Empaglin Duo Tablet 12.5/1000 mg (Empagliflozin, Metformin Hydrochloride)

Adult dose

The recommended dosage is 1 tablet once a day, twice a day. The maximum recommended daily doses for each ingredient are Empagliflozin 25 mg and Metformin 2000 mg. In cases where blood sugar control is insufficient with Metformin alone or in combination with other medications such as insulin, the recommended dosage is Empagliflozin 5 mg twice a day (total daily dose 10 mg) in addition to the existing dosage of Metformin. Empagliflozin 10 mg, if tolerated well, can be increased to Empagliflozin 25 mg if additional blood sugar control is needed. Patients switching to this medication from a combination of Empagliflozin (total daily dose 10 mg or 25 mg) and Metformin should be administered at their existing doses of both Empagliflozin and Metformin. If this medication is used alongside sulfonylureas or insulin, a dose reduction of sulfonylureas or insulin should be considered to reduce the risk of hypoglycemia (see precautions 4. Adverse reactions and 6. Interactions). To reduce gastrointestinal side effects related to Metformin, this medication should be taken with meals. If a dose is missed, it should be taken as soon as remembered. However, do not take a double dose at once, and in such cases, the missed dose should be skipped.

This medication may cause a rare side effect called severe lactic acidosis, so caution should be exercised, especially in patients with impaired kidney function, heart disease, liver disease, and others. Additionally, when taken with insulin or sulfonylurea medications, there is a risk of hypoglycemia, so blood sugar changes should be closely monitored. This medication should not be used in patients with moderate to severe renal impairment or in conditions such as acute infection, heart failure, or acute myocardial infarction. Patients receiving iodine contrast used for radiological examinations should stop taking this medication for a certain period before and after the test, and restart only after normal kidney function is confirmed. Patients undergoing surgery should also stop taking this medication 48 hours prior to surgery and resume after confirming normal kidney function post-surgery. Pregnant women or those who may become pregnant, as well as nursing mothers, should avoid taking this medication for safety. This medication can cause a decrease in fluid volume, so patients with dehydration symptoms or gastrointestinal disorders should exercise particular caution, and elderly patients or those with cardiovascular diseases should regularly monitor blood pressure and kidney function. While on this medication, urinary tract infections or genital infections may occur, so if symptoms arise, a doctor should be consulted immediately. This medication may lower Vitamin B12 levels, so regular blood tests for monitoring are necessary. In case of overdose, serious side effects such as lactic acidosis may occur, so it is important to adhere to the prescribed dosage and consult healthcare personnel immediately if abnormal symptoms occur. Finally, keep this medication out of reach of children and store it in its original container to maintain quality.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, severe rash with fever, blisters, skin peeling, pain in mouth/eye mucosa, severe skin reactions, asthma attacks, respiratory difficulties accompanied by cough and fever, breathing problems, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe headaches, thunderclap headaches

Mild side effects

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

This medication should be stored in a tightly sealed container to protect it from air and moisture, and the storage temperature should be maintained between 1 degree and 30 degrees Celsius. It is important to avoid direct sunlight and not to place it in overly hot or cold places.

Appearance

Biconvex oval film-coated tablet with dark brownish purple color

Package unit

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