Golda MB (Tablets) Instructions for Use

Marketing Authorization Holder

Pharmasintez-Tyumen, LLC (Russia)

ATC Code

A10BB09 (Gliclazide)

Active Substance

Gliclazide (Rec.INN registered by WHO)

Dosage Forms

	Golda MB	Modified-release tablets 30 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 150, 180, 200 or 300 pcs.
		Modified-release tablets 60 mg: 7, 10, 14, 20, 25, 28, 30, 40, 42, 50, 56, 60, 70, 75, 80, 84, 90, 100, 120, 125, 140, 150, 180, 250 or 300 pcs.

Dosage Form, Packaging, and Composition

Modified-release tablets white or white with a yellowish tint, round, flat-cylindrical, with a bevel.

Excipients: lactose monohydrate – 47 mg, hypromellose 2208 – 70 mg, sodium carboxymethyl starch type C – 10 mg, magnesium stearate – 2 mg, colloidal silicon dioxide – 1 mg.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (7) – cardboard packs.
10 pcs. – contour cell packaging (8) – cardboard packs.
10 pcs. – contour cell packaging (9) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
70 pcs. – jars (1) – cardboard packs.
80 pcs. – jars (1) – cardboard packs.
90 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
120 pcs. – jars (1) – cardboard packs.
150 pcs. – jars (1) – cardboard packs.
180 pcs. – jars (1) – cardboard packs.
200 pcs. – jars (1) – cardboard packs.
300 pcs. – jars (1) – cardboard packs.

Modified-release tablets white or white with a yellowish tint, round, flat-cylindrical, with a bevel and a score line.

Excipients: lactose monohydrate – 94 mg, hypromellose 2208 – 140 mg, sodium carboxymethyl starch type C – 20 mg, magnesium stearate – 4 mg, colloidal silicon dioxide – 2 mg.

7 pcs. – contour cell packaging (2) – cardboard packs.
7 pcs. – contour cell packaging (4) – cardboard packs.
7 pcs. – contour cell packaging (6) – cardboard packs.
7 pcs. – contour cell packaging (8) – cardboard packs.
7 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (7) – cardboard packs.
10 pcs. – contour cell packaging (8) – cardboard packs.
10 pcs. – contour cell packaging (9) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
25 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
70 pcs. – jars (1) – cardboard packs.
75 pcs. – jars (1) – cardboard packs.
80 pcs. – jars (1) – cardboard packs.
84 pcs. – jars (1) – cardboard packs.
90 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
120 pcs. – jars (1) – cardboard packs.
125 pcs. – jars (1) – cardboard packs.
140 pcs. – jars (1) – cardboard packs.
150 pcs. – jars (1) – cardboard packs.
180 pcs. – jars (1) – cardboard packs.
250 pcs. – jars (1) – cardboard packs.
300 pcs. – jars (1) – cardboard packs.

Clinical-Pharmacological Group

Oral hypoglycemic drug

Pharmacotherapeutic Group

Hypoglycemic agent for oral administration of the second-generation sulfonylurea group

Pharmacological Action

An oral hypoglycemic agent, a second-generation sulfonylurea derivative. Stimulates insulin secretion by pancreatic beta cells. Increases the sensitivity of peripheral tissues to insulin. Appears to stimulate the activity of intracellular enzymes (in particular, muscle glycogen synthase). Reduces the time interval from food intake to the onset of insulin secretion. Restores the early peak of insulin secretion, reduces the postprandial peak of hyperglycemia.

Gliclazide reduces platelet adhesion and aggregation, slows the development of parietal thrombosis, and increases vascular fibrinolytic activity. Normalizes vascular permeability. Has antiatherogenic properties: lowers the concentration of total cholesterol and LDL cholesterol in the blood, increases the concentration of HDL cholesterol, and also reduces the number of free radicals. Prevents the development of microthrombosis and atherosclerosis. Improves microcirculation. Reduces vascular sensitivity to adrenaline.

In diabetic nephropathy, long-term use of gliclazide results in a significant reduction in proteinuria.

Pharmacokinetics

After oral administration, it is completely absorbed from the gastrointestinal tract.

When used in a prolonged/modified-release dosage form, C_max in the blood is reached within 6 hours; C_ss is maintained for 6-12 hours.

Plasma protein binding is about 95%. V_d is about 19 L. It is metabolized mainly in the liver with the formation of 8 metabolites. The main metabolite does not have a hypoglycemic effect but affects microcirculation.

T_1/2 ranges from 12 to 20 hours. It is excreted mainly by the kidneys: 70% as metabolites, less than 1% is excreted unchanged in the urine.

Indications

Type 2 diabetes mellitus with insufficient effectiveness of diet therapy, physical activity, and weight loss.

Prevention of complications of type 2 diabetes mellitus: reducing the risk of microvascular (nephropathy, retinopathy) and macrovascular complications (myocardial infarction, stroke).

ICD codes

Dosage Regimen

Take the recommended daily dose once daily, preferably with breakfast.

Swallow the tablet whole; do not crush or chew the modified-release formulation.

Initiate therapy with a dose of 30 mg once daily.

Titrate the dose based on glycemic response, increasing in increments of 30 mg.

Allow a minimum interval of two weeks between dose adjustments.

The maximum recommended daily dose is 120 mg.

For patients switching from standard gliclazide tablets, initiate Golda MB at a dose of 30 mg once daily.

Monitor blood glucose levels regularly to determine the minimum effective dose.

In elderly patients or those with renal or hepatic impairment, initiate treatment with the lowest possible dose.

Adhere strictly to a prescribed diet and exercise regimen during therapy.

Adverse Reactions

From the digestive system rarely – anorexia, nausea, vomiting, diarrhea, epigastric pain.

From the hematopoietic system in some cases – thrombocytopenia, agranulocytosis or leukopenia, anemia (usually reversible).

From the endocrine system in case of overdose – hypoglycemia.

Allergic reactions skin rash, itching.

Contraindications

Type 1 diabetes mellitus (insulin-dependent), ketoacidosis, diabetic precoma and coma, severe renal and/or hepatic insufficiency; pregnancy, breastfeeding period; children and adolescents under 18 years of age; hypersensitivity to sulfonylurea derivatives and sulfonamides. Simultaneous use of gliclazide and imidazole derivatives (including miconazole).

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindicated for use in severe hepatic insufficiency.

Use in Renal Impairment

Contraindicated for use in severe renal insufficiency.

Pediatric Use

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

Geriatric Use

Use with caution in elderly patients.

Special Precautions

Gliclazide is used to treat non-insulin-dependent diabetes mellitus in combination with a low-calorie, low-carbohydrate diet.

During treatment, blood glucose levels should be regularly monitored on an empty stomach and after meals, as well as daily fluctuations in glucose levels.

In case of surgical interventions or decompensation of diabetes mellitus, the possibility of using insulin preparations should be considered.

If hypoglycemia develops, if the patient is conscious, glucose (or a sugar solution) should be administered orally. In case of loss of consciousness, glucose should be administered intravenously or glucagon subcutaneously, intramuscularly, or intravenously. After regaining consciousness, the patient should be given food rich in carbohydrates to prevent the recurrence of hypoglycemia.

With the simultaneous use of gliclazide with verapamil, regular monitoring of blood glucose levels is necessary; with acarbose, careful monitoring and adjustment of the dosage regimen of hypoglycemic agents is required.

Simultaneous use of gliclazide with cimetidine, phenylbutazone, danazol is not recommended.

Drug Interactions

The hypoglycemic effect of gliclazide is potentiated when used concomitantly with pyrazolone derivatives, salicylates, phenylbutazone, antibacterial sulfonamide drugs, theophylline, caffeine, MAO inhibitors.

Concomitant use with non-selective beta-blockers increases the likelihood of hypoglycemia and may also mask the tachycardia and hand tremor characteristic of hypoglycemia, while sweating may increase.

When gliclazide and acarbose are used concomitantly, an additive hypoglycemic effect is observed.

Cimetidine increases the plasma concentration of gliclazide, which can cause severe hypoglycemia (CNS depression, impaired consciousness).

When used concomitantly with corticosteroids (including topical dosage forms), diuretics, barbiturates, estrogens, progestins, combined estrogen-progestin drugs, diphenin, rifampicin, the hypoglycemic effect of gliclazide is reduced.

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.