Emlino 25/5mg Tablet

This combination contains Linagliptin and Empagliflozin, two medicines that help control blood sugar in people with type 2 diabetes.

• Linagliptin blocks the DPP-4 enzyme, which normally breaks down incretin hormones such as GLP-1 and GIP. By increasing these hormones, it promotes insulin release when blood sugar levels are high and reduces glucagon secretion, helping lower glucose production by the liver.
• Empagliflozin belongs to the SGLT2 inhibitor class. It works by preventing the kidneys from reabsorbing glucose back into the bloodstream, allowing excess glucose to be eliminated through urine and thereby reducing blood sugar levels.

Dosage and Administration

• Recommended dose: Empagliflozin 10 mg plus Linagliptin 5 mg once daily, preferably in the morning, with or without food.
• Dose adjustment: If needed, the dose may be increased to Empagliflozin 25 mg plus Linagliptin 5 mg once daily.
• Renal impairment: Kidney function should be evaluated before starting treatment. Therapy should not be initiated if eGFR is below 45 mL/min/1.73 m² and should be discontinued if eGFR falls below this level during treatment.

Drug Interactions

• Diuretics: May increase urination and the risk of dehydration or low blood pressure.
• Insulin and insulin secretagogues: Increase the risk of hypoglycemia.
• Rifampin and other strong P-glycoprotein or CYP3A4 inducers: May reduce the effectiveness of Linagliptin.
• Urine glucose testing: May produce positive glucose results due to increased urinary glucose excretion.
• 1,5-Anhydroglucitol (1,5-AG) testing: Results may not accurately reflect blood sugar control in patients taking SGLT2 inhibitors.

Contraindications

This medication should not be used in patients with:

• Severe kidney impairment
• End-stage renal disease or those undergoing dialysis
• Known hypersensitivity to Linagliptin or Empagliflozin
• Previous severe allergic reactions such as anaphylaxis, angioedema, urticaria, exfoliative skin reactions, or bronchial hyperreactivity related to these drugs

Possible Side Effects

Serious adverse effects may include:

• Pancreatitis
• Diabetic ketoacidosis
• Dehydration and low blood pressure
• Acute kidney injury
• Severe urinary tract infections, including urosepsis and pyelonephritis
• Low blood sugar, especially when combined with insulin or sulfonylureas
• Fournier’s gangrene (necrotizing fasciitis of the perineum)
• Genital fungal infections
• Severe allergic reactions
• Severe joint pain
• Bullous pemphigoid
• Heart failure

Pregnancy and Breastfeeding

• Use is not recommended during the second and third trimesters of pregnancy.
• Available data are insufficient to fully assess risks during pregnancy.
• Poorly controlled diabetes itself may pose risks to both mother and fetus.
• Consult a healthcare professional before using this medicine during pregnancy or breastfeeding.

Warnings and Precautions

Special caution is advised in patients with:

• History of pancreatitis
• Low blood pressure or dehydration
• Kidney disease or reduced kidney function
• Recurrent urinary tract infections
• Ketoacidosis risk factors
• Genital fungal infections
• Hypersensitivity reactions
• Heart failure

Patients should seek immediate medical attention if symptoms of ketoacidosis, severe infection, allergic reactions, or unusual genital pain and swelling occur.

Overdose

In case of overdose:

• Contact emergency medical services or a poison control center immediately.
• Treatment is supportive and based on clinical symptoms.
• Hemodialysis is unlikely to effectively remove Linagliptin, and the effectiveness of dialysis for Empagliflozin has not been established.

Therapeutic Class

Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitor Combination

Storage

• Store below 30°C.
• Protect from light and moisture.
• Keep out of reach of children.