Empagliflozin and Metformin Tablets 5/850 mg (Empagliflozin, Metformin Hydrochloride)

Adult dose

The recommended dosage of this medication is 1 tablet, twice a day. The dosage should remain within the maximum recommended daily dose for each component, which is 25 mg of empagliflozin and 2000 mg of metformin. For patients who do not 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 amount of 10 mg) with the established dose of metformin.

This medication is a combination treatment used for type 2 diabetes. Caution must be exercised as it can cause a rare but serious side effect known as lactic acidosis. Lactic acidosis occurs when there is an excessive accumulation of lactate in the body, with symptoms including malaise, muscle pain, shortness of breath, and abdominal pain. Additionally, when taken with insulin or sulfonylureas, there is a risk of hypoglycemia, necessitating frequent blood sugar checks and possible dosage adjustments. This medication should not be used in patients with moderate to severe renal impairment or suspected acute kidney injury. In cases of acute infections, dehydration, heart failure, or acute myocardial infarction, the use of this medication should be temporarily suspended, and it is safe to discontinue for a period before and after surgery. Patients with impaired liver function or those consuming excessive alcohol should also avoid this medication. This medication may increase the risk of urinary tract infections and genital infections; therefore, if related symptoms occur, immediate notification to medical personnel is required. Increased urination may occur, and caution is needed as hypotension or dehydration may arise due to fluid loss. Women who are pregnant or breastfeeding should not take this medication, and it is not recommended for children under 18 years of age. Elderly patients may have a higher likelihood of reduced kidney function, requiring regular monitoring of kidney function and avoidance of maximum dosage. In case of overdose, medical attention should be sought immediately as this medication can be removed via hemodialysis. Patients taking this medication should avoid alcohol, and if symptoms of hypoglycemia or lactic acidosis occur, they should consult a doctor immediately. Finally, this medication should be kept out of reach of children and stored in the original container to ensure quality maintenance.

Serious side effects

Urticaria, erythema, angioedema, perineal necrosis, ketoacidosis, lactic acidosis, pyelonephritis, urosepsis, liver abnormalities (hepatitis, acute cholecystitis, autoimmune hepatitis), cerebral infarction, myocardial infarction, concussion, fractures, worsening of heart failure, acute kidney injury, acute renal failure, jaundice, severe swelling, severe allergic reactions, severe skin reactions, shortness of breath, asthma attacks, elevated blood pressure, serious neurological effects

Mild side effects

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

This medication should be stored in a tightly closed container, protected from air and moisture. It is safest to store it at room temperature between 1°C and 30°C, avoiding extremes of heat or cold.

Appearance

Yellowish-white, double convex, oval-shaped film-coated tablets

Package unit

10 tablets/box [(10 tablets/PTP x 1)], 60 tablets/box [(10 tablets/PTP x 6)], 60 tablets/bottle, 30 tablets/bottle