Amplejine Met Tablet 5/1000 milligrams (Empagliflozin, Metformin Hydrochloride)

Adult dose

The recommended dosage of this medication is 1 tablet, taken 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 dosage is 5 mg of empagliflozin twice daily (total daily dose of 10 mg) along with the existing dose of metformin. If tolerance to 10 mg of empagliflozin (total daily dose) is good, further blood sugar control may be required.

This medication may cause a rare but serious side effect called severe lactic acidosis, so caution is necessary. When taking this medication with other diabetes drugs such as insulin or sulfonylureas, the risk of hypoglycemia may increase, so care should be taken. This medication should not be used in certain patients with moderate to severe renal impairment, acute kidney problems, severe infections, or heart failure. When undergoing tests using iodinated contrast materials, this medication must be discontinued before and after the examination due to the risk of renal damage and lactic acidosis, and should be resumed only after normal kidney function is confirmed. Patients who are at risk of decreased fluid volume, such as those who are dehydrated due to vomiting or diarrhea, should be cautious when taking this medication and may need to temporarily discontinue it. This medication may increase the risk of urinary and genital infections, so any signs of infection should be reported to a healthcare professional immediately. Hypoglycemic symptoms may occur during treatment, so if symptoms such as dizziness, cold sweat, or severe fatigue appear, blood sugar levels should be checked, and appropriate measures should be taken. Women who are pregnant or may become pregnant, and breastfeeding women should not take this medication and should consider alternative treatment options if necessary. Elderly patients are at higher risk of renal function decline, so regular kidney function monitoring is required, and maximum dosage should be avoided while considering proper dosage adjustments. It is advisable to avoid alcohol intake during the use of this medication, as alcohol may increase the risk of lactic acidosis. Additionally, this medication may reduce vitamin B12 levels, so periodic monitoring of vitamin B12 levels is recommended for long-term use. If surgery is planned, this medication should be discontinued 48 hours prior to the surgery and resumed only after normal kidney function has been confirmed post-surgery. In cases of overdose, serious side effects such as hypoglycemia or lactic acidosis may occur, and immediate medical treatment should be sought. Caution is needed when driving or operating machinery while on this medication, and activities should be restrained if symptoms such as dizziness or drowsiness occur. Patients taking this medication should regularly check their blood sugar levels, kidney function, electrolyte levels, etc., and consult with healthcare professionals if any abnormal signs occur.

Serious side effects

Hives, angioedema, perineal necrosis, ketoacidosis, lactic acidosis, urosepsis, pyelonephritis, liver function test abnormalities, hepatitis, acute kidney injury, liver abnormalities (jaundice), severe allergic reactions, severe skin reactions, respiratory problems, sudden and severe headache, thunderclap headache, seizures, confusion, vision changes, paralysis, significantly reduced urine output, severe swelling throughout the body with accompanying high blood pressure

Mild side effects

• Nausea
• vomiting
• diarrhea
• abdominal pain
• loss of appetite
• constipation
• taste disorders
• itching
• rash
• hives

This medication may be sensitive to air or humidity, so it should be stored in a tightly sealed container. It is best to maintain the storage temperature between 1 degree and 30 degrees Celsius to preserve the medication's efficacy over time.

Appearance

Brownish-yellow, double-sided convex film-coated tablet

Package unit

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