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Enalapril (Tablets) Instructions for Use

ATC Code

C09AA02 (Enalapril)

Active Substance

Enalapril (Rec.INN registered by WHO)

Clinical-Pharmacological Group

ACE inhibitor

Pharmacotherapeutic Group

Agents acting on the renin-angiotensin system; angiotensin-converting enzyme (ACE) inhibitors

Pharmacological Action

ACE inhibitor. It is a prodrug from which the active metabolite enalaprilat is formed in the body. It is believed that the mechanism of the antihypertensive action is associated with the competitive inhibition of ACE activity, which leads to a decrease in the rate of conversion of angiotensin I to angiotensin II (which has a pronounced vasoconstrictive effect and stimulates the secretion of aldosterone in the adrenal cortex).

As a result of the decrease in the concentration of angiotensin II, a secondary increase in plasma renin activity occurs due to the elimination of the negative feedback during renin release and a direct decrease in aldosterone secretion. In addition, enalaprilat appears to affect the kinin-kallikrein system by preventing the breakdown of bradykinin.

Due to its vasodilatory action, it reduces total peripheral vascular resistance (afterload), pulmonary capillary wedge pressure (preload) and resistance in the pulmonary vessels; increases cardiac output and exercise tolerance.

In patients with chronic heart failure, long-term use of Enalapril increases exercise tolerance and reduces the severity of heart failure (assessed by NYHA criteria). Enalapril in patients with mild to moderate heart failure slows its progression and also slows the development of left ventricular dilatation. In left ventricular dysfunction, Enalapril reduces the risk of major ischemic outcomes (including the incidence of myocardial infarction and the number of hospitalizations for unstable angina).

Pharmacokinetics

When taken orally, about 60% is absorbed from the gastrointestinal tract. Concurrent food intake does not affect absorption. It is metabolized in the liver by hydrolysis to form enalaprilat, through the pharmacological activity of which the antihypertensive effect is realized. The binding of enalaprilat to plasma proteins is 50-60%.

The T1/2 of enalaprilat is 11 hours and increases in renal failure. After oral administration, 60% of the dose is excreted by the kidneys (20% as enalapril, 40% as enalaprilat), 33% is excreted through the intestines (6% as enalapril, 27% as enalaprilat). After intravenous administration of enalaprilat, 100% is excreted by the kidneys unchanged.

Indications

Arterial hypertension (including renovascular), chronic heart failure (as part of combination therapy).

Prevention of the development of clinically significant heart failure in patients with asymptomatic left ventricular dysfunction (as part of combination therapy).

Prevention of coronary ischemia in patients with left ventricular dysfunction in order to reduce the incidence of myocardial infarction and the frequency of hospitalizations for unstable angina.

ICD codes

ICD-10 code Indication
I10 Essential [primary] hypertension
I15.0 Renovascular hypertension
I20.0 Unstable angina
I21 Acute myocardial infarction
I50.0 Congestive heart failure
ICD-11 code Indication
BA00.Z Essential hypertension, unspecified
BA04.Y Other specified secondary arterial hypertension
BA40.0 Unstable angina
BA41.Z Acute myocardial infarction, unspecified
BD10 Congestive heart failure

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

For arterial hypertension, initiate therapy at 2.5 mg to 5 mg orally, once daily.

Adjust the dose based on individual patient response. The usual maintenance dose is 10 mg to 20 mg per day, administered as a single dose or in two divided doses.

For chronic heart failure, start with a low initial dose of 2.5 mg once daily under close medical supervision due to the risk of symptomatic hypotension.

Titrate the dose gradually to a target maintenance dose of 10 mg to 20 mg daily, given in one or two divided doses, as tolerated by the patient.

In patients with renal impairment, adjust the dosage based on creatinine clearance. For a creatinine clearance of 30 to 80 mL/min, the initial dose is 5 mg daily.

For a creatinine clearance below 30 mL/min, including patients on dialysis, the initial dose is 2.5 mg daily. Subsequent dosing should be titrated based on therapeutic response and tolerability.

For the prevention of heart failure in asymptomatic left ventricular dysfunction, the recommended dose is 2.5 mg to 5 mg twice daily, titrated as tolerated to 20 mg daily in divided doses.

The maximum recommended daily dose is 80 mg. Do not exceed this limit.

Administer the tablets orally, with or without food. Monitor blood pressure and renal function periodically during therapy.

Adverse Reactions

From the nervous system: dizziness, headache, feeling of tiredness, increased fatigue; very rarely when used in high doses – sleep disorders, nervousness, depression, imbalance, paresthesia, tinnitus.

From the cardiovascular system: orthostatic hypotension, fainting, palpitations, chest pain; very rarely when used in high doses – flushing.

From the digestive system: nausea; rarely – dry mouth, abdominal pain, vomiting, diarrhea, constipation, impaired liver function, increased activity of liver transaminases, increased blood bilirubin concentration, hepatitis, pancreatitis; very rarely when used in high doses – glossitis.

From the hematopoietic system: rarely – neutropenia; in patients with autoimmune diseases – agranulocytosis.

From the urinary system: rarely – impaired renal function, proteinuria.

From the respiratory system: dry cough.

From the reproductive system: very rarely when used in high doses – impotence.

Dermatological reactions: very rarely when used in high doses – hair loss.

Allergic reactions: rarely – skin rash, angioedema.

Other: rarely – hyperkalemia, muscle cramps.

Contraindications

History of angioedema, bilateral renal artery stenosis or stenosis of the artery of a single kidney, hyperkalemia, porphyria, concurrent use with aliskiren in patients with diabetes mellitus or impaired renal function (creatinine clearance <60 ml/min), pregnancy, lactation period (breastfeeding), children and adolescents under 18 years of age, hypersensitivity to enalapril and other ACE inhibitors.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy. If pregnancy occurs, enalapril should be discontinued immediately.

Enalapril is excreted in breast milk. If its use is necessary during lactation, the issue of discontinuing breastfeeding should be decided.

Use in Hepatic Impairment

Use with particular caution in patients with impaired liver function.

Pediatric Use

The safety and efficacy of enalapril in children have not been established.

Special Precautions

Use with particular caution in patients with autoimmune diseases, diabetes mellitus, impaired liver function, severe aortic stenosis, subaortic muscular stenosis of unclear etiology, hypertrophic cardiomyopathy, with loss of fluid and salts. In case of prior treatment with saluretics, particularly in patients with chronic heart failure, the risk of developing orthostatic hypotension increases, so before starting treatment with enalapril, it is necessary to compensate for the loss of fluid and salts.

During long-term treatment with enalapril, it is necessary to periodically monitor the peripheral blood picture. Sudden discontinuation of enalapril does not cause a sharp increase in blood pressure.

During surgical interventions while taking enalapril, arterial hypotension may develop, which should be corrected by administering a sufficient amount of fluid.

Before examining the function of the parathyroid glands, Enalapril should be discontinued.

Effect on the ability to drive vehicles and mechanisms

Caution is required when driving vehicles or performing other work that requires increased attention, as dizziness is possible, especially after taking the initial dose of enalapril.

Drug Interactions

With simultaneous use with immunosuppressants, cytostatics, the risk of developing leukopenia increases.

With simultaneous use of potassium-sparing diuretics (including spironolactone, triamterene, amiloride), potassium preparations, salt substitutes and dietary supplements containing potassium, the development of hyperkalemia is possible (especially in patients with impaired renal function), because ACE inhibitors reduce the content of aldosterone, which leads to potassium retention in the body against the background of limited potassium excretion or its additional intake.

With simultaneous use of opioid analgesics and agents for anesthesia, the antihypertensive effect of enalapril is enhanced.

With simultaneous use of “loop” diuretics, thiazide diuretics, the antihypertensive effect is enhanced. There is a risk of developing hypokalemia. Increased risk of impaired renal function.

With simultaneous use with azathioprine, the development of anemia is possible, which is due to the inhibition of erythropoietin activity under the influence of ACE inhibitors and azathioprine.

A case of anaphylactic reaction and myocardial infarction has been described with the use of allopurinol in a patient receiving Enalapril.

Acetylsalicylic acid in high doses may reduce the antihypertensive effect of enalapril.

It has not been definitively established whether acetylsalicylic acid reduces the therapeutic efficacy of ACE inhibitors in patients with coronary artery disease and heart failure. The nature of this interaction depends on the course of the disease.

Acetylsalicylic acid, by inhibiting COX and prostaglandin synthesis, can cause vasoconstriction, which leads to a decrease in cardiac output and worsening of the condition in patients with heart failure receiving ACE inhibitors.

With simultaneous use of beta-blockers, methyldopa, nitrates, calcium channel blockers, hydralazine, prazosin, an enhancement of the antihypertensive effect is possible.

With simultaneous use with NSAIDs (including indomethacin), the antihypertensive effect of enalapril is reduced, apparently due to inhibition of prostaglandin synthesis under the influence of NSAIDs (which are believed to play a certain role in the development of the hypotensive effect of ACE inhibitors). The risk of developing impaired renal function increases; hyperkalemia is rarely observed.

With simultaneous use of insulin, hypoglycemic agents of sulfonylurea derivatives, the development of hypoglycemia is possible.

With simultaneous use of ACE inhibitors and interleukin-3, there is a risk of arterial hypotension.

With simultaneous use with clozapine, there are reports of syncope development.

With simultaneous use with clomipramine, an enhancement of the action of clomipramine and the development of toxic effects are reported.

With simultaneous use with co-trimoxazole, cases of hyperkalemia development have been described.

With simultaneous use with lithium carbonate, the concentration of lithium in the blood serum increases, which is accompanied by symptoms of lithium intoxication.

With simultaneous use with orlistat, the antihypertensive effect of enalapril is reduced, which can lead to a significant increase in blood pressure and the development of a hypertensive crisis.

It is believed that with simultaneous use with procainamide, the risk of developing leukopenia may increase.

With simultaneous use with enalapril, the effect of drugs containing theophylline is reduced.

There are reports of the development of acute renal failure in patients after kidney transplantation with simultaneous use with cyclosporine.

With simultaneous use with cimetidine, the T1/2 of enalapril increases and its concentration in the blood plasma increases.

It is believed that a decrease in the effectiveness of antihypertensive agents is possible with simultaneous use with erythropoietins.

With simultaneous use with ethanol, the risk of developing arterial hypotension increases.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Mapichem AG (Switzerland)

Manufactured By

CSPC Ouyi Pharmaceutical, Co. Ltd. (China)

Dosage Form

Bottle Rx Icon Enalapril Tablets 20 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril maleate 20 mg

10 pcs. – blister packs (2) – cardboard packs.

Marketing Authorization Holder

Sun Pharmaceutical Industries, Ltd. (India)

Dosage Form

Bottle Rx Icon Enalapril Tablets 10 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril maleate 10 mg

10 pcs. – non-blister contour packs (1) – cardboard packs.
10 pcs. – non-blister contour packs (2) – cardboard packs.
10 pcs. – strips (2) – cardboard packs.
10 pcs. – non-blister contour packs (3) – cardboard packs.

Marketing Authorization Holder

Sun Pharmaceutical Industries, Ltd. (India)

Dosage Form

Bottle Rx Icon Enalapril Tablets 5 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril maleate 5 mg

10 pcs. – non-blister contour packs (1) – cardboard packs.
10 pcs. – non-blister contour packs (2) – cardboard packs.
10 pcs. – strips (2) – cardboard packs.
10 pcs. – non-blister contour packs (3) – cardboard packs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Forms

Bottle Rx Icon Enalapril Tablets 5 mg: 10, 20, 40, 60, 80, 100, 120, 160, or 200 pcs.
Tablets 10 mg: 10, 20, 40, 60, 80, 100, 120, 160, or 200 pcs.
Tablets 20 mg: 10, 20, 40, 60, 80, 100, 120, 160 or 200 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a yellowish tint, round, flat-cylindrical, with a score and a bevel.

1 tab.
Enalapril maleate 5 mg

Excipients: lactose monohydrate (milk sugar) – 74.1 mg, potato starch – 17 mg, sodium bicarbonate – 2.6 mg, calcium stearate – 1.3 mg.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (8) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
20 pcs. – blister packs (1) – cardboard packs.
20 pcs. – blister packs (2) – cardboard packs.
20 pcs. – blister packs (4) – cardboard packs.
20 pcs. – blister packs (6) – cardboard packs.
20 pcs. – blister packs (8) – cardboard packs.
20 pcs. – blister packs (10) – cardboard packs.


Tablets white or white with a yellowish tint, round, flat-cylindrical, with a score and a bevel.

1 tab.
Enalapril maleate 10 mg

Excipients: lactose monohydrate (milk sugar) – 66.6 mg, potato starch – 17 mg, sodium bicarbonate – 5.1 mg, calcium stearate – 1.3 mg.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (8) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
20 pcs. – blister packs (1) – cardboard packs.
20 pcs. – blister packs (2) – cardboard packs.
20 pcs. – blister packs (4) – cardboard packs.
20 pcs. – blister packs (6) – cardboard packs.
20 pcs. – blister packs (8) – cardboard packs.
20 pcs. – blister packs (10) – cardboard packs.


Tablets white or white with a yellowish tint, round, flat-cylindrical, with a score and a bevel.

1 tab.
Enalapril maleate 20 mg

Excipients: lactose monohydrate (milk sugar) – 133.2 mg, potato starch – 34 mg, sodium bicarbonate – 10.2 mg, calcium stearate – 2.6 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – contour cell packs (6) – cardboard packs.
20 pcs. – contour cell packs (8) – cardboard packs.
20 pcs. – contour cell packs (10) – cardboard packs.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 5 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril 5 mg

10 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 10 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril 10 mg

10 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.

Marketing Authorization Holder

Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)

Dosage Form

Bottle Rx Icon Enalapril Tablets 10 mg: 10, 20, 25, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril 10 mg

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
25 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – dark glass jars (1) – cardboard packs.
30 pcs. – dark glass jars (1) – cardboard packs.
40 pcs. – dark glass jars (1) – cardboard packs.
50 pcs. – dark glass jars (1) – cardboard packs.

Marketing Authorization Holder

Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)

Dosage Form

Bottle Rx Icon Enalapril Tablets 5 mg: 10, 20, 25, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril 5 mg

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
25 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – dark glass jars (1) – cardboard packs.
30 pcs. – dark glass jars (1) – cardboard packs.
40 pcs. – dark glass jars (1) – cardboard packs.
50 pcs. – dark glass jars (1) – cardboard packs.

Marketing Authorization Holder

Izvarino Pharma LLC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 5 mg: 10, 20, 30, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets from white to white with a yellowish tint, round, biconvex.

1 tab.
Enalapril maleate 5 mg

Excipients: microcrystalline cellulose – 73 mg, pregelatinized corn starch – 30 mg, talc – 3 mg, colloidal silicon dioxide – 1 mg, magnesium stearate – 1 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.

Marketing Authorization Holder

Izvarino Pharma LLC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 10 mg: 10, 20, 30, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets of red-brown color, round, biconvex; with light and dark inclusions on the surface and on the cross-section.

1 tab.
Enalapril maleate 10 mg

Excipients: microcrystalline cellulose – 68 mg, pregelatinized corn starch – 30 mg, talc – 3 mg, colloidal silicon dioxide – 1 mg, magnesium stearate – 1 mg, red iron oxide – 2 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.

Marketing Authorization Holder

Izvarino Pharma LLC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 20 mg: 10, 20, 30, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets from light pink to pink, round, biconvex; with light and dark inclusions on the surface and on the cross-section.

1 tab.
Enalapril maleate 20 mg

Excipients: microcrystalline cellulose – 70 mg, pregelatinized corn starch – 43 mg, talc – 4.1 mg, colloidal silicon dioxide – 1.4 mg, magnesium stearate – 1.4 mg, red iron oxide – 0.1 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.

Marketing Authorization Holder

Kvadrat-S LLC (Russia)

Manufactured By

Valenta Pharm, JSC (Russia)

Or

YUGPHARM, LLC (Russia)

Packaging and Quality Control Release

VALENTA PHARM, JSC (Russia)

Or

YUGPHARM, LLC (Russia)

Dosage Forms

Bottle Rx Icon Enalapril Tablets 5 mg: 20 or 50 pcs.
Tablets 10 mg: 20 or 50 pcs.
Tablets 20 mg: 20 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets round, flat-cylindrical, white or white with a yellowish tint, with a bevel.

1 tab.
Enalapril maleate (calculated as 100%) 5 mg

Excipients: lactose monohydrate (milk sugar) – 91.24 mg, potato starch – 9.21 mg, talc – 2.2 mg, hypromellose – 1.25 mg, calcium stearate – 1.1 mg.

10 pcs. – contour cell packs (2) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.


Tablets round, flat-cylindrical, white or white with a yellowish tint, with a bevel.

1 tab.
Enalapril maleate (calculated as 100%) 10 mg

Excipients: lactose monohydrate (milk sugar) – 183.08 mg, potato starch – 17.62 mg, talc – 4.6 mg, hypromellose – 2.5 mg, calcium stearate – 2.2 mg.

10 pcs. – contour cell packs (2) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.


Tablets round, flat-cylindrical, white or white with a yellowish tint, with a bevel and a score on one side.

1 tab.
Enalapril maleate (calculated as 100%) 20 mg

Excipients: lactose monohydrate (milk sugar) – 364.96 mg, potato starch – 36.84 mg, talc – 8.8 mg, hypromellose – 5 mg, calcium stearate – 4.4 mg.

10 pcs. – contour cell packs (2) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Chemopharm, LLC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 5 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white, round, biconvex, with a score on one side.

1 tab.
Enalapril maleate 5 mg

Excipients: lactose monohydrate – 106 mg, magnesium carbonate – 71.645 mg, gelatin – 7.8 mg, crospovidone – 7.8 mg, magnesium stearate – 1.755 mg.

10 pcs. – blisters (2) – cardboard packs.

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Chemopharm, LLC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 10 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white, round, biconvex, with a score on one side.

1 tab.
Enalapril maleate 10 mg

Excipients: lactose monohydrate – 125 mg, magnesium carbonate – 84.6 mg, gelatin – 9.2 mg, crospovidone – 9.2 mg, magnesium stearate – 2 mg.

10 pcs. – blisters (2) – cardboard packs.

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Chemopharm, LLC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 20 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white, round, biconvex, with a score on one side.

1 tab.
Enalapril maleate 20 mg

Excipients: lactose monohydrate – 116.4 mg, magnesium carbonate – 120 mg, gelatin – 10.7 mg, crospovidone – 10.7 mg, magnesium stearate – 2.2 mg.

10 pcs. – blisters (2) – cardboard packs.

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Hemofarm, A.D. (Serbia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 5 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white, round, biconvex, with a score on one side.

1 tab.
Enalapril maleate 5 mg

Excipients: lactose monohydrate – 106 mg, magnesium carbonate – 71.645 mg, gelatin – 7.8 mg, crospovidone – 7.8 mg, magnesium stearate – 1.755 mg.

10 pcs. – blisters (2) – cardboard packs.

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Hemofarm, A.D. (Serbia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 10 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white, round, biconvex, with a score on one side.

1 tab.
Enalapril maleate 10 mg

Excipients: lactose monohydrate – 125 mg, magnesium carbonate – 84.6 mg, gelatin – 9.2 mg, crospovidone – 9.2 mg, magnesium stearate – 2 mg.

10 pcs. – blisters (2) – cardboard packs.

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Hemofarm, A.D. (Serbia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 20 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white, round, biconvex, with a score on one side.

1 tab.
Enalapril maleate 20 mg

Excipients: lactose monohydrate – 116.4 mg, magnesium carbonate – 120 mg, gelatin – 10.7 mg, crospovidone – 10.7 mg, magnesium stearate – 2.2 mg.

10 pcs. – blisters (2) – cardboard packs.

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Hemofarm, A.D. (Serbia)

Labeled By

CHEMOPHARM, LLC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 10 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white, round, biconvex, with a score on one side.

1 tab.
Enalapril maleate 10 mg

Excipients: lactose monohydrate – 125 mg, magnesium carbonate – 84.6 mg, gelatin – 9.2 mg, crospovidone – 9.2 mg, magnesium stearate – 2 mg.

10 pcs. – blisters (2) – cardboard packs.

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Hemofarm, A.D. (Serbia)

Labeled By

HEMOFARM, LLC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 20 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white, round, biconvex, with a score on one side.

1 tab.
Enalapril maleate 20 mg

Excipients: lactose monohydrate – 116.4 mg, magnesium carbonate – 120 mg, gelatin – 10.7 mg, crospovidone – 10.7 mg, magnesium stearate – 2.2 mg.

10 pcs. – blisters (2) – carton packs.

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Hemofarm, A.D. (Serbia)

Labeled By

HEMOFARM, LLC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 5 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white, round, biconvex, with a score on one side.

1 tab.
Enalapril maleate 5 mg

Excipients: lactose monohydrate – 106 mg, magnesium carbonate – 71.645 mg, gelatin – 7.8 mg, crospovidone – 7.8 mg, magnesium stearate – 1.755 mg.

10 pcs. – blisters (2) – carton packs.

Marketing Authorization Holder

Novosibkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 10 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril maleate 10 mg

10 pcs. – contour cell blisters (2) – carton packs.

Marketing Authorization Holder

Novosibkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 5 mg: 20, 30, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril maleate 5 mg

10 pcs. – contour cell blisters (2) – carton packs.
10 pcs. – contour cell blisters (3) – carton packs.
10 pcs. – contour cell blisters (5) – carton packs.
50 pcs. – polymer jars (1) – carton packs.
20 pcs. – polymer jars (1) – carton packs.
100 pcs. – polymer jars (1) – carton packs.

Marketing Authorization Holder

Novosibkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 20 mg: 20, 30, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril maleate 20 mg

10 pcs. – contour cell blisters (2) – carton packs.
10 pcs. – contour cell blisters (3) – carton packs.
10 pcs. – contour cell blisters (5) – carton packs.
50 pcs. – polymer jars (1) – carton packs.
20 pcs. – polymer jars (1) – carton packs.
30 pcs. – polymer jars (1) – carton packs.
100 pcs. – polymer jars (1) – carton packs.

Marketing Authorization Holder

Organika, JSC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 10 mg: 20, 30, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril maleate 10 mg

10 pcs. – contour cell blisters (2) – carton packs.
10 pcs. – contour cell blisters (3) – carton packs.
10 pcs. – contour cell blisters (5) – carton packs.

Marketing Authorization Holder

Pranapharm, LLC (Russia)

Dosage Forms

Bottle Rx Icon Enalapril Tablets 2.5 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 50, 60, 70, 80, 90 or 100 pcs.
Tablets 5 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 50, 60, 70, 80, 90 or 100 pcs.
Tablets 10 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 50, 60, 70, 80, 90 or 100 pcs.
Tablets 20 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 50, 60, 70, 80, 90 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets round, biconvex, white or almost white, without a chamfer and score; slight marbling is allowed.

1 tab.
Enalapril maleate 2.5 mg

Excipients: lactose monohydrate, microcrystalline cellulose (type 102), povidone K-25, crospovidone, colloidal silicon dioxide, magnesium stearate.

7 pcs. – contour cell blisters (from 1 to 5 pcs.) – carton packs.
10 pcs. – contour cell blisters (from 1 to 10 pcs.) – carton packs.


Tablets round, flat-cylindrical, white or almost white with a chamfer, without a score; slight marbling is allowed.

1 tab.
Enalapril maleate 5 mg

Excipients: lactose monohydrate, microcrystalline cellulose (type 102), povidone K-25, crospovidone, colloidal silicon dioxide, magnesium stearate.

7 pcs. – contour cell blisters (from 1 to 5 pcs.) – carton packs.
10 pcs. – contour cell blisters (from 1 to 10 pcs.) – carton packs.


Tablets round, flat-cylindrical, white or almost white with a chamfer and a score; slight marbling is allowed.

1 tab.
Enalapril maleate 10 mg

Excipients: lactose monohydrate, microcrystalline cellulose (type 102), povidone K-25, crospovidone, colloidal silicon dioxide, magnesium stearate.

7 pcs. – contour cell blisters (from 1 to 5 pcs.) – carton packs.
10 pcs. – contour cell blisters (from 1 to 10 pcs.) – carton packs.


Tablets round, flat-cylindrical, white or almost white with a chamfer, without a score; slight marbling is allowed.

1 tab.
Enalapril maleate 20 mg

Excipients: lactose monohydrate, microcrystalline cellulose (type 102), povidone K-25, crospovidone, colloidal silicon dioxide, magnesium stearate.

7 pcs. – contour cell blisters (from 1 to 5 pcs.) – carton packs.
10 pcs. – contour cell blisters (from 1 to 10 pcs.) – carton packs.

Marketing Authorization Holder

Raduga Production CJS (Russia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 20 mg: 10, 20, 30, 40, 50, or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril 20 mg

10 pcs. – contour cell blisters (1) – carton packs.
10 pcs. – contour cell blisters (2) – carton packs.
10 pcs. – contour cell blisters (3) – carton packs.
10 pcs. – contour cell blisters (4) – carton packs.
10 pcs. – contour cell blisters (5) – carton packs.
20 pcs. – contour cell blisters (1) – carton packs.
20 pcs. – contour cell blisters (2) – carton packs.
20 pcs. – contour cell blisters (3) – carton packs.
30 pcs. – contour cell blisters (1) – carton packs.
30 pcs. – contour cell blisters (2) – carton packs.

Marketing Authorization Holder

Raduga Production CJS (Russia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 5 mg: 10, 20, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril 5 mg

10 pcs. – contour cell blisters (1) – carton packs.
10 pcs. – contour cell blisters (2) – carton packs.
10 pcs. – contour cell blisters (3) – carton packs.
10 pcs. – contour cell blisters (5) – carton packs.
10 pcs. – contour cell blisters (2) – carton packs.
20 pcs. – contour cell blisters (1) – carton packs.
20 pcs. – contour cell blisters (2) – carton packs.

Marketing Authorization Holder

Raduga Production CJS (Russia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 10 mg: 10, 20, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril 10 mg

10 pcs. – contour cell blisters (1) – carton packs.
10 pcs. – contour cell blisters (2) – carton packs.
10 pcs. – contour cell blisters (2) – carton packs.
10 pcs. – contour cell blisters (3) – carton packs.
10 pcs. – contour cell blisters (5) – carton packs.
20 pcs. – contour cell blisters (1) – carton packs.
20 pcs. – contour cell blisters (3) – carton packs.

Marketing Authorization Holder

Rif LLC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 5 mg: 10, 20, 30, 40, 50, 60, 80, 100, 200, 400, 600, 800, or 1000 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril maleate 5 mg

10 pcs. – contour cell blisters (1) – carton packs.
10 pcs. – contour cell blisters (2) – carton packs.
10 pcs. – blisters (2) – carton packs.
10 pcs. – contour cell blisters (4) – carton packs.
10 pcs. – contour cell blisters (6) – carton packs.
10 pcs. – contour cell blisters (8) – carton packs.
10 pcs. – contour cell blisters (10) – carton packs.
10 pcs. – contour cell blisters (20) – carton packs.
10 pcs. – contour cell blisters (40) – carton packs.
10 pcs. – contour cell blisters (60) – carton packs.
10 pcs. – contour cell blisters (80) – carton packs.
10 pcs. – contour cell blisters (100) – carton packs.
20 pcs. – contour cell blisters (1) – carton packs.
20 pcs. – contour cell blisters (10) – carton packs.
20 pcs. – contour cell blisters (20) – carton packs.
30 pcs. – contour cell blisters (1) – carton packs.
30 pcs. – contour cell blisters (10) – carton packs.
30 pcs. – contour cell blisters (20) – carton packs.
40 pcs. – contour cell blisters (1) – carton packs.
40 pcs. – contour cell blisters (10) – carton packs.
40 pcs. – contour cell blisters (20) – carton packs.
50 pcs. – contour cell blisters (1) – carton packs.
50 pcs. – contour cell blisters (10) – carton packs.
50 pcs. – contour cell blisters (20) – carton packs.
100 pcs. – contour cell blisters (1) – carton packs.
100 pcs. – contour cell blisters (10) – carton packs.
100 pcs. – contour cell blisters (20) – carton packs.

Marketing Authorization Holder

Rif LLC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 10 mg: 10, 20, 30, 40, 50, 60, 80, 100, 200, 400, 600, 800, or 1000 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril maleate 10 mg

10 pcs. – contour cell blisters (1) – carton packs.
10 pcs. – blisters (2) – carton packs.
10 pcs. – contour cell blisters (2) – carton packs.
10 pcs. – contour cell blisters (4) – carton packs.
10 pcs. – contour cell blisters (6) – carton packs.
10 pcs. – contour cell blisters (8) – carton packs.
10 pcs. – contour cell blisters (10) – carton packs.
10 pcs. – contour cell blisters (20) – carton packs.
10 pcs. – contour cell blisters (40) – carton packs.
10 pcs. – contour cell blisters (60) – carton packs.
10 pcs. – contour cell blisters (80) – carton packs.
10 pcs. – contour cell blisters (100) – carton packs.
10 pcs. – polymer containers (1) – carton packs.
10 pcs. – polymer containers (10) – carton packs.
10 pcs. – polymer containers (20) – carton packs.
20 pcs. – polymer containers (20) – carton packs.
20 pcs. – polymer containers (1) – carton packs.
20 pcs. – polymer containers (10) – carton packs.
30 pcs. – polymer containers (10) – carton packs.
30 pcs. – polymer containers (1) – carton packs.
30 pcs. – polymer containers (20) – carton packs.
40 pcs. – polymer containers (20) – carton packs.
40 pcs. – polymer containers (1) – carton packs.
40 pcs. – polymer containers (10) – carton packs.
50 pcs. – polymer containers (10) – carton packs.
50 pcs. – polymer containers (1) – carton packs.
50 pcs. – polymer containers (20) – carton packs.
100 pcs. – polymer containers (1) – carton packs.
100 pcs. – polymer containers (10) – carton packs.
100 pcs. – polymer containers (20) – carton packs.

Marketing Authorization Holder

Rif LLC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 20 mg: 10, 20, 30, 40, 50, 60, 80, 100, 200, 400, 600, 800, or 1000 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril maleate 20 mg

10 pcs. – contour cell blisters (1) – carton packs.
10 pcs. – contour cell blisters (2) – carton packs.
10 pcs. – contour cell blisters (4) – carton packs.
10 pcs. – contour cell blisters (6) – carton packs.
10 pcs. – contour cell blisters (8) – carton packs.
10 pcs. – contour cell blisters (10) – carton packs.
10 pcs. – contour cell blisters (20) – carton packs.
10 pcs. – contour cell blisters (40) – carton packs.
10 pcs. – contour cell blisters (60) – carton packs.
10 pcs. – contour cell blisters (80) – carton packs.
10 pcs. – contour cell blisters (100) – carton packs.
10 pcs. – polymer containers (1) – carton packs.
10 pcs. – polymer containers (10) – carton packs.
10 pcs. – polymer containers (20) – carton packs.
20 pcs. – polymer containers (1) – carton packs.
20 pcs. – polymer containers (10) – carton packs.
20 pcs. – polymer containers (20) – carton packs.
30 pcs. – polymer containers (1) – carton packs.
30 pcs. – polymer containers (10) – carton packs.
30 pcs. – polymer containers (20) – carton packs.
40 pcs. – polymer containers (1) – carton packs.
40 pcs. – polymer containers (10) – carton packs.
40 pcs. – polymer containers (20) – carton packs.
50 pcs. – polymer containers (1) – carton packs.
50 pcs. – polymer containers (10) – carton packs.
50 pcs. – polymer containers (20) – carton packs.
100 pcs. – polymer containers (1) – carton packs.
100 pcs. – polymer containers (10) – carton packs.
100 pcs. – polymer containers (20) – carton packs.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Tablets 10 mg: 20, 30, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets from white to white with a yellowish tint, round, flat-cylindrical, with a bevel and a score; the score is on one side; the presence of “marbling” is allowed.

1 tab.
Enalapril maleate 10 mg

Excipients: lactose monohydrate, talc, microcrystalline cellulose, calcium stearate, colloidal silicon dioxide (aerosil), crospovidone.

10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.

Marketing Authorization Holder

Pharmaceutical Information Hotline – 003, LLC (Russia)

Manufactured By

Pharmacor Production, LLC (Russia)

Dosage Forms

Bottle Rx Icon Enalapril Tablets 10 mg: 20, 30, 40, 50, or 60 pcs.
Tablets 20 mg: 20, 30, 40, 50, or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets white, flat-cylindrical with a bevel and a score; slight surface irregularity is allowed.

1 tab.
Enalapril maleate 10 mg

Excipients: Ludipress granulate (lactose monohydrate – 93%, povidone K30 – 3.5%, crospovidone – 3.5%) – 89 mg, magnesium stearate – 1 mg.

10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.


Tablets white, flat-cylindrical with a bevel and a cross-shaped score; slight surface irregularity is allowed.

1 tab.
Enalapril maleate 20 mg

Excipients: Ludipress granulate (lactose monohydrate – 93%, povidone K30 – 3.5%, crospovidone – 3.5%) – 178 mg, magnesium stearate – 2 mg.

10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.

Marketing Authorization Holder

Pharmacor Production, LLC (Russia)

Dosage Forms

Bottle Rx Icon Enalapril Tablets 10 mg: 20 pcs.
Tablets 20 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white, flat-cylindrical, with a bevel and a score; slight surface irregularity is allowed.

1 tab.
Enalapril maleate 10 mg

Excipients: Ludipress granulate (lactose monohydrate, povidone K30, crospovidone) – 89 mg, magnesium stearate – 1 mg or lactose monohydrate – 82.8 mg, povidone K30 – 3.1 mg, crospovidone – 3.1 mg, magnesium stearate – 1 mg.

10 pcs. – contour cell blisters (2) – cardboard packs.


Tablets white, flat-cylindrical, with a bevel and a cross-shaped score; slight surface irregularity is allowed.

1 tab.
Enalapril maleate 20 mg

Excipients: Ludipress granulate (lactose monohydrate, povidone K30, crospovidone) – 178 mg, magnesium stearate – 2 mg or lactose monohydrate – 165.6 mg, povidone K30 – 6.2 mg, crospovidone – 6.2 mg, magnesium stearate – 2 mg.

10 pcs. – contour cell blisters (2) – cardboard packs.

Marketing Authorization Holder

Rif LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Or

Ozon Pharm, LLC (Russia)

Dosage Forms

Bottle Rx Icon Enalapril Alfaktiv Tablets 5 mg
Tablets 10 mg
Tablets 20 mg

Dosage Form, Packaging, and Composition

Tablets

1 tab.
Enalapril maleate 5 mg

10 pcs. – contour cell blisters – cardboard packs (10 pcs.) – By prescription
10 pcs. – contour cell blisters (10 pcs.) – cardboard packs (100 pcs.) – By prescription
10 pcs. – contour cell blisters (2 pcs.) – cardboard packs (20 pcs.) – By prescription
10 pcs. – contour cell blisters (4 pcs.) – cardboard packs (40 pcs.) – By prescription
10 pcs. – contour cell blisters (6 pcs.) – cardboard packs (60 pcs.) – By prescription
10 pcs. – contour cell blisters (8 pcs.) – cardboard packs (80 pcs.) – By prescription
20 pcs. – contour cell blisters – cardboard packs (20 pcs.) – By prescription
20 pcs. – contour cell blisters (10 pcs.) – cardboard packs (200 pcs.) – By prescription
20 pcs. – contour cell blisters (2 pcs.) – cardboard packs (40 pcs.) – By prescription
20 pcs. – contour cell blisters (4 pcs.) – cardboard packs (80 pcs.) – By prescription
20 pcs. – contour cell blisters (6 pcs.) – cardboard packs (120 pcs.) – By prescription
20 pcs. – contour cell blisters (8 pcs.) – cardboard packs (160 pcs.) – By prescription


Tablets

1 tab.
Enalapril maleate 10 mg

10 pcs. – contour cell blisters – cardboard packs (10 pcs.) – By prescription
10 pcs. – contour cell blisters (10 pcs.) – cardboard packs (100 pcs.) – By prescription
10 pcs. – contour cell blisters (2 pcs.) – cardboard packs (20 pcs.) – By prescription
10 pcs. – contour cell blisters (4 pcs.) – cardboard packs (40 pcs.) – By prescription
10 pcs. – contour cell blisters (6 pcs.) – cardboard packs (60 pcs.) – By prescription
10 pcs. – contour cell blisters (8 pcs.) – cardboard packs (80 pcs.) – By prescription
20 pcs. – contour cell blisters – cardboard packs (20 pcs.) – By prescription
20 pcs. – contour cell blisters (10 pcs.) – cardboard packs (200 pcs.) – By prescription
20 pcs. – contour cell blisters (2 pcs.) – cardboard packs (40 pcs.) – By prescription
20 pcs. – contour cell blisters (4 pcs.) – cardboard packs (80 pcs.) – By prescription
20 pcs. – contour cell blisters (6 pcs.) – cardboard packs (120 pcs.) – By prescription
20 pcs. – contour cell blisters (8 pcs.) – cardboard packs (160 pcs.) – By prescription


Tablets

1 tab.
Enalapril maleate 20 mg

10 pcs. – contour cell blisters – cardboard packs (10 pcs.) – By prescription
10 pcs. – contour cell blisters (10 pcs.) – cardboard packs (100 pcs.) – By prescription
10 pcs. – contour cell blisters (2 pcs.) – cardboard packs (20 pcs.) – By prescription
10 pcs. – contour cell blisters (4 pcs.) – cardboard packs (40 pcs.) – By prescription
10 pcs. – contour cell blisters (6 pcs.) – cardboard packs (60 pcs.) – By prescription
10 pcs. – contour cell blisters (8 pcs.) – cardboard packs (80 pcs.) – By prescription
20 pcs. – contour cell blisters – cardboard packs (20 pcs.) – By prescription
20 pcs. – contour cell blisters (10 pcs.) – cardboard packs (200 pcs.) – By prescription
20 pcs. – contour cell blisters (2 pcs.) – cardboard packs (40 pcs.) – By prescription
20 pcs. – contour cell blisters (4 pcs.) – cardboard packs (80 pcs.) – By prescription
20 pcs. – contour cell blisters (6 pcs.) – cardboard packs (120 pcs.) – By prescription
20 pcs. – contour cell blisters (8 pcs.) – cardboard packs (160 pcs.) – By prescription

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Forte Tablets 20 mg: 10, 20, 30, 40, 50, 60 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, flat-cylindrical in shape with a bevel and a score. The presence of marbling is allowed.

1 tab.
Enalapril maleate 20 mg

Excipients: lactose monohydrate – 200 mg, microcrystalline cellulose – 205.5 mg, calcium stearate – 4.6 mg, talc – 13.8 mg, colloidal silicon dioxide (aerosil) – 2.3 mg, crospovidone (colloidal CL-M, polyplasdone XL-10) – 13.8 mg.

10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
20 pcs. – contour cell blisters (2) – cardboard packs.
20 pcs. – contour cell blisters (3) – cardboard packs.
20 pcs. – contour cell blisters (5) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Marketing Authorization Holder

Sandoz, d.d. (Slovenia)

Manufactured By

Salutas Pharma, GmbH (Germany)

Or

Novartis Neva, LLC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Hexal Tablets 5 mg: 10, 20, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white, oval, biconvex, with a smooth surface, with a score and an imprint “EN 5” on one side.

1 tab.
Enalapril maleate 5 mg

Excipients: sodium bicarbonate, lactose monohydrate, corn starch, talc, hypromellose, magnesium stearate.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.

Marketing Authorization Holder

Sandoz, d.d. (Slovenia)

Manufactured By

Salutas Pharma, GmbH (Germany)

Or

Novartis Neva, LLC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Hexal Tablets 10 mg: 10, 20, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets red-brown with darker or lighter specks, oval, biconvex, with a smooth surface, with a score and an imprint “EN 10” on one side.

1 tab.
Enalapril maleate 10 mg

Excipients: sodium bicarbonate, lactose monohydrate, corn starch, talc, magnesium stearate, iron oxide red dye.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.

Marketing Authorization Holder

Sandoz, d.d. (Slovenia)

Manufactured By

Salutas Pharma, GmbH (Germany)

Or

Novartis Neva, LLC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Hexal Tablets 20 mg: 10, 20, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets light orange with darker or lighter specks, oval, biconvex, with a smooth surface, with a score and an imprint “EN 20” on one side.

1 tab.
Enalapril maleate 20 mg

Excipients: sodium bicarbonate, lactose monohydrate, corn starch, talc, magnesium stearate, iron oxide red dye, iron oxide yellow dye.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Renewal Tablets 5 mg: 20, 30, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril maleate 5 mg

10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Renewal Tablets 10 mg: 20, 30, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril maleate 10 mg

10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle Rx Icon Enalapril Renewal Tablets 20 mg: 20, 30 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril maleate 20 mg

10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.

Marketing Authorization Holder

Velpharm, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

Or

Marbiopharm, JSC (Russia)

Or

Uralbiopharm, JSC (Russia)

Dosage Forms

Bottle Rx Icon Enalapril Velpharm Tablets 5 mg: from 7 to 140 pcs.
Tablets 10 mg: from 7 to 140 pcs.
Tablets 20 mg: from 7 to 140 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a yellowish tint, round, flat-cylindrical, with a score and a bevel.

1 tab.
Enalapril maleate 5 mg

Excipients: lactose monohydrate, microcrystalline cellulose (type 102), pregelatinized corn starch, colloidal silicon dioxide (aerosil), calcium stearate.

7 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
10 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
14 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
70 pcs. – polymer jars (1) – cardboard packs.
80 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.


Tablets white or white with a yellowish tint, round, flat-cylindrical, with a score and a chamfer.

1 tab.
Enalapril maleate 10 mg

Excipients: lactose monohydrate, microcrystalline cellulose (type 102), pregelatinized corn starch, colloidal silicon dioxide (aerosil), calcium stearate.

7 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
10 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
14 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
70 pcs. – polymer jars (1) – cardboard packs.
80 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.


Tablets white or white with a yellowish tint, round, flat-cylindrical, with a score and a chamfer.

1 tab.
Enalapril maleate 20 mg

Excipients: lactose monohydrate, microcrystalline cellulose (type 102), pregelatinized corn starch, colloidal silicon dioxide (aerosil), calcium stearate.

7 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
10 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
14 pcs. – contour cell packs (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
70 pcs. – polymer jars (1) – cardboard packs.
80 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Marketing Authorization Holder

Agio Pharmaceuticals, Ltd. (India)

Dosage Form

Bottle Rx Icon Enalapril-Agio Tablets 2.5 mg: 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril maleate 2.5 mg

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.

Marketing Authorization Holder

Agio Pharmaceuticals, Ltd. (India)

Dosage Form

Bottle Rx Icon Enalapril-Agio Tablets 5 mg: 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril maleate 5 mg

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.

Marketing Authorization Holder

Agio Pharmaceuticals, Ltd. (India)

Dosage Form

Bottle Rx Icon Enalapril-Agio Tablets 10 mg: 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril maleate 10 mg

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.

Marketing Authorization Holder

Agio Pharmaceuticals, Ltd. (India)

Dosage Form

Bottle Rx Icon Enalapril-Agio Tablets 20 mg: 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril maleate 20 mg

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Bottle Rx Icon Enalapril-AKOS Tablets 10 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white with a yellowish tint, flat-cylindrical in shape, with a score.

1 tab.
Enalapril maleate 10 mg

10 pcs. – contour cell packs (2) – cardboard packs.

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle Rx Icon Enalapril-Akri® Tablets 5 mg: 20, 30, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril maleate 5 mg

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (100) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle Rx Icon Enalapril-Akri® Tablets 10 mg: 20, 30, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril maleate 10 mg

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (100) – cardboard packs.

Marketing Authorization Holder

Polpharma Pharmaceutical Works, Sa (Poland)

Dosage Forms

Bottle Rx Icon Enalapril-Akrikhin Tablets 5 mg: 20, 30, or 60 pcs.
Tablets 10 mg: 20, 30, or 60 pcs.
Tablets 20 mg: 20, 30, or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets white, oblong, biconvex, with a score on both sides.

1 tab.
Enalapril maleate 5 mg

Excipients: sodium bicarbonate, croscarmellose sodium, lactose monohydrate, pregelatinized corn starch, magnesium stearate.

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.


Tablets white, round, flat-cylindrical, with a chamfer on both sides.

1 tab.
Enalapril maleate 10 mg

Excipients: sodium bicarbonate, croscarmellose sodium, lactose monohydrate, pregelatinized corn starch, magnesium stearate.

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.


Tablets white, round, flat-cylindrical, with a chamfer on both sides.

1 tab.
Enalapril maleate 20 mg

Excipients: sodium bicarbonate, croscarmellose sodium, lactose monohydrate, pregelatinized corn starch, magnesium stearate.

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.

Marketing Authorization Holder

RosMedPreparaty, CJS (Russia)

Dosage Form

Bottle Rx Icon Enalapril-Ros Tablets 10 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril 10 mg

10 pcs. – contour cell packs (2) – cardboard packs.

Marketing Authorization Holder

TAD PHARMA GmbH (Germany)

Dosage Form

Bottle Rx Icon Enalapril-TAD Tablets 2.5 mg: 20, 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, biconvex.

1 tab.
Enalapril maleate 2.5 mg

Excipients: lactose monohydrate 64.9 mg, corn starch 11.2 mg, sodium bicarbonate 1.3 mg, talc 3 mg, hypromellose 1.25 mg, magnesium stearate 0.85 mg.

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.

Marketing Authorization Holder

TAD PHARMA GmbH (Germany)

Dosage Form

Bottle Rx Icon Enalapril-TAD Tablets 5 mg: 20, 30, or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a chamfer and a score on one side.

1 tab.
Enalapril maleate 5 mg

Excipients: lactose monohydrate 129.8 mg, corn starch 22.4 mg, sodium bicarbonate 2.6 mg, talc 6 mg, hypromellose 2.5 mg, magnesium stearate 1.7 mg.

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.

Marketing Authorization Holder

TAD PHARMA GmbH (Germany)

Dosage Form

Bottle Rx Icon Enalapril-TAD Tablets 10 mg: 20, 30, 60, 100, 200, 500, or 1000 pcs.

Dosage Form, Packaging, and Composition

Tablets red-brown in color with individual inclusions of white and/or dark red color on the surface and in the tablet mass, round, flat-cylindrical, with a chamfer and a score on one side.

1 tab.
Enalapril maleate 10 mg

Excipients: lactose monohydrate 124.6 mg, corn starch 21.4 mg, sodium bicarbonate 5.1 mg, talc 6 mg, magnesium stearate 1.7 mg, iron oxide red 1.2 mg.

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.
10 pcs. – blisters (20) – cardboard packs.
10 pcs. – blisters (50) – cardboard packs.
10 pcs. – blisters (100) – cardboard packs.

Marketing Authorization Holder

TAD PHARMA GmbH (Germany)

Dosage Form

Bottle Rx Icon Enalapril-TAD Tablets 20 mg: 20, 30, 60, 100, 200, 500, or 1000 pcs.

Dosage Form, Packaging, and Composition

Tablets light orange in color with individual inclusions of white and/or from brown to dark red color on the surface and in the tablet mass, round, flat-cylindrical, with a chamfer and a score on one side.

1 tab.
Enalapril maleate 20 mg

Excipients: lactose monohydrate 117.8 mg, corn starch 13.9 mg, sodium bicarbonate 10.2 mg, talc 6 mg, magnesium stearate 1.7 mg, iron oxide red 0.1 mg, iron oxide yellow 0.3 mg.

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.
10 pcs. – blisters (20) – cardboard packs.
10 pcs. – blisters (50) – cardboard packs.
10 pcs. – blisters (100) – cardboard packs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Merckle, GmbH (Germany)

Dosage Form

Bottle Rx Icon Enalapril-Teva Tablets 2.5 mg: 10, 20, 30, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white, round, biconvex.

1 tab.
Enalapril maleate 2.5 mg

Excipients: lactose monohydrate 64 mg, corn starch 11.2 mg, talc 3 mg, sodium bicarbonate 1.3 mg, hypromellose 1.25 mg, magnesium stearate 0.85 mg.

10 pcs. – Al/Al blisters (1) – cardboard packs.
10 pcs. – Al/Al blisters (2) – cardboard packs.
10 pcs. – Al/Al blisters (3) – cardboard packs.
10 pcs. – Al/Al blisters (5) – cardboard packs.
10 pcs. – Al/Al blisters (10) – cardboard packs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Merckle, GmbH (Germany)

Dosage Form

Bottle Rx Icon Enalapril-Teva Tablets 5 mg: 10, 20, 30, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white, round, biconvex, with a score.

1 tab.
Enalapril maleate 5 mg

Excipients: lactose monohydrate 129.8 mg, corn starch 22.4 mg, talc 6 mg, sodium bicarbonate 2.6 mg, hypromellose 2.5 mg, magnesium stearate 1.7 mg.

10 pcs. – Al/Al blisters (1) – cardboard packs.
10 pcs. – Al/Al blisters (2) – cardboard packs.
10 pcs. – Al/Al blisters (3) – cardboard packs.
10 pcs. – Al/Al blisters (5) – cardboard packs.
10 pcs. – Al/Al blisters (10) – cardboard packs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Merckle, GmbH (Germany)

Dosage Form

Bottle Rx Icon Enalapril-Teva Tablets 10 mg: 10, 20, 30, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets red-brown in color with individual specks, round, biconvex, with a score.

1 tab.
Enalapril maleate 10 mg

Excipients: lactose monohydrate 124.6 mg, corn starch 21.4 mg, talc 6 mg, sodium bicarbonate 5.1 mg, magnesium stearate 1.7 mg, iron oxide red 1.2 mg.

10 pcs. – Al/Al blisters (1) – cardboard packs.
10 pcs. – Al/Al blisters (2) – cardboard packs.
10 pcs. – Al/Al blisters (3) – cardboard packs.
10 pcs. – Al/Al blisters (5) – cardboard packs.
10 pcs. – Al/Al blisters (10) – cardboard packs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Merckle, GmbH (Germany)

Dosage Form

Bottle Rx Icon Enalapril-Teva Tablets 20 mg: 10, 20, 30, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets light orange in color with individual specks, round, biconvex, with a score.

1 tab.
Enalapril maleate 20 mg

Excipients: lactose monohydrate 117.8 mg, corn starch 13.9 mg, talc 6 mg, sodium bicarbonate 10.2 mg, magnesium stearate 1.7 mg, iron oxide red 0.1 mg, iron oxide yellow 0.3 mg.

10 pcs. – Al/Al blisters (1) – cardboard packs.
10 pcs. – Al/Al blisters (2) – cardboard packs.
10 pcs. – Al/Al blisters (3) – cardboard packs.
10 pcs. – Al/Al blisters (5) – cardboard packs.
10 pcs. – Al/Al blisters (10) – cardboard packs.

Marketing Authorization Holder

Uralbiopharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Enalapril-UBF Tablets 10 mg: 10, 20, 30, 40, 50 or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Enalapril 10 mg

10 pcs. – contour cell packs (1) – cardboard packs
10 pcs. – contour cell packs (2) – cardboard packs
10 pcs. – contour cell packs (3) – cardboard packs
10 pcs. – contour cell packs (4) – cardboard packs
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
10 pcs. – polymer jars (2) – cardboard packs.
10 pcs. – polymer jars (4) – cardboard packs.
10 pcs. – polymer jars (5) – cardboard packs.
10 pcs. – polymer jars (6) – cardboard packs.

Table of Contents

TABLE OF CONTENTS