Empagliflozin/Metformin Hydrochloride Tablets 12.5/500 mg (Empagliflozin, Metformin Hydrochloride)

Adult dose

The recommended dosage of this medication is 1 tablet, twice a day. The dosage should not exceed a maximum of 25 mg of empagliflozin and 2000 mg of metformin. For patients with insufficient blood glucose control using metformin alone or in combination with other medications, it is recommended to use 5 mg of empagliflozin twice daily along with the existing metformin dosage. If tolerance is good, it may be increased to 10 mg to 25 mg of empagliflozin.

This medication is composed of two ingredients that aid in blood glucose control. During the use of this medication, there may be a rare side effect called severe lactic acidosis, so attention to symptoms is necessary. Especially, when taken concurrently with insulin or sulfonylurea medications, hypoglycemia may occur, so caution is required. This medication should not be administered to patients with moderate to severe renal impairment, nor should it be used in cases of acute kidney problems or serious infections. Additionally, it should not be administered to patients with type 1 diabetes, diabetic ketoacidosis, or acute and unstable heart failure. Before and after examinations using iodine contrast agents, administration of this medication should be temporarily suspended, and it should be resumed only after confirming normal renal function. It is also safer for women who are pregnant or breastfeeding to avoid using this medication. Regular monitoring of renal function should be conducted before and during treatment, especially in elderly patients or those with slight renal impairment, as increased caution is necessary. Adverse effects such as gastrointestinal disturbances, urinary tract infections, reproductive infections, hypoglycemia, increased urination, etc., may occur; therefore, if any unusual symptoms occur, immediate consultation with a physician is advised. Alcohol consumption may increase the risk of lactic acidosis, so it is advised to avoid it during treatment. If surgery is planned or an acute illness arises, one should consult with a physician regarding the temporary cessation of medication use. This medication may increase the risk of hypoglycemia, so dosage adjustments may be needed when used with insulin or other blood glucose-lowering agents. Furthermore, patients at risk of fluid loss or dehydration should be closely monitored for hydration status and blood pressure during treatment. During the use of this medication, it is important to regularly check liver function, renal function, and vitamin B12 levels through blood tests. It is not recommended for children or adolescents under 18 years of age, as safety and efficacy have not been established. In case of overdose, one should immediately visit the hospital for appropriate treatment, and particularly, if symptoms of lactic acidosis appear, immediate emergency treatment is required. This medication should be stored out of reach of children, and it is important to keep it in its original container to maintain quality.

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/eye mucosa, shortness of breath or breathing difficulty, asthma attack, cough + abnormal breathing with fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis.

Mild side effects

• Hypoglycemia
• urinary tract infection
• reproductive infection
• increased urination
• nausea
• vomiting
• diarrhea
• abdominal pain
• loss of appetite
• abnormal liver function tests

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a long time.

Appearance

Biconvex oval film-coated tablet with a light brownish purple hue.

Package unit

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