Parallel tablets 10mg/5mg №10×2

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Parallel tabl.5mg/10mg in a cell. pack No. 10×2
Description:
Tablets of white or almost white color, flat-cylindrical, with a chamfer and a notch on one side. The main active ingredient Amlodipine + lisinopril Release form Tablets Dosage 5 mg / 10 mg Pharmacological action Hypotensive combined agent. It has a hypotensive and antianginal effect, due to the properties of the components that make up the drug. Lisinopril – an ACE inhibitor, reduces the formation of angiotensin II, aldosterone, while increasing the formation of bradykinin (vasodilating mediator). Affects tissue renin-angiotensin-aldosterone systems. Reduces total peripheral vascular resistance, blood pressure, preload and afterload, pressure in the pulmonary capillaries. It does not affect the heart rate, while it is possible to increase the minute volume of blood and increase blood flow in the kidneys. Arteries dilate to a greater extent than veins. Improves blood supply to ischemic myocardium. With prolonged use, it reduces hypertrophy of the myocardium and arterial walls of the resistant type. Slows down the progression of left ventricular dysfunction after myocardial infarction, not complicated by heart failure. Effective in arterial hypertension with low renin activity, reduces albuminuria (by lowering blood pressure, changes in hemodynamics of the glomerular apparatus). Does not affect the concentration of glucose in the blood in patients with diabetes mellitus. The hypotensive effect develops 1 hour after administration, the maximum effect is after 6 hours, the duration of action is 24 hours. When treatment is stopped, there is no “withdrawal” syndrome (a sharp increase in blood pressure). Amlodipine is a calcium channel blocker of the dihydropyridine series; inhibits the transmembrane entry of calcium ions into cardiomyocytes and vascular smooth muscle cells (slow calcium channel blocker or calcium channel blocker). The hypotensive effect of amlodipine is based on a relaxing effect on vascular smooth muscle. The exact mechanism of action of amlodipine in angina pectoris has not been fully established, however, amlodipine reduces myocardial ischemia by expanding the coronary and peripheral arteries and arterioles in unchanged and ischemic areas of the myocardium, reducing peripheral vascular resistance, reducing afterload, and myocardial oxygen demand. It has a long-term dose-dependent hypotensive effect. In arterial hypertension, a single daily dose provides a clinically significant decrease in blood pressure for 24 hours (in the patient’s position “lying” and “standing”). It does not cause a sharp decrease in blood pressure, a decrease in exercise tolerance, LV ejection fraction. Reduces the degree of LV myocardial hypertrophy. It does not affect myocardial contractility and conduction, does not cause a reflex increase in heart rate, inhibits platelet aggregation, increases glomerular filtration rate, and has a weak natriuretic effect. In diabetic nephropathy does not increase the severity of microalbuminuria. It does not adversely affect the metabolism and plasma lipids. A significant decrease in blood pressure is observed after 6-10 hours; the duration of the effect is 24 hours. Indications for use Treatment of essential arterial hypertension in adults. The drug Paralel 5 mg/10 mg is indicated as an alternative to patients in whom the simultaneous administration of the indicated doses of amlodipine and lisinopril provides adequate control of blood pressure. Dosage and administration Take orally, regardless of food intake. The recommended dose is 1 tablet per day. The maximum daily dose is 1 tablet. As a rule, a fixed dose combination is not suitable for initial therapy. Parallel 5 mg / 10 mg is prescribed only to those patients in whom the optimal maintenance doses are titrated to 10 mg of lisinopril and 5 mg of amlodipine. If dose adjustment is necessary, dose titration of the individual components should be considered. Patients with impaired renal function. To determine the optimal initial and maintenance dose for patients with renal insufficiency, it is necessary to individually titrate doses using separately lisinopril and amlodipine. During treatment with the drug Paralel 5 mg / 10 mg, it is necessary to monitor kidney function, the content of potassium and sodium in the blood serum. In case of deterioration of renal function, the drug should be discontinued and replaced with lisinopril and amlodipine in adequate doses. Patients with impaired liver function. For patients with mild to moderate hepatic impairment, there are no recommendations on the dosing regimen, therefore, treatment should be started with caution, with the lowest recommended doses. The optimal initial and maintenance doses are determined individually by titrating the dose separately for lisinopril and amlodipine. The pharmacokinetics of amlodipine in severe hepatic impairment has not been studied. In patients with severe hepatic insufficiency, amlodipine should be administered at the lowest initial dose, followed by a gradual increase in dose. Children and adolescents (<18 years). Safety and efficacy in children and adolescents under 18 years of age have not been established. Elderly patients (<65 years). Elderly patients should use the drug with caution. In the course of the conducted clinical studies, no age-related changes in the efficacy and safety of lisinopril were found. To establish the optimal maintenance dose, you should first individually select the dose, using separately lisinopril and amlodipine. Application during pregnancy and lactation It is not recommended to take the drug Paralell in the first trimester of pregnancy, the reception is contraindicated in the second and third trimester of pregnancy. There is no experience with the use of lisinopril and amlodipine in pregnant women in controlled clinical trials. If pregnancy occurs, the drug should be stopped immediately and, if necessary, the doctor will prescribe alternative treatment using antihypertensive drugs with a known safety profile for use during pregnancy. Epidemiological data on the risk of teratogenicity associated with the use of lisinopril and other ACE inhibitors during the first trimester of pregnancy are not convincing, but a small increase in risk cannot be ruled out. It is known that the use of ACE inhibitors during the II and III trimester of pregnancy induces fetotoxicity (decrease in kidney function, oligohydramnios, slowing of the ossification of the skull bones) and neonatal toxicity (renal failure, arterial hypotension, hyperkalemia). If an ACE inhibitor was used during the second or third trimester of pregnancy, an ultrasound examination of the function of the kidneys and the skull of the fetus is recommended. For infants and newborns whose mothers took ACE inhibitors, it is recommended to monitor in case of timely detection of arterial hypotension. The safety of amlodipine use during pregnancy has not been established, and reproductive toxicity has been noted in animal studies when used at high doses. Therefore, use during pregnancy is allowed only in cases where there is no safer alternative, and the risk associated with the disease itself outweighs the possible harm to the mother and fetus. Breast-feeding. It is not recommended to use lisinopril and amlodipine during breastfeeding. If treatment is necessary, it is recommended to use alternative antihypertensive drugs with an established safety profile (especially during breastfeeding of newborns and premature babies). Fertility (ability to fertilize). Controlled clinical studies of the effect of lisinopril and amlodipine on fertility have not been conducted. In some patients treated with calcium channel blockers (amlodipine), reversible biochemical changes in the heads of spermatozoa were observed. Influence on the ability to drive vehicles and other potentially dangerous mechanisms The drug can affect these types of activities, since dizziness, fatigue, nausea, and a decrease in the speed of psychomotor reactions may occur. Therefore, it is individually necessary to determine at what dose it is impossible to drive vehicles or work with mechanisms that require increased concentration of attention. Caution is advised, especially at the start of treatment. Precautions Associated with lisinopril: Significant symptomatic hypotension may occur in patients with hyponatremia and/or hypovolemia. Before starting a course of therapy, it is necessary to correct hyponatremia or hypovolemia, and when using the first doses of the drug, it is necessary to monitor its effect on blood pressure. Arterial hypotension in acute myocardial infarction. Treatment with lisinopril should not be initiated in patients with acute myocardial infarction who are at risk of further serious hemodynamic deterioration after treatment with vasodilators. These are patients with systolic blood pressure (SBP) of 100 mm Hg. Art. or lower, as well as with cardiogenic shock. During the first 3 days after myocardial infarction, the dose of lisinopril should be reduced if the SBP is 120 mm Hg. Art. or below. Maintenance doses should be reduced to 5 mg or temporarily to 2.5 mg if SBP is 100 mm Hg. Art. or below. If arterial hypotension persists (SBP less than 90 mm Hg persists for more than 1 hour), lisinopril should be discontinued. Aortic and mitral valve stenosis/hypertrophic cardiomyopathy. As with other ACE inhibitors, lisinopril should be used with caution in patients with mitral valve stenosis and left ventricular outflow tract obstruction (aortic stenosis or hypertrophic cardiomyopathy). With renal artery stenosis (especially if it is bilateral or there is only one kidney and there is a narrowing of the mouth of the renal artery), in the presence of hyponatremia and / or hypovolemia, as well as in case of insufficient blood supply, lisinopril can lead to a decrease in kidney function, acute renal failure, which after interruption of therapy is reversible. Renal failure. In case of renal insufficiency (CC < 80 ml / min), the initial dose of lisinopril should be selected depending on the patient's CC, and then depending on the patient's response to treatment. During therapy, it is necessary to monitor the content of potassium and the concentration of creatinine in the blood serum. In patients with heart failure, hypotension after initiation of treatment with ACE inhibitors may lead to further deterioration of renal function. In such cases, acute renal failure has been reported, but is usually reversible. In some patients with bilateral renal artery stenosis or with stenosis of the artery to a single kidney who received ACE inhibitors, an increase in serum urea and creatinine concentrations was observed, usually reversible upon discontinuation of treatment. This is especially likely in patients with renal insufficiency. In the case of concomitant vasorenal arterial hypertension, there is an increased risk of developing severe arterial hypotension and renal failure. In such patients, treatment should be initiated under close medical supervision at low doses and dose titrated carefully. Since treatment with diuretics may contribute to the development of the above conditions, their use should be discontinued, while renal function should be monitored during the first weeks of lisinopril therapy. In some patients with arterial hypertension without significant previous vasorenal hypertension, an increase in the concentration of urea and creatinine in the blood serum, usually insignificant and transient, was noted, especially in cases where lisinopril was used simultaneously with a diuretic. This is especially likely in patients with previous renal insufficiency. Dose reduction and/or withdrawal of the diuretic and/or lisinopril may be required. In acute myocardial infarction, treatment with lisinopril should not be initiated in patients with evidence of renal insufficiency, which is defined as serum creatinine levels greater than 177 µmol/L and/or proteinuria greater than 500 mg/24 hours. In case of impaired renal function during treatment with lisinopril (serum creatinine concentration exceeding 265 µmol / l, 2 times higher than the corresponding value before treatment), the doctor should consider the advisability of discontinuing lisinopril. With liver failure, the excretion of amlodipine from the body may be delayed. There is no exact dose, but in such patients the drug should be taken with caution. Angioedema. When taking ACE inhibitors, in particular lisinopril, angioedema may occur with swelling of the face, extremities, lips, epiglottis and larynx. In this case, it is necessary to immediately cancel the drug, the patient should be under the supervision of a physician until the symptoms disappear completely. If edema develops on the face, lips and extremities, it usually resolves spontaneously, but the use of antihistamines is good for reducing the intensity of its signs. Angioedema with laryngeal edema can be fatal. Swelling of the tongue, epiglottis and larynx can lead to blockage of the airways, so the immediate adoption of such therapeutic measures is necessary: inject subcutaneously 0.1% adrenaline solution at a dose of 0.3-0.5 ml (0.3-0.5 mg) or 0.1 ml (0.1 mg) slowly intravenously, after which a glucocorticoid and an antihistamine drug should be administered under the control of the patient's vital signs. Anaphylactic reactions are possible during hemodialysis using a membrane with polyacrylonitrile (AN 69), during low-density lipoprotein apheresis and during desensitization to hymenoptera insects (bee venom, wasps). Impact on the liver. In rare cases, the use of ACE inhibitors was accompanied by a syndrome that began with cholestatic jaundice or hepatitis and developed into fulminant hepatic necrosis and in some cases was fatal. The mechanism of this syndrome is unclear. Patients receiving Parallel who develop jaundice or increased activity of "liver" enzymes should stop the drug and carefully monitor their condition. Neutropenia/agranulocytosis. Rare cases of neutropenia, agranulocytosis, thrombocytopenia and anemia have been reported in patients treated with ACE inhibitors. In patients with normal renal function and in the absence of other aggravating factors, neutropenia is rare. Neutropenia and agranulocytosis are reversible and disappear after discontinuation of the ACE inhibitor. Parallel should be used with extreme caution in patients with systemic connective tissue disease, during immunosuppressive therapy, during treatment with allopurinol or procainamide, or a combination of these aggravating factors, especially in the presence of previous renal dysfunction. Some of these patients developed serious infectious diseases, in which some cases did not respond to antibiotic treatment. In such patients during treatment | | Parallel drug, it is necessary to periodically monitor the number of leukocytes (blood test with counting the leukocyte formula). Patients should be warned about the need to inform the doctor about the first signs of an infectious disease. With extensive surgical interventions or with the use of an anesthetic that causes hypotension, lisinopril inhibits the compensatory release of angiotensin II. Arterial hypotension, which is noted in this case, can be eliminated by introducing a physiological solution of sodium chloride. When using a standard dose in the elderly, there was a higher level of active substances in the blood plasma, so the dose in these patients should be set with caution, although there was no significant difference in efficacy in young and elderly patients. Double blockade of the renin-angiotensin-aldosterone system. Dual blockade of the renin-angiotensin-aldosterone system is associated with an increased risk of hypotension, hyperkalemia, and renal dysfunction (including acute renal failure) compared with monotherapy. Dual RAAS blockade with an ACE inhibitor, ARB II, or Aliskiren cannot be recommended for any patient, especially those with diabetic nephropathy. In some cases, when the combined use of an ACE inhibitor and ARB II is absolutely indicated, careful observation by a specialist and mandatory monitoring of kidney function, water and electrolyte balance, and blood pressure are necessary. This refers to the use of candesartan or valsartan as add-on therapy to ACE inhibitors in patients with chronic heart failure. Conducting a double blockade of the RAAS under the close supervision of a specialist and mandatory monitoring of kidney function, water and electrolyte balance and blood pressure is possible in patients with chronic heart failure with intolerance to aldosterone antagonists (spironolactone), who have persistent symptoms of chronic heart failure, despite other adequate therapy. Cough. During the use of ACE inhibitors, cough was often observed. As a rule, the cough is unproductive, persistent and stopped after drug withdrawal. In the differential diagnosis of cough, it is necessary to take into account the cough associated with the use of ACE inhibitors. Racial affiliation. Blacks who used ACE inhibitors were more likely to experience angioedema compared with patients of other races. Like other ACE inhibitors, lisinopril is less effective as an antihypertensive agent in patients of the black race compared to patients of other races. This effect may be associated with a pronounced predominance of low-renin status in black patients with arterial hypertension. Hyperkalemia. In some patients treated with ACE inhibitors, an increase in serum potassium was observed. The risk group for the development of hyperkalemia are patients with renal failure, type 2 diabetes mellitus, acute heart failure, dehydration, metabolic acidosis, or with the simultaneous use of potassium-sparing diuretics, potassium-containing nutritional supplements, potassium-containing salt substitutes, or any other drugs that lead to an increase in potassium content in serum (for example, heparin). If necessary, simultaneous use with the above drugs is recommended to monitor the content of potassium in the blood serum. Patients with diabetes. In patients with diabetes mellitus taking oral hypoglycemic drugs or receiving insulin, during the first month of treatment with an ACE inhibitor, it is necessary to control the level of sugar in the blood (see section "Interaction with other drugs"). Associated with amlodipine: The safety and efficacy of amlodipine in hypertensive crisis has not been established. Patients with heart failure. Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure as they may increase the risk of cardiovascular events and mortality. Use in patients with hepatic impairment. In patients with hepatic insufficiency, an increase in the half-life of amlodipine and an increase in the AUC value are noted, however, appropriate dosing recommendations have not been developed. Therefore, the use of amlodipine should be started with the lowest dose in the dosing range; initiation of treatment and dose escalation should be done with caution. Patients with severe hepatic impairment may require slow dose titration and close medical supervision. Elderly patients. Elderly patients with impaired renal function should be dose adjusted using lisinopril and amlodipine separately. During treatment, body weight control and supervision by a dentist is necessary (to prevent soreness, bleeding and gum hyperplasia). Children. Due to the lack of data on efficacy and safety, the use of Paralel in children under 18 years of age is contraindicated. Interactions with other drugs Interactions associated with lisinopril: - Substances that increase potassium levels: potassium-sparing diuretics, potassium supplements or substitutes that can increase potassium levels. Heparin in combination with ACE inhibitors can lead to hyperkalemia, especially in patients with renal insufficiency. When prescribing a drug that affects the content of potassium, simultaneously with lisinopril, the content of potassium in the blood serum should be monitored. Simultaneous administration should be carried out with extreme caution and regular monitoring of the state of kidney function and the content of potassium in the blood serum. Potassium-sparing diuretics can be used simultaneously with the drug Paralel only under the condition of careful medical supervision. – Diuretics: there may be a sharp decrease in blood pressure. The likelihood of symptomatic hypotension while taking lisinopril can be minimized by discontinuing the diuretic before starting treatment with lisinopril. Simultaneous use should be carried out with caution. Lisinopril softens the kaliuretic effect of diuretics. - Other antihypertensive drugs: concomitant use may enhance the hypotensive effect of Paralell. Simultaneous reception with nitroglycerin, other nitrates or vasodilators can lead to a pronounced decrease in blood pressure. – Dual blockade of the renin-angiotensin-aldosterone system: Based on the available data, dual blockade of the RAAS with an ACE inhibitor, ARB II, or Aliskiren cannot be recommended in any patient, especially in patients with diabetic nephropathy. In patients with diabetes mellitus or moderate/severe renal insufficiency (GFR < 60 ml/min/1.73 m2), the concomitant use of Aliskiren with an ACE inhibitor or ARB II is contraindicated. In some cases, when the combined use of an ACE inhibitor and ARB II is absolutely indicated, careful observation by a specialist and mandatory monitoring of kidney function, water and electrolyte balance, and blood pressure are necessary. - Tricyclic antidepressants / antipsychotics / general anesthetics / narcotic analgesics: in combination with lisinopril, they increase the hypotensive effect. – Ethanol: enhances the antihypertensive effect. Lisinopril enhances the manifestations of alcohol intoxication. - Allopurinol, procainamide, cytostatics or immunosuppressants (systemic glucocorticosteroids): may lead to an increased risk of leukopenia when used with ACE inhibitors. - Antacids and cholestyramine: when taken together, the bioavailability of ACE inhibitors is reduced. – Sympathomimetics: may reduce the antihypertensive effect of ACE inhibitors. It is necessary to carefully monitor the achievement of the desired effect. - Hypoglycemic agents: concomitant use of ACE inhibitors and hypoglycemic drugs (insulin and oral hypoglycemic agents) may increase the risk of hypoglycemia. Most often, such conditions are observed during the first week of combined treatment and in patients with renal insufficiency. – Non-steroidal anti-inflammatory drugs: possible decrease in antihypertensive effect. An additive effect with the use of NSAIDs and ACE inhibitors is manifested in an increase in the content of potassium in the blood serum and can lead to a deterioration in kidney function. These effects are usually reversible. Very rarely, acute renal failure may develop, especially in elderly and dehydrated patients. - Lithium-containing medicines: the degree of excretion of lithium may decrease, so the level of lithium in the blood plasma must be regularly monitored. When combined with lithium-containing drugs, it is possible to increase the manifestation of their neurotoxic effect (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus). The combined use of lisinopril and lithium-containing drugs is not recommended. - Gold-containing drugs: with the simultaneous use of ACE inhibitors and gold-containing drugs (sodium aurothiomalate) intravenously, a symptom complex is described, including facial flushing, nausea, vomiting, dizziness and arterial hypotension. - Acetylsalicylic acid, thrombolytics: lisinopril can be used simultaneously with acetylsalicylic acid (in cardiological doses), thrombolytics. Interactions associated with amlodipine: - CYP3A4 inhibitors: studies in elderly patients have shown that diltiazem inhibits the metabolism of amlodipine, probably through CYP3A4 (increased plasma concentration by 50% and increased the effect of amlodipine), which is also possible with other CYP3A4 inhibitors (protease inhibitors, azole antifungals, macrolide antibiotics, verapamil, diltiazem). Caution is required when co-administered with amlodipine. - CYP3A4 inducers: concomitant use with anticonvulsant drugs (eg, carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone), rifampicin, drugs containing St. The simultaneous use of amlodipine and inducers of the CYP3A4 isoenzyme should be carried out with caution. - Grapefruit, grapefruit juice: co-administration with amlodipine is not recommended, as in some patients this may lead to an increase in the bioavailability of amlodipine, resulting in an increase in its antihypertensive effect. – Dantrolene (infusion): in animal studies, ventricular fibrillation and cardiovascular failure with concomitant hyperkalemia and death have been observed after administration of verapamil and intravenous administration of dantrolene. Due to the risk of developing hyperkalemia, it is recommended to avoid the simultaneous use of calcium channel blockers such as amlodipine in patients predisposed to malignant hyperthermia, as well as for the treatment of malignant hyperthermia. - Other medicinal products: The antihypertensive effect of amlodipine is enhanced by medicinal products with antihypertensive properties. In clinical drug interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, warfarin, or cyclosporine. – Simvastatin: Co-administration of repeated doses of 10 mg amlodipine and 80 mg simvastatin resulted in a 77% increase in simvastatin concentrations compared with simvastatin alone. The dose of simvastatin in patients taking amlodipine should be limited to 20 mg daily. Contraindications Associated with lisinopril: hypersensitivity to lisinopril or any other ACE inhibitor; angioedema in history, including against the background of the use of ACE inhibitors; hereditary or idiopathic angioedema; second and third trimesters of pregnancy (see Precautions section); simultaneous use with Aliskiren in patients with diabetes mellitus or in patients with moderate / severe renal insufficiency (GFR < 60 ml / min / 1.73 m2). Associated with amlodipine: hypersensitivity to amlodipine or other dihydropyridine derivatives; severe arterial hypotension; shock (including cardiogenic); obstruction of the outflow tract of the left ventricle (for example, severe aortic stenosis); hemodynamically unstable heart failure after acute myocardial infarction. Parallel-related: All of the above contraindications associated with the use of individual components also apply to the Parallel combination drug. hypersensitivity to any of the excipients included in the composition; children under 18 years of age (efficacy and safety have not been established). Composition Per tablet: active substances - amlodipine (in the form of amlodipine besylate) - 5 mg, lisinopril (in the form of lisinopril dihydrate) - 10 mg; excipients: sodium starch glycolate (type A), magnesium stearate (E-470), microcrystalline cellulose (E-460). OverdosageSymptoms: marked expansion of peripheral vessels, which is accompanied by an excessive decrease in blood pressure, cardiovascular shock, electrolyte imbalance, renal failure, hyperventilation, tachycardia, bradycardia, dizziness, anxiety and cough. Symptomatic treatment: it is necessary to provide the patient with a horizontal position, monitor the work of the heart, blood pressure, electrolyte and water exchange indicators, and also correct these indicators if necessary. In severe arterial hypotension, the patient should be given a horizontal position, raising his lower limbs, and intravenous administration of infusion solutions should be prescribed. If this therapy is ineffective, it is necessary to prescribe vasoconstrictors (vasopressors) of peripheral action, unless their use is contraindicated. Calcium gluconate can be administered to interrupt calcium channel blockage. Since the absorption of amlodipine is prolonged, gastric lavage may be effective. Lisinopril can be excreted from the body by hemodialysis, but amlodipine is not subjected to hemodialysis due to the strong degree of binding to blood proteins. Side effects The frequency of side effects is given in the following gradation: very often (? 1/10); often (?1/100, <1/10); infrequently (?1/1000, <1/100); rarely (?1/10000, <1/1000); very rarely (<1/10000); unknown (according to the available data, it is not possible to determine the frequency of occurrence). Blood and lymphatic system disorders: Adverse reactions of lisinopril: very rarely - bone marrow depression, agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anemia, lymphadenopathy. Undesirable reactions of amlodipine: very rarely - thrombocytopenia, leukopenia. Immune system disorders: Adverse reactions of lisinopril: very rarely - autoimmune disorders. Adverse reactions of amlodipine: very rarely - allergic reactions. Endocrine system disorders: Adverse reactions of lisinopril: rarely - syndrome of inappropriate secretion of antidiuretic hormone (SIAH). Metabolic and nutritional disorders: Adverse reactions of lisinopril: very rarely - hypoglycemia. Adverse reactions of amlodipine: very rarely - hyperglycemia. Mental disorders: Adverse reactions of lisinopril: infrequently - mood changes, sleep disturbances, hallucinations; rarely - a mental disorder; unknown - depression. Undesirable reactions of amlodipine: infrequently - insomnia, mood changes (including anxiety), depression; rarely - confusion. Nervous system disorders: Adverse reactions of lisinopril: often - dizziness, headache; infrequently - vertigo, paresthesia, dysgeusia; unknown - fainting; rarely - parosmia. Undesirable reactions of amlodipine: often - drowsiness, dizziness, headache (especially during the initial period of treatment); infrequently - fainting, tremor, dysgeusia, hypesthesia, paresthesia; very rarely - muscle hypertonicity, peripheral neuropathy; unknown - extrapyramidal disorders. On the part of the organ of vision: Undesirable reactions of amlodipine: infrequently - visual disturbances (including diplopia). Hearing disorders and labyrinth disorders: Adverse reactions of amlodipine: infrequently - tinnitus. Cardiac disorders: Adverse reactions of lisinopril: infrequently - myocardial infarction, possibly caused by a pronounced decrease in blood pressure in high-risk patients, tachycardia, palpitations. Undesirable reactions of amlodipine: often - palpitations; infrequently - arrhythmia, including bradycardia, ventricular tachycardia, atrial fibrillation; very rarely - myocardial infarction. Vascular disorders: Adverse reactions of lisinopril: often - orthostatic hypotension; infrequently - a violation of cerebral circulation, possibly caused by a pronounced decrease in blood pressure in high-risk patients, Raynaud's syndrome. Adverse reactions of amlodipine: often - skin flushing; infrequently - a decrease in blood pressure; very rarely - vasculitis. Respiratory, thoracic and mediastinal disorders: Adverse reactions of lisinopril: often - cough; infrequently - rhinitis; very rarely - bronchospasm, allergic alveolitis / eosinophilic pneumonia, sinusitis. Adverse reactions of amlodipine: often - shortness of breath; infrequently - cough, rhinitis. Gastrointestinal disorders: Adverse reactions of lisinopril: often - diarrhea, vomiting; infrequently - abdominal pain, nausea, indigestion; rarely - dryness of the oral mucosa; very rarely - pancreatitis, intestinal angioedema. Adverse reactions of amlodipine: often - abdominal pain, nausea, dyspepsia, constipation, diarrhea; infrequently - vomiting, dry mouth; very rarely - pancreatitis, gastritis, gingival hyperplasia. Liver and biliary tract disorders: Adverse reactions of lisinopril: very rarely - liver failure, hepatitis, cholestatic jaundice. Adverse reactions of amlodipine: very rarely - hepatitis, jaundice. Skin and subcutaneous tissue disorders: Adverse reactions of lisinopril: infrequently - rash, itching; rarely - psoriasis, urticaria, alopecia, hypersensitivity / angioedema of the face, limbs, lips, tongue, head of the crack and / or larynx; very rarely - toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus vulgaris, increased sweating, skin pseudolymphoma. Undesirable reactions of amlodipine: infrequently - alopecia, purpura, discoloration of the skin, increased sweating, itching, rash, exanthema; very rarely - angioedema, exfoliative dermatitis, Stevens-Johnson syndrome, erythema multiforme, Quincke's edema, photosensitivity, urticaria. Musculoskeletal and