Pharma Empagliflozin/Metformin Duo Tablet 12.5/850 mg (Empagliflozin, Metformin Hydrochloride)

Adult dose

The recommended dosage for this medication is 1 tablet once in the morning and once in the evening. It should not exceed Empagliflozin 25 mg and Metformin 2000 mg per day, considering each patient's treatment regimen, efficacy, and tolerability. For patients who cannot achieve sufficient blood glucose control with Metformin alone or in combination with other medications, it is recommended to take Empagliflozin 5 mg twice a day (total of 10 mg) along with their current Metformin dosage. If the 10 mg dosage of Empagliflozin is well tolerated but additional blood glucose control is needed, the dosage may be escalated to Empagliflozin 25 mg (daily total). For individuals switching from the combination therapy of Empagliflozin (10 mg or 25 mg daily total) and Metformin, it should be based on their previous dosage of Empagliflozin and Metformin. When co-administering this medication with sulfonylureas or insulin, dosage reduction of the sulfonylurea or insulin may 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 associated with Metformin. If a dose is missed, take it as soon as remembered; however, do not take double the amount at once, and skip the missed dose in such cases. Special populations: Renal impairment patients: No dosage adjustments are needed for mild renal impairment. This medication contains Metformin, which should be used with caution 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 without other risk factors for lactic acidosis. For these patients, start with Metformin at 500 mg or 850 mg once daily and initiate with individualized doses for Empagliflozin and Metformin as single agents. The maximum daily dose for Metformin hydrochloride that can be administered with this medication is 1000 mg, given as 500 mg twice daily. Renal function should be closely monitored every 3 to 6 months (refer to Precautions 3. Use with caution in patients 1). If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73m2, this medication should be discontinued immediately (refer to Precautions 2. Do not administer to patients 2). Elderly: Patients aged 75 years and older should take into account the risks of renal function and fluid volume reduction.

This medication is used to treat diabetes and helps in controlling blood sugar. Caution is necessary as serious side effects like lactic acidosis may occur when taking this medication. Lactic acidosis occurs when excessive levels of lactic acid build up in the body and can be life-threatening in severe cases. Patients with poor kidney function, severe infections, dehydration, or severe heart conditions should not be administered this medication. Pregnant or breastfeeding women are also advised not to take this medication. This medication can cause hypoglycemia when taken in conjunction with insulin or other diabetes medications, so blood sugar levels should be monitored regularly, and other medication dosages adjusted as necessary. When undergoing testing or surgery involving iodine contrast agents, this medication should be discontinued for a certain period before and after the procedure, and resumed only once kidney function has returned to normal. This medication increases glucose excretion in urine, leading to an increased frequency of urination, and risk of urinary or genital infections. If any of these symptoms occur, consult a healthcare professional. Due to a potential decrease in vitamin B12 levels, regular blood tests are recommended. Excessive alcohol consumption should be avoided while taking this medication, and care should be taken to prevent fluid loss or dehydration. Elderly or patients with impaired kidney function require additional caution when taking this medication, and regular kidney function tests should be conducted. Side effects may include gastrointestinal disturbances, hypoglycemia, infections, liver function abnormalities, skin rashes, etc., and any unusual symptoms should be reported to a healthcare professional immediately. In case of an overdose, appropriate treatment such as blood dialysis may be required, so it is crucial to adhere to the prescribed dosage. This medication is not recommended for children, and it should be stored out of reach of children in its original container.

Serious side effects

Hives, perineal necrosis, ketoacidosis, lactic acidosis, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, pyelonephritis, urosepsis, liver abnormalities (liver function disorders, hepatitis), sudden and severe headache, seizures, confusion, visual disturbances, paralysis, significant decrease in urine output, generalized severe edema, elevated blood pressure

Mild side effects

• Hypoglycemia
• urinary tract infections
• genital infections
• increased urination
• nausea
• vomiting
• diarrhea
• abdominal pain
• loss of appetite
• constipation

This medication should be stored in a tightly closed container to prevent exposure to air and moisture, ideally at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain its efficacy over time.

Appearance

A white, oval, film-coated tablet that is convex on both sides with a pink tint

Package unit

60 tablets/box [10 tablets/PTP x 6], 10 tablets/box [10 tablets/PTP x 1], 30 tablets/bottle, 60 tablets/bottle