Empagliflozin/Metformin Hydrochloride Tablet 12.5/500 mg (Empagliflozin, Metformin Hydrochloride)

Adult dose

The recommended dosage of this medicine is 1 tablet, twice a day. The daily maximum recommended doses for each ingredient should not exceed 25 mg of empagliflozin and 2000 mg of metformin. In cases where metformin is used alone or in combination with insulin or other medications, the recommended dosing is 5 mg of empagliflozin twice a day (total of 10 mg) along with the current dose of metformin. If tolerance is good and additional blood sugar control is needed, the dose of empagliflozin can be increased up to 25 mg (total per day). In the case of patients switching from empagliflozin (10 mg or 25 mg total per day) combined with metformin, they should be administered the existing doses of empagliflozin and metformin. When combining this medicine with sulfonylureas or insulin, a dose reduction of sulfonylureas or insulin should be considered to decrease the risk of hypoglycemia (refer to Precautions 4. Adverse Reactions and 6. Interactions). This medicine should be taken with meals to reduce gastrointestinal side effects associated with metformin. If a dose is missed, take it as soon as remembered. However, do not take a double dose, and skip the missed dose if such a situation arises. Special populations Patients with renal impairment Dose adjustments are not needed for patients with mild renal impairment. This medicine contains metformin and can be used with dose adjustments if there are no other accompanying symptoms that could increase the risk of lactic acidosis in patients with estimated glomerular filtration rate (eGFR) of 45-59 ml/min/1.73m2 or CrCl of 45-59 ml/min. In such patients, the starting dose of metformin is 500 mg or 850 mg once a day, thus starting treatment with empagliflozin and metformin as monotherapy is advised. The maximum daily dose of metformin hydrochloride that can be used with this medicine is 1000 mg, which can be administered as 500 mg twice a day. Careful monitoring of kidney function every 3-6 months is necessary (refer to Precautions 3. Use with caution in the following patients 1) reference). If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73m2, this medicine should be discontinued immediately (refer to Precautions 2. Do not administer in the following patients 2) reference). Elderly Patients aged 75 years and older should consider the risk of decreased kidney function and fluid volume loss.

This medicine is used to control blood sugar levels. Care should be taken as rare side effects such as severe lactic acidosis may occur when taking this medicine. Lactic acidosis can lead to a dangerous state due to excessive accumulation of lactic acid in the body and can be life-threatening in severe cases. This medicine should not be used in patients with poor kidney function, acute infections, dehydration, or unstable cardiac function. It is also safe not to use this medicine in pregnant or nursing women. If this medicine is used in conjunction with other blood sugar-lowering agents, there is a risk of hypoglycemia, thus if taken with other medications, consultation with a doctor for dose adjustments is necessary. Regular monitoring of kidney function is required during treatment, and immediate consultation with a doctor should be sought in case of dehydration or severe vomiting or diarrhea. Urinary tract infections or genital infections may occur during the course of taking this medicine, so prompt treatment should be sought if related symptoms arise. Additionally, as this medicine may cause fluid volume loss, particularly elderly individuals or those with low blood pressure should take caution. Before undergoing surgery or tests using iodine contrast agents, this medicine should be discontinued for a certain period before and after the surgery or test, and re-therapy should resume only after confirming normal kidney function. During the course of taking this medicine, it is advised to avoid alcohol consumption, and regular blood tests are recommended as vitamin B12 levels may decrease. In case of overdose, immediate hospital visit for appropriate treatment is required, especially if lactic acidosis symptoms are suspected, quick medical action is necessary. The safety and efficacy of this medicine have not been established in children, thus it is not to be used in patients under 18 years of age. It is important to keep this medicine out of the reach of children and store it in its original container.

Serious side effects

Urticaria, angioedema, necrotizing fasciitis of the perineum, lactic acidosis, ketoacidosis, urosepsis, pyelonephritis, severe edema, severe allergic reaction, liver abnormalities (jaundice), severe neurological symptoms, fever with severe rash, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory distress, sudden severe headache, lightning-like headache, seizures, confusion, visual disturbances, paralysis, urination.

Mild side effects

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

This medicine must be kept in a tightly closed container to protect from air and moisture. It is also best to store the medicine in a temperature range of 1 to 30 degrees Celsius, avoiding extremely hot or cold places.

Appearance

Biconvex oval film-coated tablet with a light brownish purple color.

Package unit

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