Empagliflozin/Metformin Film-Coated Tablets 12.5/850 mg

Adult dose

The recommended dose of this medication is 1 tablet, twice daily. For patients who cannot achieve adequate blood sugar control with metformin alone or in combination with other medications such as insulin, the recommended dose is empagliflozin 5 mg twice daily (total 10 mg per day) and the patient's existing metformin dosage. When tolerating empagliflozin 10 mg (total daily dose) well and requiring additional blood glucose control, it can be increased to 25 mg (total daily dose).

This medication is used for treating diabetes and should not be administered to patients with poor kidney function or those experiencing acute kidney issues. Additionally, patients with severe infections, heart failure, liver dysfunction, pregnant or nursing women should not use this medication. While this medication lowers blood glucose levels, there is a risk of hypoglycemia when used with insulin or other hypoglycemic agents, so caution is advised. Regular kidney function tests should be conducted before and during treatment to ensure there are no issues, and the medication should be temporarily stopped in case of dehydration, severe vomiting, or diarrhea. During the use of this medication, urinary tract infections or genital infections may occur, so if symptoms of infection arise, notify a healthcare provider immediately. Furthermore, this medication can decrease fluid volume, which may lead to low blood pressure or dehydration symptoms, hence patients, particularly the elderly or those with cardiovascular conditions, should be cautious. Pregnant women or those who might become pregnant should not take this medication; nursing mothers should discontinue breastfeeding while on this medication to be safe. The risk of lactic acidosis may increase when taken with alcohol, so alcohol consumption should be avoided. Patients scheduled for surgery should stop taking the medication 48 hours prior and resume only after normal kidney function has been restored post-surgery. During the use of this medication, blood sugar levels should be frequently monitored, and immediate action should be taken if symptoms of hypoglycemia appear. Finally, this medication is not recommended for children, and elderly patients may require dose adjustments based on their kidney function.

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, paleness, severe rash with fever, blisters, skin peeling, pain in oral or ocular mucosa, shortness of breath or difficulty in breathing, asthma attacks, respiratory distress accompanied by cough and fever, yellowing of skin or eyes (jaundice), overall fatigue, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, markedly reduced urine output

Mild side effects

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

This medication may be sensitive to air and moisture, hence should be stored in a tightly closed container. It is also important to maintain the medication at temperatures between 1 to 30 degrees Celsius to preserve its effectiveness.

Appearance

Pinkish-white, double convex, oval film-coated tablet

Package unit

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