Losartan FT tablets p/o 100mg №10×3

Name:
Losartan ft.
Description:
Dosage 100 mg: round biconvex film-coated tablets, white or almost white. The main active ingredient Losartan Form of release film-coated tablets 10 tablets in a blister pack of PVC film and flexible packaging based on aluminum foil. Each 3 blister packs with a leaflet are placed in a pack of cardboard. Dosage 100 mg Pharmacological action Losartan is a synthetic angiotensin II receptor antagonist (type AT1) for oral administration. Angiotensin II, a strong vasoconstrictor, is the main active hormone of the renin-angiotensin system and an important factor in determining the pathophysiology of arterial hypertension. Angiotensin II binds to AT1 receptors, which are found in many tissues (eg, vascular smooth muscle, adrenal glands, kidneys, and heart) and produces a number of important biological effects, including vasoconstriction and aldosterone release. Angiotensin II also stimulates the proliferation of smooth muscle cells. Losartan selectively blocks AT1 receptors. In vitro and in vivo, losartan and its pharmacologically active metabolite containing a carboxyl group (E-3174) block all physiologically significant effects of angiotensin II, regardless of the source or route of its synthesis. Losartan is not an agonist or blocker of other hormone receptors or ion channels that play an important role in the regulation of the functioning of the cardiovascular system. In addition, losartan does not inhibit angiotensin-converting enzyme (kininase II), an enzyme that destroys bradykinin. As a result, there is no increase in bradykinin-mediated adverse effects. The use of losartan eliminates the negative feedback between angiotensin II and renin secretion, which leads to an increase in plasma renin activity. An increase in plasma renin activity leads to an increase in the level of angiotensin II in blood plasma. Despite these increases, the antihypertensive effect and the decrease in plasma aldosterone concentration are maintained, indicating effective blockade of angiotensin II receptors. After discontinuation of losartan, plasma renin activity and angiotensin II levels returned to baseline within 3 days. Both losartan and its major active metabolite have much stronger affinity for AT1 receptors than for AT2 receptors. The active metabolite is 10-40 times more active than losartan (in terms of body weight). Losartan has no effect on autonomic reflexes and no long-term effect on plasma norepinephrine levels. Losartan is equally effective in lowering blood pressure in male and female patients, in younger (<65 years) and elderly patients with hypertension. Discontinuation of losartan in patients with arterial hypertension did not lead to a sharp increase in blood pressure (rebound syndrome). In patients with arterial hypertension, losartan did not have a clinically significant effect on heart rate, despite a significant decrease in blood pressure. Losartan has been shown to be effective in lowering blood pressure in children with hypertension. The ability of losartan to reduce the risk of stroke in adult patients with hypertension in combination with left ventricular hypertrophy, signs of which are present on the electrocardiogram, has been demonstrated (however, there is data indicating that the use of this indication in patients of the black race does not have a sufficient beneficial effect). Losartan has a nephroprotective effect in adult patients with hypertension and type II diabetes mellitus with proteinuria. Also shown is the beneficial effect of losartan in the treatment of chronic heart failure in adult patients who could not be prescribed angiotensin-converting enzyme (ACE) inhibitors. In patients with arterial hypertension and proteinuria in the absence of diabetes, the use of losartan potassium significantly reduces proteinuria, fractional excretion of albumin and IgG. Losartan maintains the glomerular filtration rate and reduces the filtration fraction. In patients with left ventricular failure, losartan at doses of 25 mg and 50 mg had favorable hemodynamic and neurohormonal effects (increased cardiac index, decreased pulmonary capillary wedge pressure, systemic vascular resistance, mean systemic arterial pressure and heart rate, decreased levels of circulating aldosterone and norepinephrine). The incidence of hypotension was dose-dependent in these patients with heart failure. Losartan has been shown to have a slight and transient uricosuric effect. Typically, losartan causes a decrease in serum uric acid levels (usually < 0.4 mg/dL); this effect persisted during long-term therapy. In clinical studies, it was found that the incidence of cough with losartan is significantly lower than with ACE inhibitors. After oral administration, losartan is well absorbed. Approximately 14% of an oral dose of losartan is converted to the active metabolite. Elimination of losartan and its metabolites occurs in the bile and urine. In elderly patients with hypertension, plasma concentrations of losartan and its active metabolite do not differ significantly from those in younger patients with hypertension. In women with hypertension, plasma levels of losartan were up to 2 times higher than in men with hypertension, while plasma levels of the active metabolite did not differ between men and women. In patients with mild to moderate alcoholic cirrhosis of the liver, after oral administration of losartan, plasma concentrations of losartan and its active metabolite were 5 and 1.7 times higher, respectively, than those in young male volunteers (see sections "Method of administration and dose ”, “Special instructions and precautions”). Plasma concentrations of losartan do not change in patients with creatinine clearance > 10 ml/min. In patients on hemodialysis, the exposure of losartan is approximately 2 times higher than in patients with normal renal function. Plasma concentrations of the active metabolite do not change in patients with impaired renal function and in patients on hemodialysis. Neither losartan nor its active metabolite is excreted from the body by hemodialysis. In a study of the pharmacokinetics of losartan after oral administration in children with hypertension aged > 1 month to < 16 years, it was shown that the active metabolite is formed in all age groups. The values of the pharmacokinetic parameters of losartan were approximately similar in children of different ages. The values of the pharmacokinetic parameters of the active metabolite differed to a greater extent in children from different age groups. Statistically significant differences were noted between preschool children and adolescents. Exposure in children aged 1 month to 3 years was relatively high. Indications for use - Treatment of essential hypertension in adults and children aged 6-18 years. - Treatment of kidney disease in adult patients with hypertension and type II diabetes mellitus with proteinuria ≥ 0.5 g / day as part of antihypertensive therapy (see sections "Contraindications", "Special instructions and precautions", "Interaction with other medicinal products and other forms of interaction). - Treatment of chronic heart failure in adult patients when ACE inhibitors cannot be prescribed due to their intolerance (for example, the appearance of a cough) or the presence of contraindications to their use. Patients with heart failure who have been stabilized on the background of the use of ACE inhibitors should not be replaced with losartan. Patients should have a left ventricular ejection fraction of ≤ 40%, be clinically stable, and be receiving appropriate therapy for chronic heart failure. - To reduce the risk of cardiovascular morbidity and mortality in adult patients with hypertension in combination with left ventricular hypertrophy, signs of which are present on the electrocardiogram (however, there is evidence indicating that the use for this indication in patients of the black race does not provide sufficient favorable effect). Route of administration and doses Route of administration Inside, regardless of the meal. The 25 mg tablet can be divided according to risk into equal doses. A tablet or half a tablet (in case of splitting the tablet with a dosage of 25 mg) should be swallowed whole with a glass of water. It is recommended to take the drug every day at about the same time. Doses Hypertensive patients For most patients, the starting and maintenance doses are usually 50 mg once daily. The maximum antihypertensive effect is achieved 3-6 weeks after the start of the drug. In some patients, an additional beneficial effect can be achieved by increasing the dose to 100 mg 1 time per day (it is recommended to take it in the morning). Losartan can be used in conjunction with other antihypertensive drugs, in particular with diuretics (for example, hydrochlorothiazide) (see sections "Contraindications", "Special instructions and precautions", "Interaction with other drugs and other forms of interaction"). Patients with arterial hypertension in combination with type II diabetes mellitus and proteinuria ≥ 0.5 g / day The usual starting dose is 50 mg 1 time per day. The dose can be increased to 100 mg 1 time per day, depending on the dynamics of blood pressure, but not earlier than 1 month after the start of therapy (since the maximum antihypertensive effect is achieved 3-6 weeks after the start of the drug). Losartan may be used in combination with other antihypertensive agents (e.g. diuretics, calcium channel blockers, α- or β-blockers, agents with a central action (see sections "Contraindications", "Special instructions and precautions", "Interaction with other medicinal products"). drugs and other forms of interaction "), as well as in combination with insulin and other commonly used hypoglycemic agents (for example, sulfonylurea derivatives, glitazones, glucosidase inhibitors). Patients with heart failure In patients with heart failure, the starting dose is usually 12.5 mg 1 in general, it is necessary to titrate the dose at 1-week intervals (i.e., sequentially increase the daily dose of 12.5 mg - 25 mg - 50 mg - 100 mg up to a maximum dose of 150 mg 1 time per day) depending on the effect achieved and tolerability of the drug by the patient.Reducing the risk of stroke in adult patients with arterial al hypertension in combination with left ventricular hypertrophy, signs of which are present on the electrocardiogram. Usually, the starting dose is 50 mg 1 time per day. Depending on the dynamics of blood pressure, it may be appropriate to add a low dose of hydrochlorothiazide to the indicated dose of losartan and / or increase the dose of losartan to 100 mg 1 time per day. Special groups of patients Patients with intravascular hypovolemia (with a reduced circulating blood volume) In patients with intravascular hypovolemia (for example, in patients receiving high doses of diuretics), consideration should be given to starting therapy with losartan at a dose of 25 mg 1 time per day (see section " Special Instructions and Precautions). Patients with impaired renal function and patients on hemodialysis In patients with impaired renal function and in patients on hemodialysis, no adjustment of the starting dosage regimen is required. Patients with hepatic impairment Consideration should be given to prescribing a lower dose of losartan to patients with a history of hepatic impairment. There is no experience with the use of losartan in patients with severe hepatic impairment. Therefore, losartan is contraindicated in patients with severe hepatic impairment (see sections "Contraindications", "Special Instructions and Precautions"). Children aged 6 months - < 6 years The safety and efficacy of losartan in this age group have not been established. Dosing recommendations cannot be made (see section "Contraindications"). Children aged 6-18 years For patients who are able to swallow a tablet and whose body weight is in the range from > 20 to < 50 kg, the recommended dose is 25 mg 1 time per day. In exceptional cases, the dose may be increased to a maximum of 50 mg 1 time per day. The dose must be adjusted depending on the dynamics of blood pressure. In patients weighing > 50 kg, the usual dose is 50 mg once daily. In exceptional cases, the dose may be increased to a maximum of 100 mg 1 time per day. Daily doses greater than 1.4 mg/kg (or greater than 100 mg) have not been studied in children. Other indications for use in children The use of losartan in children under 6 years of age is not allowed, since available data on the use in this age group are limited (see section “Contraindications”). The use of losartan in children with a glomerular filtration rate < 30 ml / min / 1.73 m2 is not recommended, since there are no available data on the use in this category of patients (see also the section "Special Instructions and Precautions"). The use of losartan in children with impaired liver function is not recommended (see also the section "Special Instructions and Precautions"). Elderly patients Correction of the dosing regimen is usually not required. However, in patients over 75 years of age, consideration should be given to initiating losartan therapy at a daily dose of 25 mg. If you have taken an overdose of the drug, immediately seek advice from your doctor or a doctor at the nearest medical institution (for example, a polyclinic or a hospital emergency department); at the same time, if possible, take with you the package with the medicine and the leaflet for medical use. An overdose may cause a drop in blood pressure, an increase or decrease in heart rate (see also the section "Overdose"). The drug is taken 1 time per day. If you miss your next dose of medicine, take your next prescribed dose at the usual time, forgetting about the missed dose. It is not allowed to take a double dose in order to compensate for the missed one! In the future, continue to take the drug in accordance with the established regimen. Use during pregnancy and lactation Pregnancy When prescribing the drug LOSARTAN FT to patients with preserved childbearing potential, patients must be informed of the likelihood of developing toxic effects on the fetus and the need to immediately consult a doctor if pregnancy occurs during the period of use of the drug! The use of the drug LOZARTAN FT is not recommended during the first trimester of pregnancy and is contraindicated in the II and III trimesters of pregnancy (see sections "Contraindications", "Special instructions and precautions"). Epidemiological data regarding the risk of teratogenicity when exposed to ACE inhibitors during the first trimester of pregnancy do not allow the formation of unambiguous conclusions; however, a slight increase in risk cannot be ruled out. While there are no controlled epidemiological data on the risk associated with the use of angiotensin II receptor antagonists, a similar risk may also exist for this class of drugs. Unless continued use of an angiotensin II receptor antagonist is considered essential, patients planning pregnancy should be replaced with an angiotensin II receptor antagonist by another antihypertensive drug that has a proven favorable safety profile for use in pregnancy. If pregnancy is established during therapy with losartan, the use of losartan should be immediately discontinued and, if necessary, alternative therapy should be prescribed. It is known that the use of angiotensin II receptor antagonists in the second and third trimesters of pregnancy has toxic effects on the human fetus (decrease in kidney function, oligohydramnios, slowing of the ossification of the skull) and on the newborn (renal failure, hypotension, hyperkalemia). This increases the morbidity and risk of fetal and neonatal death. If losartan has been taken since the second trimester of pregnancy, ultrasound monitoring of the kidneys and skull is necessary. Children whose mothers took losartan during pregnancy should be closely monitored for the development of hypotension. Lactation No information is available regarding the use of losartan during breastfeeding. Preference should be given to other drugs for which the safety profile has been studied to a greater extent when used during breastfeeding, especially when breastfeeding a newborn or premature baby (see section "Contraindications"). Precautions Hypersensitivity reactions Patients with a history of angioedema (swelling of the face, lips, pharynx, tongue) should be under strict supervision (see sections "Side Effects", "Contraindications"). Hypotension and fluid and electrolyte disturbances With a decrease in circulating blood volume and / or with a decrease in the level of sodium in the blood (hyponatremia), developing, for example, due to the intensive use of diuretics, dietary salt restriction, diarrhea or vomiting, symptomatic hypotension may occur, especially after taking the first dose of the drug and after increasing the dose. These conditions must be corrected before starting the use of the drug LOZARTAN FT, or you should start using the drug LOZARTAN FT at a lower dose (see section "Method of administration and doses"). This information also applies to children aged 6-18. Electrolyte disorders Electrolyte disorders are often observed in patients with impaired renal function with or without diabetes and should be taken into account. In patients with type II diabetes mellitus in combination with nephropathy, hyperkalemia may develop during the use of losartan (see section "Side Effects"). Careful monitoring of plasma potassium concentrations and creatinine clearance is necessary, especially in patients with heart failure and creatinine clearance of 30-50 ml / min. The simultaneous use of the drug LOZARTAN FT with potassium-sparing diuretics, potassium supplements and potassium-containing salt substitutes is not recommended (see section "Interaction with other medicinal products and other forms of interaction"). Impaired liver function In patients with cirrhosis of the liver, a significant increase in the concentration of losartan in blood plasma was revealed. Consideration should be given to the use of a lower dose of losartan in the presence of a history of mild to moderate hepatic impairment. Due to the lack of experience in the therapeutic use of losartan in severe hepatic impairment, LOSARTAN FT is contraindicated in patients with severe hepatic impairment (see sections "Method of administration and doses", "Contraindications" and "Pharmacological properties"). The use of losartan in children with impaired liver function is not recommended (see section "Method of administration and doses"). Renal impairment As a consequence of inhibition of the renin-angiotensin-aldosterone system, impairment of renal function, including renal failure, has been noted (particularly in patients whose renal function depends on the activity of the renin-angiotensin-aldosterone system, for example, in those patients in who have severe heart failure or pre-existing renal dysfunction). As with the use of other drugs that affect the renin-angiotensin-aldosterone system, an increase in blood urea and serum creatinine levels has been reported in patients with bilateral renal artery stenosis or stenosis of the artery to a single kidney; these changes in renal function may be reversible upon discontinuation of therapy. Losartan should be used with caution in patients with bilateral renal artery stenosis or stenosis of the artery to a single kidney. The use of losartan in children with a glomerular filtration rate < 30 ml / min / 1.73 m2 is not recommended, since there are no available data on the use in this category of patients (see also the section "Method of administration and doses"). It is necessary to regularly monitor renal function during the use of losartan, as renal function may deteriorate. This is especially necessary if losartan is used against the background of fever, dehydration and other conditions that can lead to impaired renal function. It has been shown that the simultaneous use of losartan and ACE inhibitors leads to impaired renal function. Therefore, the simultaneous use of these drugs is not recommended (see section "Interaction with other drugs and other forms of interaction"). Renal transplantation There is no experience of use in patients who have recently undergone kidney transplantation. Primary hyperaldosteronism In patients with primary hyperaldosteronism, therapy with antihypertensive agents that act by inhibiting the renin-angiotensin system is usually ineffective. Therefore, the use of LOZARTAN FT is not recommended in this category of patients. Ischemic heart disease and cerebrovascular disease As with any antihypertensive drug, losartan can cause an excessive decrease in blood pressure, which in patients with coronary heart disease and / or cerebrovascular disease can lead to myocardial infarction or stroke. Heart failure In patients with heart failure with or without impaired renal function, as with other drugs acting on the renin-angiotensin system, there is a risk of developing severe arterial hypotension and impaired renal function (often acute). There is insufficient experience with the use of losartan in patients with heart failure in combination with severe renal impairment, in patients with severe heart failure (NYHA class IV), in patients with heart failure in combination with symptomatic, life-threatening arrhythmias. Therefore, losartan should be used with caution in these categories of patients. The simultaneous use of losartan and a β-blocker also requires caution. Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with other vasodilators, special care should be taken in patients with aortic or mitral valve stenosis or obstructive hypertrophic cardiomyopathy. Auxiliary components This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medicine. Before using, be sure to consult a doctor. Ethnic characteristics Losartan and other angiotensin antagonists, as well as ACE inhibitors, appear to be less effective in lowering blood pressure in patients of the black race compared to members of other races. This phenomenon may be due to the fact that low renin activity is more common in the population of blacks with hypertension. Pregnancy Losartan should not be started during pregnancy. Unless continued use of losartan is considered absolutely necessary, patients planning a pregnancy should switch to other antihypertensive agents for which a favorable safety profile has been established when used during pregnancy. If pregnancy is detected during the use of losartan, the use of the drug should be immediately discontinued and, if necessary, another drug should be prescribed (see sections "Contraindications", "Fertility, pregnancy and lactation"). Dual blockade of the renin-angiotensin-aldosterone system There is evidence that the simultaneous use of ACE inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalemia and deterioration of renal function (including the development of acute renal failure). In this regard, a double blockade of the renin-angiotensin-aldosterone system through the simultaneous use of ACE inhibitors, angiotensin II receptor blockers or aliskiren is not recommended (see sections "Interaction with other drugs and other forms of interaction", "Contraindications"). In cases where dual blockade of the renin-angiotensin-aldosterone system is considered absolutely necessary, such therapy should be carried out only under the supervision of a specialist and with the obligatory frequent close monitoring of renal function, electrolyte levels and blood pressure. In patients with diabetic nephropathy, ACE inhibitors and angiotensin II receptor blockers should not be administered simultaneously. Influence on the ability to drive vehicles or other moving mechanisms Studies of the effect on the ability to drive vehicles and work with moving mechanisms have not been conducted. However, when driving vehicles or when working with moving mechanisms, as well as when planning these types of activities, it must be borne in mind that dizziness or drowsiness may occasionally occur when using antihypertensive drugs, in particular at the beginning of treatment or when increasing doses of drugs. Interaction with other drugs Other antihypertensive agents may increase the hypotensive effect of losartan. The combined use of losartan with agents that can cause hypotension (hypotension may be the main effect or adverse reaction), for example, with tricyclic antidepressants, antipsychotics, baclofen, amifostine, may increase the risk of hypotension. Losartan is metabolized predominantly with the participation of the CYP2C9 isoenzyme from the cytochrome P450 system with the formation of an active carboxylated metabolite. There is information that rifampicin (an inducer of enzymes involved in metabolism) reduces the concentration of the active metabolite in plasma by 40%. Fluconazole (a CYP2C9 inhibitor) reduces the exposure of the active metabolite by approximately 50%. The clinical significance of these effects is unknown. No change in exposure was found with the simultaneous use of losartan and fluvastatin (a weak inhibitor of CYP2C9). As with other drugs that block angiotensin II or its effects, the concomitant use of losartan with agents that retain potassium in the body (eg, potassium-sparing diuretics spironolactone, triamterene, amiloride), or with agents that can increase potassium levels (eg, heparin , potassium supplements or salt substitutes containing potassium) may lead to an increase in serum potassium levels. Therefore, the simultaneous use of these drugs and losartan is not recommended. As with the use of other drugs that affect the excretion of sodium, the use of losartan may decrease the excretion of lithium. A reversible increase in serum lithium concentrations and the development of its toxic effects have been reported with the simultaneous use of lithium and ACE inhibitors. There are also very rare similar reports with the use of angiotensin II receptor antagonists and lithium. Co-administration of lithium and losartan should be done with caution. If the appointment of such a combination is considered absolutely necessary, with the simultaneous use of lithium salts and losartan, it is necessary to carefully monitor the level of lithium in the blood serum. With the simultaneous use of angiotensin II antagonists and non-steroidal anti-inflammatory drugs (i.e., selective cyclooxygenase-2 inhibitors, acetylsalicylic acid in doses that have an anti-inflammatory effect, non-selective non-steroidal anti-inflammatory drugs), the antihypertensive effect of angiotensin II antagonists may be weakened. The use of angiotensin II antagonists or diuretics in conjunction with non-steroidal anti-inflammatory drugs may lead to an increased risk of worsening renal function, up to acute renal failure, as well as an increase in serum potassium levels, especially in patients with pre-existing severe renal impairment. This combination should be used with caution, especially in elderly patients. When using this combination, patients should control the water balance (including ensuring an adequate drinking regimen); in addition, renal function should be monitored at the start of combination therapy and periodically thereafter. In some patients with impaired renal function receiving therapy with non-steroidal anti-inflammatory drugs (including selective cyclooxygenase-2 inhibitors), the simultaneous use of angiotensin II receptor antagonists may cause further deterioration of renal function; this effect is usually reversible. Compared with the use of a single drug that acts on the renin-angiotensin-aldosterone system, dual blockade of the renin-angiotensin-aldosterone system by the combined use of an ACE inhibitor, an angiotensin II receptor blocker, or aliskiren in patients with cardiovascular or cerebrovascular disease or with type II diabetes mellitus in combination with signs of target organ damage is accompanied by a higher incidence of adverse reactions such as hypotension, hyperkalemia and decreased renal function (including acute renal failure) (see sections "Contraindications", "Special instructions and measures precautions"). Dual blockade of the renin-angiotensin-aldosterone system with ACE inhibitors, angiotensin II receptor antagonists, or aliskiren cannot be recommended for any patient; in particular, such therapy should not be given to patients with diabetic nephropathy. In cases where dual blockade of the renin-angiotensin-aldosterone system is considered absolutely necessary, such therapy should be carried out only under the supervision of a specialist and with the obligatory frequent close monitoring of renal function, electrolyte levels and blood pressure. The simultaneous use of losartan with products containing aliskiren in patients with diabetes mellitus or with impaired renal function (glomerular filtration rate < 60 ml / min / 1.73 m2) is contraindicated (see section "Contraindications"). Contraindications - Known individual hypersensitivity to losartan and / or to any of the auxiliary components of the drug. - Hereditary angioedema or angioedema in history against the background of the use of an ACE inhibitor or an angiotensin II receptor antagonist. - Severe liver dysfunction. - The period of pregnancy (see sections "Special instructions and precautions", "Fertility, pregnancy and lactation"). - The period of breastfeeding (see section "Fertility, pregnancy and lactation"). - The simultaneous use of losartan with products containing aliskiren is contraindicated in patients with diabetes mellitus or with impaired renal function (glomerular filtration rate < 60 ml / min / 1.73 m2) (see section "Interaction with other drugs and other forms of interaction "). - Age less than 6 years (efficacy and safety not established). Composition Each film-coated tablet contains: tablet core: active ingredient: - dosage 25 mg: 25 mg losartan potassium; - dosage of 50 mg: 50 mg of losartan potassium; - dosage of 100 mg: 100 mg of losartan potassium; excipients: lactose monohydrate, pregelatinized starch, magnesium stearate, microcrystalline cellulose; tablet shell: hypromellose, titanium dioxide, talc, macrogol 6000. Overdose Available data on overdose in humans are limited. The most likely symptoms of overdose are hypotension and tachycardia; due to parasympathetic (vagal) stimulation, bradycardia may occur. If symptomatic hypotension occurs, supportive therapy should be provided. The necessary measures depend on the time elapsed since the overdose was taken, on the type and severity of the symptoms. The priority direction of assistance should be considered a set of measures to stabilize the function of the cardiovascular system. When ingesting an excess dose, the appointment of a sufficient dose of activated charcoal is indicated. Careful monitoring of vital signs is necessary; if necessary, these indicators should be corrected. Neither losartan nor its active metabolite can be removed from the body by hemodialysis. Side effect Undesirable reactions are distributed by type and by frequency of occurrence. The frequency of occurrence of adverse reactions is estimated according to the following scheme: very often (≥ 1/10); often (≥ 1/100 to < 1/10); infrequently (≥ 1/1000 to < 1/100); rarely (≥ 1/10,000 to < 1/1,000); very rarely (< 1/10000); frequency unknown (frequency cannot be established from available data). In controlled clinical trials, the most common adverse reaction was dizziness. The adverse reactions listed below have been reported in clinical studies and post-marketing experience. Data obtained in clinical studies Patients with arterial hypertension - Nervous system disorders: often - dizziness; infrequently - drowsiness, headache, sleep disturbances. - Disorders of the organ of hearing and labyrinth disorders: often - vertigo. - Cardiac disorders: infrequently - palpitations, tachycardia, angina pectoris. - Vascular disorders: infrequently - (orthostatic) hypotension, including dose-dependent orthostatic effects, especially in patients with intravascular hypovolemia, for example, in patients with severe heart failure or in patients receiving high doses of diuretics (orthostatic hypotension - a decrease in blood pressure that occurs when moving from a lying or sitting position to a standing position). - Gastrointestinal disorders: infrequently - abdominal pain, constipation (including persistent). - Disorders of the skin and subcutaneous ti