anesthesia. With the development of depression, drug therapy is recommended to be canceled. Influence on the ability to drive vehicles and complex mechanisms Prestilol does not have a direct effect on the patient’s ability to drive a vehicle and work with mechanisms, but individual reactions should be taken into account, especially at the initial stage of use or when replacing the drug, associated with a decrease in blood pressure. Pharmacological properties Pharmacodynamics Prestilol is a combined antihypertensive drug consisting of a selective beta1-blocker and an ACE inhibitor (bisoprolol + perindopril). Bisoprolol is a highly selective beta1-adrenergic receptor blocker that does not have a stimulating and corresponding membrane-stabilizing effect. In general, it does not affect airway resistance and metabolic processes, since it has only a slight affinity for beta2-adrenergic receptors involved in metabolic regulation, as well as beta2-adrenergic receptors of bronchial and vascular smooth muscles. Bisoprolol retains selective activity for beta1-adrenergic receptors outside the range of therapeutic doses. Perindopril is an ACE inhibitor that converts angiotensin I to the vasoconstrictor angiotensin II. In addition, ACE (kinase II) promotes the breakdown of bradykinin, which has a vasodilating effect, to a heptapeptide. As a result of ACE inhibition, the level of angiotensin II concentration in blood plasma decreases, causing an increase in plasma renin activity and a decrease in aldosterone secretion. Suppression of ACE against the background of inactivation of bradykinin is accompanied by an increase in the activity of the prostaglandin system, the circulating and tissue kallikrein-kinin system. It is assumed that this effect causes the antihypertensive effect of ACE inhibitors and is part of the mechanism for the development of cough and some other side effects. The therapeutic effect of perindopril is due to the active metabolite perindoprilat, while other metabolites do not have an inhibitory effect on ACE in vitro. Bisoprolol has no significant negative inotropic effects. After ingestion, its maximum effect occurs after 3-4 hours. The half-life (T1 / 2) is 10-12 hours, so bisoprolol continues to act for 24 hours. The maximum antihypertensive effect is achieved after 14 days of use. With IHD (coronary heart disease) without CHF (chronic heart failure), a single dose of bisoprolol reduces heart rate (heart rate) and stroke volume, which causes a decrease in cardiac output and oxygen consumption. Regular intake of Prestilol helps to reduce the initially increased peripheral vascular resistance. Suppression of renin activity in blood plasma is considered as the main mechanism of action that provides beta-blockers with an antihypertensive effect. Bisoprolol, blocking the beta-adrenergic receptors of the heart, reduces the sympathetic-adrenergic reaction, resulting in a decrease in heart rate and myocardial contractility, which leads to a decrease in myocardial oxygen demand in angina pectoris caused by coronary artery disease. In the treatment of arterial hypertension of any severity, perindopril lowers systolic and diastolic blood pressure (BP) in the supine and standing position. The decrease in blood pressure is achieved as a result of a decrease in total peripheral vascular resistance (OPVR), which leads to an improvement in peripheral blood flow without disturbing heart rate. Reception of perindopril, as a rule, increases only renal blood flow, while the glomerular filtration rate (GFR) remains unchanged. The clinical efficacy and safety of bisoprolol in CHF III-IV functional class according to the NYHA classification (New York Heart Association) are confirmed by the results of the studies. In patients with an ejection fraction of less than 35%, there was a decrease in overall mortality from 17.3% to 11.8%. In addition, Prestilol helps to reduce the incidence of sudden death, the number of episodes requiring hospitalization, a significant improvement in the functional status of CHF according to the NYHA classification. After a single oral administration of perindopril, the maximum antihypertensive effect develops within 4-6 hours and persists for at least 24 hours. The fall in blood pressure is fast. In patients with an adequate response to treatment, taking Prestilol for 30 days allows normalization of blood pressure, which persists without the development of tachyphylaxis. Sudden withdrawal of the drug does not cause a rebound effect. Perindopril reduces left ventricular hypertrophy, has a vasodilating effect, helps to restore the elasticity of large arteries and reduce the ratio of wall thickness and lumen of small arteries. The simultaneous use of thiazide diuretics contributes to the mutual enhancement of effects, reduces the risk of developing hypokalemia associated with diuretic therapy. In the treatment of stable coronary artery disease without clinical symptoms of CHF, the addition of perindopril to patients taking a beta-blocker significantly reduces the absolute risk of cardiovascular mortality, non-fatal myocardial infarction and / or cardiac arrest. The results of clinical studies of combination therapy with an angiotensin II receptor antagonist (ARA II) indicate that in patients with diabetic nephropathy, ACE inhibitors and ARA II should not be combined. The safety and efficacy of Prestilol in patients under 18 years of age have not been established. Pharmacokinetics The rate and degree of absorption of the active substances in the composition of Prestilol does not differ significantly from the pharmacokinetics of bisoprolol and perindopril when used as monotherapy. After oral administration, the absorption of bisoprolol from the gastrointestinal tract occurs almost completely (more than 90%), its bioavailability is about 90%. Perindopril is rapidly absorbed after oral administration. The maximum concentration (Cmax) of the substance is achieved in the blood plasma within 1 hour, T1 / 2 from the blood plasma – 1 hour. The relationship between dose and plasma concentration of perindopril is linear. The volume of distribution (Vd) of bisoprolol is 3.5 l/kg, plasma protein binding is approximately 30%. Vd of free perindoprilat is approximately 0.2 l / kg, the relationship with plasma proteins (mostly with ACE) is dose-dependent and amounts to 20%. Metabolism in the liver is 50% of bisoprolol with the formation of inactive metabolites. Bisoprolol is excreted through the kidneys: 50% – in the form of inactive metabolites and 50% – unchanged. Its total clearance is 15 l / h, T1 / 2 from blood plasma – 10-12 hours. Perindopril is a prodrug. It is metabolized to form the active metabolite perindoprilat and five inactive metabolites. 27% of the amount taken orally in the form of perindoprilat enters the bloodstream. The maximum concentration of the active metabolite in plasma is reached within 3-4 hours. Simultaneous ingestion of food reduces the rate of biotransformation and bioavailability of perindopril, so it is recommended to take it in the morning before meals. Perindoprilat is excreted through the kidneys. The final T1 / 2 of the free fraction is 17 hours, the equilibrium state is reached within 96 hours. The pharmacokinetics of bisoprolol does not depend on age and is linear. In case of impaired liver function or renal failure, dose adjustment is not required. In patients with CHF, pharmacokinetics in patients with impaired liver or kidney function has not been established. It should be borne in mind that in patients with class III CHF (according to the NYHA classification), the level of bisoprolol concentration in the blood plasma is higher, and T1 / 2 is from 12 to 22 hours. With renal and heart failure in elderly patients, the excretion of perindoprilat is slowed down. In this regard, in patients with renal insufficiency, it is recommended to adjust the dose, taking into account the degree of impaired renal function or creatinine clearance (CC). The clearance of perindoprilat during dialysis is 70 ml / min. In patients with cirrhosis of the liver, dose adjustment of Prestilol is not required. Indications for use The use of Prestilol is indicated in patients with stable coronary artery disease and / or arterial hypertension, and / or stable chronic heart failure with reduced systolic function of the left ventricle in cases where therapy involves the simultaneous administration of bisoprolol and perindopril in appropriate doses. Dosage and administration Prestilol tablets are taken orally, in the morning before meals, 1 time per day. The dose of the drug is determined by the doctor based on clinical indications, including taking into account the doses of bisoprolol and perindopril of previous monotherapy. If bisoprolol 2.5 mg and perindopril 2.5 mg are indicated, 1/2 tablet of Prestilol 5 mg + 5 mg should be taken once a day. When prescribing the drug at a dose of 2.5 mg of bisoprolol and 5 mg of perindopril, 1/2 tablet with a dosage of 5 mg + 10 mg should be taken 1 time per day. In case of impaired renal function, a single dose of Prestilol is prescribed taking into account individual CC in the blood and can be the following amount of active ingredients (bisoprolol + perindopril): CC 60 ml / min and above: initial dose – 2.5 mg + 5 mg. In the absence of the desired therapeutic effect and good tolerance, the dose of bisoprolol can be increased and Prestilol 5 mg + 5 mg or 10 mg + 5 mg tablets can be used; CC 30-60 ml / min: 2.5 mg + 2.5 mg (1/2 tablet at a dose of 5 mg + 5 mg); CC less than 30 ml / min: the drug should not be taken. It is recommended to use the selection of doses of each component separately. For the treatment of elderly patients, doses should be prescribed in accordance with the recommendations for patients with impaired renal function, doses should be titrated under the close supervision of a physician. Use during pregnancy and lactation The use of Prestilol is contraindicated during gestation and breastfeeding. When planning pregnancy, it is necessary to switch to the use of an alternative antihypertensive agent with an established safety profile. Interaction with other drugs With the simultaneous use of Prestilol: aliskiren, potassium-sparing diuretics, ACE inhibitors, non-steroidal anti-inflammatory drugs (NSAIDs), angiotensin II receptor blockers, heparins, immunosuppressants (cyclosporine, tacrolimus and similar drugs), trimethoprim, drugs containing potassium salts: increase the risk of developing hyperkalemia; centrally acting antihypertensives (including clonidine, methyldopa, rilmenidine, moxonidine): contribute to the worsening of heart failure, cause a decrease in heart rate, a decrease in cardiac output and vasodilation. Abrupt discontinuation of therapy without prior reduction in the dose of beta-blocker significantly increases the risk of developing rebound hypertension; quinidine, disopyramide, phenytoin, flecainide, lidocaine, propafenone and other class I antiarrhythmics: may affect AV conduction and increase the negative inotropic effect; slow calcium channel blockers (verapamil, diltiazem): adversely affect contractility and AV conduction. In / in the introduction of verapamil against the background of therapy with beta-blockers can cause severe arterial hypotension and AV blockade; angiotensin II receptor blockers and aliskiren: The combination of ACE inhibitors with an angiotensin II receptor blocker or aliskiren causes a double blockade of the renin-aldosterone-angiotensin system (RAAS), due to arterial hypotension, hyperkalemia, or decreased renal function (including acute renal failure), often occurring on the background of this combination; estramustine: increases the risk of developing angioedema and similar adverse events; lithium preparations: contribute to a reversible increase in the concentration of lithium in the blood and associated toxic effects; insulin, oral hypoglycemic agents: there is an increase in their hypoglycemic effect; NSAIDs, including acetylsalicylic acid (at a dose of 3 g per day or more), cyclooxygenase 2 (COX-2) inhibitors, non-selective NSAIDs: can weaken the hypotensive effect of Prestilol, cause deterioration of kidney function, including the development of acute renal failure. Patients with initially reduced kidney function and in old age are at particular risk; vasodilators and antihypertensives (nitroglycerin and other nitrates, tricyclic antidepressants, phenothiazines, barbiturates and other drugs that cause a decrease in blood pressure): may increase the antihypertensive effect of Prestilol; tricyclic antidepressants, antipsychotics, drugs for general anesthesia: cause an increased risk of arterial hypotension; isoprenaline, dobutamine and other beta-sympathomimetics: there is a decrease in the therapeutic effect of each of the drugs. Sympathomimetics that activate alpha- and beta-adrenergic receptors (including norepinephrine, epinephrine) increase intermittent claudication; felodipine, amlodipine and other blockers of slow calcium channels of the dihydropyridine series: increase the risk of hypotension, further deterioration of the pumping function of the ventricles of the heart in heart failure; class III antiarrhythmics (including amiodarone): enhance the effect on AV conduction; parasympathomimetics: cause a decrease in AV conduction and an increase in the risk of developing bradycardia; local beta-blockers (for example, eye drops): may increase the systemic effects of bisoprolol; digitalis preparations: help to reduce heart rate and slow down AV conduction; baclofen: causes an increase in the antihypertensive effect of perindopril; Potassium-sparing diuretics: In patients with reduced BCC and / or salt content, the use of potassium-sparing diuretics may cause an excessive decrease in blood pressure during the initial stages of therapy with an ACE inhibitor. In this regard, it is recommended to avoid combination with potassium-sparing diuretics, to replenish the BCC or increase salt intake before starting therapy with perindopril, and to start taking perindopril with a low initial dose. In patients with CHF, the dose of a non-potassium-sparing diuretic should be reduced before starting therapy with an ACE inhibitor. Treatment should be accompanied by careful monitoring of renal function; potassium-sparing diuretics (spironolactone, eplerenone): the combination of eplerenone or spironolactone in the dose range of 12.5–50 mg per day with low doses of ACE inhibitors in patients with functional class II–IV heart failure (according to the NYHA classification) who have previously taken ACE inhibitors and ” loop diuretics, increases the risk of developing hyperkalemia (up to death). Therefore, prior to the appointment of combination therapy, the presence of hyperkalemia and impaired renal function should be excluded, and during the treatment period, regularly (1 time in 7 days for the first 30 days, then 1 time in 30 days) monitor the concentration of creatinine and potassium in the blood; racecadotril: an antidiarrheal agent may contribute to the development of angioedema; sirolimus, temsirolimus, everolimus: taking mTOR inhibitors (mammalian target of rapamycin) increases the likelihood of developing angioedema; mefloquine: increased risk of bradycardia; monoamine oxidase (MAO) inhibitors, except MAO type B inhibitors: it is possible to increase the effects of beta-blockers and the risk of a hypertensive crisis; linagliptin, saxagliptin, vildagliptin, sitagliptin (gliptins): cause an increased risk of angioedema; gold preparations (sodium aurothiomalate): the introduction of gold preparations may be accompanied by flushing of the face, nausea, vomiting, arterial hypotension. Contraindicationscardiogenic shock; acute heart failure; episodes of decompensated heart failure requiring intravenous (IV) administration of inotropic agents; sick sinus syndrome; AV blockade (atrioventricular blockade) II and III degree in the absence of a pacemaker; sinoatrial blockade; severe arterial hypotension (systolic blood pressure less than 100 mm Hg); severe bradycardia (heart rate less than 60 beats per minute); severe disorders of peripheral arterial circulation; Raynaud’s syndrome in severe form; untreated pheochromocytoma; severe form of chronic obstructive pulmonary disease; severe bronchial asthma; metabolic acidosis; hereditary or idiopathic angioedema; Quincke’s edema (angioneurotic edema) against the background of taking ACE inhibitors in history; concomitant therapy with aliskiren-containing agents in patients with diabetes mellitus or with impaired renal function (GFR less than 60 ml / min per 1.73 m2 of body surface area); collapse; period of pregnancy; breast-feeding; age up to 18 years; established hypersensitivity to ACE inhibitors; individual intolerance to the components of the drug. With caution, Prestilol should be prescribed to patients with a high risk of developing severe arterial hypotension, with hypovolemia and hyponatremia (compliance with a salt-free diet, previous diuretic therapy, dialysis, vomiting and / or diarrhea), the presence of risk factors for the development of hyperkalemia, cerebrovascular diseases (including cerebrovascular insufficiency) , coronary insufficiency, a history of angioedema, restrictive cardiomyopathy, congenital heart defects, hemodynamically significant organic lesions of the heart valves, myocardial infarction (done in the last 3 months), bradycardia, AV blockade of the 1st degree, mitral stenosis, aortic stenosis, hypertrophic cardiomyopathy, Prinzmetal’s angina, renovascular hypertension, impaired renal function (GFR less than 90 ml / min), bilateral renal artery stenosis, stenosis of the artery of a single kidney, hemodialysis using high-flow membranes, in the period after transplantation glasses, type 1 diabetes mellitus, large fluctuations in blood glucose levels in type 2 diabetes mellitus, bronchial asthma, obstructive airways disease, neutropenia, agranulocytosis, thrombocytopenia, anemia, peripheral arterial occlusive disease, pheochromocytoma, hyperthyroidism, psoriasis, severe dysfunction liver, glucose-6-phosphate dehydrogenase deficiency, connective tissue diseases (including systemic lupus erythematosus, scleroderma), depression (including history), adherence to a strict diet, treatment of patients of the black race, abrupt withdrawal of therapy. You should inform the doctor about taking Prestilol during the LDL apheresis procedure (low-density lipoprotein), concomitant administration of desensitizing therapy, lithium preparations, potassium-sparing diuretics, angiotensin receptor blockers, aliskiren-containing drugs, slow calcium channel blockers, class I antiarrhythmic drugs, centrally acting antihypertensive drugs, preparations of potassium salts, surgical intervention using general anesthesia. Composition In 1 tablet, the content of active ingredients can be (it corresponds to the engraving on the tablet): tablets at a dose of 5 mg + 5 mg: bisoprolol fumarate – 5 mg (equivalent to the content of 4.24 mg of bisoprolol) + perindopril arginine – 5 mg (equivalent to the content of 3, 39 mg perindopril); tablets at a dose of 5 mg + 10 mg: bisoprolol fumarate – 5 mg (equivalent to the content of 4.24 mg of bisoprolol) + perindopril arginine – 10 mg (equivalent to the content of 6.79 mg of perindopril); tablets at a dose of 10 mg + 5 mg: bisoprolol fumarate – 10 mg (equivalent to the content of 8.49 mg of bisoprolol) + perindopril arginine – 5 mg (equivalent to the content of 3.39 mg of perindopril); tablets at a dose of 10 mg + 10 mg: bisoprolol fumarate – 10 mg (equivalent to the content of 8.49 mg of bisoprolol) + perindopril arginine – 5 mg (equivalent to the content of 6.79 mg of perindopril). Excipients: pregelatinized starch, microcrystalline cellulose, croscarmellose sodium, calcium carbonate, sodium carboxymethyl starch, magnesium stearate, anhydrous colloidal silicon. The composition of the film shell: macrogol 6000, glycerol, titanium dioxide, hypromellose, iron dye yellow oxide, magnesium stearate, iron dye red oxide. Overdose When taking an increased dose of Prestilol, it is necessary to take into account the symptoms associated with an overdose of beta-blockers and ACE inhibitors. Symptoms of an overdose of beta-blockers: arterial hypotension, bradycardia, acute heart failure, bronchospasm, hypoglycemia. Treatment: the appointment of symptomatic therapy. Careful monitoring of the patient’s condition is necessary. In the event of a sharp deterioration in the course of heart failure, the patient should be prescribed an intravenous diuretic, inotropic and vasodilators. With the development of bradycardia, intravenous atropine is indicated. In the absence of a sufficient clinical effect, a drug with a positive chronotropic effect (isoprenaline) can be administered; if necessary, a transvenous installation of an artificial pacemaker is recommended. With severe arterial hypotension – in / in the introduction of fluids, vasoconstrictor drugs, glucagon. If careful monitoring of the patient’s condition indicates the development of AV-blockade of the II-III degree, an isoprenaline infusion or a transvenous pacemaker is required. With bronchospasm, the introduction of bronchodilators (including isoprenaline, beta2-sympathomimetics and / or aminophylline) is necessary, with hypoglycemia – in / in the introduction of glucose. The use of hemodialysis is ineffective. Symptoms of an overdose of ACE inhibitors: arterial hypotension, palpitations, tachycardia, bradycardia, cough, dizziness, anxiety, water and electrolyte imbalance, renal failure, hyperventilation, circulatory shock. Treatment: the appointment of symptomatic therapy. It is necessary to ensure control of the concentration of electrolytes and creatinine in the blood serum, indicators of the main vital functions of the body. With severe arterial hypotension, the patient should be placed on his back and raise his legs. Assign intravenous infusion of 0.9% sodium chloride solution, if necessary – intravenous administration of a solution of catecholamines and / or angiotensin II. An artificial pacemaker may be required. Side effects Undesirable reactions established against the background of monotherapy with bisoprolol during clinical trials and / or in the post-registration period: infections and infestations: rarely – rhinitis; mental disorders: infrequently – sleep disturbances, depression; rarely – terrible dreams, hallucinations; from the nervous system: often – headache, dizziness; rarely – fainting; on the part of the organ of vision: rarely – reduced tearing; very rarely – conjunctivitis; on the part of the organ of hearing: rarely – hearing impairment; from the side of the heart: very often – bradycardia; often – worsening of the course of heart failure; infrequently – a violation of AV conduction; from the side of the vessels: often – a decrease in blood pressure (including accompanying effects), a feeling of numbness or coldness of the extremities; infrequently – orthostatic hypotension; from the gastrointestinal tract: often – abdominal pain, nausea, vomiting, constipation, diarrhea; from the hepatobiliary system: rarely – cytolytic or cholestatic hepatitis; from the respiratory system, chest organs and mediastinum: infrequently – bronchospasm; dermatological reactions: rarely – hypersensitivity reactions in the form of skin itching, redness, rash; very rarely – alopecia, development of psoriasis or aggravation of its course, the appearance of a psoriasis-like rash; from the musculoskeletal system and connective tissue: infrequently – muscle spasms, muscle weakness; from the reproductive system and mammary glands: rarely – a violation of potency; general disorders: often – increased fatigue, asthenia; laboratory indicators: rarely – an increase in the activity of hepatic transaminases, an increase in the level of triglycerides. Adverse reactions established against the background of monotherapy with perindopril during clinical trials and / or in the post-registration period: infections and infestations: very rarely – rhinitis; on the part of the blood and lymphatic system: infrequently – eosinophilia; very rarely – agranulocytosis, leukopenia, pancytopenia, thrombocytopenia, neutropenia, with congenital deficiency of glucose-6-phosphate dehydrogenase – hemolytic anemia; on the part of metabolism and nutrition: infrequently – hypoglycemia, transient hyperkalemia, hyponatremia; mental disorders: infrequently – sleep disorders, mood disorders; very rarely – confusion; from the nervous system: often – headache, paresthesia, dizziness, dysgeusia, vertigo; infrequently – drowsiness, fainting; on the part of the organ of vision: often – visual impairment; on the part of the organ of hearing: often – tinnitus; from the side of the heart: infrequently – palpitations, tachycardia; very rarely – arrhythmia, angina pectoris, myocardial infarction; from the side of the vessels: often – a decrease in blood pressure (including accompanying effects); infrequently – vasculitis; very rarely – stroke (more often in high-risk patients, possibly due to a significant decrease in blood pressure); from the respiratory system, chest organs and mediastinum: often – cough, shortness of breath; infrequently – bronchospasm; very rarely – eosinophilic pneumonia; from the gastrointestinal tract: often – abdominal pain, nausea, vomiting, dyspepsia, constipation, diarrhea; infrequently – dryness of the oral mucosa; very rarely – pancreatitis; from the hepatobiliary system: very rarely – cytolytic or cholestatic hepatitis; dermatological reactions: often – skin itching, rash; infrequently – angioedema (face, lips, mucous membranes, tongue, glottis and / or larynx, limbs), urticaria, pemphigoid, photosensitivity reactions, hyperhidrosis; rarely – aggravation of the course of psoriasis; very rarely – erythema multiforme; from the musculoskeletal system and connective tissue: often – muscle spasms; infrequently – arthralgia, myalgia; from the urinary system: infrequently – impaired renal function; very rarely – acute renal failure; from the reproductive system and mammary glands: infrequently – erectile dysfunction; general disorders: often – asthenia; infrequently – malaise, chest pain, peripheral edema, hyperthermia; laboratory indicators: infrequently – an increase in the level of urea concentration in the blood, an increase in the content of creatinine in the blood; rarely – an increase in the activity of hepatic transaminases, an increase in the level of bilirubin in the blood; very rarely – a decrease in hemoglobin and hematocrit; others: infrequently – falls. Storage conditionsKeep away from children. Store at temperatures up to 30 °C. Buy Prestilol tablets p/o 5mg/10mg No. 30