Glyxambi 25mg/5mg Empagliflozin/Linagliptin Tablets 30s

Glyxambi 25mg/5mg Empagliflozin/Linagliptin Tablets 30s is a prescription fixed-dose combination medicine containing empagliflozin 25mg and linagliptin 5mg in each film-coated tablet.

Glyxambi is used with an appropriate diet and physical-activity programme to improve blood-glucose control in selected adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is considered appropriate.

The two active ingredients lower blood glucose through complementary mechanisms. Empagliflozin increases glucose removal through the urine, while linagliptin supports glucose-dependent insulin release and reduces glucagon activity.

Glyxambi 25mg/5mg is generally not the starting strength. The referenced product information recommends starting with Glyxambi 10mg/5mg once daily. The dose may be increased to 25mg/5mg once daily when the lower strength is tolerated and additional glycaemic control is required.

Glyxambi 25mg/5mg Product Information

What Is Glyxambi 25mg/5mg Used For?

Glyxambi is used to improve glycaemic control in adults aged 18 years and above with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate.

It may be considered for patients whose blood glucose remains inadequately controlled with:

• Metformin and empagliflozin
• Metformin and linagliptin
• A sulfonylurea and one of the Glyxambi active ingredients
• Metformin, a sulfonylurea and one of the active ingredients
• Empagliflozin and linagliptin taken as separate tablets

The exact treatment combination depends on the patient’s HbA1c, kidney function, current diabetes medicines, risk of hypoglycaemia and overall medical condition.

Glyxambi should not be selected merely to reduce the number of tablets being taken. The treating doctor must confirm that both active ingredients and the 25mg/5mg strength are appropriate.

How Glyxambi Works

Empagliflozin

Empagliflozin is a sodium-glucose co-transporter 2 inhibitor, commonly abbreviated as an SGLT2 inhibitor.

SGLT2 proteins in the kidneys normally return filtered glucose to the bloodstream. Empagliflozin blocks this process, allowing more glucose to leave the body through the urine and helping reduce blood-glucose levels.

Linagliptin

Linagliptin is a dipeptidyl peptidase-4 inhibitor, commonly abbreviated as a DPP-4 inhibitor.

Linagliptin prolongs the activity of incretin hormones. These hormones help the pancreas release insulin when blood glucose is elevated and help reduce the amount of glucose released by the liver.

By combining the two mechanisms in one tablet, Glyxambi targets blood-glucose control through both urinary glucose removal and incretin-related glucose regulation.

How to Take Glyxambi 25mg/5mg

• Take Glyxambi exactly as prescribed by the treating doctor.
• The 25mg/5mg strength is generally taken as one tablet once daily when prescribed.
• Swallow the tablet whole with water.
• Glyxambi may be taken with or without food.
• Take it at approximately the same time each day.
• Do not increase, reduce or stop treatment without medical advice.
• Do not change between Glyxambi 10mg/5mg and 25mg/5mg without a new instruction.
• Continue the diet, physical activity and glucose-monitoring programme recommended by the healthcare professional.

When Glyxambi is used with metformin, the prescribed metformin treatment is generally continued. When it is used with insulin or a sulfonylurea, the doctor may reduce the insulin or sulfonylurea dose to lower the risk of hypoglycaemia.

What to Do If a Dose Is Missed

Take the missed dose as soon as it is remembered unless it is nearly time for the next scheduled dose.

Do not take two doses on the same day to compensate for a missed dose. Continue with the next dose at the usual time.

Consult a doctor or pharmacist if several doses have been missed or there is uncertainty about restarting treatment.

Monitoring During Treatment

A healthcare professional may monitor:

• HbA1c and blood-glucose levels
• Kidney function
• Blood pressure and hydration status
• Symptoms of genital or urinary infection
• Signs of diabetic ketoacidosis
• Frequency of hypoglycaemia when insulin or a sulfonylurea is used
• Symptoms suggesting pancreatitis
• Skin blistering or other hypersensitivity reactions

Kidney function should be assessed before treatment and periodically afterward. The suitability of Glyxambi and the expected glucose-lowering effect may change when kidney function declines.

Important Safety Information

• Glyxambi is a prescription medicine and should not be shared with another person.
• It is not intended for the treatment of type 1 diabetes.
• It must not be used to treat diabetic ketoacidosis.
• It is not approved as a general weight-loss medicine.
• Tell the doctor about kidney disease, liver disease, low blood pressure or recurrent urinary infections.
• Tell the doctor about previous pancreatitis, gallstones or very high triglyceride levels.
• Inform the healthcare team before major surgery, prolonged fasting or hospitalisation for a serious illness.
• Tell the prescriber about insulin, sulfonylureas, diuretics, lithium and all other medicines being used.
• Maintain appropriate fluid intake unless a healthcare professional has prescribed fluid restriction.

Diabetic Ketoacidosis Warning

SGLT2 inhibitors, including empagliflozin, have been associated with diabetic ketoacidosis, commonly abbreviated as DKA. DKA is a serious and potentially life-threatening condition caused by excessive ketone accumulation.

DKA may occur even when the blood-glucose reading is not extremely high.

Stop taking Glyxambi and seek urgent medical attention if symptoms occur such as:

• Nausea or vomiting
• Abdominal pain
• Loss of appetite
• Excessive thirst
• Rapid or unusually deep breathing
• Difficulty breathing
• Confusion
• Unusual tiredness or sleepiness
• Sweet or unusual-smelling breath

The risk may increase during severe illness, dehydration, prolonged fasting, major surgery, excessive alcohol intake, sudden insulin reduction or conditions that substantially increase insulin requirements.

Glyxambi may need to be temporarily interrupted during major surgery or serious acute illness. Blood ketone testing may be preferred to urine testing when DKA is suspected.

Dehydration and Low Blood Pressure

Empagliflozin increases glucose and fluid removal through the urine. This may cause dehydration, reduced circulating fluid volume or low blood pressure in susceptible patients.

The risk may be greater in:

• Adults aged 75 years and above
• Patients taking diuretics or several blood-pressure medicines
• Patients with low blood pressure
• Patients experiencing vomiting or diarrhoea
• Patients with fever, heavy sweating or reduced fluid intake

Possible symptoms include dizziness, faintness, weakness, dry mouth, unusual thirst or reduced urine output.

Obtain medical advice when significant fluid loss occurs. Temporary interruption may be required until the patient is clinically stable and adequately hydrated.

Genital and Urinary Infections

Empagliflozin increases the amount of glucose passed through the urine. This can increase the likelihood of certain genital fungal infections and urinary tract infections.

Possible symptoms include:

• Pain or burning during urination
• Frequent or urgent urination
• Fever or chills
• Back or side pain
• Blood in the urine
• Genital itching, redness or irritation
• Unusual genital discharge

Seek prompt medical advice for symptoms of infection. Severe urinary infection, kidney infection or urosepsis requires urgent assessment.

Fournier’s Gangrene Warning

A rare but serious infection known as necrotising fasciitis of the perineum or Fournier’s gangrene has been reported with SGLT2 inhibitors.

Seek urgent medical attention for pain, tenderness, redness or swelling around the genitals or the area between the genitals and anus, particularly when accompanied by fever or feeling generally unwell.

Glyxambi should be discontinued and urgent medical and surgical treatment initiated when Fournier’s gangrene is suspected.

Pancreatitis Warning

DPP-4 inhibitors, including linagliptin, have been associated with acute pancreatitis.

Stop taking Glyxambi and seek prompt medical attention for severe and persistent abdominal pain, particularly when the pain spreads to the back or occurs with nausea and vomiting.

If acute pancreatitis is confirmed, Glyxambi should not normally be restarted. Additional caution is required in patients with a previous history of pancreatitis.

Bullous Pemphigoid Warning

Bullous pemphigoid, an autoimmune blistering skin disorder, has been reported in patients taking linagliptin.

Contact a doctor promptly if new skin blisters, widespread itching, sores or peeling develop. Glyxambi may need to be stopped when bullous pemphigoid is suspected.

Hypoglycaemia

Glyxambi used without insulin or a sulfonylurea generally has a relatively low risk of causing hypoglycaemia. The risk increases when it is combined with insulin or medicines that stimulate insulin release.

Possible symptoms of low blood glucose include:

• Shaking or sweating
• Hunger
• Dizziness
• Headache
• Blurred vision
• Rapid heartbeat
• Anxiety, confusion or unusual behaviour

The treating doctor may need to reduce the insulin or sulfonylurea dose. Patients should follow their individual hypoglycaemia treatment plan.

Possible Side Effects

Not everyone experiences side effects. Possible effects associated with Glyxambi include:

• Urinary tract infection
• Genital fungal infection
• Increased urination
• Thirst
• Dizziness or low blood pressure
• Nasopharyngitis or upper respiratory symptoms
• Cough
• Constipation
• Skin rash or itching
• Temporary changes in kidney-function test results
• Hypoglycaemia when combined with insulin or a sulfonylurea

Persistent, worsening or troublesome side effects should be discussed with a doctor or pharmacist.

Serious Symptoms Requiring Medical Attention

Seek prompt or urgent medical attention if any of the following occurs:

• Symptoms of diabetic ketoacidosis
• Severe or persistent abdominal pain suggesting pancreatitis
• Severe dehydration, fainting or very low blood pressure
• Fever with painful urination or back pain
• Severe genital or perineal pain, redness or swelling
• Swelling of the face, lips, tongue or throat
• Difficulty breathing or swallowing
• New skin blisters or widespread peeling
• A severe or unexpected allergic reaction

Who Should Not Take Glyxambi?

Glyxambi should not be used by patients with a known allergy to:

• Empagliflozin
• Linagliptin
• Another SGLT2 inhibitor
• Another DPP-4 inhibitor
• Another ingredient in the tablet

It is also unsuitable for type 1 diabetes and must not be used to treat diabetic ketoacidosis.

Professional assessment is required for patients with significant kidney impairment, severe liver impairment, recurrent dehydration, recurrent urinary infections, previous pancreatitis or another condition that may increase treatment risk.

Medicine Interactions

Tell the doctor and pharmacist about all prescription medicines, non-prescription products, traditional medicines and supplements being used.

Medicines requiring particular consideration include:

• Insulin: combined use may increase the risk of hypoglycaemia.
• Sulfonylureas: medicines such as gliclazide or glimepiride may increase hypoglycaemia risk.
• Diuretics: combined use may increase fluid loss, dehydration and low blood pressure.
• Other blood-pressure medicines: additional blood-pressure reduction may occur.
• Lithium: empagliflozin may reduce blood lithium concentrations and additional monitoring may be necessary.
• Strong enzyme or transporter inducers: medicines such as rifampicin, carbamazepine, phenobarbital or phenytoin may reduce linagliptin exposure and effectiveness.
• Other SGLT2 or DPP-4 inhibitors: therapeutic duplication should be avoided unless specifically directed.

Do not start, stop or change another medicine without consulting the treating doctor or pharmacist.

Pregnancy and Breastfeeding

Patients who are pregnant, planning a pregnancy or think they may be pregnant should inform their doctor before taking Glyxambi.

Use during pregnancy should be avoided as a precaution because adequate human pregnancy data are unavailable and empagliflozin may affect kidney development later in pregnancy.

Glyxambi should not be used during breastfeeding because a risk to the nursing infant cannot be excluded.

Use in Children and Adolescents

The safety and effectiveness of Glyxambi have not been established in patients below 18 years old. It should not be supplied to a child or adolescent unless supported by the current Malaysian product information and a specialist prescription.

Does Glyxambi Treat Heart Failure or Chronic Kidney Disease?

Empagliflozin as a single active ingredient has additional approved indications in certain products and jurisdictions, including heart failure and chronic kidney disease.

These indications should not automatically be transferred to the Glyxambi combination product. Glyxambi’s product-specific indication is blood-glucose control in selected adults with type 2 diabetes when both empagliflozin and linagliptin are appropriate.

Patients prescribed empagliflozin for a heart or kidney indication should not substitute Glyxambi without medical direction.

Storage Instructions

• Store according to the conditions printed on the Malaysian carton and package insert.
• Keep the tablets in their original blister packaging until required.
• Protect from excessive heat and moisture.
• Keep out of reach of children.
• Do not use tablets that appear wet, damaged, discoloured or deteriorated.
• Do not use after the expiry date printed on the supplied packaging.
• Product packaging, registration number, manufacturer, batch number and expiry date may vary between supplied batches.

Frequently Asked Questions

What are the active ingredients in Glyxambi 25mg/5mg?

Each film-coated tablet contains empagliflozin 25mg and linagliptin 5mg.

What type of medicine is Glyxambi?

Glyxambi combines an SGLT2 inhibitor with a DPP-4 inhibitor in one fixed-dose tablet.

What is Glyxambi used for?

Glyxambi is used with diet and physical activity to improve glycaemic control in selected adults with type 2 diabetes when treatment with both empagliflozin and linagliptin is appropriate.

Is Glyxambi 25mg/5mg the starting dose?

Generally, no. The referenced product information recommends Glyxambi 10mg/5mg as the starting dose. The dose may be increased to 25mg/5mg when the lower strength is tolerated and additional glucose control is required.

How often is Glyxambi 25mg/5mg taken?

When prescribed, the 25mg/5mg strength is generally taken as one tablet once daily. Follow the individual dispensing label and prescription.

Can Glyxambi be taken with food?

Yes. Glyxambi may be taken with or without food and should be swallowed whole with water.

Can Glyxambi be used for type 1 diabetes?

No. Glyxambi should not be used for type 1 diabetes because of the increased risk of diabetic ketoacidosis.

Can Glyxambi treat diabetic ketoacidosis?

No. Glyxambi must not be used to treat diabetic ketoacidosis. Empagliflozin may itself increase DKA risk in certain circumstances.

Can Glyxambi cause low blood glucose?

The risk is relatively low when Glyxambi is used without insulin or a sulfonylurea. The risk increases when these medicines are used together.

Why can Glyxambi cause genital infections?

Empagliflozin increases glucose removal through the urine. Additional glucose around the urinary and genital areas may encourage the growth of certain fungi and bacteria.

Can Glyxambi cause pancreatitis?

Acute pancreatitis has been reported with DPP-4 inhibitors, including linagliptin. Severe and persistent abdominal pain requires prompt medical assessment.

Is Glyxambi a weight-loss medicine?

No. Glyxambi is not approved as a general weight-loss medicine. Any change in body weight during treatment should be discussed with the treating healthcare professional.

Can Glyxambi be used for heart failure or chronic kidney disease?

Do not assume that the additional indications of empagliflozin-only products apply to Glyxambi. Glyxambi should be used only for its product-specific approved indication and prescribed treatment plan.

Is Glyxambi a prescription medicine in Malaysia?

Yes. Glyxambi is a prescription medicine and should only be supplied and used according to a valid prescription and professional instructions.

What is the Malaysian registration number for Glyxambi 25mg/5mg?

NPRA records include MAL18016005AZ and MAL25096006ACSZ for Glyxambi 25mg/5mg presentations manufactured at different registered sites. Verify the exact number printed on the supplied carton.

Who manufactures Glyxambi 25mg/5mg?

Registered Malaysian presentations include products manufactured by Boehringer Ingelheim Pharma GmbH & Co. KG and Rottendorf Pharma GmbH in Germany. Confirm the manufacturer on the supplied pack.

How many tablets are supplied in one pack?

The P-Hub listing contains 30 tablets, supplied as three blister strips of ten tablets.

Can pharmacies request Glyxambi through P-Hub?

Glyxambi 25mg/5mg Empagliflozin/Linagliptin Tablets 30s is listed in the P-Hub B2B catalogue for approved pharmacy members. Quotation, ordering eligibility and supply are subject to P-Hub membership requirements, prescription medicine controls and current stock availability.

Prescription Medicine Notice

Glyxambi 25mg/5mg is a prescription medicine. It should only be supplied, dispensed and used according to applicable Malaysian requirements and the instructions of a registered doctor or pharmacist.

The information on this page is provided for pharmacy catalogue and professional product-reference purposes. It does not replace an individual diabetes assessment, prescription, approved Malaysian package insert or advice from a qualified healthcare professional.

Product appearance, packaging, registration number, manufacturing site, batch number, availability and expiry date may vary. Verify all information on the physical product packaging and approved insert before dispensing or use.

Product Information Sources

• European Medicines Agency – Glyxambi Professional and Patient Product Information
  
• Singapore National Drug Formulary – Glyxambi 25mg/5mg Product Information
  
• National Pharmaceutical Regulatory Agency Malaysia – Fixed-Dose Combination Comparator Register
  
• National Pharmaceutical Regulatory Agency Malaysia – Glyxambi Manufacturing-Site Registration
  

Product information last reviewed: 12 July 2026.