Anhe

Quick links to important sections

Medically reviewed

Laura Arias

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 Anhe

This foundational section defines the medicine Anhe, detailing its composition, classification, and general purpose.

Property Description
Active ingredient Glibenclamide, Metformin Hydrochloride
Form Tablet (Fixed-Dose Combination, FDC)
Pharmacological class Oral Antihyperglycemic Agent
Common use Management of high blood sugar in type 2 diabetes mellitus
Origin Synthetic

What Type of Medicine is Anhe?

Anhe is classified as an oral antihyperglycemic agent and is provided as a prescription-only medicine for adult patients. It is specifically structured as a fixed-dose combination (FDC) product, meaning it integrates two different active components into a single dosage unit. This composition places it within the broad therapeutic category of blood glucose lowering agents, distinguishing its dual strategy from single-ingredient treatments. This combination approach is used for patients who require more than one mechanism to achieve blood sugar control.

Active Ingredients and Composition of Anhe

Anhe is formulated as a tablet for oral administration and contains the two key active ingredients / chemical substances: Glibenclamide and Metformin Hydrochloride (Metformin). Glibenclamide belongs to the sulfonylurea class, while Metformin is the primary agent in the biguanide class, which improves the body's response to insulin. This confirmed composition offers a comprehensive approach to blood sugar management. Both active components are synthetic compounds, ensuring pharmaceutical consistency within the oral dosage form. Other popular FDC brands containing the same INN formulation include Glucovance and Glibomet, positioning Anhe as a widely recognized therapeutic option.

The General Purpose of Anhe’s Dual Action

The general purpose of Anhe is to utilize its inherent dual mechanism of action to achieve a powerful synergistic effect in stabilizing blood sugar levels. This strategy is essential for type 2 diabetes mellitus management, as it addresses both insulin secretion and insulin resistance simultaneously. This comprehensive action is designed to maintain a healthier glucose balance for the patient.

What side effects are possible with Anhe?

Possible Side Effects and Safety Information

The safety profile of Anhe, a fixed-dose combination of Glibenclamide and Metformin, is defined by regulatory agencies based on the known risks of its two active components. Official documentation classifies adverse reactions by frequency and the body system affected, ensuring a neutral communication of possible risks.


Adverse Reaction Categories

Common adverse reactions, defined as those frequently observed in clinical trials, primarily involve Gastrointestinal Disorders. These include diarrhea, nausea, vomiting, and abdominal pain, often reported at the start of treatment. Other common effects include headache and dizziness (Nervous System Disorders)

.

Serious adverse reactions, while rare, are explicitly documented and center on metabolic risks:

  • Lactic Acidosis: This is a very rare but severe metabolic complication associated with the Metformin component, with increased risk in the presence of certain conditions.
  • Severe Hypoglycaemia: The potential for dangerously low blood sugar is linked to the Glibenclamide component, affecting Metabolism and Nutrition Disorders.

Population-Specific Safety Constraints

The official label mandates specific safety constraints for certain patient groups and conditions. The risk of Lactic Acidosis increases significantly in individuals with renal impairment; consequently, the medicine is restricted or contraindicated in cases of severe kidney dysfunction. Caution is also warranted for elderly patients and those with hepatic impairment. The label also notes that conditions causing tissue hypoxia (e.g., cardiac failure) or procedures using iodinated contrast materials require specific safety management. Furthermore, the risk of Vitamin B12 deficiency is associated with long-term exposure to the Metformin component.

Overdose and Emergency Response

Overdose Manifestations and Severe Outcomes

Overdose of Anhe (Glibenclamide/Metformin) is characterized by two primary, severe metabolic states documented in regulatory sources. The Glibenclamide component poses a risk of Profound Hypoglycemia (low blood sugar), which may present with anxiety, confusion, tremors, sweating, seizures, or coma. The Metformin component carries the risk of Lactic Acidosis, a potentially life-threatening complication associated with symptoms like deep, rapid breathing (hyperpnoea), severe muscle pain, weakness, and cardiovascular collapse. This risk is notably increased in patients with impaired renal function due to reduced drug clearance, as stated in official labeling.

When Immediate Medical Help is Required

Regulatory documents mandate specific immediate actions. The medication must be stopped immediately if symptoms suggestive of Lactic Acidosis occur. Urgent medical attention is required if the patient has collapsed, experienced a seizure, has trouble breathing, or cannot be awakened. Such manifestations constitute a medical emergency requiring immediate hospitalization.

While no specific antidote is known for Lactic Acidosis, management procedures officially described include immediate administration of intravenous glucose for severe hypoglycemia, and hemodialysis for Metformin removal and correction of severe acidosis. Patients typically require prolonged hospital observation, often for 24 hours or more, to monitor for recurring hypoglycemia.

Therapeutic Uses of Anhe

What Anhe Treats: Main Uses and Benefits

Anhe (Glibenclamide/Metformin) is a combination oral anti-diabetic agent relevant for the long-term, chronic management of Type 2 Diabetes Mellitus. Its therapeutic focus plays a role in managing consistent glycemic stability for adult patients. This combination is applied when a patient's Type 2 Diabetes is not adequately managed by diet and exercise alone.

It is generally introduced in clinical situations where the condition requires additional symptomatic support to address the core symptomatic pattern of elevated blood glucose markers. Anhe assists with controlling inadequate blood sugar levels, Support for Long-Term Stability, and Simplification of the Treatment Regimen.


Quick Fact: Support for Managing Elevated Glucose Markers

This medication is applied in situations where symptoms related to systemic imbalance persist, which commonly includes high HbA1c readings and persistently high fasting and postprandial blood sugar. The primary benefit assists with working toward individualized, long-term glucose targets and supports general well-being during symptomatic phases. This dual therapy is relevant when groups of symptoms, particularly high glucose levels, require combined therapeutic support after initial monotherapy is considered no longer appropriate. The fixed-dose combination (FDC) structure offers a distinct practical benefit by reducing the daily pill burden for individuals with chronic conditions. This convenience assists with improved patient adherence to the prescribed treatment plan, which generally assists with maintaining functional stability.

Regulatory References

  1. NIH MedlinePlus overview on Glyburide and Metformin

Eligibility and Restrictions for Use

The eligibility for using Anhe (Glibenclamide/Metformin) is strictly defined by regulatory documents, which permit its use only in adult patients with Type 2 Diabetes Mellitus. Eligibility is constrained by specific medical conditions and organ function:


Contraindicated Populations (Must Not Use)

Contraindication Basis
Severe Renal Impairment eGFR below 30 mL/min/1.73 m^2.
Acute Metabolic Acidosis Includes diabetic ketoacidosis and lactic acidosis.
Severe Hepatic Failure Non-eligibility due to metabolic risk.
Hypersensitivity To Metformin, Glibenclamide, or other sulfonamides.
Pregnancy/Lactation Use is officially contraindicated or not recommended.

Age and Condition-Based Restrictions

Use is not recommended in the pediatric population (under 18 years) as safety and efficacy have not been established. Use in older adults requires caution and close monitoring of kidney function.

Temporary discontinuation of the medicine is required before or at the time of procedures involving intravascular iodinated contrast media or major surgery, and use should only be reinstituted after renal function is confirmed to be normal.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

The interaction profile for Anhe (Glibenclamide/Metformin Hydrochloride) is defined by pharmacokinetic and pharmacodynamic constraints documented in regulatory sources.

Pharmacokinetic and Pharmacodynamic Interactions

Classification Interacting Entity / Category
Exposure Modification (Accumulation) Drugs that inhibit renal tubular secretion (e.g., Cimetidine, Ranolazine) may increase Metformin systemic exposure.
Absorption Alteration Colesevelam reduces the absorption of the Glibenclamide component, requiring a mandatory 4-hour separation window.
Pharmacodynamic Synergy Insulin and other Insulin Secretagogues increase the risk of additive hypoglycemic effects.
Metabolic Risk Potentiation Excessive Alcohol or Carbonic Anhydrase Inhibitors (e.g., Topiramate) potentiate the effect of Metformin on lactate metabolism, increasing the risk of lactic acidosis.

Procedural and Population-Specific Restrictions

The regulatory documents establish strict restrictions for procedures involving Iodinated Contrast Agents, which necessitate the temporary discontinuation of Anhe to manage the high risk of acute renal injury and subsequent drug accumulation. Additionally, Elderly Patients (age 65 or greater) and patients with Impaired Renal Function have a documented heightened risk of accumulation and interaction-induced lactic acidosis.

Mechanism of Action

How Anhe Works: A Dual Mechanistic Strategy

Anhe utilizes two distinct and complementary mechanisms of action, influencing molecular pathways governing glucose homeostasis.


Pancreatic Ion Channel Modulation for Insulin Secretion

The Glibenclamide component initiates the mechanism by acting as a secretagogue, engaging the Sulfonylurea Receptor 1 ( SUR1) on the pancreatic beta-cell membrane. This molecular binding causes the immediate closure and inhibition of the K ATP ion channel, initiating a rapid cellular depolarization cascade. The resulting influx of calcium triggers the fusion and exocytosis of pre-formed insulin granules, leading to an increase in circulating endogenous insulin concentration which results in increased glucose uptake by tissues.


Hepatic Enzyme Regulation and Insulin Sensitization

The Metformin component employs a distinct anti-gluconeogenic and sensitizing mechanism, primarily by influencing the cellular energy state via mitochondrial Complex I inhibition. This cascade leads to the activation of AMP-activated protein kinase ( AMPK), an enzyme that suppresses the activity of key gluconeogenic enzymes in the liver. The physiological consequence is a reduction in hepatic glucose output coupled with an enhancement of peripheral insulin sensitivity in muscle and adipose tissue.


Synergistic Modulation of Glucose Homeostasis

The combination of the two mechanisms supports a comprehensive modulation of the glucose regulatory system. While Glibenclamide rapidly boosts insulin supply, Metformin enhances the physiological response to circulating insulin and limits new glucose synthesis, resulting in a coordinated physiological effect on glucose regulatory pathways.

Dosage and Administration Information

How to Use Anhe: Official Administration Guidelines

Anhe, a fixed-dose combination (FDC) tablet containing Glibenclamide and Metformin Hydrochloride, is used following specific procedural requirements. Its use is standardized based on an oral route of administration and an established schedule for long-term chronic management.


Administration Scope

Feature Official Regulatory Guideline
Route of administration Oral administration only.
Timing in relation to meals Tablets must be taken with meals. Intake should be followed by a meal with sufficient carbohydrate content.

Labeled Dosing and Schedule

Administration begins with the lowest effective dose, typically 1.25 mg/250 mg (Glibenclamide/Metformin HCl) once or twice daily. The dose is adjusted (titrated) in incremental steps, generally performed every 2 weeks or longer, based on assessment. Maintenance dosing is typically administered in divided doses, twice daily. The official maximum daily dosage is 20 mg of Glibenclamide and 2000 mg of Metformin HCl.


Special Procedural and Population Constraints

The official protocol details specific constraints for certain populations and procedural steps. If a dose is missed, it should be skipped to avoid double dosing, and the regular schedule should be resumed with the next planned dose. For older adults, a conservative dosage adjustment is required. Furthermore, use is not recommended in patients with clinical evidence of hepatic impairment and is prohibited (contraindicated) for those with severe renal impairment (eGFR <30 mL/min/1.73 m^2). These constraints ensure the standardized use aligns with established parameters.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Anhe


Evidence for Use in Type 2 Diabetes Mellitus (T2DM)

The primary body of research for Anhe, the fixed-dose combination of Glibenclamide and Metformin, consists of Randomized Controlled Trials (RCTs). These short- to intermediate-term studies were used in research exploring how high blood sugar is managed in adult patients with Type 2 Diabetes Mellitus (T2DM). The studies examined patients whose condition was not adequately managed by lifestyle changes alone, or those who had experienced treatment failure using only one of the active ingredients as monotherapy. Research specifically monitored how key biomarkers, such as Glycated Hemoglobin ( HbA1 c), Fasting Plasma Glucose (FPG), and Postprandial Glucose (PPG), changed over defined time intervals.

When researchers compared the FDC to using only a single ingredient, studies suggest that studies reported measurements of HbA1 c values that were lower in the combination group compared to the control groups. Studies report how these key sugar markers evolved in the observed populations during the study period. This evidence contributes to the broader evidence landscape by providing context about the use of two different medicines combined into one tablet for the chronic management of T2DM.

Comparing the Fixed-Dose Combination to Single-Ingredient Treatments

Studies specifically explored the differences between taking the two ingredients together in one tablet versus taking Metformin alone or Glibenclamide alone. These trials were designed to examine outcomes related to systemic or functional imbalance in blood sugar. Research highlights measured changes during the study period, indicating that the use of both agents simultaneously, as studied, was associated with patterns of larger changes in FPG and PPG concentrations. Furthermore, trials described patterns where the percentage of patients achieving defined glycemic targets was higher in the combination group compared to monotherapy groups. Studies report how the simplified dosing schedule was observed in some studies to be associated with higher reported patient adherence to the prescribed regimen compared to scenarios where patients took the two active ingredients as separate pills.


Long-Term Studies and Follow-Up

The core evidence used for regulatory purposes focuses mainly on short- to intermediate-term study durations, typically ranging up to 52 weeks (one year). These research scenarios primarily explore short-term symptom changes and the immediate impact on blood sugar biomarkers. Research provides insight into short-term changes in HbA1 c and related markers, which contributes to understanding symptom patterns and maintaining a healthier glucose balance.

However, long-term effects are not fully established beyond these initial follow-up durations. There is limited information for long-term outcomes regarding the FDC's specific impact on the progression of major macrovascular or microvascular complications associated with long-term diabetes. Existing studies provide limited insight into how the combination pill affects these critical long-term health outcomes.


Evidence in Specific Patient Groups

Research explored different study populations, including patients who were treatment-naïve and those who were not achieving their blood sugar goals. Results apply only to the populations studied, which were predominantly adults with established T2DM.

Data for certain groups remain insufficient. For instance, evidence is limited for specific subsets of the population, such as older adults with multiple other health conditions (comorbidities). Because Type 2 Diabetes is a progressive condition, research notes the fixed-dose nature was associated with reduced flexibility in dose titration, which was a consideration in the study design. Research does not determine whether an individual will respond similarly to the group patterns observed in these studies.


What Research Gaps and Uncertainties Remain

While the available evidence contributes to understanding symptom patterns, several research limitation frames are acknowledged in the scientific literature. Follow-up durations were limited in many primary trials, meaning that a clear picture of the combination's effects over many years is not fully developed. Subgroup findings are uncertain for specific patient profiles where more targeted data would be beneficial.

Another uncertainty relates to the flexibility of the dosing. Since Anhe is a fixed-dose combination, the available research may not fully address the optimal approach for patients requiring frequent or fine-tuned adjustments to the dosages of the individual components. Research provides context but not individual predictions, and the findings describe group patterns, not guaranteed personal outcomes. These limitations highlight areas where future research is needed to provide more comprehensive long-term data.

Frequently Asked Questions (FAQ)

Common questions about Anhe (FAQ)

Q: Can Anhe cause unusual mood changes or sleeplessness?

Official product information indicates that common side effects primarily affect the gastrointestinal and nervous systems. These reactions commonly include headache and dizziness. Unusual mood changes or sleeplessness (insomnia) are not typically listed in the medicine’s primary adverse reaction profile provided by regulatory agencies.

Q: How common are serious side effects from Anhe?

According to regulatory documents, Lactic Acidosis, a severe complication associated with the Metformin component, is described as very rare. The Glibenclamide component also carries a known risk of causing severe low blood sugar (hypoglycaemia). Official information details these risks, but the specific frequency data can vary depending on the patient group studied.

Q: Can taking Anhe affect my appetite or weight?

Official product summaries indicate that some patients may experience changes related to their weight and appetite, which is associated with the Metformin component. Additionally, common side effects include gastrointestinal issues such as nausea and vomiting, particularly when treatment is initiated.

Q: Is Anhe known to cause interactions with common vitamins or supplements?

Regulatory documents state that long-term use of the Metformin component is associated with a possible decrease in Vitamin B12 levels in some individuals. Regulatory documents also address the importance of considering all vitamins and supplements that a person is taking.

Q: Are there special considerations for young adults taking Anhe?

Anhe is not recommended for use in the pediatric population (patients under 18 years old) as safety and effectiveness have not been established. For all adult patients, use is generally standardized, but regulatory caution is warranted and requires regular monitoring of organ function.

Q: Is Anhe found in breast milk if a mother is taking it?

Official product information states that the active components of Anhe are secreted into breast milk. Therefore, due to this transfer, the medicine is officially contraindicated (must not be used) or not recommended during the period of lactation.

Q: How is Anhe eliminated from the body?

The body eliminates the active ingredients primarily through the action of the kidneys. This process, known as renal excretion, is the main route for removing the Metformin component. This is why official guidelines require careful monitoring of kidney function during use.

Q: Is Anhe absorbed better if I take it at a certain time of day?

Regulatory guidelines specify that the tablets should be taken with meals to standardize absorption. The official documents do not specify a difference in absorption based on whether the dose is taken in the morning or evening, as long as the meal requirement is met.

Q: What does 'contraindication' mean regarding Anhe?

A contraindication is a specific medical condition or situation where the medicine must not be used. Regulatory documents define this as a state where the potential risks of the drug significantly outweigh any possible benefit for that individual, such as having severe kidney impairment or a known allergy to the ingredients.

Q: Is it normal to feel tired during the first few weeks on Anhe?

While many common side effects are listed, regulatory summaries do not explicitly include general tiredness (fatigue) as a common adverse reaction. The most commonly listed effects are related to the gastrointestinal system, as well as headache and dizziness.

Q: Why do some people need blood tests while they are on Anhe?

Monitoring with blood tests is necessary according to official documents for specific safety reasons. These tests help to assess kidney function (which prevents the drug from building up) and also check for the possible long-term risk of Vitamin B12 deficiency.

Q: What should I do if a side effect from Anhe doesn't go away?

Official patient information states that a healthcare provider should be consulted if side effects are persistent, worsen over time, or become serious. A healthcare professional can then review the situation and provide guidance.

Q: Can I take Anhe with my regular pain relievers?

The drug interaction profile listed in regulatory documents focuses on specific medications that could affect kidney function or lactate metabolism. Common over-the-counter pain relievers are not generally listed in the specific, critical drug interactions that are prohibited.

Q: Can I drive or operate machinery while taking Anhe?

Official product information notes that the risk of hypoglycemia (low blood sugar) may affect a person's ability to drive or operate machinery. Symptoms of low blood sugar, such as dizziness or impaired concentration, are listed as potential issues that may impact these activities.

Q: Does Anhe have a 'black box warning' from the FDA?

The Metformin component of Anhe is associated with a specific Boxed Warning (also called a Black Box Warning) issued by the FDA. This warning highlights the potential for Lactic Acidosis, which is a rare but severe metabolic complication.

Q: Is Anhe a controlled substance or addictive in any way?

According to regulatory classification documents, Anhe is not a controlled substance. Furthermore, the active components have no known potential for addiction or dependence as defined by official regulatory bodies.

Q: How long does the effect of one dose of Anhe usually last?

The official dosing schedule is typically twice daily, which is determined by how long the medicine takes to be processed and eliminated by the body. This schedule provides an indication of the general duration of the effect.

How should Anhe be stored and disposed of?

How to Store and Dispose of Anhe?

Anhe (Glibenclamide/Metformin) must be stored strictly according to the conditions defined in the official labeling to maintain product stability and quality. The tablets should be kept at controlled room temperature, typically between 20 C and 25 C. It is mandatory to protect the medicine from moisture and to store it away from excessive heat. Do not refrigerate or freeze Anhe.

Storage Requirement Condition
Temperature Controlled Room Temperature (20 C - 25 C)
Container Keep in original container, tightly closed
Protection Protect from moisture and excessive heat
Child Safety Store out of the sight and reach of children

For disposal, unused or expired Anhe must not be flushed down the toilet or placed in household trash. Always use an official medicine take-back program or follow local pharmaceutical waste regulations for proper disposal.

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

Available in countries:

Equivalent of Anhe found in:

A-Z Index: