Ramipril (Tablets, Capsules) Instructions for Use

Instructions
Dosage forms

ATC Code

C09AA05 (Ramipril)

Active Substance

Ramipril (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 ramiprilat 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 is a potent vasoconstrictor substance. 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. 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 signs of chronic heart failure after myocardial infarction, Ramipril reduces the risk of sudden death, the progression of heart failure to severe/resistant failure, and reduces the number of hospitalizations for heart failure.

It is known that Ramipril significantly reduces the incidence of myocardial infarction, stroke, and cardiovascular death in patients with increased cardiovascular risk due to vascular diseases (coronary artery disease, previous stroke, or peripheral vascular disease) or diabetes mellitus, who have at least one additional risk factor (microalbuminuria, arterial hypertension, increased total cholesterol levels, low HDL levels, smoking). It reduces overall mortality and the need for revascularization procedures, slows the onset and progression of chronic heart failure. In both patients with and without diabetes, Ramipril significantly reduces existing microalbuminuria and the risk of developing nephropathy. These effects are observed in patients with both elevated and normal blood pressure.

The hypotensive effect of ramipril develops approximately after 1-2 hours, reaches a maximum within 3-6 hours, and lasts for at least 24 hours.

Pharmacokinetics

When taken orally, absorption is 50-60%; food does not affect the extent of absorption but slows down absorption. C_max is reached in 2-4 hours. It is metabolized in the liver to form the active metabolite ramiprilat (which inhibits ACE 6 times more actively than Ramipril), inactive diketopiperazine, and is glucuronidated. All formed metabolites, except for ramiprilat, have no pharmacological activity. Plasma protein binding for ramipril is 73%, for ramiprilat – 56%. Bioavailability after oral administration of 2.5-5 mg of ramipril is 15-28%; for ramiprilat – 45%. After daily administration of ramipril at a dose of 5 mg/day, the steady-state plasma concentration of ramiprilat is reached by the 4th day.

T_1/2 for ramipril is 5.1 hours; in the distribution and elimination phase, the decrease in the serum concentration of ramiprilat occurs with T_1/2 – 3 hours, followed by a transitional phase with T_1/2 – 15 hours, and a long terminal phase with very low plasma concentrations of ramiprilat and T_1/2 – 4-5 days. T_1/2 increases in chronic renal failure. V_d of ramipril is 90 L, of ramiprilat – 500 L. 60% is excreted by the kidneys, 40% through the intestines (mainly in the form of metabolites). In case of impaired renal function, the excretion of ramipril and its metabolites slows down in proportion to the decrease in creatinine clearance; in case of impaired liver function, the conversion to ramiprilat slows down; in heart failure, the concentration of ramiprilat increases by 1.5-1.8 times.

Indications

Arterial hypertension; chronic heart failure; heart failure developing in the first few days after acute myocardial infarction; diabetic and non-diabetic nephropathy; reduction of the risk of myocardial infarction, stroke, and cardiovascular mortality in patients with high cardiovascular risk, including patients with confirmed coronary artery disease (with or without a history of myocardial infarction), patients who have undergone percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, with a history of stroke, and patients with occlusive lesions of peripheral arteries.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
I10	Essential [primary] hypertension
I50.0	Congestive heart failure
I63	Cerebral infarction
I73	Other peripheral vascular diseases
N08.3	Glomerular disorders in diabetes mellitus
N08.8	Glomerular disorders in other diseases classified elsewhere

ICD-11 code	Indication
4A44.8	Thromboangiitis obliterans
8B11	Cerebral ischemic stroke
BA00.Z	Essential hypertension, unspecified
BD10	Congestive heart failure
BD42.0	Raynaud’s disease
BD42.1	Raynaud’s syndrome
BD4Z	Chronic obliterative arterial diseases, unspecified
BD5Z	Diseases of arteries or arterioles, unspecified
EG00	Dilation of skin vessels of the extremities
GB4Z	Glomerular diseases, unspecified
MB40.7	Acroparesthesia
MF83	Diabetic glomerular changes
MF84	Proliferative glomerulonephritis due to immunodeficiency
MF85	Anti-glomerular basement membrane antibody disease
MF8Y	Other specified clinical findings in specimens from the urinary system

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.

Take orally, once or twice daily. The initial dose for hypertension is 2.5 mg once daily.

For heart failure post-myocardial infarction, initiate therapy at 1.25 mg twice daily.

For nephropathy or high cardiovascular risk, the initial dose is 2.5 mg once daily.

Titrate the dose gradually, based on therapeutic response and tolerability. Double the dose at intervals of 1-2 weeks.

The maintenance dose is typically 2.5-5 mg once daily for most indications. The maximum recommended dose is 10 mg per day.

In elderly patients or those with renal impairment, initiate therapy at a lower dose of 1.25 mg once daily. Adjust subsequent doses based on creatinine clearance.

For patients with a creatinine clearance below 40 mL/min, the maximum daily dose should not exceed 5 mg.

Administer the dose consistently, with or without food. Monitor blood pressure and renal function regularly during therapy.

Adverse Reactions

From the cardiovascular system arterial hypotension; rarely – chest pain, tachycardia.

From the central nervous system dizziness, weakness, headache; rarely – sleep disorders, mood disorders.

From the digestive system diarrhea, constipation, loss of appetite; rarely – stomatitis, abdominal pain, pancreatitis, cholestatic jaundice.

From the respiratory system dry cough, bronchitis, sinusitis.

From the urinary system rarely – proteinuria, increased concentration of creatinine and urea in the blood (mainly in patients with impaired renal function).

From the hematopoietic system rarely – neutropenia, agranulocytosis, thrombocytopenia, anemia.

From laboratory parameters hyperkalemia, hyponatremia.

Allergic reactions skin rash, angioedema and other hypersensitivity reactions.

Other rarely – muscle spasms, impotence, alopecia.

Contraindications

Severe impairment of renal and liver function, bilateral renal artery stenosis or stenosis of the artery of a single kidney; condition after kidney transplantation; primary hyperaldosteronism, hyperkalemia, aortic stenosis, pregnancy, lactation (breastfeeding), children and adolescents under 18 years of age, hypersensitivity to ramipril and other ACE inhibitors.

Use in Pregnancy and Lactation

Ramipril is contraindicated for use during pregnancy and during lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated in severe impairment of liver function.

Use in Renal Impairment

Contraindicated in severe impairment of renal function, condition after kidney transplantation. In patients with concomitant impaired renal function, doses are selected individually according to the creatinine clearance values. Before starting treatment, all patients must undergo a study of renal function.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

In patients with concomitant impaired renal function, doses are selected individually according to the creatinine clearance values. Before starting treatment, all patients must undergo a study of renal function. During treatment with ramipril, regular monitoring of renal function, blood electrolyte composition, blood levels of liver enzymes, and peripheral blood picture (especially in patients with diffuse connective tissue diseases, in patients receiving immunosuppressants, allopurinol) is carried out. In patients who have a deficiency of fluid and/or sodium, correction of water and electrolyte disturbances must be carried out before starting treatment. During treatment with ramipril, hemodialysis using polyacrylonitrile membranes should not be performed (increased risk of anaphylactic reactions).

Drug Interactions

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 into the body.

With simultaneous use with NSAIDs, a decrease in the hypotensive effect of ramipril, impaired renal function is possible.

With simultaneous use with “loop” or thiazide diuretics, the antihypertensive effect is enhanced. Marked arterial hypotension, especially after taking the first dose of a diuretic, apparently occurs due to hypovolemia, which leads to a transient increase in the hypotensive effect of ramipril. There is a risk of developing hypokalemia. The risk of impaired renal function increases.

With simultaneous use with agents that have a hypotensive effect, an enhancement of the hypotensive effect is possible.

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

With simultaneous use with allopurinol, cytostatics, immunosuppressants, procainamide, an increased risk of developing leukopenia is possible.

With simultaneous use with lithium carbonate, an increase in the concentration of lithium in the blood serum is possible.

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

Ramipril [Atoll LLC (Russia)]
Tablets 2.5 mg: from 7 to 300 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon Pharm, LLC (Russia)

Ozon, LLC (Russia)

Dosage Form

Ramipril

Tablets 2.5 mg: from 7 to 300 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, biconvex, with a score.

	1 tab.
Ramipril	2.5 mg

Excipients : lactose monohydrate (milk sugar) – 92.00 mg, sodium bicarbonate – 2.5 mg, croscarmellose sodium – 2.00 mg, sodium stearyl fumarate – 1.00 mg.

From 7 to 30 pcs. – blister packs (from 1 to 10 pcs.) – cardboard packs.
From 10 to 100 pcs. – jars (1) – cardboard packs.

Ramipril [Atoll LLC (Russia)]
Tablets 5 mg: from 7 to 300 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon Pharm, LLC (Russia)

Ozon, LLC (Russia)

Dosage Form

Ramipril

Tablets 5 mg: from 7 to 300 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Ramipril	5 mg

Excipients : lactose monohydrate (milk sugar) – 87.00 mg, sodium bicarbonate – 5 mg, croscarmellose sodium – 2.00 mg, sodium stearyl fumarate – 1.00 mg.

From 7 to 30 pcs. – blister packs (from 1 to 10 pcs.) – cardboard packs.
From 10 to 100 pcs. – jars (1) – cardboard packs.

Ramipril [Atoll LLC (Russia)]
Tablets 10 mg: from 7 to 300 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon Pharm, LLC (Russia)

Ozon, LLC (Russia)

Dosage Form

Ramipril

Tablets 10 mg: from 7 to 300 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Ramipril	10 mg

Excipients : lactose monohydrate (milk sugar) – 174.00 mg, sodium bicarbonate – 10 mg, croscarmellose sodium – 4.00 mg, sodium stearyl fumarate – 2.00 mg.

From 7 to 30 pcs. – blister packs (from 1 to 10 pcs.) – cardboard packs.
From 10 to 100 pcs. – jars (1) – cardboard packs.

Ramipril [Belmedpreparaty RUP (Republic of Belarus)]
Tablets 1.25 mg: 30 pcs.
Tablets 2.5 mg: 30 pcs.
Tablets 5 mg: 30 pcs.
Tablets 10 mg: 30 pcs.

Marketing Authorization Holder

Belmedpreparaty RUP (Republic of Belarus)

Dosage Forms

	Ramipril	Tablets 1.25 mg: 30 pcs.
		Tablets 2.5 mg: 30 pcs.
		Tablets 5 mg: 30 pcs.
		Tablets 10 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Tablets round, biconvex, white or almost white.

	1 tab.
Ramipril	1.25 mg

Excipients : pregelatinized starch, hypromellose, sodium stearyl fumarate, microcrystalline cellulose.

10 pcs. – blister pack (3) – cardboard packs.

Tablets round, flat-cylindrical, with a bevel, light yellow in color; the presence of inclusions on the surface of the tablets is allowed.

	1 tab.
Ramipril	2.5 mg

Excipients : pregelatinized starch, hypromellose, sodium stearyl fumarate, yellow iron oxide, microcrystalline cellulose.

10 pcs. – blister pack (3) – cardboard packs.

Tablets round, flat-cylindrical, with a bevel, light pink in color; the presence of inclusions on the surface of the tablets is allowed.

	1 tab.
Ramipril	5 mg

Excipients : pregelatinized starch, hypromellose, sodium stearyl fumarate, red iron oxide, microcrystalline cellulose.

10 pcs. – blister pack (3) – cardboard packs.

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

	1 tab.
Ramipril	10 mg

Excipients : pregelatinized starch, hypromellose, sodium stearyl fumarate, microcrystalline cellulose.

10 pcs. – blister pack (3) – cardboard packs.

Ramipril [Biocom, JSC (Russia)]
Tablets 2.5 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, or 50 pcs.

Marketing Authorization Holder

Biocom, JSC (Russia)

Dosage Form

Ramipril

Tablets 2.5 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Ramipril	2.5 mg

Excipients : ludipress – 92 mg, sodium bicarbonate – 2.5 mg, microcrystalline cellulose – 2 mg, magnesium stearate – 1 mg.

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

Ramipril [Biocom, JSC (Russia)]
Tablets 5 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, or 50 pcs.

Marketing Authorization Holder

Biocom, JSC (Russia)

Dosage Form

Ramipril

Tablets 5 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Ramipril	5 mg

Excipients: ludipress – 129.92 mg, sodium bicarbonate – 5 mg, microcrystalline cellulose – 3.63 mg, magnesium stearate – 1.45 mg.

7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (5) – cardboard packs.
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.

Ramipril [Biocom, JSC (Russia)]
Tablets 10 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, or 50 pcs.

Marketing Authorization Holder

Biocom, JSC (Russia)

Dosage Form

Ramipril

Tablets 10 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Ramipril	10 mg

Excipients: ludipress – 172 mg, sodium bicarbonate – 10 mg, microcrystalline cellulose – 6 mg, magnesium stearate – 2 mg.

Ramipril [Pranapharm, LLC (Russia)]
Tablets 1.25 mg: 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.
Tablets 2.5 mg: 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.
Tablets 5 mg: 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.
Tablets 10 mg: 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.

Marketing Authorization Holder

Pranapharm, LLC (Russia)

Dosage Forms

	Ramipril	Tablets 1.25 mg: 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.
		Tablets 2.5 mg: 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.
		Tablets 5 mg: 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.
		Tablets 10 mg: 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Ramipril	1.25 mg

Excipients: lactose monohydrate – 58 mg, microcrystalline cellulose (type 102) – 20 mg, corn starch – 15 mg, povidone K25 – 4.75 mg, sodium stearyl fumarate – 1 mg.

7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
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. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (7) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.

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

	1 tab.
Ramipril	2.5 mg

Excipients: lactose monohydrate – 116 mg, microcrystalline cellulose (type 102) – 40 mg, corn starch – 30 mg, povidone K25 – 9.5 mg, sodium stearyl fumarate – 2 mg.

7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
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. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (7) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.

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

	1 tab.
Ramipril	5 mg

Excipients: lactose monohydrate – 78 mg, microcrystalline cellulose (type 102) – 20.2 mg, corn starch – 19 mg, povidone K25 – 6.5 mg, sodium stearyl fumarate – 1.3 mg.

7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
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. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (7) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.

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

	1 tab.
Ramipril	10 mg

Excipients: lactose monohydrate – 156 mg, microcrystalline cellulose (type 102) – 40.4 mg, corn starch – 38 mg, povidone K25 – 13 mg, sodium stearyl fumarate – 2.6 mg.

7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
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. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (7) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.

Ramipril [Tatkhimpharmpreparaty, JSC (Russia)]
Tablets 2.5 mg: 10 or 28 pcs.

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Form

Ramipril

Tablets 2.5 mg: 10 or 28 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Ramipril	2.5 mg

Excipients: microcrystalline cellulose 102, lactose (ludipress), colloidal silicon dioxide (aerosil), sodium carboxymethyl starch (primogel), magnesium stearate.

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

Ramipril [Tatkhimpharmpreparaty, JSC (Russia)]
Tablets 5 mg: 10 or 28 pcs.

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Form

Ramipril

Tablets 5 mg: 10 or 28 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Ramipril	5 mg

Excipients: microcrystalline cellulose 102, lactose (ludipress), colloidal silicon dioxide (aerosil), sodium carboxymethyl starch (primogel), magnesium stearate.

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

Ramipril [Tatkhimpharmpreparaty, JSC (Russia)]
Tablets 10 mg: 10 or 28 pcs.

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Form

Ramipril

Tablets 10 mg: 10 or 28 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Ramipril	10 mg

Excipients: microcrystalline cellulose 102, lactose (ludipress), colloidal silicon dioxide (aerosil), sodium carboxymethyl starch (primogel), magnesium stearate.

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

Ramipril Renewal [Obnovlenie Pfc, JSC (Russia)]
Tablets 2.5 mg: 10, 14, 28, 30, 56, 60, or 90 pcs.
Tablets 5 mg: 10, 14, 28, 30, 56, 60, or 90 pcs.
Tablets 10 mg: 10, 14, 28, 30, 56, 60 or 90 pcs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Forms

	Ramipril Renewal	Tablets 2.5 mg: 10, 14, 28, 30, 56, 60, or 90 pcs.
		Tablets 5 mg: 10, 14, 28, 30, 56, 60, or 90 pcs.
		Tablets 10 mg: 10, 14, 28, 30, 56, 60 or 90 pcs.

Dosage Form, Packaging, and Composition

Tablets round, flat-cylindrical, light pink or orange-pink in color, with a score; marbling and inclusions of a darker or lighter shade are allowed.

	1 tab.
Ramipril	2.5 mg

Excipients: lactose monohydrate, pregelatinized starch, croscarmellose sodium, sodium bicarbonate, [pigment mixture consisting of: lactose monohydrate, iron oxide red, iron oxide yellow], magnesium stearate.

10 pcs. – contour cell pack (1) – cardboard packs.
10 pcs. – contour cell pack (3) – cardboard packs.
10 pcs. – contour cell pack (6) – cardboard packs.
10 pcs. – contour cell pack (9) – cardboard packs.
14 pcs. – contour cell pack (1) – cardboard packs.
14 pcs. – contour cell pack (2) – cardboard packs.
14 pcs. – contour cell pack (4) – cardboard packs.
15 pcs. – contour cell pack (2) – cardboard packs.
15 pcs. – contour cell pack (4) – cardboard packs.
15 pcs. – contour cell pack (6) – cardboard packs.

Tablets round, flat-cylindrical, light pink or orange-pink in color, with a score; marbling and inclusions of a darker or lighter shade are allowed.

	1 tab.
Ramipril	5 mg

Tablets round, flat-cylindrical, light pink or orange-pink in color, with a score; marbling and inclusions of a darker or lighter shade are allowed.

	1 tab.
Ramipril	10 mg

Ramipril-Akos [Sintez PJSC (Russia)]
Tablets 2.5 mg: 14, 20, 21, 28, 30, 40, 42, 60, 63 or 90 pcs.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Ramipril-Akos

Tablets 2.5 mg: 14, 20, 21, 28, 30, 40, 42, 60, 63 or 90 pcs.

Dosage Form, Packaging, and Composition

Tablets pink in color with a slight brownish tint, with visible inclusions, round, flat-cylindrical, with a bevel and a score.

	1 tab.
Ramipril	2.5 mg

Excipients: magnesium stearate – 1 mg, talc – 2 mg, sodium carboxymethyl starch (sodium starch glycolate) – 2 mg, microcrystalline cellulose – 35 mg, dye iron oxide red (ferric oxide red) – 0.1 mg, lactose monohydrate – 57.4 mg.

7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (6) – cardboard packs.
7 pcs. – contour cell packs (9) – 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 (6) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.

Ramipril-Akos [Sintez PJSC (Russia)]
Tablets 5 mg: 14, 20, 21, 28, 30, 40, 42, 60, 63 or 90 pcs.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Ramipril-Akos

Tablets 5 mg: 14, 20, 21, 28, 30, 40, 42, 60, 63 or 90 pcs.

Dosage Form, Packaging, and Composition

Tablets pink with a slight brownish tint, with visible inclusions, round, flat-cylindrical, with a bevel, without a score.

	1 tab.
Ramipril	5 mg

Excipients: magnesium stearate – 1 mg, talc – 2 mg, sodium carboxymethyl starch (sodium starch glycolate) – 2 mg, microcrystalline cellulose – 35 mg, iron oxide red dye (red iron oxide) – 0.1 mg, lactose monohydrate (milk sugar) – 57.9 mg.

Ramipril-Akos [Sintez PJSC (Russia)]
Tablets 10 mg: 14, 20, 21, 28, 30, 40, 42, 60, 63 or 90 pcs.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Ramipril-Akos

Tablets 10 mg: 14, 20, 21, 28, 30, 40, 42, 60, 63 or 90 pcs.

Dosage Form, Packaging, and Composition

Tablets pink with a slight brownish tint, with visible inclusions, round, flat-cylindrical, with a bevel, without a score.

	1 tab.
Ramipril	10 mg

Excipients: magnesium stearate – 2 mg, talc – 4 mg, sodium carboxymethyl starch (sodium starch glycolate) – 4 mg, microcrystalline cellulose – 70 mg, iron oxide red dye (red iron oxide) – 0.2 mg, lactose monohydrate – 109.8 mg.

Ramipril-Akrikhin [Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)]
Tablets 1.25 mg: 30 pcs.

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Ramipril-Akrikhin

Tablets 1.25 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Tablets from light yellow to yellow, inclusions are allowed; flat-cylindrical, with a bevel.

	1 tab.
Ramipril (calculated as 100% substance)	1.25 mg

Excipients: lactose monohydrate – 82.7 mg, sodium bicarbonate – 0.3 mg, microcrystalline cellulose – 10 mg, hypromellose – 0.5 mg, arginine – 0.15 mg, croscarmellose sodium – 2 mg, colloidal silicon dioxide – 1 mg, methylated silicon dioxide (colloidal hydrophobic silicon dioxide) – 1 mg, sodium stearyl fumarate – 1 mg, iron oxide yellow dye – 0.1 mg.

10 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – polyethylene bottles (1) – cardboard packs.

Ramipril-Akrikhin [Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)]
Tablets 2.5 mg: 30 pcs.
Tablets 5 mg: 30 pcs.
Tablets 10 mg: 30 pcs.

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Forms

	Ramipril-Akrikhin	Tablets 2.5 mg: 30 pcs.
		Tablets 5 mg: 30 pcs.
		Tablets 10 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Tablets round, flat-cylindrical in shape, with a bevel and a score, from light yellow to yellow, inclusions are allowed.

	1 tab.
Ramipril (calculated as 100% substance)	2.5 mg

Excipients: lactose monohydrate – 165.4 mg, sodium bicarbonate – 0.6 mg, microcrystalline cellulose – 20 mg, hypromellose (type 2910) – 1 mg, arginine – 0.3 mg, croscarmellose sodium – 4 mg, colloidal silicon dioxide – 2 mg, methylated silicon dioxide (colloidal hydrophobic silicon dioxide) – 2 mg, sodium stearyl fumarate – 2 mg, iron oxide yellow dye – 0.2 mg.

10 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – polyethylene bottles (1) – cardboard packs.

Tablets round, flat-cylindrical in shape, with a bevel, from light pink with a brownish tint to pink, inclusions are allowed.

	1 tab.
Ramipril (calculated as 100% substance)	5 mg

Excipients: lactose monohydrate – 103.4 mg, sodium bicarbonate – 1.2 mg, microcrystalline cellulose – 13 mg, hypromellose (type 2910) – 0.65 mg, arginine – 0.2 mg, croscarmellose sodium – 2.6 mg, colloidal silicon dioxide – 1.3 mg, methylated silicon dioxide (colloidal hydrophobic silicon dioxide) – 1.3 mg, sodium stearyl fumarate – 1.3 mg, iron oxide yellow dye – 0.05 mg.

10 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – polyethylene bottles (1) – cardboard packs.

Tablets round, flat-cylindrical in shape, with a bevel and a score, from light pink with a brownish tint to pink, inclusions are allowed.

	1 tab.
Ramipril (calculated as 100% substance)	10 mg

Excipients: lactose monohydrate – 206.8 mg, sodium bicarbonate – 2.4 mg, microcrystalline cellulose – 26 mg, hypromellose (type 2910) – 1.3 mg, arginine – 0.4 mg, croscarmellose sodium – 5.2 mg, colloidal silicon dioxide – 2.6 mg, methylated silicon dioxide (colloidal hydrophobic silicon dioxide) – 2.6 mg, sodium stearyl fumarate – 2.6 mg, iron oxide yellow dye – 0.1 mg.

10 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – polyethylene bottles (1) – cardboard packs.

Ramipril-Nanolek^® [NANOLEK LLC (Russia)]
Tablets 2.5 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, or 50 pcs.
Tablets 5 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, or 50 pcs.
Tablets 10 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, or 50 pcs.

Marketing Authorization Holder

NANOLEK LLC (Russia)

Manufactured By

NANOLEK LLC (Russia)

Pharmatsevt, LLC (Russia)

Dosage Forms

	Ramipril-Nanolek^®	Tablets 2.5 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, or 50 pcs.
		Tablets 5 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, or 50 pcs.
		Tablets 10 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets light yellow or yellow in color, with inclusions of a darker or lighter shade, round, flat-cylindrical, with a bevel.

	1 tab.
Ramipril	2.5 mg

Excipients: microcrystalline cellulose – 61.6 mg, lactose monohydrate (milk sugar) – 42 mg, pregelatinized starch – 30 mg, hypromellose – 7.5 mg, sodium bicarbonate – 2.5 mg, sodium stearyl fumarate – 2.25 mg, croscarmellose sodium (primellose) – 1.5 mg, iron oxide yellow dye (E172) – 0.15 mg.

Tablets light pink or pink in color, with inclusions of a darker or lighter shade, round, flat-cylindrical, with a bevel.

	1 tab.
Ramipril	5 mg

Excipients: microcrystalline cellulose – 60 mg, lactose monohydrate (milk sugar) – 40.5 mg, pregelatinized starch – 28.1 mg, hypromellose – 7.5 mg, sodium bicarbonate – 5 mg, sodium stearyl fumarate – 2.25 mg, croscarmellose sodium (primellose) – 1.5 mg, iron oxide red dye (E172) – 0.15 mg.

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

	1 tab.
Ramipril	10 mg

Excipients: microcrystalline cellulose – 56.5 mg, lactose monohydrate (milk sugar) – 37.5 mg, pregelatinized starch – 24.75 mg, hypromellose – 7.5 mg, sodium bicarbonate – 10 mg, sodium stearyl fumarate – 2.25 mg, croscarmellose sodium (primellose) – 1.5 mg.

Ramipril-SZ [Severnaya Zvezda NAO (Russia)]
Tablets 2.5 mg: 14, 28, 30, 42, 56, 60 or 90 pcs.
Tablets 5 mg: 14, 28, 30, 42, 56, 60 or 90 pcs.
Tablets 10 mg: 14, 28, 30, 42, 56, 60 or 90 pcs.

Marketing Authorization Holder

Severnaya Zvezda NAO (Russia)

Dosage Forms

	Ramipril-SZ	Tablets 2.5 mg: 14, 28, 30, 42, 56, 60 or 90 pcs.
		Tablets 5 mg: 14, 28, 30, 42, 56, 60 or 90 pcs.
		Tablets 10 mg: 14, 28, 30, 42, 56, 60 or 90 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Ramipril	2.5 mg

Excipients: lactose monohydrate (milk sugar) – 74 mg, microcrystalline cellulose 102 – 15 mg, sodium bicarbonate – 2.5 mg, arginine – 0.5 mg, hypromellose (hydroxypropyl methylcellulose) – 1.5 mg, croscarmellose sodium (primellose) – 3 mg, magnesium stearate – 1 mg.

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
14 pcs. – contour cell packs (1) – cardboard packs.
14 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (3) – cardboard packs.
14 pcs. – contour cell packs (4) – cardboard packs.
28 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
28 pcs. – polymer bottles (1) – cardboard packs.
30 pcs. – polymer bottles (1) – cardboard packs.
90 pcs. – polymer bottles (1) – cardboard packs.

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

	1 tab.
Ramipril	5 mg

Excipients: lactose monohydrate (milk sugar) – 106 mg, microcrystalline cellulose 102 – 25 mg, sodium bicarbonate – 5 mg, arginine – 0.5 mg, hypromellose (hydroxypropyl methylcellulose) – 3 mg, croscarmellose sodium (primellose) – 4 mg, magnesium stearate – 1.5 mg.

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

	1 tab.
Ramipril	10 mg

Excipients: lactose monohydrate (milk sugar) – 111 mg, microcrystalline cellulose 102 – 56 mg, sodium bicarbonate – 10 mg, arginine – 1 mg, hypromellose (hydroxypropyl methylcellulose) – 4 mg, croscarmellose sodium (primellose) – 6 mg, magnesium stearate – 2 mg.

Ramipril-VERTEX [Vertex, JSC (Russia)]
Capsules 2.5 mg: 28 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Ramipril-VERTEX

Capsules 2.5 mg: 28 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 3, with a white body and a yellow cap; capsule contents – powder or compacted mass of white or almost white color, disintegrating when pressed with a glass rod.

	1 caps.
Ramipril	2.5 mg

Excipients: lactose monohydrate – 141.5 mg, colloidal silicon dioxide – 3 mg, sodium lauryl sulfate – 1.5 mg, calcium stearate – 1.5 mg.

Composition of hard gelatin capsules body (titanium dioxide – 2%, gelatin – up to 100%), cap (titanium dioxide – 2%, iron oxide yellow (iron oxide) – 0.6286%, gelatin – up to 100%).

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

Ramipril-VERTEX [Vertex, JSC (Russia)]
Capsules 5 mg: 28 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Ramipril-VERTEX

Capsules 5 mg: 28 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 3, yellow; capsule contents – powder or compacted mass of white or almost white color, disintegrating when pressed with a glass rod.

	1 caps.
Ramipril	5 mg

Excipients: lactose monohydrate – 139 mg, colloidal silicon dioxide – 3 mg, sodium lauryl sulfate – 1.5 mg, calcium stearate – 1.5 mg.

Composition of hard gelatin capsules titanium dioxide – 2%, yellow iron oxide (iron oxide) – 0.6286%, gelatin – up to 100%.

14 pcs. – contour cell packaging (2) – cardboard packs.

Ramipril-VERTEX [Vertex, JSC (Russia)]
Capsules 10 mg: 28 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Ramipril-VERTEX

Capsules 10 mg: 28 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 3, white in color; the capsule contents are a powder or compacted mass of white or almost white color, which disintegrates when pressed with a glass rod.