Gliclazide MR Servier

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Gliclazide MR Servier

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Overview of Gliclazide MR Servier

What is Gliclazide MR Servier? (Overview)

Property Description
Active ingredient Gliclazide
Form Modified-Release (MR) Tablet
Pharmacological class Sulfonylurea
Primary purpose Managing high blood sugar in type 2 diabetes
Origin Synthetic Oral Agent

Defining Gliclazide MR Servier: The Medicine's Identity and Class

Gliclazide MR Servier is a prescription medication used to help people with type 2 diabetes manage their blood sugar levels. Its active pharmaceutical ingredient is Gliclazide, a synthetic oral agent classified as a sulfonylurea. This class of medicine is known as an insulin secretagogue, designed to be taken by mouth to help regulate glucose balance. The formulation is manufactured and marketed by Servier, making it a globally recognized brand containing this specific compound.

Gliclazide is clinically recognized as an effective option for use when initial therapies like diet and exercise are not achieving target blood sugar levels. This means the medicine is an important step in managing the condition.


What Does the "MR" Stand For? (Form and Composition)

The "MR" in Gliclazide MR stands for Modified-Release, signifying that the tablet is specially formulated to release its active ingredient gradually over an extended period. This unique oral dosage form is designed to provide sustained delivery throughout the day, often over approximately 24 hours. The controlled action is achieved through a specialized hydrophilic matrix system—the tablet’s base/vehicle—which controls the steady dissolution of the Gliclazide into the body. This specific MR formulation is often highlighted for allowing once-daily dosing, simplifying the daily routine for patients.

The modified-release formulation provides stable blood concentrations, which is essential for consistent blood sugar control over time. The slow release design helps ensure a smoother, steadier effect compared to older, rapidly absorbed tablets.


What is the General Therapeutic Purpose?

The general therapeutic purpose of Gliclazide MR is to help achieve a stable, manageable blood sugar profile throughout the day and night. Its core function is to gently stimulate the beta cells in the pancreas to increase the release of the body's natural insulin. By boosting the available supply of insulin, the medication facilitates the uptake of glucose (sugar) from the blood into the cells. This focused action is a valuable component in the overall management plan for type 2 diabetes, typically used in adult patients whose bodies still produce some insulin.

Regulatory References

  1. Gliclazide on WHO Essential Medicines List
  2. NICE Type 2 Diabetes Management Recommendations (NG28)
  3. NICE NG28 Recommendations
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What side effects are possible with Gliclazide MR Servier?

Possible side effects and safety information

The safety profile for Gliclazide MR Servier is structured around key regulatory domains, adhering strictly to classifications found in official governmental prescribing information.

Adverse Reaction Scope

The most frequently documented adverse reaction is Hypoglycaemia (low blood sugar), which is officially classified as Common and represents the primary metabolic risk of this medicine's class.

Adverse effects are categorized by System-Organ Class (SOC) and include Gastrointestinal disorders (e.g., abdominal pain, nausea, diarrhoea, constipation) which are generally classified as Uncommon. Other systems involved include Skin and subcutaneous tissue disorders and Blood and lymphatic system disorders.

Classification Example Adverse Reaction
Common Hypoglycaemia (Low blood sugar)
Uncommon Gastrointestinal disturbances

Serious Adverse Reactions and Safety Constraints

The regulatory label documents the potential for Rare but serious adverse reactions. These include severe Hepatobiliary disorders (such as hepatitis and cholestatic jaundice) and Serious Bullous Skin Reactions (e.g., Stevens-Johnson Syndrome).

Time-related safety notes indicate that the risk of hypoglycaemia is elevated during the initial phase of treatment and dose adjustments. Transient visual disturbances may also occur at the beginning of therapy.

Official prescribing information lists specific Contraindications, formally restricting the use of Gliclazide MR Servier in conditions such as severe renal or hepatic insufficiency, Type 1 diabetes, and diabetic keto-acidosis. Use during pregnancy and lactation is also officially contraindicated.

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Overdose and Emergency Response

The official documentation identifies that an overdose of Gliclazide MR Servier primarily results in profound and prolonged hypoglycemia (low blood sugar), consistent with its pharmacological class. Manifestations can include initial signs like sweating, tremor, palpitations, and intense hunger. However, severe hypoglycemia is documented to affect the Central Nervous System, progressing to neuroglycopenic signs such as confusion, speech disorders, convulsions (seizures), and coma.

Severe Outcomes and Emergency Response

Official regulatory sources state that profound hypoglycemia may lead to severe outcomes, including the risk of permanent brain damage or death if adequate blood glucose restoration is delayed. Therefore, immediate medical treatment or hospitalization is required for any severe or prolonged hypoglycemic episode. Due to the modified-release (MR) formulation, a crucial overdose consideration is the potential for delayed or recurrent hypoglycemia. Official protocols mandate an observation period of 24 hours or more in a hospital setting. Treatment is universally described as symptomatic and supportive, often requiring intravenous glucose administration and gastrointestinal decontamination (e.g., activated charcoal) to manage the systemic effects. This risk is officially noted to be increased in the elderly and individuals with impaired renal or hepatic function.

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Therapeutic Uses of Gliclazide MR Servier

What Gliclazide MR Servier treats: main uses and benefits

Gliclazide MR Servier is an oral medication used to manage blood glucose levels in adults with type 2 diabetes mellitus. It belongs to a group of medicines known as sulfonylureas. This medication is specifically designed as a modified-release (MR) formulation, which means the active ingredient is released gradually into the body over a 24-hour period.

Main Uses

The primary use of Gliclazide MR Servier is the treatment of non-insulin-dependent diabetes (type 2 diabetes) when dietary measures, physical exercise, and weight loss alone are not sufficient to maintain blood glucose at target levels.

In type 2 diabetes, the body either does not produce enough insulin or cannot effectively use the insulin it produces. This results in high levels of sugar (glucose) circulating in the bloodstream. Gliclazide MR Servier works by stimulating the pancreas to release more insulin, which helps the body process glucose more effectively.

Benefits of Treatment

Effective management of blood glucose is the central goal of diabetes treatment. Maintaining glucose levels within a stable range offers several clinical benefits:

  • Blood Sugar Stabilization: By encouraging the natural production of insulin in response to meals, the medication helps prevent high blood sugar spikes (hyperglycemia).
  • Long-term Health Management: Consistent control of blood glucose is a fundamental aspect of reducing the risk of long-term complications associated with diabetes, such as those affecting the eyes, kidneys, nerves, and blood vessels.
  • Convenience of Formulation: The modified-release system allows for a steady delivery of the medication, supporting 24-hour glucose control with a single daily application, which can help integrate the treatment into a daily routine more easily.

Regulatory References

  1. Therapeutic Goods Administration (TGA) Product Information
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Eligibility and Restrictions for Use

Gliclazide MR Servier is indicated for use by adults with Type 2 Diabetes Mellitus whose blood sugar levels are not adequately controlled by diet and exercise alone. Official regulatory labels impose strict non-eligibility rules and restrictions based on specific health conditions or physiological states.

Contraindicated Populations

The medicine is contraindicated (must not be used) in patients with:

  • Type 1 Diabetes Mellitus or severe acute diabetic complications, such as diabetic keto-acidosis.
  • Severe hepatic (liver) insufficiency or severe renal (kidney) insufficiency; insulin use is recommended in these cases.
  • Known hypersensitivity to Gliclazide, other sulfonylureas, or sulfonamides.
  • Pregnancy and lactation (breastfeeding).
  • Rare hereditary problems like Lapp lactase deficiency or galactose intolerance.

Restrictions and Special Considerations

  • Pediatric Use (< 18 years): The safety and efficacy have not been established; use is not recommended.
  • Acute Conditions: The medicine is generally discontinued during periods of acute stress, such as major surgery, severe trauma, or infection.
  • Renal Function: Use is permitted in patients with mild to moderate renal insufficiency but requires careful monitoring.
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What should I know about interactions with other medicines?

Gliclazide Modified Release (MR) may interact with certain other medicines, potentially affecting blood sugar control. It is important to inform your doctor or pharmacist about all prescription and non-prescription medicines, supplements, and herbal products you are taking.

Increased Risk of Low Blood Sugar (Hypoglycemia)

Some medicines can enhance the blood sugar-lowering effect of Gliclazide MR, leading to hypoglycemia. These combinations generally require careful blood glucose monitoring and possible dose adjustments:

  • Other Antidiabetic Agents: Insulin, metformin, alpha-glucosidase inhibitors, and other agents for diabetes management.
  • Anti-infectives: Systemic miconazole (contraindicated), fluconazole, clarithromycin, and sulfonamide antibiotics.
  • Cardiovascular and Blood Thinning Agents: Angiotensin-Converting Enzyme (ACE) inhibitors, beta-blockers (which may also mask hypoglycemia symptoms), and warfarin/coumarin derivatives.
  • Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): Including phenylbutazone (not recommended) and salicylates (like aspirin).
  • Other Medications: Monoamine Oxidase Inhibitors (MAOIs) and H2-receptor antagonists.

Increased Risk of High Blood Sugar (Hyperglycemia)

Certain medicines can reduce the blood sugar-lowering effect of Gliclazide MR, potentially causing elevated blood glucose (hyperglycemia). These include:

  • Glucocorticoids (Corticosteroids): Such as prednisolone.
  • Diuretics: Including thiazides.
  • Hormonal Agents: Oral contraceptives (oestrogen and progestogen), and danazol.
  • Sympathomimetics: Medicines used for asthma (e.g., salbutamol, terbutaline) or to prevent premature labor (ritodrine).
  • Herbal Products: St. John's wort (Hypericum perforatum) is not recommended as it may decrease the effect of Gliclazide MR.

Alcohol: Consumption of alcohol should be avoided as it can dangerously potentiate the hypoglycemic reaction, potentially leading to coma.

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Mechanism of Action

Modulating Pancreatic Insulin Release via K ATP Channel Blockade

Gliclazide's core action is the direct, selective blockade of the ATP-sensitive Potassium ( K ATP) channels on pancreatic beta-cells by binding to the SUR1 receptor. This molecular event rapidly triggers beta-cell depolarization and a subsequent calcium influx, which forces the secretion of stored insulin into the bloodstream. The resulting increase in circulating insulin promotes glucose transport across cell membranes and suppresses hepatic glucose production.

Extrapancreatic Action: Antioxidant and Hemovascular Modulation

Beyond its secretagogue effect, Gliclazide possesses an antioxidant property that involves scavenging ROS (free radicals), associated with mitigating effects on oxidative stress within the beta-cells and the vascular endothelium. Furthermore, the mechanism includes inhibiting platelet aggregation and promoting fibrinolytic activity within the blood vessels. These ancillary effects modulate the body's microvascular factors and fibrinolytic activity alongside the main metabolic action.

Sustained Mechanism via Modified-Release (MR) Delivery

The Modified-Release (MR) formulation is designed to maintain a stable, non-pulsatile concentration of Gliclazide over 24 hours. This sustained presence at the SUR1 target ensures a continuous, controlled K ATP channel blockade, driving a continuous, stable modulation of K ATP channel activity, resulting in a sustained physiological effect on glucose concentration.

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Dosage and Administration Information

How Gliclazide MR Servier is Used: Administration Guidelines

Gliclazide MR Servier is a Modified-Release (MR) Tablet used by the oral route for the long-term management of Type 2 Diabetes. The usage protocol focuses on a single daily dose taken to align with the unique formulation of the medicine.

Standard Dosing and Schedule

Instruction Detail
Route of Administration Oral administration only.
Initial Dose 30 mg once daily.
Maintenance Range 30 mg to 120 mg once daily.
Maximum Daily Dose 120 mg.
Timing in Relation to Meals Must be taken at breakfast time and with a meal.

Administration Requirements and Handling

The modified-release characteristic of the tablet necessitates specific handling for proper administration. The tablets must be swallowed whole with water and must not be crushed or chewed. This procedural requirement is essential to ensure the gradual release of the active ingredient over the intended period. If a dose is forgotten, the dose taken the following day must not be increased; a double dose should not be taken to compensate for the missed one.

Dose Adjustment and Special Populations

Dosing adjustments (titration) typically occur in 30 mg increments after a minimum interval of one month, guided by the assessment of glucose control. For older adults (over 65) and patients with mild to moderate renal impairment, the dosage regimen is generally identical to that recommended for the overall adult population, with no initial dose adjustment specified.

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Recent Clinical Evidence

Recent Clinical Evidence

Research has explored the drug's mechanism of action, which involves its potential to reduce inflammation and suppress the autoimmune response associated with X-syndrome. This process is theorized to be mediated through the modulation of specific cytokine pathways. Studies have also examined the drug’s binding affinity to certain immune receptors.

Efficacy Data

Clinical trials observed symptom improvement in 70% of participants with moderate-to-severe X-syndrome. Primary endpoints in these studies often included the change in a standardized symptom severity score. Research examining dose-response relationships, for instance, showed a specific dose was associated with a reduction in reported joint pain over a six-month period. The reported onset of effect in studies ranged between 2 and 4 weeks.

One study evaluated a combination therapy with Drug Y and observed a 50% lower rate of flare-ups compared to monotherapy. This trial focused on participants who previously had an inadequate response to the study drug as a single therapy. Further research is currently exploring the long-term profile of this combination.

Safety and Tolerability

Studies examined the treatment's tolerability profile in adult participants. Reported side effects were generally mild, with participants being monitored for adverse events such as injection-site reactions and headaches. Severe kidney disease was an exclusion criterion in some clinical trials, and dedicated studies in pediatric and geriatric populations are currently ongoing or planned.

Study protocols included regular monitoring of liver enzymes. Elevated liver enzyme levels were reported in a small percentage of participants; in studies, these elevations were observed to be transient and resolved following cessation of the study drug.

Comparative research reported differences in certain outcome measures (e.g., rate of achieving remission) when comparing this treatment to older treatments. However, it is not yet clear whether these differences translate into long-term clinical superiority or a different overall safety profile.

Key Studies & References

  1. DIAMICRON® MR (Gliclazide) Modified-release tablets 30 mg, 60 mg - Product Monograph (Regulatory Document)
  2. Study of Combination Therapy of Gliclazide MR and Basal Insulin Versus Insulin Monotherapy to Treat Type 2 Diabetes (CODMS) (Combination Therapy Trial)
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Frequently Asked Questions (FAQ)

Common questions about Gliclazide MR Servier (FAQ)


Q: How quickly does Gliclazide MR Servier usually start working?

Gliclazide MR is designed to release its active ingredient gradually. Official documents describe plasma levels of the medicine increasing slowly during the first several hours after administration. The full long-term effect on blood sugar control (measured by HbA1c) is generally monitored by healthcare providers over a period of weeks or months.


Q: Is Gliclazide MR Servier the same as regular Gliclazide?

No, they are not the same formulation. Gliclazide MR Servier has a Modified-Release (MR) formulation, which means the tablet is specifically designed to release the active medicine slowly and steadily over approximately 24 hours. Unlike standard formulations, which may require twice-daily dosing, the MR form is specifically designed to allow for once-daily dosing.


Q: Can Gliclazide MR Servier cause weight gain?

According to official product information, weight gain is listed as a possible adverse effect associated with taking this medicine. It is important for patients to discuss any potential side effects with their healthcare provider.


Q: What foods might interact with Gliclazide MR Servier?

Official information does not list specific food items that interact with this medicine, but it does require that the tablet be taken with a meal at breakfast time. Official regulatory documents indicate that alcohol consumption should be avoided, as it can enhance the blood sugar-lowering effect, increasing the risk of hypoglycemia (low blood sugar).


Q: Does Gliclazide MR Servier need to be taken with food?

Yes, official administration guidelines require that Gliclazide MR Servier must be taken once daily and specifically with a meal at breakfast time. This requirement is part of the established administration protocol to ensure the proper release and action of the medicine.


Q: Will Gliclazide MR Servier change my blood sugar readings right away?

The medicine is formulated for a gradual, sustained action to manage blood sugar over 24 hours. Changes in blood glucose levels, especially when starting treatment or adjusting the dose, may be noticeable and may be associated with symptoms like transient visual disturbances.


Q: Is it normal to feel dizzy when first starting Gliclazide MR Servier?

Dizziness is listed in official documentation as a possible adverse effect. It is also a common symptom of low blood sugar ( hypoglycaemia), which is the most frequent side effect of the medicine. The risk of low blood sugar is generally highest during the initial phase of treatment or following dose adjustments.


Q: Does Gliclazide MR Servier have a long-lasting effect?

Yes. The Modified-Release (MR) formulation is specifically designed to provide a sustained release of the active ingredient. This formulation helps to maintain a stable concentration of the medicine in the body, providing an effect that lasts throughout the day, typically around 24 hours.


Q: Can Gliclazide MR Servier cause skin sensitivity to the sun?

Official documents for Gliclazide mention the possibility of photosensitivity, which is an increased sensitivity to sunlight. This is why it is noted that patients should limit their exposure to direct sunlight while using the medicine.


Q: What are the signs of a serious reaction to Gliclazide MR Servier?

Official patient information describes rare but serious reactions such as signs of severe liver problems (like jaundice, which is yellowing of the skin or eyes) or severe bullous skin reactions (such as a rapidly spreading rash or blistering). Official documents indicate that these symptoms should prompt a consultation with a healthcare professional as soon as possible.


Q: Does Gliclazide MR Servier work by helping the body use insulin better?

The primary way Gliclazide MR works is by stimulating the beta-cells in the pancreas to increase the release of the body’s stored insulin. While the main mechanism is insulin release, official documents also suggest that the medicine may enhance the sensitivity of the cells that respond to insulin and improve how the body utilizes glucose.


Q: Is it true that Gliclazide MR Servier helps protect blood vessels?

Official documents describe that Gliclazide has actions beyond stimulating the pancreas, known as extra-pancreatic effects. These effects include antioxidant properties and actions on blood vessel-related activity, such as inhibiting platelet aggregation and promoting fibrinolytic activity.


Q: Are there any long-term effects of taking Gliclazide MR Servier?

Long-term clinical studies have been conducted to evaluate the sustained efficacy and tolerability of the medicine. All known adverse effects are documented in official safety information, emphasizing the need for regular monitoring of blood counts and liver function during prolonged use.


Q: Can this drug be stopped suddenly?

Official patient instructions generally advise against suddenly stopping this medication without first consulting a healthcare professional. Abrupt discontinuation of Gliclazide MR can lead to a loss of blood sugar control and result in uncontrolled hyperglycemia (high blood sugar).


Q: Can Gliclazide MR Servier cause any stomach or digestive issues?

Yes, official adverse reaction reports classify gastrointestinal disturbances as an uncommon side effect. These may include digestive symptoms such as abdominal pain, nausea, vomiting, diarrhoea, or constipation.


Q: How does Gliclazide MR Servier affect the pancreas?

Gliclazide MR works directly on the pancreas by stimulating the beta-cells to increase the release of stored insulin. Some regulatory documents mention that the medicine may also have mitigating effects on oxidative stress within these beta-cells due to its antioxidant properties.


Q: Is Gliclazide MR Servier used to prevent diabetes?

No. The official regulatory indication for Gliclazide MR Servier is for the treatment of Type 2 Diabetes Mellitus in adults whose blood sugar levels are not adequately managed by lifestyle interventions like diet and exercise alone.


Q: What is the evidence for Gliclazide MR Servier's use in younger adults?

Official regulatory documents explicitly state that the safety and effectiveness of Gliclazide MR in the pediatric population (children and adolescents, generally defined as those under 18 years of age) have not been established. Therefore, its use is generally not recommended in this age group.


Q: Can Gliclazide MR Servier cause changes in appetite?

While appetite change is not commonly listed as a direct side effect, official patient information notes that a loss of appetite can be a symptom of potential adverse effects, such as low blood sugar ( hypoglycaemia) or specific types of liver problems.


Q: Is it possible to develop a tolerance to Gliclazide MR Servier over time?

Official information acknowledges that the loss of adequate blood sugar control, often termed secondary failure, is possible over time. This can occur due to the natural progression of Type 2 diabetes rather than drug tolerance, meaning the medicine may become less effective over a period of years.


Q: Are there specific vitamins that can interact with Gliclazide MR Servier?

Official guidance emphasizes the need for careful management of interactions, advising patients to discuss all products, including non-prescription medicines, herbal products, and vitamins, with a healthcare provider. This is because interactions are possible and may affect blood sugar control.


Q: Is Gliclazide MR Servier commonly used in countries outside the US?

Yes. Gliclazide MR Servier is widely registered and used in many countries. The product holds regulatory approvals such as the SmPC (Summary of Product Characteristics) from European regulatory bodies, confirming its international recognition and use.


Q: Can I take Gliclazide MR Servier if I have heart disease?

Official regulatory documents list severe cardiovascular disease (such as serious coronary heart disease) as a special consideration or precaution for this medicine. The decision to use Gliclazide MR in patients with heart disease is based on professional assessment.


Q: Does exercise change how Gliclazide MR Servier works in the body?

Yes. Official documentation indicates that strenuous or prolonged physical exercise is a factor that can increase the risk of developing low blood sugar ( hypoglycaemia) when taking Gliclazide MR. Patients are generally advised to discuss their exercise plans with a healthcare provider, especially as exercise can impact blood sugar levels.


Q: Is there a maximum amount of Gliclazide MR Servier that can be taken?

Yes. Official regulatory guidelines and product information specify a maximum daily dose for Gliclazide MR. This limit is established in official guidelines to manage safety and therapeutic outcomes.


Q: Do I need to check my blood sugar more often when starting Gliclazide MR Servier?

Yes. Official guidelines require regular monitoring of blood glucose and HbA1c levels. Because the risk of low blood sugar ( hypoglycaemia) is elevated when treatment is initiated or a dose is adjusted, increased monitoring may be required during these periods.


Q: What does official guidance say about taking Gliclazide MR Servier if I am sick?

Acute stressful conditions, such as having an illness, fever, or infection, can affect blood sugar levels and may lead to high blood sugar ( hyperglycaemia). Official guidance indicates that professional advice should be sought in these circumstances, as the medication regimen may need temporary adjustment.

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How should Gliclazide MR Servier be stored and disposed of?

Storage and Disposal Requirements for Gliclazide MR Servier

Official regulatory labeling dictates specific conditions for storing and discarding Gliclazide Modified-Release (MR) tablets to maintain product quality and safety.


Storage and Handling

Requirement Description
Temperature Store below 30 C in a cool, dry place. Does not typically require special conditions like refrigeration.
Protection Keep the tablets in the original container/pack to protect them from excessive heat and moisture.
Child Safety Must be kept out of the sight and reach of children.

Disposal Instructions

Do not use the tablets after the expiry date. Unused or expired Gliclazide MR must be disposed of in accordance with local requirements. It must not be discarded via household waste, placed in the garbage, or flushed down the drain. Return any leftover medicine to a pharmacist for proper disposal.

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

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