Empagliflozin and Metformin Hydrochloride Tablet 12.5/1000 mg

Adult dose

Take 1 tablet at a time, twice daily. The dosage should be determined based on the patient's current treatment regimen, efficacy, and tolerability, without exceeding a maximum of 25 mg of empagliflozin and 2000 mg of metformin. If blood sugar control is insufficient, 5 mg of empagliflozin twice daily (total 10 mg) is recommended alongside the existing metformin dosage. Titration to 25 mg (total) of empagliflozin may be considered if tolerability is good.

This medication helps to control blood sugar. However, it can, although rarely, cause a serious condition known as lactic acidosis, which can be life-threatening, so caution is required. Also, when used with other diabetes medications, severe hypoglycemia can occur, necessitating careful monitoring of blood sugar levels. Patients with allergies to any of the ingredients in this medication or severely impaired kidney function should not use it. It is also not safe to administer during acute illnesses that can affect kidney function, such as severe dehydration, infections, heart problems, or acute myocardial infarction. This medication should not be administered to patients with type 1 diabetes, diabetic ketoacidosis, acute heart failure, or those scheduled for tests using radiopaque materials. Regular monitoring of kidney function is necessary before starting and during treatment with this medication, especially for elderly patients or those with mildly impaired kidney function, requiring more frequent checks. In situations where there is a risk of fluid loss, caution should be exercised when administering this medication, and the dosage of other medications like insulin or sulfonylureas may be adjusted to reduce the risk of hypoglycemia. While on this medication, side effects such as gastrointestinal disorders, hypoglycemia, urinary tract infections, genital infections, increased urination, nausea, vomiting, diarrhea, abdominal pain, loss of appetite, constipation, abnormal liver function tests, taste disturbances, erythema, thirst, increased serum lipids, increased serum creatinine, decreased glomerular filtration rate, decreased vitamin B12 concentration, headache, dizziness, weight loss, insomnia, fever, vascular stent stenosis, vascular stent thrombosis, upper respiratory infections, and facial edema may occur, so immediate consultation with a healthcare provider is advised if these symptoms arise. Women who are pregnant or may become pregnant, as well as nursing mothers, are advised not to use this medication unless necessary and should consult a specialist. Additionally, alcohol consumption can increase the risk of lactic acidosis, so excessive drinking should be avoided while taking this medication. In cases of impending surgery or acute illnesses, this medication should be discontinued 48 hours prior to the procedure and resumed only after kidney function has returned to normal. This medication poses a particularly high risk of fluid loss in elderly patients, necessitating careful attention and regular kidney function tests and symptom monitoring. In cases of overdose, treatments such as hemodialysis may be required, so accurate adherence to dosage is crucial, and if any unusual symptoms appear, immediate medical attention should be sought. To use this medication safely, it is important to follow the doctor's instructions carefully, undergo regular examinations, and promptly address any unusual symptoms.

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rashes with high fever, blisters, skin peeling, pain in the oral/ocular mucosa, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden.

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 sealed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius. This helps to ensure the medication's effectiveness and safety.

Appearance

Biconvex oval film-coated tablet with a dark brownish-purple color on both sides.

Package unit

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