enam tablets 10 mg 20 pcs. (enalapril)

Release form

Tablets

Packing

20 pcs.

Indications

Essential hypertension of any severity.

Renovascular hypertension.

Heart failure of any severity.

In patients with clinical manifestations of HF, Enam® is also indicated for:

increasing patient survival

slowing the progression of HF

reducing the frequency of hospitalizations for heart failure.

Prevention of the development of clinically severe heart failure.

In patients without clinical symptoms of heart failure with left ventricular dysfunction, Enam® is indicated for: slowing the development of clinical manifestations of heart failure

reducing the frequency of hospitalizations for heart failure.

Prevention of coronary ischemia in patients with left ventricular dysfunction.

Enam® is indicated for: reducing the incidence of myocardial infarction

reducing the frequency of hospitalizations for unstable angina pectoris.

Contraindications

Hypersensitivity to any component of the drug.

A history of angioedema associated with the use of ACE inhibitors, as well as hereditary or idiopathic angioedema.

Concomitant use with aliskiren and drugs containing aliskiren in patients with diabetes mellitus and / or moderate or severe impaired renal function (GFR less than 60 ml / min / 1.73 m2 of body surface area) [see section “Interaction with other drugs”].

Concomitant use with angiotensin II receptor antagonists in patients with diabetic nephropathy.

Age under 18 years (efficacy and safety not established).

Pregnancy and the period of breastfeeding.

Hereditary lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.

Precautions: Bilateral renal artery stenosis or stenosis of a single kidney artery stenosis after kidney transplantation aortic or mitral stenosis hypertrophic obstructive cardiomyopathy coronary heart disease or cerebrovascular disease renal failure renovascular hypertension inhibition of bone marrow hematopoietic and systemic hematopoietic diseases. ), immunosuppressive therapy, treatment with allopurinol or pro ainamida or a combination of these complicating factors hepatic failure diabetes hyperkalemia while the use of potassium-sparing diuretics, potassium preparations, potassium-containing substitutes for sodium chloride and lithium preparations during the apheresis of low-density lipoprotein apheresis (LDL-apheresis) using dextran sulfate aggravated allergic history or angioedema in the anamnesis of the condition, accompanied by a decrease in the volume of circulating blood (including diuretic therapy, compliance with salt, dialysis, diarrhea or vomiting) during desensitization with an allergen from hymenoptera venom in patients who are not and dialysis using high-flow membranes (such as AN 69В®)

in patients after major surgery or during general anesthesia in patients of the Negroid race.

Special instructions

Symptomatic arterial hypotension

Symptomatic arterial hypotension is rarely observed in patients with uncomplicated hypertension. In patients with hypertension taking enalapril, arterial hypotension develops more often against the background of dehydration, which occurs, for example, as a result of diuretic therapy, restriction of salt intake, in patients on dialysis, as well as in patients with diarrhea or vomiting (see sections "Side effects" "Interaction with other drugs"). Symptomatic arterial hypotension was also observed in patients with heart failure with or without renal failure. Arterial hypotension develops more often in patients with a more severe degree of heart failure with hyponatremia or impaired renal function, in which higher doses of “loop” diuretics are used. In these patients, treatment with Enam® should begin under medical supervision, which should be especially careful when changing the dose of Enam® and / or diuretic. Similarly, patients with coronary heart disease or cerebrovascular diseases in whom an excessive decrease in blood pressure can lead to the development of myocardial infarction or stroke should be monitored.

With the development of arterial hypotension, the patient should be laid down and, if necessary, introduce 0.9% sodium chloride solution. Transient arterial hypotension when taking EnamВ® is not a contraindication for further use and increasing the dose of the drug, which can be continued after filling the volume of fluid and normalizing blood pressure.

In some patients with heart failure and with normal or low blood pressure, EnamВ® may cause an additional decrease in blood pressure. This reaction to taking the drug is expected and is not a reason for stopping treatment. In cases when arterial hypotension takes a stable character, the dose should be reduced and / or treatment with a diuretic and / or EnamВ® drug should be discontinued.

Aortic or mitral stenosis / hypertrophic obstructive cardiomyopathy

Like all drugs with vasodilating effects, ACE inhibitors should be prescribed with caution to patients with obstruction of the outflow path from the left ventricle.

Impaired renal function

In some patients, arterial hypotension, which develops after treatment with ACE inhibitors, can lead to further impairment of renal function.

In some cases, the development of acute renal failure, usually reversible, has been reported.

In patients with renal insufficiency, a reduction in the dose and / or frequency of administration of the drug may be required (see section "Dosage and Administration"). In some patients with bilateral renal artery stenosis or stenosis of a single kidney artery, an increase in the concentration of urea in the blood and creatinine in the blood serum was observed. The changes were usually reversible and the indicators returned to baseline after discontinuation of treatment. This nature of the changes is most likely in patients with renal failure.

In some patients who did not show any kidney disease before treatment, EnamВ® in combination with diuretics usually caused a slight and transient increase in blood urea and creatinine in the blood serum. In such cases, a dose reduction and / or withdrawal of the diuretic and / or EnamВ® preparation may be required.

Kidney transplantation

There is no experience with patients after kidney transplantation, therefore treatment with EnamВ® is not recommended in patients after kidney transplantation.

Hepatic insufficiency

The use of ACE inhibitors has rarely been associated with the development of the syndrome, starting with cholestatic jaundice or hepatitis and progressing to fulminant liver necrosis, sometimes fatal. The mechanism of this syndrome has not been studied. If there is jaundice or a significant increase in the activity of “liver” transaminases, against the background of the use of ACE inhibitors, the drug should be discontinued and appropriate adjuvant therapy should be prescribed, the patient should be under appropriate supervision.

Neutropenia / agranulocytosis

Neutropenia / agranulocytosis, thrombocytopenia and anemia have been observed in patients taking ACE inhibitors. Neutropenia rarely occurs in patients with normal renal function and without other complicating factors. Enalapril should be used with extreme caution in patients with systemic diseases of the connective tissue (systemic lupus erythematosus, scleroderma, etc.), taking immunosuppressive therapy, allopurinol or procainamide, or a combination of these complicating factors, especially if there are already existing renal impairment. Some of these patients developed serious infectious diseases, which in some cases did not respond to intensive antibiotic therapy. If enalapril is used in such patients, regular monitoring of the number of leukocytes and lymphocytes in the blood is recommended, and patients should be warned about the need to report any signs of an infectious disease.

Hypersensitivity Reactions / Angioedema edema

With the use of ACE inhibitors, including EnamВ®, rare cases of angioedema of the face, limbs, lips, tongue, vocal folds and / or larynx occurred during different periods of treatment. In very rare cases,

has been reported to develop intestinal edema. In such cases, you should immediately stop taking EnamВ® and carefully monitor the patient's condition in order to control and correct clinical symptoms. Even in cases where only swelling of the tongue is observed without the development of respiratory distress syndrome, patients may need long-term follow-up, since therapy with antihistamines and corticosteroids may be insufficient.

Death has been very rarely reported due to angioedema associated with laryngeal edema or tongue edema. Swelling of the tongue, vocal folds or larynx can lead to airway obstruction, especially in patients who have undergone surgical interventions on the respiratory system. In cases where edema is localized in the area of ​​the tongue, vocal folds or larynx and can cause airway obstruction, appropriate treatment should be prescribed immediately, which may include subcutaneous administration of a 0.1% solution of epinephrine (epinephrine) (0.3-0.5 ml) and / or ensure airway obstruction.

In patients of the Negroid race who took ACE inhibitors, angioedema was observed more often than in patients of other races.

Patients with a history of angioedema not associated with ACE inhibitors may be at greater risk of developing angioedema during therapy with ACE inhibitors (see section “Contraindications”).

In patients taking both ACE inhibitors and mTOR inhibitors, gliptins, racecadotril or estramustine, there was an increased risk of developing angioedema.

Anaphylactoid reactions during desensitization by an allergen from Hymenoptera venom

In rare cases, patients taking ACE inhibitors developed life-threatening anaphylactoid reactions during desensitization by an allergen from Hymenoptera venom. Undesirable reactions can be avoided if, before starting desensitization, the ACE inhibitor is temporarily discontinued.

Anaphylactoid reactions during LDL apheresis

Life-threatening anaphylactoid reactions have rarely been observed in patients taking ACE inhibitors during LDL apheresis using dextran sulfate. The development of these reactions can be avoided if the ACE inhibitor is temporarily discontinued before the start of each LDL apheresis procedure.

patients, hemodialysis

Anaphylactoid reactions were observed in patients undergoing dialysis using high-flow membranes (such as AN 69В®) and simultaneously receiving treatment with ACE inhibitors. In these patients, it is necessary to use dialysis membranes of a different type or antihypertensive drugs of other classes.

Cough

There have been cases of coughing during therapy with ACE inhibitors. As a rule, a cough is unproductive, permanent and stops after discontinuation of therapy. Cough associated with the use of ACE inhibitors should be considered in the differential diagnosis of cough.

Surgery / general anesthesia

During major surgeries or general anesthesia with antihypertensive agents, enalaprilat blocks the formation of angiotensin II, caused by the compensatory release of renin. If at the same time a marked decrease in blood pressure develops, due to a similar mechanism, it can be corrected by an increase in the volume of circulating blood.

Hyperkalemia (see section “Interaction with other medicines”)

The risk of developing hyperkalemia is observed with renal failure, diabetes mellitus, as well as with the use of potassium-sparing diuretics (for example, spironolactone, eplerenone, triamterene or amiloride), potassium supplements or potassium-containing preparations containing co-trimoxazole.

The use of potassium supplements, potassium-sparing diuretics or potassium salts, especially in patients with impaired renal function, can lead to a significant increase in serum potassium. Hyperkalemia can lead to serious, sometimes fatal, arrhythmias.

If you need to use EnamВ® and the above medicines at the same time, you should be careful and regularly monitor the content of potassium in the blood serum.

Hypoglycemia

Patients with diabetes taking oral hypoglycemic agents or insulin should be informed about the need for regular monitoring of blood glucose concentrations (hypoglycemia) before starting the use of ACE inhibitors, especially during the first month of the simultaneous use of these drugs (see section “Interaction with other medicines”).

Lithium preparations

The simultaneous use of lithium and enalapril preparations is not recommended (see section "Interaction with other drugs").

Double blockade of the renin-angiotensn-aldosterone system

The development of arterial hypotension, syncope, stroke, hyperkalemia and impaired renal function (including acute renal failure) in susceptible patients, especially if combination therapy with drugs affecting RAAS is used (see section “Interaction with other medicines”). The simultaneous use of Enam® with aliskiren or aliskiren-containing drugs in patients with diabetes mellitus and / or with moderate or severe renal failure (GFR less than 60 ml / min / 1, 73 m2 of body surface area) is contraindicated and not recommended in other patients. The simultaneous use of Enam® with ARA II in patients with diabetic nephropathy is contraindicated and not recommended in other patients (see section "Contraindications").

Use in elderly patients

Clinical studies of the efficacy and safety of enalapril were similar in elderly and younger patients with hypertension.

Race

As with other ACE inhibitors, enalapril appears to lower blood pressure less effectively in patients of the Negroid race than in patients of other races, which may be explained by a higher prevalence of conditions with low plasma renin activity in the population of patients of the Negroid race with hypertension.

The effect of Enam® on the ability to drive vehicles and operate machinery has not been studied. However, some undesirable effects (eg, dizziness) that were observed while taking Enam® may affect the ability to drive vehicles and work with mechanisms (see section “Side effects”).

Composition

Each tablet 2.5 mg, 5 mg, 10 mg and 20 mg contains: Active ingredient:

enalapril maleate 2.5 mg, 5 mg, 10 mg or 20 mg, respectively.

Excipients: 2.5 mg and 5 mg tablets: anhydrous lactose, maleic acid, zinc stearate

10 mg and 20 mg tablets: anhydrous lactose, zinc stearate.

Dosage and administration of

Enam® is taken orally, regardless of food intake.

Essential hypertension

The initial dose is 10-20 mg 1 time per day, depending on the severity of hypertension. With a mild degree of hypertension, the recommended initial dose is 10 mg once a day. With other degrees of hypertension, the initial dose is 20 mg once a day. Maintenance dose - 1 tablet 20 mg 1 time per day. The dosage is selected individually for each patient, but the maximum dose should not exceed 40 mg

per day, which is taken once or divided into 2 doses, depending on the patient's tolerance to the drug.

Renovascular hypertension

Since in patients of this group blood pressure and renal function may be especially sensitive to ACE inhibition, therapy is started with a low initial dose of 5 mg or less. Then the dose is selected in accordance with the needs and condition of the patient. Usually an effective dose of Enam® is 20 mg once daily with daily use. Caution should be exercised when using Enam® in patients who have recently taken diuretics (see "Concomitant treatment of hypertension with diuretics" below).

Dosage with concomitant treatment of hypertension with diuretics

Symptomatic arterial hypotension may develop after the first administration of Enam®. This effect is most likely in patients who take diuretics. The drug is recommended to be used with caution, since in these patients, a violation of the water-electrolyte balance may be observed. Reception of diuretics should be stopped 2-3 days before the start of therapy with Enam®. If this is not possible, the initial dose of Enam® should be reduced (to 5 mg or less) to determine the primary effect of the drug on blood pressure. Further, the dosage should be selected taking into account the needs and condition of the patient.

Dosage for renal failure

The interval between doses of Enam® should be increased and / or the dose should be reduced.

Creatinine clearance, ml / min Initial dose, mg / day

<80> 30 ml / min 5-10 mg

10 ml / min 2.5 mg


* See "Precautions", "Special Instructions".

** Enalapril undergoes dialysis. Dose adjustment in days when dialysis is not performed, it should be carried out depending on the level of blood pressure.

Heart failure / asymptomatic left ventricular dysfunction

The initial dose of Enam® in patients with clinically severe HF or asymptomatic left ventricular dysfunction is 2.5 mg. In this case, the use of the drug should be carried out under close medical supervision to determine the primary effect of the drug on blood pressure. Enam® can be used to treat heart failure with severe clinical manifestations, usually together with diuretics and, when necessary, with cardiac glycosides. In the absence of symptomatic arterial hypotension (resulting from treatment with Enam®) or after correction, the dose should be gradually increased to the usual maintenance dose of 20 mg, which is taken either once or divided into 2 doses, depending on the patient's tolerance to the drug. Dose selection can be carried out within 2-4 weeks

or in a shorter time, if there are residual signs and symptoms of heart failure. Such a therapeutic regimen effectively reduces mortality rates in patients with clinically expressed HF.

Both before and after the start of treatment with Enam®, regular monitoring of blood pressure and renal function should be carried out (see the “Special Instructions” section), since the development of arterial hypotension with the subsequent (more rare) occurrence of acute renal failure was reported . In patients taking diuretics, the dose of diuretics should be reduced, if possible, before starting treatment with Enam®. The development of arterial hypotension after taking the first dose of Enam® does not mean that arterial hypotension will re-develop with prolonged treatment, and does not indicate the need to stop taking the drug. When treating with Enam®, the potassium content in the blood serum should also be monitored (see the “Interaction with Other Medicines” section).

Overdose of

Symptoms and treatment of clopidogrel overdose

Overdose of clopidogrel can lead to an increase in bleeding time with subsequent complications in the form of bleeding. If bleeding occurs, appropriate treatment is required. Antidote to including hemolysis cases in patients with glucose-6-phosphate dehydrogenase deficiency.

Drug interaction

With the simultaneous administration of Enam with NSAIDs, the hypotensive effect of enalapril with potassium-sparing diuretics (spironolactone, triamteren, amiloride) may decrease - hyperkalemia with lithium salts may develop - delayed lithium excretion (plasma blood lithium concentration control is shown).

Ethanol enhances the hypotensive effect of the drug. With simultaneous use with antipyretic and analgesic drugs, a decrease in Enam's effectiveness is possible. Enalapril weakens the effects of theophylline-containing drugs. Cimetidine prolongs the action of enalapril. The simultaneous use of diuretics, beta-blockers, methyldopa, nitrates, calcium channel blockers, hydralazine, prazosin enhances the hypotensive effect of enalapril. The use of Enam together with anesthetics with antihypertensive effect can cause arterial hypotension.

Overdose

Symptoms: Hypotension.

Treatment: it is necessary to put the patient, to raise legs. In mild cases of overdose, the patient is prescribed saline. In more serious cases, in the conditions of the hospital carry out activities aimed at stabilizing blood pressure, in / in enter saline solution or plasma substitutes. Use of hemodialysis is possible.

Storage Conditions

At a temperature not exceeding 25 ° C.

Keep out of the reach and sight of children!

Shelf life

3 years.

Deystvuyushtee substance

Эnalapril

Medicines senna form

tablets

Possible Product Names

ENAM 0.01 N20 TABLE

Enam 10mg Tab. X20 (R)

Enam 10mg No. 20 tab

ENAM 10MG. No. 20 TAB.

Enam Tab 10 mg x 20



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