Empagliflozin/Metformin Film-Coated Tablet 5/1000 mg

Adult dose

The recommended dosage of this medication is 1 tablet, taken twice daily. The dosage should be determined considering the current treatment regimen, efficacy, and tolerability of each patient without exceeding the maximum recommended daily doses of empagliflozin 25 mg and metformin 2000 mg. For patients unable to achieve sufficient blood sugar control with metformin alone or in combination therapies with insulin or other drugs, the recommended dosage is 5 mg of empagliflozin taken twice daily (total daily dose 10 mg) along with the existing dose of metformin. If there is good tolerability of 10 mg of empagliflozin (total daily dose), it may be escalated to 25 mg (total daily dose) if additional blood sugar control is needed. Patients switching from combination therapy of empagliflozin (total daily dose 10 mg or 25 mg) and metformin will start with their existing doses of empagliflozin and metformin. When this medication is prescribed in conjunction with sulfonylureas or insulin, a dosage reduction of sulfonylureas or insulin should be considered to reduce the risk of hypoglycemia (refer to precautions 4. Adverse reactions and 6. Interactions). This medication should be taken with meals to minimize gastrointestinal side effects related to metformin. If a dose is missed, it should be taken as soon as remembered. However, double dosing should not occur; missed doses should be skipped. Special Considerations for Special Populations: Renal Impairment. Dose adjustments are not necessary for patients with mild renal impairment. As this medication contains metformin, it may be used in patients with an estimated glomerular filtration rate (eGFR) of 45-59 ml/min/1.73m2 or a creatinine clearance (CrCl) of 45-59 ml/min, provided they do not have other symptoms that may increase the risk of lactic acidosis. For such patients, the starting dose of metformin is 500 mg or 850 mg once daily, hence initiating treatment with individual agents of empagliflozin and metformin. The maximum daily dose of metformin hydrochloride that can be given is 1000 mg, administered as 500 mg twice daily. Kidney function should be closely monitored every 3-6 months (see precautionary notes, reference 3. Carefully administer to the following patients 1)). If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73m2, this medication must be discontinued immediately (see precautionary notes 2. Do not administer to the following patients 2)). In the elderly, patients over 75 years old should consider risks related to kidney function and reduced fluid volume.

This medication is used to control blood sugar levels and can cause a rare side effect known as severe lactic acidosis, so caution is advised. Lactic acidosis is a dangerous condition caused by an excessive buildup of lactic acid in the body and can occasionally lead to death. Additionally, taking this medication with insulin or sulfonylureas may increase the risk of hypoglycemia. Patients with allergies to any of the components should not take this medication, nor should patients with severely impaired kidney function. This medication should also be avoided in situations where acute worsening of kidney function is anticipated, such as severe infections, dehydration, heart attack, or shock. It is not administered to patients with type 1 diabetes or anyone with a history of lactic acidosis or diabetic ketoacidosis. Moreover, it should be discontinued prior to and post any radiographic contrast examinations in patients with acute heart failure. It is safest not to take this medication during pregnancy or while breastfeeding. Regular renal function tests must be conducted during treatment, and if kidney function worsens, the medicine should be discontinued. Caution is also needed for patients with a risk of fluid loss or those who have irregular meals and engage in vigorous exercise. This medication can cause gastrointestinal disturbances, urinary tract infections, genital infections, increased urination, hypoglycemia, among other side effects. Especially when taken with insulin or sulfonylureas, the risk of hypoglycemia may increase, hence monitoring blood glucose is crucial. Alcohol intake can heighten the risk of lactic acidosis, so it should be avoided during treatment. If surgery is planned or there are severe infections or trauma, the medication should be temporarily discontinued until the patient's condition improves. Extra caution should be taken when administering this medication to the elderly in relation to renal function decline and fluid loss risks. In the event of overdose, severe side effects such as lactic acidosis can arise; thus, it is imperative to adhere strictly to prescribed dosages. Safety and efficacy have not been established for children, hence it is not recommended for those under 18. If during treatment any symptoms like fever, genital or perineal pain, swelling, or rash occur, immediate contact with healthcare professionals is advised. Lastly, this medication may interact with various drugs, so it is vital to inform healthcare professionals if other medications are being taken. Finally, this medication should be stored out of reach of children and kept in its original container.

Serious side effects

Hives, severe swelling (edema), ketoacidosis, lactic acidosis, perineal necrosis, angioedema, rash, pyelonephritis, urinary sepsis, abnormal liver function tests, hepatitis, liver abnormality (jaundice), severe allergic reactions, severe skin reactions, kidney and urinary disorders (acute kidney injury, acute renal failure), sudden and severe headache, cerebrovascular accident, seizures, confusion of consciousness, visual disturbances, paralysis, myocardial infarction, heart failure, sepsis, shock

Mild side effects

• Nausea
• vomiting
• diarrhea
• abdominal pain
• loss of appetite
• constipation
• altered taste
• itching
• rash
• angioedema

This medication should be stored in a sealed container to protect it from air and moisture. Additionally, it should be kept in a location that avoids extreme temperatures, ideally at room temperature between 1 to 30 degrees Celsius.

Appearance

Yellow, oval, biconvex, film-coated tablet with a brown tint

Package unit

10 tablets/box [10 tablets/PTP*1], 60 tablets/box [10 tablets/PTP*6], 60 tablets/bottle