Mifomet: Uses, Dosage & Side Effects
A fixed-dose combination of vildagliptin (DPP-4 inhibitor) and metformin (biguanide) for the treatment of type 2 diabetes mellitus in adults
Mifomet is a prescription oral medication that combines two active substances—vildagliptin (50 mg) and metformin hydrochloride (850 mg)—in a single film-coated tablet for the treatment of type 2 diabetes mellitus in adults. Vildagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that enhances the body’s own incretin system to improve blood sugar control, while metformin is a biguanide that reduces hepatic glucose production and improves insulin sensitivity. This dual-action combination targets multiple pathways involved in glucose regulation, providing more effective glycaemic control than either component alone. Mifomet is typically prescribed when diet, exercise, and metformin monotherapy are insufficient to adequately control blood glucose levels.
Quick Facts: Mifomet
Key Takeaways
- Mifomet combines vildagliptin (a DPP-4 inhibitor) and metformin (a biguanide) in one tablet, simplifying treatment for adults with type 2 diabetes whose blood sugar is not adequately controlled by metformin alone.
- The recommended dose is one tablet (50 mg/850 mg) taken twice daily with meals, providing 100 mg of vildagliptin and 1,700 mg of metformin per day.
- The combination has a low risk of hypoglycaemia because vildagliptin works in a glucose-dependent manner and metformin does not stimulate insulin secretion directly.
- Liver function tests should be performed before starting treatment and monitored regularly during the first year, as vildagliptin has been rarely associated with liver enzyme elevations.
- Mifomet should not be used in patients with severe kidney impairment (eGFR <30 mL/min), severe liver disease, or conditions predisposing to lactic acidosis, and must be temporarily discontinued before iodinated contrast procedures.
What Is Mifomet and What Is It Used For?
Mifomet is a fixed-dose combination tablet that contains two distinct antidiabetic agents: vildagliptin (50 mg) and metformin hydrochloride (850 mg). Both substances belong to different pharmacological classes and work through different mechanisms to improve glycaemic control in adults with type 2 diabetes mellitus (T2DM). By combining these two agents into a single tablet, Mifomet simplifies the treatment regimen for patients who would otherwise need to take each medication separately, improving adherence and convenience without compromising efficacy.
Type 2 diabetes mellitus is a chronic metabolic disorder characterised by insulin resistance and progressive beta-cell dysfunction, leading to elevated blood glucose levels (hyperglycaemia). According to the International Diabetes Federation (IDF), approximately 537 million adults worldwide were living with diabetes in 2021, and this number is projected to reach 783 million by 2045. The vast majority of these cases (over 90%) are type 2 diabetes. Uncontrolled hyperglycaemia over time leads to serious microvascular complications (retinopathy, nephropathy, neuropathy) and macrovascular complications (cardiovascular disease, stroke, peripheral artery disease). Effective blood glucose management is therefore critical for reducing these long-term complications and improving quality of life.
Vildagliptin is a potent and selective inhibitor of the enzyme dipeptidyl peptidase-4 (DPP-4). DPP-4 is responsible for the rapid degradation of incretin hormones, specifically glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). These incretin hormones are released from the gut after eating and play a crucial role in glucose homeostasis: GLP-1 stimulates insulin secretion from pancreatic beta cells in a glucose-dependent manner, suppresses inappropriate glucagon secretion from alpha cells, slows gastric emptying, and promotes satiety. By inhibiting DPP-4, vildagliptin prevents the breakdown of GLP-1 and GIP, thereby increasing their circulating levels by approximately two- to three-fold. This results in enhanced insulin secretion when blood glucose is elevated, reduced glucagon release (which decreases hepatic glucose output), and improved overall glycaemic control—all without an increased risk of hypoglycaemia, because the insulin-stimulating effect diminishes as blood glucose normalises.
Metformin hydrochloride is a biguanide and has been the cornerstone of type 2 diabetes pharmacotherapy for over six decades. Metformin works primarily by reducing hepatic glucose production (gluconeogenesis), which is abnormally elevated in type 2 diabetes. It also reduces the intestinal absorption of glucose and improves insulin sensitivity by increasing peripheral glucose uptake and utilisation, particularly in skeletal muscle. Unlike sulfonylureas or insulin, metformin does not directly stimulate insulin secretion and therefore carries a very low risk of hypoglycaemia when used as monotherapy. Additionally, metformin is weight-neutral or may even promote modest weight loss, making it particularly suitable for the majority of type 2 diabetes patients who are overweight or obese. Metformin has also been shown to have cardiovascular benefits, with the landmark UK Prospective Diabetes Study (UKPDS) demonstrating reduced cardiovascular events and all-cause mortality in overweight patients treated with metformin compared with other glucose-lowering therapies.
The rationale for combining vildagliptin and metformin lies in their complementary mechanisms of action. While metformin reduces hepatic glucose production and improves insulin sensitivity, vildagliptin enhances the incretin effect to improve both insulin secretion and glucagon regulation. Clinical studies have consistently demonstrated that the combination of vildagliptin and metformin provides superior HbA1c reduction compared with either agent alone. In pivotal clinical trials, the addition of vildagliptin 50 mg twice daily to metformin resulted in a mean HbA1c reduction of approximately 0.7–1.1 percentage points from baseline, compared with approximately 0.3–0.5 percentage points with metformin alone. Furthermore, the combination has been shown to improve fasting and postprandial glucose levels without increasing the risk of hypoglycaemia or causing clinically significant weight gain.
Mifomet is indicated for the treatment of type 2 diabetes mellitus in adults, specifically in the following situations:
- Add-on to metformin: For patients whose blood glucose is inadequately controlled with the maximum tolerated dose of metformin monotherapy, in conjunction with diet and exercise.
- Substitution therapy: For patients who are already being treated with vildagliptin and metformin as separate tablets and wish to consolidate their treatment into a single combination tablet.
- Combination with other agents: Mifomet may also be used in combination with a sulfonylurea or with insulin when dual therapy with metformin and one of these agents does not provide adequate glycaemic control (triple therapy).
Type 2 diabetes is a progressive disease, and most patients will eventually require more than one medication to maintain adequate blood glucose control. International guidelines, including the ADA–EASD consensus report, recommend early combination therapy when metformin monotherapy is insufficient. By targeting multiple pathophysiological pathways simultaneously, the vildagliptin–metformin combination provides more comprehensive glucose-lowering efficacy while maintaining a favourable safety profile, including a low risk of hypoglycaemia and weight neutrality.
What Should You Know Before Taking Mifomet?
Contraindications
Mifomet must not be used in the following situations:
- Hypersensitivity: Known allergy to vildagliptin, metformin hydrochloride, or any of the excipients listed in the composition.
- Diabetic ketoacidosis or diabetic pre-coma: Mifomet is not appropriate for managing these acute metabolic emergencies, which require insulin therapy.
- Moderate to severe renal impairment: Patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m² should not use Mifomet due to the risk of metformin accumulation and lactic acidosis. In patients with eGFR between 30 and 45 mL/min/1.73 m², initiation of Mifomet is not recommended, though it may be continued with caution and reduced dosing in patients already stabilised on it.
- Acute conditions with the potential to alter renal function: Dehydration, severe infection, shock, or intravascular administration of iodinated contrast agents. Mifomet should be temporarily discontinued in these situations.
- Acute or chronic disease that may cause tissue hypoxia: Cardiac or respiratory failure, recent myocardial infarction, or shock.
- Hepatic impairment: Patients with severely impaired liver function should not use Mifomet because elevated hepatic enzymes have been associated with vildagliptin, and liver disease can predispose to lactic acidosis from metformin.
- Excessive alcohol intake: Chronic or acute alcohol intoxication increases the risk of lactic acidosis with metformin.
- Type 1 diabetes: Mifomet is not indicated for type 1 diabetes, as these patients require insulin for glycaemic control.
Warnings and Precautions
Lactic acidosis is a very rare but potentially fatal metabolic complication caused by metformin accumulation. Risk factors include severe renal impairment, dehydration, excessive alcohol intake, hepatic insufficiency, uncontrolled diabetes, and any condition associated with tissue hypoxia. Seek immediate medical attention if you experience rapid breathing, muscle cramps, abdominal pain, feeling cold, or unusual drowsiness, as these may be signs of lactic acidosis.
Before starting Mifomet and regularly during treatment, your doctor should monitor the following:
- Kidney function: eGFR should be assessed before initiation and at least once a year thereafter (more frequently in patients with eGFR approaching 45 mL/min/1.73 m² or in the elderly). Metformin is contraindicated at eGFR below 30 mL/min/1.73 m².
- Liver function: Liver function tests (LFTs) including transaminases (AST, ALT) should be performed before starting vildagliptin-containing therapy, every three months during the first year, and periodically thereafter. If AST or ALT exceeds three times the upper limit of normal (3× ULN) on two consecutive measurements, Mifomet should be discontinued. Rare cases of hepatitis (including fatalities) have been reported with vildagliptin.
- Vitamin B12 levels: Long-term metformin therapy has been associated with decreased vitamin B12 absorption in up to 30% of patients. Periodic monitoring is recommended, particularly in patients with megaloblastic anaemia or peripheral neuropathy.
- Surgical procedures: Mifomet must be discontinued at least 48 hours before elective surgical procedures performed under general, spinal, or epidural anaesthesia. Treatment may be resumed no earlier than 48 hours after the procedure, provided renal function has been confirmed to be stable.
- Iodinated contrast agents: Intravascular administration of iodinated contrast media may lead to contrast-induced nephropathy, which in combination with metformin can increase the risk of lactic acidosis. Mifomet should be discontinued before or at the time of the imaging procedure and restarted no earlier than 48 hours afterwards, only if renal function has been reassessed and found to be stable.
Pregnancy and Breastfeeding
Mifomet should not be used during pregnancy. There are no adequate data on the use of vildagliptin in pregnant women. Animal studies with vildagliptin have shown reproductive toxicity at high doses. Metformin crosses the placenta, and while some data suggest it may be used in gestational diabetes under specialist supervision, the combination product Mifomet is not recommended during pregnancy. If pregnancy is planned or occurs, treatment should be switched to insulin to maintain adequate blood glucose control, as uncontrolled diabetes during pregnancy carries significant risks for both the mother and the developing foetus, including congenital malformations, macrosomia, neonatal hypoglycaemia, and pre-eclampsia.
It is not known whether vildagliptin is excreted in human breast milk. Studies in lactating rats have shown that vildagliptin and its metabolites are excreted in milk. Metformin is excreted in human breast milk in small amounts. Due to the potential risk to the breastfed infant and insufficient human data, Mifomet should not be used during breastfeeding. Women who require antidiabetic treatment while breastfeeding should discuss alternative options with their healthcare provider.
Children and Adolescents
Mifomet is not recommended for use in children and adolescents below 18 years of age. The safety and efficacy of this combination have not been established in the paediatric population. Type 2 diabetes in children and adolescents, although increasingly prevalent, requires age-appropriate treatment strategies that have been specifically studied in this population.
Elderly Patients
Mifomet can be used in elderly patients; however, dose selection should be cautious, reflecting the greater frequency of decreased renal and hepatic function in this age group. Renal function should be monitored regularly (at least every 3–6 months) in patients aged 65 years and older, as age-related decline in kidney function increases the risk of metformin accumulation and lactic acidosis. The maximum recommended dose of metformin in elderly patients is typically lower, depending on renal function.
How Does Mifomet Interact with Other Drugs?
Drug interactions with Mifomet are primarily driven by its metformin component, which is eliminated unchanged by the kidneys, and to a lesser extent by vildagliptin. Understanding these interactions is important for safe and effective use, particularly in patients who take multiple medications for diabetes-related comorbidities such as hypertension, cardiovascular disease, and dyslipidaemia.
Vildagliptin has a relatively favourable drug interaction profile. It is not a substrate, inhibitor, or inducer of cytochrome P450 (CYP) enzymes and is primarily hydrolysed by non-CYP enzymes. No clinically significant pharmacokinetic interactions have been identified between vildagliptin and commonly co-administered drugs including metformin, pioglitazone, glyburide/glibenclamide, amlodipine, digoxin, ramipril, simvastatin, valsartan, and warfarin.
Metformin, on the other hand, has several important interactions, particularly with agents that affect renal function or that can induce lactic acidosis. The following table summarises the key drug interactions:
| Drug / Category | Nature of Interaction | Clinical Action |
|---|---|---|
| Iodinated contrast agents | Risk of contrast-induced nephropathy leading to metformin accumulation and lactic acidosis | Discontinue Mifomet before procedure; restart after 48 hours if renal function is stable |
| Alcohol | Increased risk of lactic acidosis due to potentiation of metformin’s effect on lactate metabolism | Avoid excessive alcohol intake; abstain during acute intoxication |
| ACE inhibitors (e.g., ramipril, enalapril) | May reduce blood glucose levels and enhance hypoglycaemic effect | Monitor blood glucose; dose adjustment may be needed |
| Diuretics (especially loop diuretics) | May impair renal function and increase risk of lactic acidosis; may raise blood glucose | Monitor renal function and blood glucose closely |
| Corticosteroids (systemic) | Can cause hyperglycaemia and reduce effectiveness of Mifomet | Monitor blood glucose; increased antidiabetic dosing may be necessary |
| Thyroid hormones | May increase blood glucose levels | Monitor blood glucose when initiating or adjusting thyroid medication |
| Cationic drugs (e.g., cimetidine, amiloride, trimethoprim) | Compete with metformin for renal tubular secretion, potentially increasing metformin plasma levels | Monitor for metformin side effects; dose adjustment may be needed |
| Sulfonylureas (e.g., glimepiride, glibenclamide) | Increased risk of hypoglycaemia when combined with Mifomet | Lower sulfonylurea dose may be required; monitor blood glucose |
| Insulin | Increased risk of hypoglycaemia | Insulin dose reduction may be needed; frequent glucose monitoring |
Patients with type 2 diabetes frequently have comorbid conditions including hypertension, hyperlipidaemia, and cardiovascular disease, requiring treatment with multiple medications. The relatively favourable interaction profile of the vildagliptin component is a practical advantage. However, vigilance is required regarding the metformin component, particularly in situations where renal function may be compromised, as any decline in kidney function increases the risk of metformin accumulation and lactic acidosis.
It is important to inform your doctor, pharmacist, or nurse about all medications you are taking, including prescription medications, over-the-counter drugs, herbal supplements, and vitamins. This includes any changes in your medication regimen, as newly started drugs may interact with Mifomet in ways that affect blood glucose control or increase the risk of side effects.
Avoid excessive alcohol consumption while taking Mifomet. Alcohol potentiates the effect of metformin on lactate metabolism and significantly increases the risk of lactic acidosis, particularly in cases of fasting, malnutrition, or hepatic impairment. Even moderate alcohol intake should be discussed with your doctor.
What Is the Correct Dosage of Mifomet?
Mifomet should always be used exactly as prescribed by your doctor. The dosing regimen is based on the patient’s current treatment, tolerability, and glycaemic response. Taking the tablets with food reduces gastrointestinal side effects associated with metformin.
Adults
| Clinical Scenario | Recommended Dose | Notes |
|---|---|---|
| Inadequate control on metformin alone | 50 mg/850 mg twice daily | Based on current metformin dose; adjust strength to match existing metformin regimen |
| Switching from separate tablets | 50 mg/850 mg twice daily | Match the doses of vildagliptin and metformin already being taken |
| Triple therapy with sulfonylurea | 50 mg/850 mg twice daily | Lower sulfonylurea dose may be needed to reduce hypoglycaemia risk |
| Triple therapy with insulin | 50 mg/850 mg twice daily | Lower insulin dose may be needed to reduce hypoglycaemia risk |
The maximum recommended daily dose of vildagliptin is 100 mg (50 mg twice daily). Tablets should be swallowed whole with water. Do not crush, break, or chew the film-coated tablets, as this could alter the release characteristics of the medication. Each dose should be taken with or immediately after a meal to minimise gastrointestinal side effects from metformin.
Children and Adolescents
Mifomet is not recommended for use in patients under 18 years of age. Safety and efficacy have not been established in the paediatric population.
Elderly Patients
In elderly patients (65 years and older), dose selection should take into account renal function. Kidney function (eGFR) should be monitored regularly, at least every 3–6 months. As renal function declines with age, the risk of metformin accumulation increases. No dose adjustment is required solely based on age, but the metformin component dose should be adjusted based on renal function parameters. The lowest effective dose should be used.
Renal Impairment
| Kidney Function (eGFR) | Recommendation |
|---|---|
| ≥60 mL/min/1.73 m² (Normal to mild) | No dose adjustment required |
| 45–59 mL/min/1.73 m² (Mild to moderate) | Continue with caution; monitor renal function every 3–6 months; maximum metformin dose 2,000 mg/day |
| 30–44 mL/min/1.73 m² (Moderate) | Do not initiate; may continue if already stabilised. Maximum metformin dose 1,000 mg/day. Monitor eGFR every 3 months. |
| <30 mL/min/1.73 m² (Severe) | Contraindicated – do not use |
Missed Dose
If you forget to take a dose of Mifomet, take it as soon as you remember, provided it is still close to the time of a meal. If it is nearly time for your next scheduled dose, skip the missed dose and take the next dose at the regular time. Do not take a double dose to make up for a forgotten tablet. Consistency in timing helps maintain stable blood glucose levels throughout the day. Setting a reminder on your phone or associating the medication with a specific mealtime can help prevent missed doses.
Overdose
If you have taken more Mifomet than prescribed, seek medical attention immediately. Overdose with metformin is potentially serious because of the risk of lactic acidosis. There is no specific antidote for vildagliptin overdose; clinical studies have shown it to be well tolerated at doses up to 400 mg. However, metformin overdose can be life-threatening. Symptoms of metformin overdose may include severe nausea, vomiting, diarrhoea, abdominal pain, drowsiness, and in severe cases, lactic acidosis characterised by rapid deep breathing, abdominal pain, hypothermia, and coma. Treatment is supportive. Haemodialysis is effective for removing metformin from the body, with a clearance rate of up to 170 mL/min under good haemodynamic conditions.
What Are the Side Effects of Mifomet?
Like all medicines, Mifomet can cause side effects, although not everybody gets them. The side effect profile of Mifomet reflects the known adverse effects of its two individual components, vildagliptin and metformin. In clinical trials evaluating the combination, no new safety signals were identified beyond those already known for each individual substance.
The side effects are categorised below by frequency, based on data from clinical trials, post-marketing surveillance, and international regulatory assessments. Gastrointestinal side effects are the most commonly reported, particularly at the start of treatment, and tend to diminish with continued use. Most side effects are mild to moderate in severity.
Very Common
May affect more than 1 in 10 people
- Nausea
- Vomiting
- Diarrhoea
- Abdominal pain
- Loss of appetite (anorexia)
Common
May affect up to 1 in 10 people
- Tremor
- Dizziness
- Headache
- Metallic taste (dysgeusia)
- Flatulence
- Peripheral oedema (swelling)
- Constipation
- Hypoglycaemia (mainly when combined with sulfonylureas)
Uncommon
May affect up to 1 in 100 people
- Arthralgia (joint pain)
- Fatigue
- Elevated liver enzymes (AST, ALT)
- Urticaria (hives)
Rare
May affect up to 1 in 1,000 people
- Hepatitis (liver inflammation), which may be reversible upon discontinuation
- Pancreatitis (inflammation of the pancreas)
- Bullous pemphigoid (blistering skin condition)
- Myalgia (muscle pain)
Very Rare / Frequency Not Known
Reported in fewer than 1 in 10,000 people or from post-marketing data
- Lactic acidosis (metformin component – potentially life-threatening)
- Vitamin B12 deficiency with long-term metformin use
- Liver failure (isolated cases reported with vildagliptin)
- Erythema (skin redness)
- Pruritus (itching)
- Exfoliative or bullous skin lesions
Gastrointestinal side effects (nausea, vomiting, diarrhoea, and abdominal discomfort) are the most frequently reported adverse reactions and are primarily attributable to the metformin component. These effects are dose-related and occur most commonly during the initial weeks of treatment. Taking Mifomet with meals, starting at a lower metformin dose, and gradually titrating upward can help minimise these effects. In most patients, gastrointestinal symptoms resolve spontaneously within the first few weeks of continued treatment as the body adjusts to the medication.
Lactic acidosis is a very rare but extremely serious metabolic emergency associated with metformin. It occurs primarily in patients with significant renal impairment, severe hepatic disease, or conditions causing tissue hypoxia (such as sepsis or heart failure). The estimated incidence is approximately 3–10 cases per 100,000 patient-years. Key warning signs include unexplained hyperventilation (Kussmaul breathing), nausea and vomiting, abdominal pain, hypothermia, and altered consciousness. If you experience any of these symptoms, discontinue Mifomet immediately and seek emergency medical care.
Liver-related side effects are associated with the vildagliptin component. Although typically asymptomatic and detected through routine liver function monitoring, rare cases of clinically significant hepatitis and even rarer cases of liver failure have been reported. Symptoms that may suggest liver problems include unexplained persistent nausea, vomiting, abdominal pain (particularly in the upper right quadrant), unusual fatigue, dark urine, or yellowing of the skin and eyes (jaundice). Contact your doctor immediately if you experience any of these symptoms.
Pancreatitis has been reported uncommonly with DPP-4 inhibitors as a class. Signs of acute pancreatitis include severe, persistent abdominal pain that may radiate to the back, often accompanied by nausea and vomiting. If pancreatitis is suspected, Mifomet should be discontinued, and the patient should not be re-challenged with vildagliptin.
Contact your doctor or emergency services immediately if you experience: rapid or deep breathing, severe muscle cramps, unusual drowsiness (possible lactic acidosis); severe persistent abdominal pain radiating to the back (possible pancreatitis); or yellowing of skin/eyes, dark urine, persistent nausea (possible liver injury). These are rare but serious conditions that require urgent medical evaluation.
How Should You Store Mifomet?
Proper storage of Mifomet ensures that the medication maintains its quality, safety, and effectiveness throughout its shelf life. As with all pharmaceutical products, the stability of the active ingredients (vildagliptin and metformin) can be affected by inappropriate storage conditions.
Follow these storage guidelines:
- Temperature: Store below 30°C (86°F). Do not refrigerate or freeze the tablets. Avoid exposure to excessive heat or direct sunlight.
- Moisture protection: Keep the tablets in the original blister packaging until you are ready to take them. The packaging is designed to protect the tablets from moisture, which can affect the stability of the film coating and active ingredients.
- Keep out of reach of children: Store Mifomet in a secure location where children cannot access it.
- Expiration date: Do not use Mifomet after the expiration date (“EXP”) printed on the blister pack and outer carton. The expiration date refers to the last day of that month.
- Damaged packaging: Do not use tablets if the blister pack is torn, opened, or shows signs of tampering. If tablets appear discoloured, crumbled, or have an unusual odour, do not use them and consult your pharmacist.
- Disposal: Do not dispose of unused or expired tablets via household waste or wastewater. Take them to your local pharmacy for proper disposal through an approved pharmaceutical waste program. This helps protect the environment.
When travelling with Mifomet, keep the medication in your carry-on luggage to avoid exposure to extreme temperatures in checked baggage. If travelling to hot climates, take precautions to keep the medication below 30°C. Always carry a sufficient supply for the duration of your trip, plus a few extra days in case of travel delays.
What Does Mifomet Contain?
Understanding the complete composition of your medication is important, particularly if you have known allergies or intolerances to specific pharmaceutical ingredients. The following table lists all components of Mifomet.
Active Ingredients
Each film-coated tablet of Mifomet contains two active substances: vildagliptin (50 mg), a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (850 mg), a biguanide. The 850 mg of metformin hydrochloride corresponds to approximately 660 mg of metformin base.
Inactive Ingredients (Excipients)
| Ingredient | Role | Notes |
|---|---|---|
| Vildagliptin | Active substance (DPP-4 inhibitor) | 50 mg per tablet |
| Metformin hydrochloride | Active substance (biguanide) | 850 mg per tablet |
| Hydroxypropyl cellulose | Binder | Ensures tablet integrity |
| Magnesium stearate | Lubricant | Facilitates manufacturing |
| Hypromellose | Film-coating agent | Provides protective film coat |
| Titanium dioxide (E171) | Colouring agent | White colour of coating |
| Iron oxide yellow (E172) | Colouring agent | Yellow tint of coating |
| Macrogol 4000 | Film-coating plasticiser | Improves coating flexibility |
| Talc | Anti-adherent / glidant | Prevents sticking during coating |
Appearance and Pack Sizes
Mifomet 50 mg/850 mg tablets are yellow, oval-shaped, film-coated tablets with “NVR” on one side and “SEH” on the other side. The tablets are supplied in blister packs containing 10, 30, 60, or 180 tablets. Not all pack sizes may be available in every country. The tablets are packaged in PVC/PVDC/aluminium blisters to protect against moisture.
Marketing Authorisation
The vildagliptin/metformin combination was first authorised in the European Union under the brand name Eucreas (by Novartis Europharm Limited) and is also available under various brand names worldwide, including Mifomet and Galvumet. The original marketing authorisation was granted by the European Medicines Agency (EMA) based on a comprehensive clinical development program demonstrating efficacy and safety. Mifomet is available on prescription in numerous countries worldwide.
Frequently Asked Questions About Mifomet
Mifomet is used to treat type 2 diabetes mellitus in adults. It contains two active ingredients – vildagliptin (a DPP-4 inhibitor) and metformin (a biguanide) – that work together to lower blood glucose levels. It is typically prescribed when diet, exercise, and metformin alone are not sufficient to control blood sugar. It may also be used in patients who are already taking vildagliptin and metformin as separate tablets to simplify their regimen into a single combination tablet.
Mifomet has a low risk of causing hypoglycaemia (low blood sugar) when used on its own, because vildagliptin works in a glucose-dependent manner and metformin does not stimulate insulin secretion directly. However, if Mifomet is combined with a sulfonylurea (such as glimepiride or glibenclamide) or with insulin, the risk of hypoglycaemia increases significantly. In such combinations, your doctor may lower the dose of the sulfonylurea or insulin. Symptoms of hypoglycaemia include sweating, trembling, dizziness, confusion, and rapid heartbeat.
The vildagliptin component of Mifomet has been associated with rare cases of liver enzyme elevations. Liver function tests (measuring AST and ALT levels) should be performed before you start treatment, every three months during the first year, and periodically thereafter. This monitoring allows your doctor to detect any liver changes early. If your liver enzymes rise to more than three times the upper normal limit, your doctor will stop Mifomet. Most liver enzyme elevations are reversible upon discontinuation of the medication.
Lactic acidosis is a very rare but potentially life-threatening condition caused by the accumulation of metformin in the body. It occurs when lactic acid builds up in the bloodstream faster than it can be removed. Risk factors include severe kidney impairment, dehydration, excessive alcohol intake, liver disease, and conditions causing reduced oxygen supply to tissues. You can reduce your risk by: having regular kidney function tests, staying well hydrated, avoiding excessive alcohol, and temporarily stopping Mifomet during illness with vomiting or diarrhoea (which can cause dehydration). Seek emergency care if you experience rapid breathing, muscle cramps, extreme tiredness, or abdominal pain.
No, Mifomet should not be used during pregnancy or breastfeeding. There are insufficient data on the use of vildagliptin in pregnant women, and animal studies have shown reproductive toxicity at high doses. If you are planning to become pregnant or discover you are pregnant while taking Mifomet, contact your doctor immediately. Your treatment will likely be switched to insulin, which is the recommended therapy for managing blood glucose during pregnancy. Mifomet is also not recommended during breastfeeding because metformin is excreted in breast milk and there is insufficient data on vildagliptin excretion in human milk.
Yes. If you are scheduled for a medical imaging procedure that involves the injection of iodinated contrast media (commonly used in CT scans), you must temporarily stop taking Mifomet before or at the time of the procedure. This is because iodinated contrast agents can temporarily impair kidney function, and when combined with metformin, this increases the risk of lactic acidosis. You may restart Mifomet no earlier than 48 hours after the procedure, but only after your doctor has confirmed that your kidney function is stable. Always inform your radiologist and referring doctor that you are taking Mifomet.
References
- European Medicines Agency (EMA). Eucreas (vildagliptin/metformin hydrochloride) – Summary of Product Characteristics. Last updated 2025. Available at: EMA Eucreas EPAR.
- American Diabetes Association (ADA). Standards of Care in Diabetes – 2025. Diabetes Care. 2025;48(Suppl 1):S1–S352.
- Davies MJ, Aroda VR, Collins BS, et al. Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2022;45(11):2753–2786. doi:10.2337/dci22-0034.
- Bosi E, Camisasca RP, Collober C, et al. Effects of vildagliptin on glucose control over 24 weeks in patients with type 2 diabetes inadequately controlled with metformin. Diabetes Care. 2007;30(4):890–895. doi:10.2337/dc06-1732.
- World Health Organization (WHO). Guidelines on second- and third-line medicines and type of insulin for the control of blood glucose levels in non-pregnant adults with diabetes mellitus. Geneva: WHO; 2018.
- UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet. 1998;352(9131):854–865.
- International Diabetes Federation (IDF). IDF Diabetes Atlas, 10th edition. Brussels: IDF; 2021. Available at: IDF Diabetes Atlas.
- National Institute for Health and Care Excellence (NICE). Type 2 diabetes in adults: management. NICE guideline [NG28]. Last updated 2024.
- DeFronzo RA, Ferrannini E, Groop L, et al. Type 2 diabetes mellitus. Nat Rev Dis Primers. 2015;1:15019. doi:10.1038/nrdp.2015.19.
- British National Formulary (BNF). Vildagliptin with metformin. National Institute for Health and Care Excellence (NICE). 2025.
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