Reclimet

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Reclimet

Method of action: Drugs Used In Diabets

Treatment option:

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

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 Reclimet

Property Description
Active Ingredients Gliclazide; Metformin hydrochloride
Form Oral tablet (Immediate Release or Sustained Release)
Pharmacological Class Sulfonylurea & Biguanide combination
Common Use Management of Type 2 Diabetes Mellitus
Status Prescription Only (Rx)

Reclimet is a fixed-dose combination prescription medicine used to manage high blood sugar levels in adults with Type 2 Diabetes Mellitus. It is typically prescribed when diet, exercise, and treatment with a single anti-diabetic agent have not been sufficient to achieve target blood glucose levels.

This medication’s primary feature is its dual composition, containing two different active ingredients that work through complementary mechanisms: gliclazide and metformin. The combination is formulated to enhance the anti-hyperglycemic effects of both components, offering a strategy for controlling blood sugar more effectively than using either drug alone.

  • Gliclazide is a sulfonylurea that stimulates the beta cells in the pancreas to produce and release more insulin.
  • Metformin is a biguanide that reduces the amount of glucose the liver produces while also improving the body's sensitivity to insulin.

The efficacy of combining these two drug classes has been established as an effective step-up therapy for patients whose diabetes is not controlled by metformin alone. By consolidating two distinct mechanisms into one tablet, Reclimet aims to provide a comprehensive approach to glycemic control.

Regulatory References

  1. National Library of Medicine (NIH)

What side effects are possible with Reclimet?

Possible Side Effects and Safety Information

This section describes the officially documented adverse effects and safety characteristics of the fixed-dose combination of Gliclazide and Metformin, strictly based on government regulatory prescribing information.

Frequency-Classified Adverse Reactions

Adverse reactions are formally categorized by their official likelihood:

  • Very Common (Metformin): Gastrointestinal disturbances such as diarrhea, nausea, vomiting, and abdominal pain. These effects are often transient and most frequent when treatment begins.
  • Common (Gliclazide): Hypoglycemia (low blood sugar), which is the primary risk associated with the sulfonylurea class.
  • Rare/Very Rare: Lactic Acidosis (Metformin); Hepatitis and abnormal liver function tests; and changes in blood cell counts, including leucopenia and anemia (Gliclazide).

System-Organ Classes and Serious Reactions

Regulatory documents identify specific body systems affected by adverse reactions:

  • Metabolism and Nutrition: Risk of Lactic Acidosis (a serious metabolic complication) and Hypoglycemia.
  • Hepatobiliary Disorders: Cases of abnormal liver function tests and hepatitis are documented.
  • Blood and Lymphatic System: Rare changes in blood cell counts.
  • Dermatological: Skin reactions like rash and pruritus.

Population-Specific Safety Constraints

  • Severe Renal Impairment: The medication is generally contraindicated due to the significantly increased risk of Metformin-associated Lactic Acidosis.
  • Hepatic Impairment: Use is generally contraindicated due to the dual risk of Lactic Acidosis and prolonged hypoglycemia.
  • Time-Related Pattern: The risk of Vitamin B12 deficiency/malabsorption is associated with long-term exposure to Metformin.
  • Procedural Restriction: Metformin must be temporarily discontinued prior to, or at the time of, imaging procedures using iodinated contrast agents.

Overdose and Emergency Response

Overdose and When to Seek Help

Reclimet (Glimepiride/Metformin Hydrochloride) is associated with two primary, serious risks in the event of an overdose or inappropriate use: hypoglycemia (severely low blood sugar) and lactic acidosis.

Overdose Presentations

Taking more than the prescribed dose can lead to an overdose. The most documented clinical presentations include:

  • Hypoglycemia: Overdosing can result in severe low blood glucose. This risk is elevated when the medication is combined with alcohol or other antidiabetic agents, or if meals are significantly delayed or skipped.
  • Lactic Acidosis: This is a rare, but serious, metabolic condition characterized by the buildup of lactic acid in the blood. Regulatory sources classify this as a medical emergency requiring immediate attention.

Urgent Medical Attention Required

Immediate medical attention is required if an individual experiences symptoms suggestive of lactic acidosis, as this condition is life-threatening. The drug's labeling specifically directs users to tell their doctor immediately if they notice signs such as:

  • Deep or rapid breathing (hyperventilation)
  • Persistent nausea, vomiting, or stomach pain
  • Unexplained weakness, muscle pain, or trouble breathing
  • Dizziness or an irregular heartbeat

Any instance of suspected overdose must be considered a serious situation due to the potential for these severe metabolic disturbances. Individuals should not delay seeking emergency help.

Therapeutic Uses of Reclimet

The primary therapeutic role of this medication is used for managing the chronic metabolic disorder known as Type 2 Diabetes Mellitus in adult patients. It is applied when initial efforts, including lifestyle changes and treatment with a single anti-diabetic agent, are considered insufficient to achieve target blood sugar goals. This combination approach is used to support improved management of glucose levels.

The core indications for this dual therapy include the management of uncontrolled T2DM, the targeting of persistently high HbA1c levels, and the easing of associated symptoms like excessive thirst and frequent urination. This combination is relevant in a clinical setting as a step-up therapy where supportive management with two distinct agents is considered relevant.

“The medication helps address symptom clusters that may become disruptive, assisting with the fundamental management of chronic hyperglycemia.”

By assisting with glycemic management, the medication may play a role in reducing the risk of developing serious long-term complications. Furthermore, its single-tablet format is relevant for simplifying the long-term regimen, which may help support the consistency appropriate for long-term metabolic management.


Quick Fact: Relief for Physical Discomfort
This combination therapy can support comfort during symptomatic periods, helping to ease the overall symptom burden of physical manifestations like thirst, polyuria, and fatigue caused by high circulating glucose.

Regulatory References

  1. NIH MedlinePlus overview of combination diabetes treatment

Eligibility and Restrictions for Use

The Gliclazide/Metformin combination is approved exclusively for adults diagnosed with Type 2 Diabetes Mellitus whose condition is not adequately controlled by diet, exercise, or monotherapy with a single anti-diabetic agent.

Populations for whom use is Contraindicated

Official regulatory documents prohibit use in several groups due to metabolic risks:

  • Patients with Type 1 diabetes or severe metabolic conditions such as diabetic ketoacidosis or any form of acute metabolic acidosis.
  • Individuals with severe renal impairment (typically eGFR below 30 mL/ min/1.73 m^2) or hepatic failure.
  • Any acute or chronic condition causing tissue hypoxia, such as decompensated heart failure or shock.
  • Known hypersensitivity to gliclazide, metformin, or other sulfonylureas.

Restricted Use and Age Limitations

Use is officially not recommended in children and adolescents (under 18 years) as safety and effectiveness have not been established. The medicine is also not recommended during pregnancy or breast-feeding. Specific restrictions apply to patients undergoing radiologic procedures with contrast material or elective surgery, requiring temporary discontinuation of the medication. Older adults require cautious use with mandatory renal function monitoring.

What should I know about interactions with other medicines?

Reclimet Interactions with other medicines and products

Official regulatory information identifies specific substances and drug classes that interact with the Gliclazide and Metformin components, potentially requiring monitoring or leading to restrictions.

Interaction Classifications

Classification Example Substances/Classes Interaction Outcome
Contra-indicated Combination Miconazole (systemic or oromucosal gel) Documented to severely increase the hypoglycaemic effect of Gliclazide.
Timing-Based Restriction Iodinated Contrast Agents Requires temporary discontinuation of the Metformin component at the time of or prior to imaging, with a 48-hour withholding period post-procedure, pending re-evaluation of kidney function.
Not Recommended Combination Excessive Alcohol Potentiates the risk of lactic acidosis (Metformin component) and increases the risk of the hypoglycaemic reaction (Gliclazide component).

Documented Pharmacodynamic and Exposure Interactions

Interactions that affect blood glucose levels:

  • Increased Hypoglycemia Risk: Co-administration with other anti-diabetic agents (e.g., insulin, other sulfonylureas) or non-diabetic drugs such as Phenylbutazone, Fluconazole, Beta-blockers, and ACE Inhibitors can potentiate the blood glucose lowering effect of Gliclazide.
  • Reduced Glycemic Control: Substances with diabetogenic properties, including Danazol and Glucocorticoids, may cause an increase in blood glucose levels, potentially reducing the efficacy of Reclimet. The herbal product St. John's Wort is noted to decrease Gliclazide exposure.

Interactions affecting Metformin accumulation:

  • Reduced Metformin Elimination: Drugs that inhibit renal transport, such as Ranolazine, Vandetanib, Dolutegravir, and Cimetidine, may increase the accumulation of Metformin, which is associated with an elevated risk of lactic acidosis. This risk is also heightened in elderly patients due to the likelihood of reduced kidney function.

Mechanism of Action

The combination's mechanism involves a dual, complementary action that targets two distinct physiological processes: insulin secretion and insulin sensitivity.

Modulating Pancreatic Insulin Release

The Gliclazide component acts as an insulin secretagogue by binding to the SUR1 receptor on pancreatic beta-cells. This molecular interaction inhibits the KATP channel, causing the cell membrane to depolarize and triggering the release of pre-formed insulin. This rapid mechanistic sequence contributes to the availability of insulin to facilitate immediate glucose uptake, primarily influencing postprandial (after-meal) glucose dynamics.


Suppressing Hepatic Glucose Production

The Metformin component primarily engages the AMPK pathway, often initiated by the inhibition of Mitochondrial Complex I in the liver. AMPK activation then suppresses gene expression for key gluconeogenic enzymes. The resulting physiological effect results in a reduction of the liver’s endogenous glucose output, thereby influencing fasting and basal glucose concentrations.


Enhancing Peripheral Tissue Sensitivity

Beyond the liver, Metformin's AMPK-activating mechanism extends to muscle and fat tissues. This action promotes the translocation of glucose transporters ( GLUT4) to the cell surface, enhancing the tissues’ capacity to clear glucose from the bloodstream. This insulin-sensitizing effect promotes enhanced cellular utilization of glucose throughout the body.

Dosage and Administration Information

How Reclimet is Used

Reclimet, a fixed-dose combination of Gliclazide and Metformin, is prescribed for oral administration only. Its use is structured around achieving glucose control through a standardized, gradual approach.

Official Dosing and Administration

The treatment protocol begins with the lowest available dose to minimize potential intolerance to the Metformin component. Doses are not typically increased immediately; instead, they are subject to gradual upward titration, meaning adjustments are made step-by-step over time (e.g., at intervals of 1 month or more) based on the patient's blood glucose response. The maximum daily intake is limited by the individual components, such as up to 2000 mg of Metformin.

Administration Principle Labeled Instruction
Route and Form Oral tablet only; available in Immediate Release (IR) and Modified Release (MR).
Timing and Food Must be taken with meals to enhance tolerability and reduce the risk of hypoglycemia. MR forms are usually taken with the main meal.
Tablet Integrity Tablets must be swallowed whole and should not be crushed, broken, or chewed.

Frequency and Special Constraints

The Fixed-Dose Combination (FDC) is typically taken once or twice daily, depending on the specific formulation. If a dose is missed, it should not be doubled at the next scheduled time; the patient should simply continue with the next scheduled dose as usual. Reclimet must be temporarily discontinued before or during certain procedures, such as diagnostic imaging involving iodinated contrast agents or major surgical operations.

Additionally, the kidney function of older adults requires more frequent monitoring during use, and the drug is not authorized for use in the pediatric population.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Reclimet

Reclimet, a fixed-dose combination therapy containing Metformin and Glimepiride, was studied for use in adults with Type 2 Diabetes Mellitus to examine changes in blood sugar measurements. The available evidence, primarily from short-term controlled clinical trials, contributes to the broader evidence landscape. Research has explored various aspects of the combination, and findings describe patterns observed in the studies regarding blood sugar markers under specific trial conditions.

Evidence for Use in Studies of Type 2 Diabetes Mellitus

Studies explored the use of the Glimepiride/Metformin combination, often called fixed-dose combination (FDC) therapy, in adult patients with Type 2 Diabetes Mellitus. Researchers focused on outcomes related to systemic or functional imbalance, specifically measuring glycated hemoglobin A1c (HbA1c), Fasting Plasma Glucose (FPG), and Postprandial Glucose (PPG). These studies typically included patients whose glucose levels was observed in or were not adequately addressed by lifestyle changes or by Metformin alone.

Studies report how symptoms evolved in the observed populations, and the combination therapy was associated with measured changes in blood sugar levels. Specifically, trial reports described patterns where the use of the combination therapy was observed in some studies to coincide with measured changes in HbA1c and FPG measurements over the short-term study duration. Results apply only to the populations studied and research does not determine whether an individual will respond similarly.

Comparison with Other Treatments and Placebo

Research examined how the Glimepiride/Metformin combination was evaluated in relation to its individual components (Metformin monotherapy or Glimepiride monotherapy) and, in some cases, against an inactive substance (placebo). Some trials described patterns where the magnitude of change in HbA1c and FPG measurements differed when the combination was used compared to escalating the dose of Metformin alone (uptitration). In studies that included a placebo, findings describe patterns observed where the active combination was associated with different outcomes than the placebo group regarding blood glucose measurements. However, results apply only to the specific dosages and study settings under which they were conducted.

Long-Term Studies and Durability of Response

Findings help contextualize short-term changes, with many of the controlled trials having follow-up durations that were limited, often lasting six months to one year. Long-term effects are not fully established by dedicated, multi-year randomized controlled trials focusing specifically on the Reclimet combination product. Limited information is available for long-term outcomes, such as the patterns of occurrence of microvascular or macrovascular complications (like heart disease or kidney damage) in relation to the combination beyond the known long-term data for the individual components. Research is ongoing in the broader field of diabetes to better understand these outcomes.

What Remains Unclear or Requires More Research

The main limitations in the current evidence landscape include limited information for long-term outcomes that go beyond the two-year mark. Sample sizes were modest in some combination trials, and evidence quality varies across studies due to differences in design and populations. The available data are still emerging, and research is ongoing to provide more insight into long-term reporting of adverse events and the consistency of outcomes across diverse global populations and comorbidities.

Key Studies & References

  1. Long-term Cardiovascular Outcomes in Type 2 Diabetes Mellitus: The Role of Metformin and Sulfonylurea Components (Reference for Long-term data reliance)

Frequently Asked Questions (FAQ)

Common questions about Reclimet (FAQ)

Q: How is Reclimet different from plain Metformin?

A: Reclimet is a fixed-dose combination containing Metformin (a biguanide) and Gliclazide (a sulfonylurea). Metformin improves insulin sensitivity, while Gliclazide stimulates the pancreas to release more insulin. The combination provides a dual, complementary action for glycemic management, which is the rationale for its use when Metformin alone is insufficient.


Q: How long does it take for Reclimet to start working to lower blood sugar?

A: The Gliclazide component acts relatively quickly to stimulate insulin release, which immediately influences after-meal blood sugar. However, achieving stable blood sugar concentrations takes longer and is accomplished through dose adjustments over time. Official instructions require periodic monitoring to guide this process.


Q: Is it normal to have stomach issues when first starting Reclimet?

A: Yes, gastrointestinal disturbances like diarrhea, nausea, and abdominal pain are classified in regulatory documents as Very Common side effects. These effects are officially documented as being most frequent and often transient when treatment is initiated. The official product information states the medication must be taken with meals, as this step is designed to help minimize these issues and enhance tolerability.


Q: Can Reclimet interact with over-the-counter cold medicine?

A: Regulatory information identifies classes of drugs that interact with Reclimet. For example, some over-the-counter medicines may contain ingredients that can affect kidney function or potentiate the blood sugar-lowering effect of Gliclazide. All patients are instructed to inform their prescriber about all over-the-counter medicines they take for full evaluation of potential interactions.


Q: Is Reclimet safe for elderly patients?

A: Official prescribing information notes that use in older adults requires cautious monitoring. This is due to the potential for reduced kidney function, which can increase the risk of complications from the Metformin component. The regulatory instructions require more frequent monitoring of renal function for elderly patients.


Q: Why do doctors prescribe Reclimet instead of separate pills?

A: Reclimet is a fixed-dose combination (FDC) used to simplify the treatment regimen. Regulatory documents state the FDC is intended to combine two complementary anti-hyperglycemic effects into one tablet. This is a standard strategy for consolidating the treatment process.


Q: How long can someone typically stay on Reclimet?

A: The medication is intended for the long-term, chronic management of Type 2 Diabetes Mellitus. It may be continued as long as the therapeutic benefits are maintained and no official contraindications arise that require discontinuation. A healthcare provider is responsible for long-term monitoring.


Q: Does taking Reclimet mean I have to change my diet?

A: Yes. Official regulatory labeling specifies that Reclimet is intended to be used as an adjunct to diet and exercise. The medication works by supporting the body's natural glucose-controlling mechanisms, and it is not a substitute for maintaining a healthy lifestyle.


Q: Do people on Reclimet need to monitor their blood sugar more often?

A: Yes, regulatory documents require patients taking this medication to regularly monitor their blood sugar levels. This is essential due to the presence of Gliclazide, which is a sulfonylurea that carries an inherent risk of hypoglycemia (low blood sugar).


Q: What should I do if my blood sugar is still high while on Reclimet?

A: If blood sugar remains high, the official administration guidance is that the dose may be adjusted by a healthcare provider. High readings should be reported to the prescribing clinician for appropriate evaluation and guidance, as adjustments must be made gradually.


Q: Does Reclimet help with weight loss?

A: Official labeling for Reclimet focuses on glycemic control and does not list weight loss as an approved indication for the combination product. Any changes in body weight would be a secondary observation and not the primary function of the medication.


Q: Are there any vitamins or supplements I should avoid while taking Reclimet?

A: Official documents note that the herbal product St. John's Wort can decrease the concentration of the Gliclazide component in the body. Furthermore, the Metformin component is associated with a risk of Vitamin B12 deficiency/malabsorption with long-term use. A healthcare provider is responsible for evaluating the need for Vitamin B12 monitoring or supplementation.


Q: Will Reclimet cause me to feel tired or fatigued?

A: General fatigue is not listed as a common side effect in regulatory documents. However, tiredness and discomfort are potential symptoms associated with very rare but serious adverse reactions, such as Lactic Acidosis, or with hypoglycemia (low blood sugar). Any sudden or unusual tiredness should be reported to a healthcare professional.


Q: Is there a generic version of Reclimet available?

A: Yes. Fixed-dose combination products containing Gliclazide and Metformin are available generically. They may be marketed under various brand names, and availability depends on the specific formulation and region.


Q: Why does the packaging say 'Extended Release' or 'XR' sometimes?

A: The medication is available in both Immediate Release (IR) and Modified Release (MR) or Extended Release (XR) formulations. The MR/XR forms are designed to release the medication slowly over a longer period. This formulation is typically associated with better tolerability for the Metformin component and can allow for once-daily administration.


Q: Does Reclimet cure diabetes or just manage it?

A: Reclimet is a prescription medicine used for the management of Type 2 Diabetes Mellitus. According to official documents, the medication is intended to help control high blood sugar levels in adults but does not provide a cure for the condition.


Q: What kind of research supports the use of Reclimet for diabetes?

A: Regulatory approvals are based on data from controlled clinical trials. The official documentation indicates that studies focused on the combination therapy's ability to achieve and maintain clinically relevant changes in blood sugar measurements, particularly HbA1c (a long-term measure) and Fasting Plasma Glucose (FPG).


Q: Are there any long-term effects of taking Reclimet?

A: Official labeling notes that the risk of Vitamin B12 deficiency/malabsorption is associated with long-term exposure to the Metformin component. A healthcare provider is responsible for monitoring patients for the potential development of this deficiency over the long term.


Q: What if I experience diarrhea that doesn't go away while taking Reclimet?

A: Diarrhea is a common side effect that is usually temporary. However, persistent or severe diarrhea should be reported to a healthcare provider for prompt evaluation. Such symptoms require medical attention as they may be signs of a metabolic issue or lead to dehydration.


Q: Does Reclimet cause metallic taste in the mouth?

A: Yes, official regulatory labeling lists taste disturbance or a metallic taste in the mouth as a common side effect associated with the Metformin component of the medication.


Q: Can Reclimet affect my cholesterol levels?

A: Official product information focuses on glycemic control. Cholesterol changes are not officially listed as a primary side effect or safety warning for the combination product, though the Metformin component is known to affect lipid metabolism.


Q: Does Reclimet help with insulin resistance?

A: Yes. The Metformin component of Reclimet is known to enhance the body’s sensitivity to insulin. This mechanism, called the insulin-sensitizing effect, directly addresses the condition known as insulin resistance.


Q: Is it common for my doctor to adjust the dose after I start Reclimet?

A: Yes. The standard administration protocol involves starting with the lowest effective dose. The dose is then subject to gradual upward titration (step-by-step adjustments) over time based on the patient's measured blood glucose response and tolerability.


Q: Why is Reclimet often given as a second-line treatment?

A: Reclimet is typically prescribed when patients have not achieved adequate blood sugar control with diet, exercise, and treatment using only a single anti-diabetic agent (monotherapy). Official indications position it as a step-up or second-line therapy.


Q: Does Reclimet cause headaches?

A: Regulatory documents list headaches as a possible adverse reaction, though they are not categorized as one of the most common side effects. Headaches may also be a sign of low blood sugar (hypoglycemia).


Q: Can Reclimet affect my appetite?

A: Yes. Loss of appetite or decreased appetite is officially listed as a common gastrointestinal side effect associated with the Metformin component of Reclimet.


Q: What is the success rate of Reclimet in managing A1C?

A: Official documentation reports patterns where clinical studies showed that the combination therapy was associated with measured changes in HbA1c (A1C) and Fasting Plasma Glucose. A single 'success rate' percentage that applies to all patients is not provided, as individual results can vary.


Q: Can Reclimet make me sweat more?

A: Yes. Increased sweating is a recognized and documented sign of hypoglycemia (low blood sugar), which is a common side effect of the Gliclazide component. This symptom requires blood sugar monitoring, as increased sweating is a recognized sign of low blood sugar (hypoglycemia).


Q: Are there common skin issues associated with Reclimet?

A: Yes. Regulatory documents list various dermatological reactions as possible side effects. These can include skin reactions such as rash, pruritus (itching), and urticaria (hives).

How should Reclimet be stored and disposed of?

How to Store and Dispose of Reclimet

Reclimet tablets must be stored according to regulatory requirements to ensure potency and integrity. Store the medicine at room temperature, specifically not exceeding 25°C (77°F), and keep it from freezing. The container must be kept tightly closed in a dry place and protected from light and moisture. As a mandatory safety measure, the product must be stored out of the reach of children and pets.

Disposal Instructions

Expired or unused Reclimet should be disposed of via an official drug take-back program or authorized collection site. If a take-back option is unavailable, the medicine is not to be flushed down the toilet. For household disposal, tablets should be mixed with an unappealing substance, sealed in a bag, and then placed in the trash.

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

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