Empavex Tablets 12.5/500 mg (Empagliflozin, Metformin Hydrochloride)

Adult dose

The recommended dose of this medication is 1 tablet at a time, twice a day. The dosage is determined based on the current therapy, efficacy, and tolerability, without exceeding the maximum daily recommended doses of Empagliflozin 25 mg and Metformin 2000 mg. Patients unable to achieve adequate blood glucose control with Metformin alone or in combination with other medications such as insulin should take 5 mg of Empagliflozin twice a day (10 mg total daily dose) along with the current dose of Metformin.

This medication can cause a rare but serious side effect known as severe lactic acidosis, so caution is needed. Care should be taken if this drug is used in conjunction with insulin or sulfonylurea medications, as there is a risk of hypoglycemia. This drug should not be used in patients with significantly impaired renal function or acute conditions that may affect renal function. Patients in acute or chronic metabolic acidosis, those with type 1 diabetes, or those suffering from acute myocardial infarction, shock, etc. should also avoid this medication. Administration should be suspended when undergoing tests involving iodine-based contrasts, and it can be resumed once kidney function has returned to normal. Patients scheduled for surgery should stop taking this medication 48 hours prior to surgery and can resume once normal kidney function has been confirmed post-surgery. It is safest for pregnant women, those who may become pregnant, and nursing mothers not to use this medication. As this drug is affected by kidney function, regular checks of renal function should be conducted before and during administration, and if renal function worsens, discontinuation of the medication is necessary. Patients at risk of fluid loss or dehydration should be monitored closely for fluid status while using this drug. This medication may increase the risk of urinary or genital infections, so any infection symptoms should be reported to a healthcare professional immediately. Long-term use may decrease vitamin B12 levels, so it is advisable to periodically check vitamin B12 levels. Alcohol consumption may increase the risk of lactic acidosis, so excessive drinking should be avoided while taking this medication. This drug can induce hypoglycemia, so care should be taken in cases of missed meals or after vigorous exercise, and immediate action should be taken if hypoglycemic symptoms occur. Elderly patients are at higher risk of diminished kidney function, so dosage adjustments and regular monitoring of kidney function are necessary. Overdose may result in severe side effects such as lactic acidosis, necessitating immediate medical attention. This drug has not been established for safety and effectiveness in children and is not recommended for those under 18 years of age. While taking this medication, periodic checks of blood glucose control are required, and interactions with other medications should be discussed with a healthcare professional.

Serious side effects

• Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction,
• Severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin reaction,
• Shortness of breath or difficulty breathing, asthma attack, respiratory problems accompanied by cough and fever,
• Yellowing of the skin or eyes (jaundice), severe lethargy, liver abnormalities (jaundice),
• Sudden and very severe headaches

Mild side effects

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is best maintained at room temperature between 1 to 30 degrees Celsius. This will help the medication retain its effectiveness for a longer duration and be safely used.

Appearance

Light brownish-purple, bilaterally convex oval film-coated tablets

Package unit

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