Empagliflozin/Metformin Hydrochloride 5/850 mg Tablets

Adult dose

The recommended dose of this medication is 1 tablet, twice a day. It is decided considering the current treatment regimen, efficacy, and tolerability of each patient, within the limits of not exceeding a total daily dose of 25 mg of empagliflozin and 2000 mg of metformin. Patients who cannot achieve adequate blood sugar control with metformin alone or other medications such as insulin should take empagliflozin 5 mg twice daily (total daily amount 10 mg) and metformin.

This medication can cause a rare but very serious condition known as lactic acidosis, so if symptoms appear, medical personnel should be notified immediately. Also, when taken with other diabetes medications, there may be a risk of hypoglycemia, so blood sugar levels should be monitored carefully. This medication should not be used in patients with severely impaired kidney function, acute kidney problems, severe infections, heart failure, or acute myocardial infarction. Before and after tests using iodinated contrast agents, the medication should be temporarily discontinued, and it should be restarted only after kidney function is confirmed to be normal. This medication is not to be administered to women who are pregnant or may become pregnant or to breastfeeding women. Elderly patients or those with reduced kidney function should regularly monitor kidney function and adjust the dosage as needed. This medication may cause gastrointestinal disturbances, urinary infections, genital infections, increased urination, hypoglycemia, and other side effects, so if any unusual symptoms occur, immediate consultation with a healthcare provider is necessary. In particular, in cases where there is a risk of dehydration or fluid loss, fluid status should be monitored closely, and medication may be temporarily discontinued if necessary. Vitamin B12 levels may decrease; therefore, regular blood testing is advisable for long-term users. Alcohol consumption may increase the risk of side effects associated with this medication, so care should be taken to avoid excessive drinking while taking it. If fever, pain in the genital area or perineum, erythema, or swelling occurs during the use of this medication, immediate notification to medical personnel is necessary due to the possibility of serious infection. In case of planned surgery, this medication should be discontinued 48 hours prior to surgery, and it should be restarted only after confirming normal recovery of kidney function post-surgery. This medication is not recommended for children under 18 years of age as clinical safety and efficacy have not been established. In cases of overdose, immediate medical attention is required, particularly due to the risk of lactic acidosis.

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with coughing and fever, skin or eye jaundice, extreme lethargy, sudden and severe headache, lightning headache, seizure, confusion, visual disturbances, paralysis

Mild side effects

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

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve its efficacy and safety over time.

Appearance

White film-coated tablet that is oval and biconvex with a yellow hue

Package unit

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