Glimepiride (Tablets) Instructions for Use

Instructions
Dosage forms

ATC Code

A10BB12 (Glimepiride)

Active Substance

Glimepiride (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Oral hypoglycemic drug

Pharmacotherapeutic Group

Drugs for the treatment of diabetes mellitus; hypoglycemic drugs, other than insulins; sulfonylurea derivatives

Pharmacological Action

An oral hypoglycemic agent, a sulfonylurea derivative. It stimulates insulin secretion by the pancreatic beta-cells and increases insulin release. It increases the sensitivity of peripheral tissues to insulin.

Pharmacokinetics

After multiple oral administration at a dose of 4 mg/day, the C_max in blood serum is reached in approximately 2.5 hours and is 309 ng/ml; there is a linear relationship between the dose and C_max, as well as between the dose and AUC. Food intake does not have a significant effect on absorption.

The V_d is about 8.8 L. Plasma protein binding is more than 99%.

Clearance is about 48 ml/min.

It undergoes metabolism. Hydroxylated and carboxylated metabolites of glimepiride are formed, apparently as a result of metabolism in the liver, and are found in urine and feces.

The T_1/2 is 5-8 hours. After administration of high doses of glimepiride, the T_1/2 increases. After a single oral administration of a radiolabeled dose of glimepiride, 58% of the radioactivity was found in urine and 35% in feces. No unchanged active substance was found in urine.

The T_1/2 of the hydroxylated and carboxylated metabolites of glimepiride were about 3-6 hours and 5-6 hours, respectively.

In patients with impaired renal function (with low creatinine clearance), a tendency towards an increase in the clearance of glimepiride and a decrease in its mean serum concentrations was observed. Thus, there is no additional risk of glimepiride accumulation in this category of patients.

Indications

Type 2 diabetes mellitus (non-insulin-dependent) in case of ineffectiveness of diet therapy and physical exercise.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
E11	Type 2 diabetes mellitus

ICD-11 code	Indication
5A11	Type 2 diabetes mellitus

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 the tablets orally, typically with the first main meal of the day or a substantial breakfast to reduce the risk of hypoglycemia.

Swallow the tablet whole with water; do not crush or chew it.

The initial and maintenance doses must be set individually based on regular monitoring of blood glucose and glycated hemoglobin (HbA1c) levels.

The recommended initial dose is 1 mg taken once daily.

If necessary, increase the daily dose gradually, using increments of 1 mg at intervals of 1-2 weeks based on the patient’s glycemic response.

The usual maintenance dose is 1 mg to 4 mg taken once daily.

Some patients, particularly those with more severe insulin resistance, may require a higher maintenance dose.

The maximum recommended daily dose is 8 mg.

For patients being switched from other oral hypoglycemic agents, consider the potency and duration of action of the previous medication; a temporary treatment hiatus may be necessary to avoid an additive effect.

During periods of stress, such as trauma, surgery, or infection, temporary insulin therapy may be required.

Regularly reassess the dosage when the patient’s body weight changes, lifestyle is modified, or other factors that may predispose to hypo- or hyperglycemia occur.

If hypoglycemia occurs, immediately administer a rapid-acting carbohydrate source.

Adverse Reactions

From the metabolic system: hypoglycemia, hyponatremia.

From the digestive system: nausea, vomiting, epigastric discomfort, abdominal pain, diarrhea, increased activity of liver transaminases, cholestasis, jaundice, hepatitis (up to the development of liver failure).

From the hematopoietic system: thrombocytopenia, leukopenia, erythropenia, granulocytopenia, agranulocytosis, pancytopenia, hemolytic anemia.

From the organ of vision: transient visual disturbances.

Allergic reactions: itching, urticaria, skin rash; rarely – dyspnea, drop in blood pressure, anaphylactic shock, allergic vasculitis, photosensitivity.

Contraindications

Type 1 diabetes mellitus (insulin-dependent), ketoacidosis, precoma, coma, hepatic failure, renal failure (including patients on hemodialysis), pregnancy, breastfeeding period, children and adolescents under 18 years of age, hypersensitivity to glimepiride, other sulfonylurea derivatives and sulfonamides.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy. In case of planned pregnancy or if pregnancy occurs, the woman should be switched to insulin.

During lactation, the woman should be switched to insulin.

In experimental studies, it was found that Glimepiride is excreted in breast milk.

Use in Hepatic Impairment

Contraindicated in hepatic failure.

Use in Renal Impairment

Contraindicated in renal failure (including patients on hemodialysis).

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

Use with caution in patients with concomitant endocrine diseases affecting carbohydrate metabolism (including thyroid dysfunction, adenohypophyseal or adrenocortical insufficiency).

In stressful situations (trauma, surgery, infectious diseases accompanied by fever), it may be necessary to temporarily transfer the patient to insulin.

It should be taken into account that symptoms of hypoglycemia may be smoothed out or completely absent in elderly patients, patients with neurocirculatory dystonia, or those receiving simultaneous treatment with beta-blockers, clonidine, reserpine, guanethidine, or other sympatholytics.

When compensation of diabetes mellitus is achieved, sensitivity to insulin increases; in this regard, during treatment, the need for glimepiride may decrease. To avoid the development of hypoglycemia, it is necessary to reduce the dose or discontinue Glimepiride in a timely manner. Dose adjustment should also be carried out when the patient’s body weight changes or when their lifestyle changes, or when other factors contributing to the development of hypo- or hyperglycemia appear.

When switching to Glimepiride from another drug, it is necessary to take into account the degree and duration of the effect of the previous hypoglycemic agent. It may be necessary to temporarily discontinue treatment to avoid an additive effect.

In the first weeks of treatment, the risk of developing hypoglycemia may increase, which requires particularly strict monitoring of the patient. Factors contributing to the development of hypoglycemia include: irregular, inadequate nutrition; changes in the usual diet; alcohol consumption, especially in combination with skipping a meal; changes in the usual regimen of physical activity; simultaneous use of other medications. Hypoglycemia can be quickly stopped by immediate intake of carbohydrates.

During treatment, regular monitoring of blood and urine glucose levels, as well as the concentration of glycated hemoglobin, is necessary.

Effect on the ability to drive vehicles and mechanisms

During treatment, one should refrain from engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Drug Interactions

Enhancement of the hypoglycemic effect of glimepiride is possible with simultaneous use with insulin or other hypoglycemic drugs, ACE inhibitors, allopurinol, anabolic steroids and androgens, chloramphenicol, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, phenyramidol, fibrates, fluoxetine, guanethidine, ifosfamide, MAO inhibitors, miconazole, PAS, pentoxifylline (with injectable administration in high doses), phenylbutazone, azapropazone, oxyphenbutazone, probenecid, quinolones, salicylates, sulfinpyrazone, sulfonamides, tetracyclines.

Weakening of the hypoglycemic effect of glimepiride is possible with simultaneous use with acetazolamide, barbiturates, corticosteroids, diazoxide, diuretics, epinephrine (adrenaline) and other sympathomimetics, glucagon, laxatives (after long-term use), nicotinic acid (in high doses), estrogens and progestogens, phenothiazine, phenytoin, rifampicin, thyroid hormones.

With simultaneous use, histamine H₂-receptor blockers, clonidine and reserpine can both potentiate and reduce the hypoglycemic effect of glimepiride.

Against the background of glimepiride use, the effect of coumarin derivatives may be enhanced or weakened.

Ethanol may enhance or weaken the hypoglycemic effect of glimepiride.

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

Glimepiride [Atoll LLC (Russia)]
Tablets 1 mg: from 10 to 600 pcs.
Tablets 2 mg: from 10 to 600 pcs.
Tablets 3 mg: from 10 to 600 pcs.
Tablets 4 mg: from 10 to 600 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Forms

	Glimepiride	Tablets 1 mg: from 10 to 600 pcs.
		Tablets 2 mg: from 10 to 600 pcs.
		Tablets 3 mg: from 10 to 600 pcs.
		Tablets 4 mg: from 10 to 600 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Glimepiride	1 mg

Excipients: lactose monohydrate (milk sugar) – 79.3 mg, microcrystalline cellulose (MCC-101 Premium) – 12 mg, sodium carboxymethyl starch – 4 mg, povidone K25 – 2.5 mg, magnesium stearate – 0.7 mg, polysorbate-80 – 0.5 mg.

From 10 to 50 pcs. – blister packs (from 1 to 12 pcs.) – cardboard packs.
From 10 to 120 pcs. – jars (1) – cardboard packs.

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

	1 tab.
Glimepiride	2 mg

Excipients: lactose monohydrate (milk sugar) – 78.3 mg, microcrystalline cellulose (MCC-101 Premium) – 12 mg, sodium carboxymethyl starch – 4 mg, povidone K25 – 2.5 mg, magnesium stearate – 0.7 mg, polysorbate-80 – 0.5 mg.

From 10 to 50 pcs. – blister packs (from 1 to 12 pcs.) – cardboard packs.
From 10 to 120 pcs. – jars (1) – cardboard packs.

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

	1 tab.
Glimepiride	3 mg

Excipients: lactose monohydrate (milk sugar) – 117.45 mg, microcrystalline cellulose (MCC-101 Premium) – 18 mg, sodium carboxymethyl starch – 6 mg, povidone K25 – 3.75 mg, magnesium stearate – 1.05 mg, polysorbate-80 – 0.75 mg.

From 10 to 50 pcs. – blister packs (from 1 to 12 pcs.) – cardboard packs.
From 10 to 120 pcs. – jars (1) – cardboard packs.

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

	1 tab.
Glimepiride	4 mg

Excipients: lactose monohydrate (milk sugar) – 156.6 mg, microcrystalline cellulose (MCC-101 Premium) – 24 mg, sodium carboxymethyl starch – 8 mg, povidone K25 – 5 mg, magnesium stearate – 1.4 mg, polysorbate-80 – 1 mg.

From 10 to 50 pcs. – blister packs (from 1 to 12 pcs.) – cardboard packs.
From 10 to 120 pcs. – jars (1) – cardboard packs.

Glimepiride [Pranapharm, LLC (Russia)]
Tablets 1 mg
Tablets 2 mg
Tablets 3 mg
Tablets 4 mg

Marketing Authorization Holder

Pranapharm, LLC (Russia)

Dosage Forms

	Glimepiride	Tablets 1 mg
		Tablets 2 mg
		Tablets 3 mg
		Tablets 4 mg

Dosage Form, Packaging, and Composition

Tablets

	1 tab.
Glimepiride	1 mg

10 pcs. – blister packs (3 pcs.) – cardboard packs (30 pcs.) – By prescription
10 pcs. – blister packs (4 pcs.) – cardboard packs (40 pcs.) – By prescription
10 pcs. – blister packs (5 pcs.) – cardboard packs (50 pcs.) – By prescription
10 pcs. – blister packs (6 pcs.) – cardboard packs (60 pcs.) – By prescription
10 pcs. – blister packs (9 pcs.) – cardboard packs (90 pcs.) – By prescription

Tablets

	1 tab.
Glimepiride	2 mg

Tablets

	1 tab.
Glimepiride	3 mg

Tablets

	1 tab.
Glimepiride	4 mg

Glimepiride [Rapharma, JSC (Russia)]
Tablets 2 mg: 10, 15, 30, 60, or 100 pcs.

Marketing Authorization Holder

Rapharma, JSC (Russia)

Dosage Form

Glimepiride

Tablets 2 mg: 10, 15, 30, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Glimepiride	2 mg

Excipients: microcrystalline cellulose – 75 mg, lactose monohydrate – 62.5 mg, croscarmellose sodium – 4.5 mg, povidone K30 – 4.5 mg, magnesium stearate – 1.5 mg.

10 pcs. – blister packs (aluminum/PVC) (3) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (6) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (9) – cardboard packs.
15 pcs. – blister packs (aluminum/PVC) (2) – cardboard packs.
15 pcs. – blister packs (aluminum/PVC) (4) – cardboard packs.
15 pcs. – blister packs (aluminum/PVC) (6) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Glimepiride [Rapharma, JSC (Russia)]
Tablets 3 mg: 10, 15, 30, 60, or 100 pcs.

Marketing Authorization Holder

Rapharma, JSC (Russia)

Dosage Form

Glimepiride

Tablets 3 mg: 10, 15, 30, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, biconvex, without a score.

	1 tab.
Glimepiride	3 mg

Excipients: microcrystalline cellulose – 90 mg, lactose monohydrate – 74.4 mg, croscarmellose sodium – 5.4 mg, povidone K30 – 5.4 mg, magnesium stearate – 1.8 mg.

Glimepiride [Rapharma, JSC (Russia)]
Tablets 4 mg: 10, 15, 30, 60, or 100 pcs.

Marketing Authorization Holder

Rapharma, JSC (Russia)

Dosage Form

Glimepiride

Tablets 4 mg: 10, 15, 30, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Glimepiride	4 mg

Excipients: microcrystalline cellulose – 100 mg, lactose monohydrate – 82 mg, croscarmellose sodium – 6 mg, povidone K30 – 6 mg, magnesium stearate – 2 mg.

10 pcs. – contour cell packaging (aluminum/PVC) (3) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (6) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (9) – cardboard packs.
15 pcs. – contour cell packaging (aluminum/PVC) (2) – cardboard packs.
15 pcs. – contour cell packaging (aluminum/PVC) (4) – cardboard packs.
15 pcs. – contour cell packaging (aluminum/PVC) (6) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.

Glimepiride [Pharmproekt, JSC (Russia)]
Tablets 2 mg: 30 pcs.

Marketing Authorization Holder

Pharmproekt, JSC (Russia)

Dosage Form

Glimepiride

Tablets 2 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Tablets from white to white with a creamy tint, round, flat-cylindrical, with a bevel.

	1 tab.
Glimepiride (calculated as 100% substance)	2 mg

Excipients: lactose monohydrate – 107.8 mg, microcrystalline cellulose – 14 mg, pregelatinized starch – 3.9 mg, sodium lauryl sulfate – 1.3 mg, magnesium stearate – 1 mg.

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

Glimepiride [Pharmproekt, JSC (Russia)]
Tablets 3 mg: 30 pcs.

Marketing Authorization Holder

Pharmproekt, JSC (Russia)

Dosage Form

Glimepiride

Tablets 3 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Tablets light yellow, round, flat-cylindrical, with a bevel.

	1 tab.
Glimepiride (calculated as 100% substance)	3 mg

Excipients: lactose monohydrate – 106.148 mg, microcrystalline cellulose – 14 mg, pregelatinized starch – 3.9 mg, sodium lauryl sulfate – 1.95 mg, magnesium stearate – 1 mg, quinoline yellow dye (E104) – 0.002 mg.

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

Glimepiride [Pharmproekt, JSC (Russia)]
Tablets 4 mg: 30 pcs.

Marketing Authorization Holder

Pharmproekt, JSC (Russia)

Dosage Form

Glimepiride

Tablets 4 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Tablets light pink, round, flat-cylindrical, with a bevel; marbling is allowed.

	1 tab.
Glimepiride (calculated as 100% substance)	4 mg

Excipients: lactose monohydrate – 104.498 mg, microcrystalline cellulose – 14 mg, pregelatinized starch – 3.9 mg, sodium lauryl sulfate – 2.6 mg, magnesium stearate – 1 mg, azorubine (E122) – 0.002 mg.

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

Glimepiride [Pharmstandard-Lexredstva OJSC (Russia)]
Tablets 2 mg: 30, 60, or 100 pcs.
Tablets 3 mg: 30, 60, or 100 pcs.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Forms

	Glimepiride	Tablets 2 mg: 30, 60, or 100 pcs.
		Tablets 3 mg: 30, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Glimepiride	2 mg

Excipients: lactose monohydrate – 107.8 mg, microcrystalline cellulose – 14 mg, pregelatinized starch – 3.9 mg, sodium lauryl sulfate – 1.3 mg, magnesium stearate – 1 mg.

10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.

Tablets light yellow, flat-cylindrical, with a bevel and a score.

	1 tab.
Glimepiride	3 mg

Excipients: lactose monohydrate – 106.1452 mg, microcrystalline cellulose – 14 mg, pregelatinized starch – 3.9 mg, sodium lauryl sulfate – 1.95 mg, magnesium stearate – 1 mg, sunset yellow FCF dye (E110) – 0.00056 mg, quinoline yellow dye (E104) – 0.00424 mg.

10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.

Glimepiride [Pharmstandard-Lexredstva OJSC (Russia)]
Tablets 4 mg: 30, 60, or 100 pcs.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Glimepiride

Tablets 4 mg: 30, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets round, flat-cylindrical, from light blue or gray-blue to blue in color, with inclusions of darker and lighter color, with a bevel and a score.

	1 tab.
Glimepiride	4 mg

Excipients: lactose monohydrate (milk sugar) – 102.8 mg, microcrystalline cellulose – 14 mg, pregelatinized starch – 4 mg, sodium lauryl sulfate (sodium dodecyl sulfate) – 1.9 mg, magnesium stearate – 0.6 mg, indigo carmine – 0.1 mg, sodium carboxymethyl starch (sodium starch glycolate) – 2.6 mg.

10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.

Glimepiride [Pharmstandard-Lexredstva OJSC (Russia)]
Tablets 1 mg: 30, 60, or 100 pcs.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Glimepiride

Tablets 1 mg: 30, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Glimepiride	1 mg

Excipients: lactose monohydrate – 103.625 mg, microcrystalline cellulose (microcrystalline cellulose 101) – 14 mg, pregelatinized starch – 3.9 mg, sodium lauryl sulfate (sodium dodecyl sulfate) – 1.95 mg, magnesium stearate – 0.325 mg, sodium carboxymethyl starch (sodium starch glycolate) – 5.2 mg.

10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.

Glimepiride Canon [Canonpharma Production, CJS (Russia)]
Tablets 1 mg: 10, 30, 60, 90, 100, or 120 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Form

Glimepiride Canon

Tablets 1 mg: 10, 30, 60, 90, 100, or 120 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Glimepiride	1 mg

10 pcs. – contour cell packaging (aluminum/PVC) (1) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (3) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (6) – cardboard packs.
20 pcs. – contour cell packaging (aluminum/PVC) (3) – cardboard packs.
20 pcs. – contour cell packaging (aluminum/PVC) (5) – cardboard packs.
30 pcs. – contour cell packaging (aluminum/PVC) (1) – cardboard packs.
30 pcs. – contour cell packaging (aluminum/PVC) (2) – cardboard packs.
30 pcs. – contour cell packaging (aluminum/PVC) (3) – cardboard packs.
30 pcs. – contour cell packaging (aluminum/PVC) (4) – cardboard packs.

Glimepiride Canon [Canonpharma Production, CJS (Russia)]
Tablets 2 mg: 10, 30, 60, 90, 100, or 120 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Form

Glimepiride Canon

Tablets 2 mg: 10, 30, 60, 90, 100, or 120 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Glimepiride	2 mg

Glimepiride Canon [Canonpharma Production, CJS (Russia)]
Tablets 3 mg: 10, 30, 60, 90, 100, or 120 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Form

Glimepiride Canon

Tablets 3 mg: 10, 30, 60, 90, 100, or 120 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Glimepiride	3 mg

Glimepiride Renewal [Obnovlenie Pfc, JSC (Russia)]
Tablets 1 mg
Tablets 2 mg
Tablets 3 mg
Tablets 4 mg

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Forms

	Glimepiride Renewal	Tablets 1 mg
		Tablets 2 mg
		Tablets 3 mg
		Tablets 4 mg

Dosage Form, Packaging, and Composition

Tablets

	1 tab.
Glimepiride	1 mg

10 pcs. – contour cell packaging (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – contour cell packaging (9 pcs.) – cardboard packs (90 pcs.) – Prescription only
15 pcs. – contour cell packaging (2 pcs.) – cardboard packs (30 pcs.) – Prescription only
15 pcs. – contour cell packaging (6 pcs.) – cardboard packs (90 pcs.) – Prescription only

Tablets

	1 tab.
Glimepiride	2 mg

Tablets

	1 tab.
Glimepiride	3 mg

Tablets

	1 tab.
Glimepiride	4 mg

Glimepiride Velpharm [Velpharm-M, LLC (Russia)]
Tablets 1 mg
Tablets 2 mg
Tablets 3 mg
Tablets 4 mg

Marketing Authorization Holder

Velpharm-M, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

Velpharm-M, LLC (Russia)

Dosage Forms

	Glimepiride Velpharm	Tablets 1 mg
		Tablets 2 mg
		Tablets 3 mg
		Tablets 4 mg

Dosage Form, Packaging, and Composition

Tablets

	1 tab.
Glimepiride	1 mg

10 pcs. – jars – cardboard packs (10 pcs.) – Prescription only
10 pcs. – contour cell packaging – cardboard packs (10 pcs.) – Prescription only
10 pcs. – contour cell packaging (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – contour cell packaging (6 pcs.) – cardboard packs (60 pcs.) – Prescription only
10 pcs. – contour cell packaging (9 pcs.) – cardboard packs (90 pcs.) – Prescription only
100 pcs. – jars – cardboard packs (100 pcs.) – Prescription only
20 pcs. – jars – cardboard packs (20 pcs.) – Prescription only
30 pcs. – jars – cardboard packs (30 pcs.) – Prescription only
40 pcs. – jars – cardboard packs (40 pcs.) – Prescription only
50 pcs. – jars – cardboard packs (50 pcs.) – Prescription only
60 pcs. – jars – cardboard packs (60 pcs.) – Prescription only
70 pcs. – jars – cardboard packs (70 pcs.) – Prescription only
80 pcs. – jars – cardboard packs (80 pcs.) – Prescription only
90 pcs. – jars – cardboard packs (90 pcs.) – Prescription only

Tablets

	1 tab.
Glimepiride	2 mg

Tablets

	1 tab.
Glimepiride	3 mg

10 pcs. – jars – cardboard packs (10 pcs.) – By prescription
10 pcs. – contour cell packs – cardboard packs (10 pcs.) – By prescription
10 pcs. – contour cell packs (3) – cardboard packs (30 pcs.) – By prescription
10 pcs. – contour cell packs (6) – cardboard packs (60 pcs.) – By prescription
10 pcs. – contour cell packs (9) – cardboard packs (90 pcs.) – By prescription
100 pcs. – jars – cardboard packs (100 pcs.) – By prescription
20 pcs. – jars – cardboard packs (20 pcs.) – By prescription
30 pcs. – jars – cardboard packs (30 pcs.) – By prescription
40 pcs. – jars – cardboard packs (40 pcs.) – By prescription
50 pcs. – jars – cardboard packs (50 pcs.) – By prescription
60 pcs. – jars – cardboard packs (60 pcs.) – By prescription
70 pcs. – jars – cardboard packs (70 pcs.) – By prescription
80 pcs. – jars – cardboard packs (80 pcs.) – By prescription
90 pcs. – jars – cardboard packs (90 pcs.) – By prescription

Tablets

	1 tab.
Glimepiride	4 mg

Glimepiride-SZ [Severnaya Zvezda NAO (Russia)]
Tablets 2 mg: 30, 60, or 90 pcs.

Marketing Authorization Holder

Severnaya Zvezda NAO (Russia)

Dosage Form

Glimepiride-SZ

Tablets 2 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Glimepiride	2 mg

Excipients: mannitol – 65.2 mg, microcrystalline cellulose (102) – 12 mg, sodium carboxymethyl starch – 10 mg, povidone K30 (medium molecular weight polyvinylpyrrolidone) – 1.3 mg, crospovidone (Kollidon CL) – 9 mg, magnesium stearate – 0.5 mg.

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

Glimepiride-SZ [Severnaya Zvezda NAO (Russia)]
Tablets 3 mg: 30, 60, or 90 pcs.

Marketing Authorization Holder

Severnaya Zvezda NAO (Russia)

Dosage Form

Glimepiride-SZ

Tablets 3 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Glimepiride	3 mg

Excipients: mannitol – 97.8 mg, microcrystalline cellulose (102) – 18 mg, sodium carboxymethyl starch – 15 mg, povidone K30 (medium molecular weight polyvinylpyrrolidone) – 1.95 mg, crospovidone (Kollidon CL) – 13.5 mg, magnesium stearate – 0.75 mg.

Glimepiride-SZ [Severnaya Zvezda NAO (Russia)]
Tablets 4 mg: 30, 60, or 90 pcs.

Marketing Authorization Holder

Severnaya Zvezda NAO (Russia)

Dosage Form

Glimepiride-SZ

Tablets 4 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Glimepiride	4 mg

Excipients: mannitol – 130.4 mg, microcrystalline cellulose (102) – 24 mg, sodium carboxymethyl starch – 20 mg, povidone K30 (medium molecular weight polyvinylpyrrolidone) – 2.6 mg, crospovidone (Kollidon CL) – 18 mg, magnesium stearate – 1 mg.

Glimepiride-Teva [Pliva Hrvatska, d.o.o. (Croatia)]
Tablets 1 mg: 30 pcs.

Marketing Authorization Holder

Pliva Hrvatska, d.o.o. (Croatia)

Manufactured By

USV Ltd. (India)

Dosage Form

Glimepiride-Teva

Tablets 1 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white, oblong, with beveled edges.

	1 tab.
Glimepiride	1 mg

Excipients: lactose monohydrate – 75.4 mg, corn starch – 2.33 mg, sodium carboxymethyl starch – 5 mg, povidone – 3 mg, polysorbate 80 – 0.67 mg, talc – 1 mg, magnesium stearate – 0.6 mg.

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

Glimepiride-Teva [Pliva Hrvatska, d.o.o. (Croatia)]
Tablets 2 mg: 30 pcs.

Marketing Authorization Holder

Pliva Hrvatska, d.o.o. (Croatia)

Manufactured By

USV Ltd. (India)

Dosage Form

Glimepiride-Teva

Tablets 2 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white, oblong, with beveled edges, with a break line on one side.

	1 tab.
Glimepiride	2 mg

Excipients: lactose monohydrate – 150.8 mg, corn starch – 4.66 mg, sodium carboxymethyl starch – 10 mg, povidone – 6 mg, polysorbate 80 – 1.34 mg, talc – 2 mg, magnesium stearate – 1.2 mg.

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

Glimepiride-Teva [Pliva Hrvatska, d.o.o. (Croatia)]
Tablets 3 mg: 30 pcs.

Marketing Authorization Holder

Pliva Hrvatska, d.o.o. (Croatia)

Manufactured By

USV Ltd. (India)

Dosage Form

Glimepiride-Teva

Tablets 3 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Tablets light yellow with a brownish tint, with a marbled surface, oblong, with beveled edges, with a break line on one side.

	1 tab.
Glimepiride	3 mg

Excipients: lactose monohydrate – 149.5 mg, corn starch – 4.66 mg, sodium carboxymethyl starch – 10 mg, povidone – 7 mg, polysorbate 80 – 1.34 mg, talc – 2 mg, magnesium stearate – 1.2 mg, iron oxide yellow dye (E172) – 0.3 mg.

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

Glimepiride-Teva [Pliva Hrvatska, d.o.o. (Croatia)]
Tablets 4 mg: 30, 60, or 100 pcs.

Marketing Authorization Holder

Pliva Hrvatska, d.o.o. (Croatia)

Manufactured By

USV Ltd. (India)

Labeled By

PLIVA KRAKOW Pharmaceutical Work, SA (Poland)

Dosage Form

Glimepiride-Teva

Tablets 4 mg: 30, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Glimepiride	4 mg

10 pcs. – PVC/PVDC/aluminum foil blisters (3) – cardboard packs.
10 pcs. – PVC/PVDC/aluminum foil blisters (6) – cardboard packs.
10 pcs. – PVC/PVDC/aluminum foil blisters (10) – cardboard packs.

Glimepiride-Teva [Pliva Hrvatska, d.o.o. (Croatia)]
Tablets 4 mg: 30, 60, or 100 pcs.

Marketing Authorization Holder

Pliva Hrvatska, d.o.o. (Croatia)

Manufactured By

USV Ltd. (India)

Labeled By

Sofarimex Industria Quimica e Farmaceutica, S.A. (Portugal)

Dosage Form

Glimepiride-Teva

Tablets 4 mg: 30, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets yellow, oblong, with slight marbling, with beveled edges and a score on one side.

	1 tab.
Glimepiride	4 mg

Excipients: lactose monohydrate 199.34 mg, corn starch 6.21 mg, sodium carboxymethyl starch (type A) 13.33 mg, povidone K30 9.33 mg, polysorbate 80 1.79 mg, talc 2.67 mg, magnesium stearate 1.6 mg, iron oxide yellow dye (E 172) 0.4 mg.

Glimepiride-Vertex [Vertex, JSC (Russia)]
Tablets 1 mg: 30 or 60 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Glimepiride-Vertex

Tablets 1 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Glimepiride	1 mg

Excipients: lactose monohydrate 79.5 mg, microcrystalline cellulose 12 mg, sodium carboxymethyl starch 5 mg, povidone 1 mg, polysorbate 80 0.5 mg, magnesium stearate 1 mg.

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.

Glimepiride-Vertex [Vertex, JSC (Russia)]
Tablets 2 mg: 30 or 60 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Glimepiride-Vertex

Tablets 2 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Glimepiride	2 mg

Excipients: lactose monohydrate 159 mg, microcrystalline cellulose 24 mg, sodium carboxymethyl starch 10 mg, povidone 2 mg, polysorbate 80 1 mg, magnesium stearate 2 mg.

Glimepiride-Vertex [Vertex, JSC (Russia)]
Tablets 3 mg: 30 or 60 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Glimepiride-Vertex

Tablets 3 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Glimepiride	3 mg

Excipients: lactose monohydrate 117.6 mg, microcrystalline cellulose 18 mg, sodium carboxymethyl starch 7.5 mg, povidone 1.5 mg, polysorbate 80 0.9 mg, magnesium stearate 1.5 mg.

Glimepiride-Vertex [Vertex, JSC (Russia)]
Tablets 4 mg: 30 or 60 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Glimepiride-Vertex

Tablets 4 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Glimepiride	4 mg

Excipients: lactose monohydrate 237.5 mg, microcrystalline cellulose 36 mg, sodium carboxymethyl starch 15 mg, povidone 3 mg, polysorbate 80 1.5 mg, magnesium stearate 3 mg.

Glimepiride-Vertex [Vertex, JSC (Russia)]
Tablets 6 mg: 30 or 60 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Glimepiride-Vertex

Tablets 6 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Glimepiride	6 mg

Excipients: lactose monohydrate 235.2 mg, microcrystalline cellulose 36 mg, sodium carboxymethyl starch 15 mg, povidone 3 mg, polysorbate 80 1.8 mg, magnesium stearate 3 mg.

10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
15 pcs. – blister packs (2) – cardboard packs.
15 pcs. – blister packs (4) – cardboard packs.
20 pcs. – blister packs (3) – cardboard packs.
30 pcs. – blister packs (1) – cardboard packs.
30 pcs. – blister packs (2) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.

Medixlife (Author)

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