Empagliflozin and Metformin Hydrochloride Tablets 12.5/850 mg (Empagliflozin, Metformin Hydrochloride)

Adult dose

The recommended dosage of this medication is one tablet twice a day. The dosage is determined considering the patient's current treatment regimen, efficacy, and tolerability, within the limits of a maximum daily dosage of 25 mg of empagliflozin and 2000 mg of metformin. For patients not achieving adequate blood sugar control with metformin alone or in combination with other medications like insulin, the recommended dosage is 5 mg of empagliflozin twice a day (total 10 mg) and the patient's existing dose of metformin.

This medication helps to control blood sugar levels and is primarily used for diabetes treatment. Before taking this drug, kidney function must be confirmed to be normal; it should not be administered to patients with severely impaired kidney function. Use of this medication should be avoided or temporarily suspended in the presence of acute illnesses such as severe infections, dehydration, heart failure, or acute myocardial infarction. It is recommended that pregnant women or women who may become pregnant, as well as nursing mothers, avoid taking this medication. This drug can cause hypoglycemia; therefore, caution should be exercised for hypoglycemic symptoms if taken alongside insulin or other blood sugar-lowering agents. Urination may increase, and there is a risk of urinary tract infections or genital infections, thus medical consultation is necessary if symptoms of infection appear. Hypotension or dehydration may occur due to decreased fluid volume; particularly elderly patients or those at risk of fluid loss should be monitored closely. It is advisable to avoid use in patients with liver dysfunction, and they should be informed immediately if any symptoms of liver abnormality appear. This medication can cause lactic acidosis, a rare but serious side effect, so patients should go to the hospital immediately if symptoms like fatigue, muscle pain, shortness of breath, or abdominal pain occur. In case of scheduled surgery, the medication should be discontinued 48 hours prior to the procedure and resumed only after kidney function has normalized post-surgery. Alcohol consumption should be avoided while taking this medication, as it may increase the risk of lactic acidosis. Blood levels of vitamin B12 may decrease, so regular blood tests are recommended. The safety of this medication in children has not been established, thus it is not recommended for those under 18 years of age. In case of overdose, there is a risk of hypoglycemia or lactic acidosis, so the dosage must be strictly adhered to, and any unusual symptoms should be reported to medical personnel immediately. While taking this medication, regular monitoring of kidney function and blood sugar levels is necessary, and if any unusual symptoms arise, immediate consultation with medical personnel is needed. Additionally, this medication may interact with other medications, so if there are any other drugs being taken, it is essential to inform the healthcare provider.

Serious side effects

Hives, angioedema, necrosis of the perineum, lactic acidosis, ketoacidosis, severe allergic reactions, severe skin reactions, difficulty breathing, asthma attacks, shortness of breath, liver abnormalities (jaundice), severe neurological symptoms (sudden and severe headache, thunderclap headache, seizures, confusion, vision changes, paralysis), severe edema or urination problems (notable decrease in urine volume, severe generalized swelling, increased blood pressure), urinary sepsis, kidney

Mild side effects

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. It should be kept in a safe temperature range, avoiding both excessively hot and excessively cold conditions, typically at room temperature between 1°C and 30°C.

Appearance

Biconvex oval film-coated tablets, white with a pink tint

Package unit

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