Gliclazide Servier

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Gliclazide Servier

Property Description
Active ingredient Gliclazide
Form Modified-release (MR) oral tablet
Pharmacological class Oral Hypoglycaemic Agent, Sulfonylurea Derivative
Common use Management of Type 2 Diabetes Mellitus
Origin Synthetic Compound

Gliclazide Servier is a prescription-only synthetic medicine used for the long-term management of Type 2 Diabetes Mellitus. It is officially classified as an Oral Hypoglycaemic Agent, a drug taken by mouth to achieve the essential goal of lowering high blood sugar. Gliclazide is widely utilized as a core treatment for this condition.


What Type of Medicine is Gliclazide Servier?

Gliclazide Servier is chemically defined as a sulfonylurea derivative, belonging to the second generation of Antidiabetic Drugs. Its active chemical substance is the International Nonproprietary Name (INN) compound, Gliclazide. The general purpose of this synthetic medication is to promote effective control of the blood glucose concentration, addressing the underlying metabolic issue in Type 2 Diabetes. Gliclazide functions through its targeted action as an insulin secretagogue, meaning it encourages the body's own insulin-producing cells to increase secretion.


Composition and Form: The Modified-Release (MR) Tablet

Gliclazide Servier is supplied as an oral tablet that features a distinctive modified-release (MR) formulation. This specific preparation, often associated with the Diamicron MR trade name, is pharmacologically distinct from older immediate-release versions of Gliclazide. The MR tablet is a specialized sustained-release formulation engineered to control the rate at which the active ingredient is slowly and evenly released into the body. This characteristic provides the benefit of supporting stable blood glucose control throughout the day and night, offering an advantage in compliance and consistency.


Gliclazide's General Goal: Supporting Insulin Release

The primary function of the medicine is to act as an insulin secretagogue, with the overarching goal of improving the body's natural ability to manage sugar. It works by encouraging the release of more of the body's own stored insulin from the pancreas. By increasing the amount of circulating insulin, Gliclazide facilitates the uptake of glucose by cells, achieving the desired hypoglycaemic effect that defines its general therapeutic purpose in managing Type 2 Diabetes.

Regulatory References

  1. Gliclazide entry on WHO Essential Medicines List (EML)

What side effects are possible with Gliclazide Servier?

Possible Side Effects and Safety Information

The safety profile of Gliclazide Servier, consistent with its classification as an oral hypoglycaemic agent, is defined by its effects on blood glucose and several physiological systems, as documented in official regulatory sources.


Frequency and System-Organ Classifications

The most frequent adverse reaction is hypoglycaemia (low blood sugar), classified as Common in regulatory documents, which results from the medicine's blood glucose-lowering action. Other documented effects are grouped by the affected System Organ Class (SOC):

System Organ Class (SOC) Frequency Classification Examples of Effects
Metabolism and Nutrition Common Hypoglycaemia (low blood sugar)
Gastrointestinal Disorders Uncommon Abdominal pain, nausea, vomiting, diarrhoea, constipation
Skin Disorders Uncommon/Rare Rash, pruritus (itching), urticaria
Hepatobiliary Disorders Rare Elevated liver enzymes, hepatitis
Blood Disorders Rare Reduced blood cell counts (e.g., anaemia, thrombocytopenia)

Serious Adverse Reactions and Safety Constraints

The potential for Severe Hypoglycaemia is the most serious safety consideration, which can lead to life-threatening complications. Other rare, serious reactions include Hepatitis and severe, generalized skin reactions. Transient visual disturbances may be observed upon the initiation of treatment due to changes in blood glucose levels.

Official regulatory documents include specific safety constraints. The medicine is contraindicated and generally not recommended for individuals with severe renal or hepatic impairment due to the significantly increased and prolonged risk of severe hypoglycaemia. It is also restricted for use in cases of Type 1 diabetes and diabetic keto-acidosis.

Overdose and Emergency Response

Gliclazide Servier Overdose and When to Seek Help

Overdose of Gliclazide Servier is primarily characterized by the development of profound and sustained hypoglycaemia, which is an excessive extension of the drug's therapeutic effect leading to critically low blood sugar. Documented manifestations of overdose in regulatory sources include a progression of symptoms such as sweating, tremor, confusion, anxiety, tachycardia, and visual or speech disturbances. If uncorrected, this can escalate to life-threatening outcomes, including seizures and loss of consciousness (hypoglycaemic coma) with potential for subsequent neurological impairment.

Regulatory authorities mandate that any suspected overdose or instance of severe or prolonged hypoglycaemia requires immediate medical attention and often hospitalisation. Corrective measures described in official prescribing information include the administration of concentrated intravenous glucose (dextrose) or glucagon as specific counter-agents. Due to the inherent risk of recurrent low blood sugar associated with the modified-release (MR) formulation, an extended observation period of 12 to 24 hours or more is required under hospital supervision. Patients with impaired renal or hepatic function, along with elderly individuals, are specifically cited as being at higher risk for severe and prolonged hypoglycaemic events.

Therapeutic Uses of Gliclazide Servier

Gliclazide Servier is a prescription medicine used to manage Type 2 Diabetes Mellitus in adults. The primary therapeutic domain is helping the body maintain stable blood glucose levels, which are typically elevated in this condition (hyperglycemia).

This medication is an established part of a comprehensive treatment plan when lifestyle interventions—such as diet, physical exercise, and weight reduction—do not provide sufficient glycemic control alone. The medicine's clinical role is focused on addressing the core symptoms and categories of conditions associated with Type 2 Diabetes, specifically elevated blood glucose levels and impaired glucose regulation.

Supporting the maintenance of target blood glucose levels is a key benefit, which is necessary to help manage the risks associated with persistent high sugar levels over time.


Quick Fact: Therapeutic Focus: Blood Sugar Management

Regulatory References

  1. https://medlineplus.gov/diabetes.html

Eligibility and Restrictions for Use

Who Can and Cannot Use Gliclazide Servier?

This section defines population eligibility for Gliclazide Modified-Release (MR) tablets based strictly on government-approved prescribing information.


Eligibility and Exclusion Categories

Population Group Eligibility Status (Regulatory Labeling)
Primary Indication Approved for Adults with Type 2 Diabetes Mellitus.
Pediatric Population Not Recommended; safety and efficacy have not been established.
Type 1 Diabetes Contraindicated (absolute prohibition).
Severe Renal/Hepatic Impairment Contraindicated (absolute prohibition). Mild-to-moderate impairment requires caution.
Pregnancy/Lactation Contraindicated (absolute prohibition).
Specific Drug Combination Contraindicated when used concomitantly with systemic Miconazole.
Metabolic State Contraindicated in conditions such as diabetic keto-acidosis or coma.

Summary of Eligibility Rules

Gliclazide Servier is primarily restricted to adults diagnosed with Type 2 Diabetes. Official regulatory documents contraindicate its use in specific, non-eligible populations, including all patients with Type 1 Diabetes, severe liver or kidney failure, or those experiencing acute diabetic complications. Furthermore, the medicine is contraindicated during both pregnancy and breastfeeding. Use in children and adolescents is not recommended due to a lack of established safety and efficacy data.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Gliclazide is structured to categorize substances based on their documented effect on blood glucose control when co-administered.

Formal Contraindications and Non-Recommended Combinations

Co-administration with Miconazole (systemic route or oromucosal gel) is formally Contraindicated by regulatory authorities due to a severe increase in the hypoglycaemic effect. The consumption of Alcohol is Not Recommended as it potentiates the hypoglycaemic reaction by inhibiting the body’s compensatory mechanisms, potentially leading to hypoglycaemic coma.

Potentiation and Antagonistic Interactions

Potentiation of the blood glucose lowering effect, increasing the risk of hypoglycemia, is documented with several classes, including other Antidiabetic Agents, Beta-blockers (which may also mask hypoglycaemia symptoms), ACE Inhibitors, and certain antibiotics (e.g., Fluconazole, Clarithromycin). Conversely, medications that cause an antagonistic effect, leading to an increase in blood glucose (hyperglycaemia), include Corticosteroids, Danazol, and Beta-2 Agonists.

Exposure-Altering and Substance Interactions

Rifampicin causes a decreased hypoglycaemic effect due to enzyme induction. The herbal product St. John's Wort may also officially affect blood glucose control. Interaction with Fluoroquinolones resulting in dysglycemia has been reported, particularly in elderly patients.

Mechanism of Action

Stimulating Insulin Release by mathbfKATP Channel Inhibition

Gliclazide Servier acts on the pancreatic beta-cells by binding to the Sulfonylurea Receptor 1 (mathbfSUR1) subunit of the ATP-sensitive potassium (mathbfKATP) channel, functioning as an inhibitor. This interaction physically closes the channel, preventing the outflow of potassium ions (K^+).

Initiating the Cellular Secretory Cascade

The closure of the mathbfKATP channel triggers cellular depolarization, which opens voltage-gated calcium channels. The resulting influx of mathbfCa^2+ immediately engages the cell's exocytosis machinery, forcing the rapid release of pre-formed insulin into the bloodstream. This modulation of the humoral signaling pathway initiates systemic changes.

Systemic Modulation of Glucose Homeostasis

The pulse of secreted insulin subsequently leads to an increased uptake of glucose by peripheral tissues and a reduction in hepatic glucose output. This systemic action modifies the activity within the Glucose Homeostasis System, resulting in a decrease in the concentration of glucose in the plasma.

Dosage and Administration Information

Gliclazide Servier is administered via the oral route as a modified-release (MR) tablet. Standard administration involves taking the medication once daily, strictly synchronized with breakfast or the main meal of the day to ensure proper drug release and consistent food intake. To maintain the controlled, sustained delivery of the active ingredient, the tablet must be swallowed whole and must not be crushed or chewed.

The standard adult dosing regimen is initiated with a low dose of 30 mg once daily. The dose is then subject to titration, meaning it is gradually adjusted based on the patient's metabolic response. The interval between successive dose increments should typically be at least one month, with the total daily dose never exceeding the maximum recommended 120 mg.

Specific procedural guidance applies to administration adjustments. For older adults (aged 65 years and older) and those with mild to moderate renal impairment, the initial dosing schedule is generally the same as the standard adult regimen, though careful patient monitoring is advised. The safety and efficacy of this medication have not been established in children and adolescents. If a daily dose is forgotten, the procedural instruction is to not increase the dose taken on the subsequent day to compensate.

Recent Clinical Evidence

1. Evidence for Glycemic Control in Type 2 Diabetes

Gliclazide Modified-Release (MR) was studied for its effect on blood sugar levels in people with Type 2 Diabetes. The research examined short- to medium-term outcomes related to systemic or functional imbalance, particularly the measured Glycated Hemoglobin ( HbA1c) level. In studies comparing Gliclazide MR to other medicines taken by mouth, HbA1c reductions were observed in some studies. These findings describe patterns observed in the studies that are consistent with other medicines in this class.

In addition, research explored the occurrence of very low blood sugar, known as hypoglycemia. Comparative studies explored rates of low blood sugar against other similar medications (sulfonylureas). Data show patterns related to the incidence of hypoglycemia was observed less frequently compared to some of these older, similar medications. However, evidence quality varies across studies, and many were designed to observe changes only over shorter periods.


2. Long-Term Studies on Vascular Outcomes

A key research project was evaluated in a large-scale, long-duration study that included over 11,000 patients with Type 2 Diabetes who were already at high risk for heart and vascular problems. This research examined an intensive glucose control strategy based on Gliclazide MR, compared to a standard control strategy, over a median of five years. The primary focus of the study was to monitor a composite of major macrovascular events (e.g., nonfatal heart attack, stroke) and major microvascular events (e.g., new or worsening kidney disease).

The study reports how symptoms evolved in the observed populations: The intensive control group was characterized by lower average HbA1c levels compared to the standard strategy over the five years. The intensive control strategy was associated with a lower number of the composite major macrovascular and microvascular endpoint; findings indicate that this pattern appears to be driven mainly by the observed differences in nephropathy (kidney-related outcomes). When individual events were analyzed separately, the data show patterns related to no clear difference between the two groups for all-cause mortality, nonfatal heart attack, or nonfatal stroke during the study period.


5. What is Still Uncertain in the Research Record

The total body of research highlights areas where certainty remains low or evidence is limited. Comparative evidence is lacking for Gliclazide against many newer classes of glucose-lowering drugs in large-scale, long-term cardiovascular outcome studies. The reported patterns reflect the specific conditions under which they were conducted because the intensive strategy involved Gliclazide MR plus the sequential addition of other glucose-lowering drugs as part of the regimen that was examined.

Key Studies & References

  1. Follow-up of mortality and vascular outcomes in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial and its extension (ADVANCE-ON)

Frequently Asked Questions (FAQ)

Common questions about Gliclazide Servier (FAQ)


Q: How quickly does Gliclazide Servier start working after the first dose?

Official pharmacokinetic data describes how the medicine acts in the body. Plasma levels of the active ingredient increase steadily over approximately six hours. The concentration then remains at a consistent level, or a plateau, that is maintained until about twelve hours after the tablet is administered.

Q: Does Gliclazide Servier cause weight gain?

According to official patient information, weight gain has been reported as a possible adverse effect that may occur while using this medication. Not everyone who takes the medicine will experience this effect.

Q: What are the signs of low blood sugar (hypoglycaemia) when taking this drug?

Low blood sugar (hypoglycaemia) is a common side effect of this medicine. Symptoms described in official regulatory documents may include feeling shaky, sweating, tremor, or intense hunger. Other signs can involve reduced concentration, confusion, dizziness, and changes in heart rate such such as a rapid or irregular beat.

Q: Can Gliclazide Servier cause dizziness or lightheadedness?

Official product information states that dizziness can be a symptom associated with an episode of low blood sugar, or hypoglycemia. Since low blood sugar is a common effect of this medicine, dizziness is reported indirectly through this known side effect.

Q: What happens if Gliclazide Servier is taken when blood sugar is already low?

Regulatory safety information indicates that the risk of severe hypoglycemia is increased if the drug is taken when the body's energy intake is deficient, or during heavy or severe exercise. Severe low blood sugar can impair concentration and reaction.

Q: Is Gliclazide Servier commonly prescribed alongside Metformin?

Regulatory documents state that this medicine may be used as part of a combination therapy to treat high blood sugar. This includes use alongside other medicines, such as Metformin.

Q: Does Gliclazide Servier affect driving ability or machine operation?

The official product information advises that the ability to concentrate and react may be impaired if blood sugar levels are too low (hypoglycemia) or too high (hyperglycemia). Official regulatory documents specify that professional guidance is necessary for individuals with frequent episodes of low blood sugar regarding driving safety.

Q: Is Gliclazide Servier a permanent medication for diabetes?

Official guidance describes the treatment for Type 2 diabetes as often lifelong. The medication is therefore described as part of a long-term management plan that should only be altered under the specific direction of a healthcare professional.

Q: What non-drug products or foods should be avoided while using Gliclazide Servier?

Regulatory documents describe the known interactions with certain non-drug substances. The consumption of alcohol is generally not recommended as it potentiates the hypoglycaemic reaction. Co-administration of the herbal product St. John's Wort is also listed in official information as requiring caution.

Q: Is Gliclazide Servier used in any countries outside of Europe?

Yes, this medication is approved and used in multiple international jurisdictions. Official regulatory information, including documents from Australia (TGA) and Health Canada, indicates that the medication is available and referenced in numerous countries outside of Europe.

Q: What is the difference in how Gliclazide Servier works compared to insulin?

The mechanism of Gliclazide works by stimulating the body’s own pancreatic cells to release more of its stored insulin (an action known as an insulin secretagogue). This is different from exogenous (external) insulin, which is administered directly into the body from an outside source.

Q: Why is the 'Servier' brand name included when the drug name is Gliclazide?

Servier is the name of the originator company that developed the modified-release formulation of this medicine. Regulatory documentation and trade names (like 'Diamicron MR') often include the originator or brand name for clear product identification.

Q: Can Gliclazide Servier affect a person's mood?

Official product information states that signs of low blood sugar, a common side effect, may include mood-related changes. These can involve restlessness, aggressiveness, reduced alertness, and depression.

Q: What are the official guidelines regarding stopping Gliclazide Servier?

Official product guidance describes the medication as part of long-term therapy. Regulatory documents specify that any decision to stop or alter medication use must be made under the specific direction of a prescribing healthcare professional.

Q: Can a person take Gliclazide Servier if they have a sulfa allergy?

Official prescribing information generally states that the medicine is contraindicated if a person has ever had an allergic reaction to gliclazide, other sulfonylureas, or sulfonamide (sulfur) antibiotics. This is due to the chemical relationship between the drug class and sulfonamides.

Q: Why do doctors prescribe Gliclazide Servier instead of just focusing on diet and exercise?

Official documents indicate that this medication is prescribed for adults with Type 2 diabetes when initial management through diet, exercise, and weight loss alone has not been sufficient to maintain adequate blood sugar control. It is used to help achieve the necessary level of glycemic management.

Q: Does Gliclazide Servier lose its effectiveness over time?

Official warnings and precautions acknowledge that the blood glucose lowering effect of any oral antidiabetic agent, including Gliclazide, may lessen over time in some patients. This is often attributed to the natural progression of the severity of the diabetes.

How should Gliclazide Servier be stored and disposed of?

How to Store and Dispose of Gliclazide Servier?

Official Storage Requirements

Regulatory labeling for Gliclazide Servier tablets often indicates no special storage conditions are required in terms of temperature. However, some official product information specifies storage at a temperature below 30°C and mandates protection from moisture.

All Gliclazide tablets must be kept out of the sight and reach of children. The product should be stored in its original package to maintain its integrity.

Storage Condition Requirement
Temperature Store below 30°C or at room temperature.
Protection Protect from moisture.
Container Keep in original package.

Disposal Instructions

Official labeling generally states there are no special requirements for the disposal of Gliclazide Servier. To protect the environment, unused or expired medicine should not be disposed of in wastewater or household trash, but instead returned to a pharmacist or a drug take-back program according to local regulations.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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