Details

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• Manufacturer: Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

• Registration in Malaysia: MAL18016004AZ

Content

• Active Ingredients: Each film-coated tablet contains 25 mg of empagliflozin and 5 mg of linagliptin.

• Formulation: Pale yellow, arc triangular, flat-faced, bevel-edged tablets.

• Manufacturer: Boehringer Ingelheim Pharma GmbH & Co. KG, Germany.

• Registration in Malaysia: MAL18016004AZ.

Indications

• Type 2 Diabetes Mellitus: As an adjunct to diet and exercise to improve glycemic control in adults when treatment with both empagliflozin and linagliptin is appropriate.

• Combination Therapy: For patients inadequately controlled on monotherapy with either empagliflozin or linagliptin.

• Not for: Use in type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Instructions for Use

• Dosage:

  • Starting dose: 10 mg empagliflozin / 5 mg linagliptin once daily.

  • May increase to 25 mg empagliflozin / 5 mg linagliptin once daily if additional glycemic control is needed and the patient tolerates the medication.

• Administration: Take with or without food, swallowed whole with water.

• Renal Function: Assess renal function before initiating treatment.

  • Not recommended for patients with an eGFR below 45 mL/min/1.73 m².

  • Discontinue if eGFR falls persistently below 45 mL/min/1.73 m².

• Missed Dose: If a dose is missed and it is 12 hours or more until the next dose, take it as soon as possible. If less than 12 hours, skip the missed dose and take the next dose at the usual time. Do not double doses.

• Special Populations:

  • No dose adjustment is required for hepatic impairment.

  • Not recommended for use in patients with severe hepatic impairment.

  • Use with caution in elderly patients and those with volume depletion.