Empavex Tablets 5/500 mg (Empagliflozin, Metformin Hydrochloride)

Adult dose

The recommended dosage is 1 tablet once in the morning and once in the evening. The maximum recommended daily dosage for each ingredient is 25 mg of Empagliflozin and 2000 mg of Metformin. For patients who do not achieve adequate blood glucose control using Metformin alone or in combination with insulin or other medications, 5 mg of Empagliflozin is administered twice daily (total daily dose of 10 mg) along with the existing dose of Metformin. Tolerability is excellent, and additional blood glucose control is necessary.

This medication helps control blood sugar, but there are several precautions to be aware of during use. First, this drug can cause a rare side effect of serious lactic acidosis, so it should not be used in individuals with poor kidney function or those with severe infections, dehydration, or heart problems. Additionally, when used in conjunction with insulin or other diabetes medications, there is a risk of hypoglycemia, so blood sugar should be closely monitored. Particularly, this medicine should not be administered to patients with moderate or severe renal impairment, acute kidney issues, heart failure, or severe liver dysfunction. Before and after tests using iodinated contrast agents, this medication should be temporarily discontinued due to the risk of kidney damage and lactic acidosis, and it can be resumed once kidney function has returned to normal. Pregnant or breastfeeding women are advised against using this medication, and it is not recommended for children under 18 years of age as safety and efficacy have not been established. In elderly patients, kidney function may decline, so renal function should be checked prior to administration and monitored regularly, and excessive dosing should be avoided. If symptoms such as dehydration, vomiting, or diarrhea occur while taking this medication, immediate consultation with a physician is necessary, and alcohol consumption should be avoided as it may increase the risk of lactic acidosis. Additionally, this drug may increase the risk of urinary tract infections or genital infections, so prompt treatment should be sought if infection symptoms develop. Vitamin B12 deficiency may occur; therefore, if used for an extended period, regular monitoring of vitamin B12 levels is needed. Finally, this medication may interact with other drugs that can affect blood sugar control, so it is vital to inform a doctor or pharmacist of any other medications being taken.

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reaction, severe rash with fever, blisters, skin peeling, mucosal pain in mouth/eyes, severe skin reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory distress accompanied by cough and fever, jaundice (yellowing of skin or eyes), generalized lethargy (liver dysfunction), sudden and severe allergic reaction.

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 or moisture, so it should be stored in a tightly closed container. It is advisable to maintain storage temperatures between 1 and 30 degrees Celsius at room temperature. This will help ensure the medication's effectiveness is safely preserved.

Appearance

Orange-yellow, biconvex oval film-coated tablet

Package unit

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