Empagliflozin and Metformin Extended Release Tablets 12.5/1000 mg (Empagliflozin, Metformin Hydrochloride)

Adult dose

To reduce gastrointestinal adverse reactions associated with metformin, this medication should be taken once daily with dinner. This medication 10/1000 mg extended release and 25/1000 mg extended release should be taken once daily, with one tablet each time. Patients taking this medication 5/1000 mg extended release, 12.5/1000 mg extended release, 5/750 mg extended release, or 12.5/750 mg extended release should take two tablets at the same time once daily. To minimize gastrointestinal side effects associated with metformin, the dosage of metformin should be increased gradually. To maintain its extended-release properties, this medication should not be broken, crushed, ground, or chewed and should be swallowed whole. It is not known whether the active ingredients of the medication will be excreted in feces if inadequately dissolved. Should the patient repeatedly report that this medication is found in feces, healthcare providers should evaluate if blood glucose is adequately controlled (Refer to precautionary measures, 5. General Precautions). - For patients unable to achieve sufficient glycemic control with monotherapy of metformin or in combination with other medications such as insulin, the initial recommended dose of this medication is a total daily dose of 10 mg empagliflozin and the previous dose of metformin; if the 10 mg dose of empagliflozin is well tolerated and further glycemic control is needed, it can be increased to 25 mg empagliflozin. - Patients switching to this medication from a combination therapy of empagliflozin and metformin should receive their current doses of empagliflozin and metformin. Blood glucose control should be closely monitored during the conversion from immediate-release metformin to extended-release formulations, and dose adjustments should be made appropriately. Special populations Renal impairment As dose adjustments are needed based on renal function, periodic assessment of renal function is recommended before and after this medication administration. For patients with mild renal impairment [Creatinine Clearance (CrCl) ≧ 60 mL/min or estimated Glomerular Filtration Rate (eGFR) ≧ 60 mL/min/1.73 m2], dose adjustments of this medication are not necessary. In patients with moderate renal impairment [CKD stage 3A, Creatinine Clearance (CrCl) ≧ 45 mL/min and <60 mL/min or estimated Glomerular Filtration Rate (eGFR) ≧ 45 mL/min/1.73 m2 and <60 mL/min/1.73 m2], if tolerated well and without increased risk of lactic acidosis or associated symptoms, it can be used with dose adjustments of metformin hydrochloride as follows: - The starting dose of extended-release metformin hydrochloride should not be commenced with this medication as it is 500 mg or 750 mg once daily. The maximum daily dose for metformin hydrochloride is 1000 mg. If creatinine clearance (CrCl) decreases below 45 ml/min or estimated glomerular filtration rate (eGFR) decreases below 45 ml/min/1.73 m2, this medication should be discontinued immediately. Elderly Patients aged 75 years and older should consider the risk of renal function and decreased fluid volume.

This medication is used for the treatment of diabetes and should not be administered to patients with impaired renal function or severe liver disease. This medication can cause a rare but very serious side effect known as lactic acidosis; therefore, if the patient is in a state of dehydration, severe infection, or decreased heart function, administration should be discontinued. During the course of treatment, hypoglycemic symptoms may occur, so caution is particularly needed when used in conjunction with insulin or other antidiabetic agents. Urinary tract infections or genital infections may occur, so if symptoms of infection develop, consultation with healthcare providers should occur immediately. This medication can cause a decrease in fluid volume, so caution should be exercised regarding blood pressure and fluid status in patients at high risk of dehydration or the elderly. Pregnant or breastfeeding women are advised not to use this medication, especially during pregnancy where insulin therapy is recommended. If surgery is planned or if examinations using iodine contrast media are to be performed, administration of this medication should be discontinued for a certain period before and after the examination. This medication must be swallowed whole and should not be chewed or crushed. Vitamin B12 deficiency may occur, so it is necessary to monitor blood levels of vitamin B12 regularly during prolonged use. In case of overdose, severe side effects such as lactic acidosis could occur, so dosage must be strictly followed, and any unusual symptoms should be reported to a healthcare provider immediately. It is advisable to avoid alcohol consumption during treatment, as well as irregular meals or excessive exercise. Elderly patients may have decreased renal function, necessitating regular kidney function tests, while ensuring they do not exceed the maximum dosage. This medication may interact with other drugs, so it is essential to inform healthcare providers about any other medications being taken. Caution is required during activities such as driving or operating machinery while taking this medication.

Serious side effects

Urticaria, angioedema, chest tightness, difficulty breathing, lactic acidosis, severe swelling, ketoacidosis, urosepsis, pyelonephritis, severe allergic reactions, severe skin adverse reactions, urticaria, angioedema, perineal necrosis, liver abnormalities (liver dysfunction, jaundice), cerebral infarction, myocardial infarction, concussion, confusion, visual disturbances, paralysis, acute kidney failure, acute kidney injury, ureteral stone disease, acute cholecystitis, autoimmune

Mild side effects

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

This medication may be sensitive to air and moisture; therefore, it should be stored in a closed container. The storage temperature should ideally be maintained between 1 to 30 degrees Celsius at room temperature.

Appearance

Bright yellow oval extended-release film-coated tablet

Package unit

30 tablets/bottle