Enalapril tab.5mg in a cell.pack №10×3

Name:
Enalapril 5 and 10 mg. Release form Tablets 5 and 10 mg. MNNEnalapril. FTGApf blocker.
Description:
Pills of white color with a yellowish tint, flat-cylindrical, with a chamfer. Composition One tablet contains: active ingredient – enalapril maleate – 5 mg or 10 mg; excipients: lactose monohydrate, starch 1500 (corn starch partially pregelatinized), corn starch, sodium bicarbonate, magnesium stearate. Pharmacotherapeutic group Means that affect the renin-angiotensin system. Angiotensin-converting enzyme inhibitor. ATX code: C09AA02. Pharmacological properties Pharmacodynamics Enalapril maleate is a salt of maleic acid and enalapril. After absorption, enalapril undergoes hydrolysis to enalaprilat, which inhibits ACE, which leads to a decrease in the plasma concentration of the angiotensin II pressor compound and, as a result, to an increase in plasma renin activity and a decrease in aldosterone secretion. The drug can also block the breakdown of bradykinin, a powerful vasodepressor (vasodilator) peptide. Although the mechanism by which enalapril exerts its hypotensive effect is primarily through the suppression of the renin-angiotensin-aldosterone system, which plays the most important role in the regulation of blood pressure, the drug also exerts an antihypertensive effect in patients with low renin levels. The intake of enalapril by patients with hypertension leads to a decrease in blood pressure (BP) both in the supine and standing positions, without an increase in heart rate. Symptomatic postural hypotension is rare. In some patients, reaching the optimal level of blood pressure reduction may require several weeks of therapy. Abrupt withdrawal of enalapril is not accompanied by a rapid increase in blood pressure. Effective suppression of ACE activity usually develops within 2-4 hours after ingestion of an individual dose of enalapril. The onset of antihypertensive activity is usually observed within an hour, the maximum decrease in blood pressure is achieved within 4-6 hours after administration. The duration of action depends on the dose – in the recommended amounts, the antihypertensive and hemodynamic effects of the drug persist for at least 24 hours. In hemodynamic studies in patients with arterial hypertension, a decrease in blood pressure was accompanied by a decrease in peripheral resistance in the arteries with an increase in cardiac output and small changes in heart rate abbreviations or none. After the introduction of enalapril, there was an increase in renal blood flow; glomerular filtration rate did not change; no signs of sodium or water retention were observed. However, in patients with reduced glomerular filtration, an increase in this indicator was noted. When combined with thiazide-type diuretics, the hypotensive effect is additive. At the same time, enalapril can reduce or prevent the development of hypokalemia caused by taking thiazides. In patients with heart failure during therapy with digitalis and diuretics, enalapril reduces peripheral resistance and blood pressure. Cardiac output increases while heart rate (usually elevated in patients with heart failure) decreases; the wedge pressure in the pulmonary capillaries (DZLK) decreases. Therapy with enalapril normalizes the condition in heart failure and improves exercise tolerance. These effects persist throughout therapy. In patients with mild or moderate heart failure, the drug slows down the progression of heart dilatation and heart failure (decrease in the end diastolic and systolic volumes of the left ventricle and improvement in the ejection fraction (ejection)). In patients with left ventricular dysfunction, enalapril reduces the risk of major cardiovascular events, myocardial infarction and the number of hospitalizations for unstable angina. Pharmacokinetics Absorption. Enalapril is rapidly absorbed from the gastrointestinal tract; the maximum concentration in blood serum is reached within one hour. The degree of absorption is about 60%, while eating does not affect absorption. After absorption, enalapril is rapidly and completely hydrolyzed to enalaprilat, an active ACE inhibitor. The peak concentration of enalaprilat in the blood serum is observed 4 hours after oral administration of enalapril. The effective half-life for the accumulation of enalaprilat after repeated administration of enalapril is 11 hours. In patients with normal renal function, a stable concentration of enalaprilat in the blood serum is reached four days after the start of treatment. Distribution. In the range of therapeutically significant concentrations, the binding of enalaprilat to serum proteins is 60%. Metabolism. With the exception of conversion to enalaprilat, there are no data on further significant metabolism of enalapril. Withdrawal. Enalaprilat is excreted mainly by the kidneys. The main components in the urine are enalaprilat, which accounts for 40% of the dose, and unchanged enalapril (about 20%). Impaired kidney function. The effect of enalapril and enalaprilat in patients with renal insufficiency is enhanced. In patients with mild or moderate renal insufficiency (creatinine clearance 40-60 ml / min), after taking 5 mg of the drug once a day, the AUC value of enalaprilat is approximately two times higher than in patients with normal renal function; whereas in severe renal failure (creatinine clearance ≤ 30 ml / min), the AUC value increases by approximately eight times; the effective half-life of enalaprilat is lengthened, the time to reach a steady state is increased. Enalaprilat can be removed from the circulatory system by hemodialysis. Enalaprilat dialysis clearance is 62 ml/min. Liver failure. In patients with impaired liver function, the elimination period of enalaprilat may be prolonged. In patients with severe hepatic insufficiency, the hydrolysis of enalapril to enalaprilat may be slowed down and/or impaired. Congestive heart failure. In patients with congestive heart failure, the half-life of enalapril may be prolonged and the elimination of enalaprilat slowed down. Indications for use – arterial hypertension of various forms and severity (including renovascular hypertension); – heart failure stage I-III as part of complex therapy, including asymptomatic left ventricular dysfunction; – prevention of coronary ischemia in patients with left ventricular dysfunction. Dosage and administration Inside, regardless of the meal. Arterial hypertension The initial dose for mild arterial hypertension (AH) is 5 mg 1 time per day. For other degrees of hypertension, the initial dose is 10 mg once a day. If there is no effect, the dosage of the drug is increased by 5 mg with an interval of 1 week. Maintenance dose – 20 mg 1 time per day. The dose should not exceed 40 mg per day. Renovascular hypertension Therapy begins with a lower initial dose of 2.5 mg. The dose is selected according to the needs of the patient. The maximum daily dose is 40 mg of enalapril daily. Concomitant treatment of arterial hypertension with diuretics After the first dose of enalapril, arterial hypotension may develop. The drug is recommended to be administered with caution. Treatment with diuretics should be discontinued 2-3 days before the start of treatment with enalapril. If possible, the initial dose of enalapril should be reduced (to 5 mg or less) to determine the initial effect of the drug. Dosage in renal insufficiency The interval between doses of enalapril should be increased and / or the dose reduced. Renal function status Creatinine clearance Starting dose Slight impairment of function more than 30 ml/min 5–10 mg/day Moderate impairment of function less than 30 ml/min 2.5–5 mg/day Severe impairment or hemodialysis less than 10 ml/min 2.5 mg / day on dialysis days Heart failure / asymptomatic left ventricular dysfunction The initial dose of enalapril in patients with chronic heart failure is 2.5 mg per day, the drug should be administered under close medical supervision to establish the initial effect of the drug. Enalapril can be used in conjunction with diuretics and, when necessary, with cardiac glycosides. The dose should be increased at 1-week intervals by 5 mg to the usual maintenance daily dose of 20 mg given as a single dose or divided into two doses, depending on patient tolerance. Dose adjustments should be made over 2-4 weeks. Recommended dose titration of enalapril in patients with heart failure/asymptomatic left ventricular dysfunction Week Dose mg/day Week 1 Day 1–3: 2.5 mg/day once daily Day 4–7: 5 mg/day divided into 2 doses Week 2 10 mg/day single dose or divided into 2 doses 3rd and 4th week 20 mg/day single dose or divided into 2 doses The development of arterial hypotension after taking the first dose of enalapril does not indicate the need to stop taking the drug. Use in Elderly Patients The dose should be appropriate to the degree of impairment of the patient’s renal function. Use in Pediatrics Experience with the use of enalapril in children with arterial hypertension in clinical trials is limited. For children who can swallow tablets, the dose should be selected individually, depending on the patient’s condition and on the degree of reduction in blood pressure. The recommended starting dose is 2.5 mg for patients weighing 20 to < 50 kg and 5 mg for patients weighing > 50 kg. Enalapril is taken once a day. The dose should be adjusted as needed for the patient, up to a maximum dose of 20 mg per day if the patient’s body weight is 20 kg to < 50 kg, and 40 mg if the body weight is > 50 kg. Enalapril is not recommended for use in neonates and children with a glomerular filtration rate < 30 ml/min/1.73 m2, as there are no data on use in such patients. Side effects Adverse reactions are listed according to the classification of undesirable side effects in accordance with the damage to organs and organ systems and the frequency of development: very frequent (≥ 1/10), frequent (≥ 1/100 to < 1/10), infrequent (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000), frequency not known (cannot be estimated from available data). The frequency of side effects is listed by individual organ systems. Blood and lymphatic system disorders: infrequent - anemia (including aplastic and hemolytic); rare - neutropenia, hypohemoglobinemia, decreased hematocrit, thrombocytopenia, agranulocytosis, bone marrow suppression, pancytopenia, lymphadenopathy, autoimmune diseases. Endocrine disorders: frequency not known - syndrome of inappropriate secretion of antidiuretic hormone (SIADH). Metabolic and nutritional disorders: infrequent - hypoglycemia. Nervous system and psychiatric disorders: common - headache, depression; infrequent - confusion, insomnia, nervousness, paresthesia, dizziness; rare - abnormal dreams, sleep disturbances. On the part of the organ of vision: very common - blurred vision. Cardiovascular disorders: very common - dizziness; frequent - hypotension (including orthostatic hypotension), syncope, chest pain, rhythm disturbances, angina pectoris, tachycardia; infrequent - orthostatic hypotension, palpitations, myocardial infarction or cerebrovascular complications *, possibly secondary to excessive hypotension in patients at high risk; rare - Raynaud's phenomenon. Respiratory, thoracic and mediastinal disorders: very common - cough, common - dyspnea (shortness of breath), infrequent - rhinorrhea, pharyngitis, hoarseness, bronchospasm / asthma; rare - lung infiltrates, rhinitis, allergic alveolitis / eosinophilic pneumonia. Gastrointestinal disorders: very common - nausea; frequent - diarrhea, abdominal pain, change in taste; infrequent - intestinal obstruction, pancreatitis, vomiting, dyspepsia, constipation, anorexia, stomach irritation, dry mouth, gastric and duodenal ulcers; rare - stomatitis / aphthous ulceration, glossitis; very rare - angioedema of the intestine. Liver and biliary tract disorders: rare - liver failure, hepatocellular or cholestatic hepatitis, including hepatic necrosis, cholestasis, jaundice. Skin and subcutaneous tissue disorders: Common: Rash, hypersensitivity/angioneurotic edema: Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported; infrequent - increased sweating, itching, urticaria, alopecia; rare - exudative erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma. Renal and urinary tract disorders: infrequent - renal dysfunction, renal failure, proteinuria; rare - oliguria. Reproductive system and breast disorders: infrequent - impotence; rare - gynecomastia. Complications of a general nature and reactions at the injection site: very frequent - asthenia; frequent - fatigue; infrequent - muscle cramps, hyperemia, tinnitus, malaise, fever. Changes in laboratory parameters: frequent - hyperkalemia, hypercreatininemia; infrequent - increase in serum urea, hyponatremia; rare - increased liver enzymes, increased serum bilirubin. A complex of symptoms has been reported: fever, serositis, vasculitis, myalgia/myositis, arthralgia/arthritis, positive ANF, elevated ESR, eosinophilia, and leukocytosis. Photosensitivity or other dermatological reactions are also possible. In the event of severe side effects, treatment should be discontinued. Contraindications Hypersensitivity to enalapril and other ACE inhibitors, a history of angioedema, porphyria, pregnancy, lactation. Use with caution in primary hyperaldosteronism, bilateral stenosis of the renal arteries, stenosis of the artery of a single kidney, hyperkalemia, condition after kidney transplantation; aortic stenosis, mitral stenosis (with hemodynamic disorders), idiopathic hypertrophic subaortic stenosis, systemic connective tissue diseases, coronary heart disease, cerebrovascular diseases, diabetes mellitus, renal failure (proteinuria more than 1 g / day), liver failure, in patients on a diet with salt restriction or those on hemodialysis, while taking with immunosuppressants and saluretics, in the elderly (over 65 years). The simultaneous use of angiotensin-converting enzyme inhibitors or ATII receptor blockers with aliskiren in patients with diabetes mellitus or moderate / severe renal insufficiency (GFR less than 60 ml / min / 1.73 m2) is contraindicated. Overdose Symptoms: a pronounced decrease in blood pressure up to the development of collapse, myocardial infarction, acute cerebrovascular accident or thromboembolic complications, convulsions, stupor. Treatment: to give the patient a horizontal position with raised legs. Gastric lavage with further administration of activated charcoal. In a hospital, measures are taken to stabilize blood pressure: intravenous administration of saline or plasma substitutes. Perhaps hemodialysis. Special instructions (precautions) Symptomatic hypotension In uncomplicated arterial hypertension, symptomatic hypotension is rare. It is most likely to occur in patients with arterial hypertension due to hypovolemia, for example, due to diuretic treatment, a salt-depleted diet, dialysis, diarrhea, or vomiting. Symptomatic hypotension may also occur in patients with heart failure with or without concomitant renal failure. More likely to occur in patients with more severe heart failure due to high doses of loop diuretics, hyponatremia, or kidney damage. In such patients, treatment should be started under medical supervision, with strict adherence to selected doses of enalapril and / or diuretic. A similar principle can be applied to patients with ischemic heart disease or cerebrovascular disease, in whom a sudden decrease in blood pressure can lead to myocardial infarction or stroke. If hypotension develops, the patient should be placed in the supine position and, if necessary, intravenous infusion of 0.9% sodium chloride solution should be given to replenish plasma volume. Transient hypotension is not a contraindication for enalapril treatment. After adjusting blood pressure and plasma volume, patients subsequently generally tolerate treatment well. In some patients with heart failure with normal or low blood pressure, enalapril may cause an additional decrease in blood pressure. This effect is predictable and is usually not a reason to stop treatment. If hypotension becomes symptomatic, dose reduction and/or discontinuation of the diuretic and/or enalapril is required. Aortic or mitral valve stenosis/hypertrophic cardiomyopathy As with all vasodilators, ACE inhibitors should be used with extreme caution in patients with left ventricular outflow tract obstruction. In cases of cardiogenic shock and severe hemodynamic obstruction of the outflow tract of the left ventricle, the use of these drugs should be avoided. Impaired renal function In patients with impaired renal function (creatinine clearance < 80 ml / min), the initial dose should be adjusted taking into account creatinine clearance. Maintenance doses are prescribed according to the patient's response to treatment. At the same time, the levels of creatinine and potassium in the blood serum should be monitored regularly. In patients with severe heart failure or underlying kidney disease, including renal artery stenosis, renal failure may occur during treatment with enalapril. With timely diagnosis and appropriate treatment, this disease is usually reversible. In some patients without previously established kidney disease, while taking enalapril with a diuretic, slight and transient increases in serum urea and creatinine levels have developed. In such cases, it may be necessary to reduce the dosage of ACE inhibitors and / or cancel diuretics. This situation should increase the likelihood of predisposing renal artery stenosis. Renovascular hypertension There is an increased risk of hypotension and renal failure in patients with bilateral renal artery stenosis or stenosis of the artery to one functioning kidney and treated with ACE inhibitors. In this case, a decrease in kidney function can be manifested only by minor changes in the level of creatinine in the blood serum. In such patients, treatment should begin at low doses and under medical supervision; during treatment, careful titration and monitoring of renal function is necessary. Kidney transplantation Due to lack of experience with enalapril, treatment with enalapril is not recommended in patients with a recent kidney transplant. Liver failure During treatment with ACE inhibitors, in rare cases, a syndrome may occur that begins with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is unknown. If jaundice or a marked increase in liver enzymes develop during treatment with ACE inhibitors, treatment should be discontinued immediately and the patient should be closely monitored and treated if necessary. Neutropenia and agranulocytosis Neutropenia, agranulocytosis, thrombocytopenia and anemia have been reported in patients receiving ACE inhibitors. Neutropenia rarely occurs in patients with normal renal function and no other complications. Enalapril should be used with extreme caution in patients with vascular collagenosis (eg, systemic lupus erythematosus, scleroderma), as well as in patients treated with immunosuppressive drugs, allopurinol or procainamide, or in patients with a combination of these factors, especially with pre-existing impaired renal function. Some of these patients may develop serious infections, in some cases not responding to intensive antibiotic therapy. If enalapril is used in such patients, then periodic monitoring of the number of leukocytes is recommended. Patients should be instructed to report any signs of infection. Hypersensitivity and angioedema During treatment with ACE inhibitors, including enalapril, in rare cases, angioedema of the face, extremities, lips, tongue, pharynx and / or larynx may develop at any stage of treatment. In such cases, the drug should be immediately discontinued. Appropriate monitoring should be carried out to ensure that all symptoms have disappeared before the patient is discharged from the hospital. Even in cases where there is only swelling of the tongue, without respiratory failure, patients may require long-term follow-up, as antihistamines and corticosteroids may not be sufficient. There are very rare cases of death due to angioedema associated with edema of the larynx and tongue; in such patients with a history of surgical interventions on the airways, their obstruction is likely. In case of angioedema of the tongue, pharynx or larynx, which can cause airway obstruction, appropriate treatment should be started immediately, for example, s / c injection of a solution of adrenaline 1: 1000 (0.3 - 0.5 ml), and measures should be taken to ensure free airway patency. There have been reports that black patients receiving ACE inhibitors have a higher incidence of angioedema. Patients with a history of angioedema unrelated to treatment with ACE inhibitors have an increased risk of developing angioedema while receiving ACE inhibitors. Anaphylactoid reactions during desensitization Rarely, life-threatening anaphylactoid (allergic-type) reactions may occur in patients taking ACE inhibitors during desensitization against wasp or bee venom. These reactions can be avoided by temporarily stopping treatment with ACE inhibitors before each desensitization. Anaphylactoid reactions during LDL apheresis Patients receiving ACE inhibitors during low-density lipoprotein (LDL) apheresis with dextran sulfate may experience life-threatening anaphylactoid (allergic-type) reactions. These reactions can be avoided by temporarily stopping treatment with ACE inhibitors before each apheresis. Patients on hemodialysis There have been reports of hypersensitivity reactions and allergic-type reactions (anaphylactoid reactions) in patients undergoing dialysis using high flux density membranes (eg AN 69) and concomitantly treated with ACE inhibitors. If hemodialysis is necessary, the patient should be transferred to another class of drugs, or another type of membrane should be used for dialysis. Hypoglycemia In diabetic patients treated with oral antidiabetic drugs or insulin, blood glucose levels should be closely monitored during the first few months of concomitant treatment with ACE inhibitors. Cough During treatment with ACE inhibitors, a persistent, dry, non-productive cough may occur, which stops after treatment is discontinued. This should be included in the differential diagnosis. Surgery and anesthesia In patients undergoing major surgery or during anesthesia with drugs that cause hypotension, enalapril may block the formation of angiotensin II secondary to compensatory renin release. Hypotension associated with this mechanism can be corrected by increasing blood volume. Hyperkalemia During treatment with ACE inhibitors, including enalapril, the level of potassium in the blood may increase in some patients. Risk factors for hyperkalemia include renal failure, worsening renal function, age (>70 years), diabetes mellitus, intercurrent illness such as dehydration, acute heart failure, metabolic acidosis, and concomitant use of potassium-sparing diuretics (eg, spironolactone, eplerenone, triamterene, or amiloride). ), potassium supplements or salt substitutes containing potassium, or taking other drugs that can lead to an increase in serum potassium levels (for example, heparin). The use of potassium supplements, potassium-containing salt substitutes or potassium-sparing diuretics can lead to a significant increase in serum potassium levels, especially in patients with impaired renal function. Hyperkalemia can lead to serious, sometimes fatal, arrhythmias. In cases where the simultaneous use of enalapril and the above-mentioned agents is considered appropriate, it is recommended to regularly monitor the level of potassium in the blood serum. Use in children There is very little information on the efficacy and safety of the drug in children with arterial hypertension over the age of 6 years, and there is no experience with other indications. There are very few data on the pharmacokinetics of the drug in children over the age of 2 months. Enalapril is recommended for use in children only with arterial hypertension. Enalapril is not recommended for use in neonates and children with a glomerular filtration rate < 30 ml/min/1.73 m2, as there are no data on use in such patients (see section "Method of application and dosage"). Ethnic features As with other ACE inhibitors, the hypotensive effect of enalapril is less pronounced in dark-skinned patients, which is associated with a genetically determined decrease in their secretion of renin. Double blockade of the renin-angiotensin-aldosterone system Double 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. Special precautions regarding excipients Enalapril contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency and glucose-galactose malabsorption should not take this medicine. Interactions with other medicinal products Potassium-sparing diuretics, potassium supplements ACE inhibitors reduce diuretic-induced potassium loss. Potassium-sparing diuretics (eg, spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes can lead to hyperkalemia. If combined use is indicated in connection with proven hypokalemia, then it should be used with caution and with regular monitoring of potassium in the blood serum. Diuretics (thiazide or loop diuretics) Previous treatment with high doses of diuretics may lead to hypovolemia and the risk of hypotension. The hypotensive effect can be reduced by discontinuing diuretics, compensating for the lack of salts and fluids in the body, or taking low doses of enalapril at the initial stage of treatment. Other antihypertensive agents Concomitant use of enalapril and other antihypertensive drugs may increase the antihypertensive effect of enalapril. Simultaneous use with nitroglycerin, other nitrates or vasodilators can also lead to a decrease in blood pressure. Lithium Reversible increases in serum lithium concentrations and its toxic effects have been reported with co-administration of lithium and ACE inhibitors. Concomitant use of thiazide diuretics may lead to an increase in lithium levels and increase the risk of lithium toxicity. Therefore, the co-administration of enalapril and lithium is not recommended. If this combination is still necessary, then careful monitoring of the level of lithium in the blood serum should be carried out. Tricyclic antidepressants / antipsychotics / anesthetics / and narcotic drugs The simultaneous use of some anesthetics, tricyclic antidepressants and antipsychotics with ACE inhibitors can lead to an additional decrease in blood pressure. Non-steroidal anti-inflammatory drugs (NSAIDs) Chronic use of NSAIDs may reduce the antihypertensive effect of ACE inhibitors. NSAIDs (including COX-2 inhibitors) and ACE inhibitors have an additive effect on increasing serum potassium levels, which can lead to deterioration of kidney function. This effect is usually reversible. In rare cases, acute renal failure may occur, especially in patients with impaired renal function (for example, elderly patients or those with severe hypovolemia, including those taking diuretics). Patients should be adequately hydrated and attention should be paid to monitoring renal function after initiation of concomitant therapy and periodically thereafter. Gold preparations There have been isolated reports of nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) in patients receiving injectable gold preparations (sodium aurothiomalate) and ACE inhibitors, including enalapril. Antidiabetic drugs Epidemiological studies suggest that the concomitant use of ACE inhibitors and antidiabetic drugs (insulin, oral antidiabetic drugs) can lead to a marked decrease in blood sugar levels with a risk of hypoglycemia. This phenomenon is most likely to occur in patients with kidney damage during the first weeks of combined treatment. Alcohol Alcohol enhances the hypotensive effect of ACE inhibitors. Sympathomimetics Sympathomimetics may reduce the antihypertensive effect of ACE inhibitors. Acetylsalicylic acid, thrombolytics and β-blockers Enalapril can be safely administered simultaneously with acetylsalicylic acid (in cardiological dosage), thrombolytics and β-blockers. Cimetidine Preparations containing cimetidine prolong the action of enalapril. Dual blockade of the renin-angiotensin-aldosterone system Dual blockade of the renin-angiotensin-aldosterone system with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with an increased risk of hypotension, syncope, hyperkalemia, and renal dysfunction (including acute renal failure) compared with use one agent of the renin-angiotensin-aldosterone system. Blood pressure, renal function and electrolyte levels should be constantly monitored in patients taking enalapril and other drugs that affect the renin-angiotensin-aldosterone system. Patients suffering from diabetes are contraindicated in the use of aliskiren in conjunction with enalapril preparations. Co-administration of aliskiren with enalapril preparations should also be avoided in patients with renal insufficiency (glomerular filtration rate < 60 ml/min). Influence on the ability to drive a car or other mechanisms When driving vehicles or working with moving mechanisms, it should be borne in mind that dizziness and weakness can sometimes occur. Use during pregnancy and lactation If you are pregnant or breastfeeding, if you think you are pregnant or do not rule out the possibility of pregnancy, tell your doctor. Use during pregnancy is not recommended. Enalapril should be stopped immediately! Enalapril in the III-II trimester of pregnancy can cause disease or death of the fetus or newborn. The use of enalapril causes arterial hypotension, renal failure, hyperkalemia and / or skull hypoplasia in the fetus. Perhaps the development of oligohydramnios with contracture of the limbs, deformity of the facial bones of the skull, hypoplasia of the lungs. Newborns whose mothers took enalapril should be carefully examined to identify malformations. Enalapril can be partially removed from the body of the newborn by peritoneal dialysis. Enalapril and enalaprilat are excreted in breast milk. If necessary, use during lactation, breastfeeding should be discontinued. Upakovka10 tablets in a blister pack of PVC film and aluminum foil. 1, 2, 3 or 6 blister packs together with the leaflet are placed in a pack of cardboard (No. 10x1, No. 10x2, No. 10x3, No. 10x6). Storage conditions In a place protected from light and moisture, at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life 2 years. Do not use after the expiration date. Terms of dispensing from pharmaciesBy prescription. Buy Enalapril tabl.