Empagliflozin and Metformin Hydrochloride Tablet 5/1000 mg

Adult dose

The recommended dosage is 1 tablet, taken twice daily. The dosage should be determined according to each patient's current treatment regimen, efficacy, and tolerability, not exceeding empagliflozin 25 mg and metformin 2000 mg. Patients who cannot achieve adequate blood sugar control with metformin alone or in combination with other medications such as insulin should take 5 mg of empagliflozin twice daily (a total of 10 mg per day) along with their existing metformin dosage.

This medication is used to treat diabetes and helps lower blood sugar. When taking this medication, there may be a risk of a rare side effect called severe lactic acidosis. Lactic acidosis can lead to an excessive buildup of lactic acid in the body and be dangerous, potentially life-threatening in severe cases. Additionally, care should be taken when taking other diabetes medications such as insulin or sulfonylureas, as severe hypoglycemia may occur. This medication should not be administered to patients with moderately or severely reduced kidney function, acute kidney issues, severe infections, heart failure, or acute myocardial infarction. Administration must be temporarily discontinued before and after any exams or procedures using iodine-based contrast agents and resumed only after kidney function returns to normal. Women who are pregnant or breastfeeding should not take this medication, and patients with reduced liver function should also avoid it. Regular monitoring of kidney function and blood creatinine levels is necessary while taking this medication, and consultation with a doctor should be made in cases of dehydration, severe vomiting, or diarrhea. Side effects may include gastrointestinal disturbances, hypoglycemia, urinary infections, genital infections, increased urination, nausea, vomiting, diarrhea, abdominal pain, loss of appetite, constipation, abnormal liver function tests, altered taste, itching, rash, increased blood creatinine levels, decreased blood sugar, decreased and deficiency in vitamin B12, vitamin D deficiency, headache, dizziness, weakness, chest discomfort, chest pain, weight loss, insomnia, anxiety, vulvar itching, genital itching, low back pain, cough, and shortness of breath. Moreover, vitamin B12 levels may decrease, requiring testing during prolonged use. Alcohol consumption may increase the risk of lactic acidosis, so excessive drinking should be avoided while taking this medication. During the course of this medication, one should vigilantly monitor blood sugar levels as well as symptoms of ketoacidosis or lactic acidosis, and immediately consult healthcare professionals if any abnormalities occur. Elderly patients or those at risk of fluid loss should take extra caution in their usage, and they must inform healthcare providers if they are taking other medications due to potential drug interactions. This medication is not recommended for children under the age of 18, and in the case of overdose, immediate medical attention should be sought.

Serious side effects

Hives, severe swelling (edema), liver abnormalities (hepatitis, liver damage), lactic acidosis, ketoacidosis, severe allergic reactions, necrosis of the perineum, urinary sepsis and pyelonephritis, headache (severe headache, thunderclap headache), stroke, confusion, visual disturbances, paralysis, acute kidney injury, severe edema accompanied by increased blood pressure, myocardial infarction, shock, acute and unstable heart failure, pulmonary embolism, severe respiratory dysfunction, deep vein thrombosis, pneumonia.

Mild side effects

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

This medication should be kept in a tightly closed container to protect it from air and moisture and stored at room temperature between 1 to 30 degrees Celsius. This will help maintain the medication's effectiveness and ensure safe usage.

Appearance

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

Package unit

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