Gliclazide: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 29, 2026

Gliclazide

Sulfonylureas

Sold as DIAMICRON MR

GB MHRACA Health Canada

Drug class: Sulfonylureas
Availability: See label
Routes: Oral
Markets covered: 2
Products on record: 81

A10BBSulfonylureas

Overview

Gliclazide is an active pharmaceutical ingredient in the Sulfonylureas group (A10BB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	60	May 29, 2026
CA Canada	Health Canada	21	May 5, 2026

GBUnited Kingdom· MHRA

60 products

Uses

GBOfficial regulatory label· revised May 29, 2026[1]

Non insulin dependent diabetes (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose.

How to take

CACanada· Health Canada

21 products

Uses

CAOfficial regulatory label· revised May 5, 2026[2]

GLICLAZIDE MR TABLETS (gliclazide modified-release tablets 30 mg and 60 mg) is indicated for: • Control of hyperglycemia in gliclazide responsive diabetes mellitus of stable, mild, non- ketosis prone, maturity onset or adult type which cannot be controlled by proper dietary management and exercise, or when insulin therapy is not appropriate.
1 Pediatrics (< 18 years of age) Safety and effectiveness of gliclazide in pediatrics have not been established; therefore, Health Canada has not authorized an indication for pediatric use. 4 Geriatrics).

How to take

Sources & citations

[1]MHRA (UK) · PL495650099 · revised May 29, 2026
[2]Health Canada (DPD) · 02568039 · revised May 5, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Posology Initial dose The total daily dose may vary from 40 to 320 mg taken orally. The dose should be adjusted according to the individual patient’s response, commencing with 40-80 mg daily (1 – 2 tablets) and increasing until adequate control is achieved.
A single dose should not exceed 160 mg (4 tablets). When higher doses are required, Gliclazide tablets should be taken twice daily and according to the main meals of the day. In obese patients or those not showing adequate response to Gliclazide tablets alone, additional therapy may be required.
Switching from another oral antidiabetic agent to Gliclazide 40 mg tablets:
Gliclazide 40mg Tablets can be used to replace other oral antidiabetic agents. The dosage and the half-life of the previous antidiabetic agent should be taken into account when switching to Gliclazide 40 mg Tablets. A transitional period is not generally necessary.
A starting dose of 40-80 mg ( 1 to 2 tablets) should be used and this should be adjusted to suit the patient’s blood glucose response, as described above. When switching from a hypoglycaemic sulfonylurea with a prolonged half- life, a treatment free period of a few days may be necessary to avoid an additive effect of the two products, which might cause hypoglycaemia.
• Combination treatment with other antidiabetic agents: Gliclazide Tablets can be given in combination with biguanides, alpha glucosidase inhibitors or insulin. In patients not adequately controlled with Gliclazide Tablets, concomitant insulin therapy can be initiated under close medical supervision.
Special Populations Elderly:
Gliclazide Tablets should be prescribed using the same dosing regimen recommended for patients under 65 years of age.
Renal impairment:
In patients with mild to moderate renal insufficiency, the same dosing regimen can be used as in patients with normal renal function with careful patient monitoring. These data have been confirmed in clinical trials. Patients at risk of hypoglycaemia: • undernourished or malnourished, • severe or poorly compensated endocrine disorders (hypopituitarism, hypothyroidism, adrenocorticotrophic insufficiency), • withdrawal of prolonged and/or high dose corticosteroid therapy, • severe vascular disease (severe coronary heart disease, severe carotid impairment, diffuse vascular disease); It is recommended that the minimum daily starting dose of 40-80 mg is used.
Paediatric population:
The safety and efficacy of Gliclazide in children and adolescents have not been established. No data are available. Method of administration For oral administration

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised May 29, 2026[1]

Based on the experience with gliclazide, the following undesirable effects have been reported. The most frequent adverse reaction with gliclazide is hypoglycaemia. As for other sulphonylureas, treatment with Gliclazide tablets can cause hypoglycaemia, if mealtimes are irregular and, in particular, if meals are skipped.
Possible symptoms of hypoglycaemia are: headache, intense hunger, nausea, vomiting, lassitude, sleep disorders, agitation, aggression, poor concentration, reduced awareness and slowed reactions, depression, confusion, visual and speech disorders, aphasia, tremor, paresis, sensory disorders, dizziness, feeling of powerlessness, loss of self-control, delirium, convulsions, shallow respiration, bradycardia, drowsiness and loss of consciousness, possibly resulting in coma and lethal outcome.
In addition, signs of adrenergic counter-regulation may be observed: sweating, clammy skin, anxiety, tachycardia, hypertension, palpitations, angina pectoris and cardiac arrhythmia. Usually, symptoms disappear after intake of carbohydrates (sugar).
However, artificial sweeteners have no effect. Experience with other sulphonylureas shows that hypoglycaemia can recur even when measures prove effective initially. If a hypoglycaemic episode is severe or prolonged, and even if it is temporarily controlled by intake of sugar, immediate medical treatment or even hospitalization is required.
Gastrointestinal disturbances, including abdominal pain, nausea, vomiting dyspepsia, diarrhoea, and constipation have been reported: if these should occur, they can be avoided or minimised if Gliclazide tablets are taken with breakfast.
The following undesirable effects have been more rarely reported:
Skin and subcutaneous tissue disorders: rash, pruritus, urticaria, angioedema, erythema, maculopapular rashes, bullous reactions (such as Stevens-Johnson syndrome and toxic epidermal necrolysis and autoimmune bullous disorders), and exceptionally, drug rash with eosinophilia and systemic symptoms (DRESS).
Blood and lymphatic system disorders:
Changes in haematology are rare. They may include anaemia, leucopenia, thrombocytopenia, granulocytopenia. These are in general reversible upon discontinuation of medication. Hepato-biliary disorders: raised hepatic enzyme levels (AST, ALT, alkaline phosphatase), hepatitis (isolated reports).
Discontinue treatment if cholestatic jaundice appears. These symptoms usually disappear after the discontinuation of treatment.
Eye disorders:
Transient visual disturbances may occur especially on initiation of treatment, due to changes in blood glucose levels. g. with cholestasis and jaundice) and hepatitis which regressed after withdrawal of the sulphonylurea or led to life- threatening liver failure in isolated cases.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised May 29, 2026[1]

Hypoglycaemia:
This treatment should be prescribed only if the patient is likely to have a regular food intake (including breakfast). It is important to have a regular carbohydrate intake due to the increased risk hypoglycaemia if a meal is taken late, if an inadequate amount of food is consumed or if the food is low in carbohydrate.
Hypoglycaemia is more likely to occur during low-calorie diets, following prolonged or strenuous exercise, alcohol intake or if a combination of hypoglycaemic agents is being used. 8). Some cases may be severe and prolonged. Hospitalization may be necessary and glucose administration may need to be continued for several days.
Careful selection patients, of the dose used, and clear patient directions are necessary to reduce the risk of hypoglycaemic episodes. 5).
Renal and hepatic insufficiency:
The pharmacokinetics and/or pharmacodynamics of gliclazide may be altered in patients with hepatic insufficiency or severe renal failure. A hypoglycaemic episode occurring in these patients may be prolonged, so appropriate management should be initiated.
8), treatment, and conditions that predispose to its development, should be explained to the patient and to family members. The patient should be informed of the importance of following dietary advice, of taking regular exercise, and of regular monitoring of blood glucose levels.
Poor blood glucose control:
Blood glucose control in a patient receiving antidiabetic treatment may be affected by any of the following: St. 5), fever, trauma, infection or surgical intervention. In some cases, it may be necessary to administer insulin. The hypoglycaemic efficacy of any oral antidiabetic agent, including gliclazide, is attenuated over time in many patients: this may be due to progression in the severity of the diabetes, or to a reduced response to treatment.
This phenomenon is known as secondary failure, which is distinct from primary failure, when an active substance is ineffective as first-line treatment. Adequate dose adjustment and dietary compliance should be considered before classifying the patient as secondary failure.

This is not medical advice. Consult a qualified healthcare professional.