Jadiflozin M Tablet 12.5/850 mg (Empagliflozin, Metformin Hydrochloride)

Adult dose

The recommended dosage for this medication is 1 tablet per dose, twice daily. The total daily maximum recommended dosage for each ingredient is to not exceed Empagliflozin 25 mg and Metformin 2000 mg, considering the patient’s treatment regimen, efficacy, and tolerability. Patients with insufficient blood sugar control while on monotherapy with Metformin or in combination with other drugs like insulin should take Empagliflozin 5 mg twice a day (total daily amount 10 mg) along with their existing Metformin dosage. If a patient exhibits good tolerance for Empagliflozin 10 mg (total daily amount) but requires additional blood sugar control, the dose may be increased to Empagliflozin 25 mg (total daily amount). Patients switching to this medication from a combination of Empagliflozin (total daily amount 10 mg or 25 mg) and Metformin should be given their current dosages of Empagliflozin and Metformin. When combining this medication with sulfonylureas or insulin, dosage reduction for sulfonylureas or insulin may be considered to decrease the risk of hypoglycemia (refer to the precautions 4. Adverse Reactions and 6. Interactions). This medication should be taken with meals to minimize gastrointestinal side effects related to Metformin. If a dose is missed, take it as soon as remembered. However, do not take double the dose at once, and skip the missed dose in such cases. Special Groups Patients with renal impairment No dosage adjustment is needed for patients with mild renal impairment. This medication contains Metformin; therefore, dosage adjustment can be used in patients with estimated glomerular filtration rate (eGFR) of 45-59 ml/min/1.73m2 or creatinine clearance (CrCl) of 45-59 ml/min, only if they do not have any other symptoms that increase the risk of lactic acidosis. In such patients, the starting dose of Metformin is 500 mg or 850 mg once daily; thus, monotherapy of Empagliflozin and Metformin should be initiated separately. The maximum daily dose of Metformin hydrochloride that this medication can be used for is 1000 mg, with dosing of 500 mg twice daily. Kidney function must be closely monitored every 3-6 months (refer to precautions 3. Caution for the following patients item 1). If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73m2, the medication should be immediately discontinued (refer to precautions 2. Do not administer to the following patients item 2). Elderly Patients over 75 years should be cautious due to risks of renal function and fluid volume depletion.

This medication is used for the treatment of diabetes and helps in controlling blood sugar levels. When taking this medication, caution is necessary as a rare but serious side effect, lactic acidosis, may occur. Lactic acidosis is a condition arising from a buildup of lactic acid in the body, presenting symptoms like vomiting, abdominal pain, difficulty breathing, and weakness. Additionally, there is a risk of hypoglycemia when taken alongside other diabetes medications, thus it is essential to closely monitor blood sugar levels. Patients with impaired kidney function or those with acute infections, dehydration, or heart diseases should not take this medication, and they must stop its administration immediately if such conditions arise. Intake of this medication should be temporarily suspended before and after examinations using iodinated contrast agents, and it should be resumed only after kidney function has returned to normal. Women who are pregnant or may become pregnant and nursing mothers are advised not to take this medication. During treatment, urinary tract infections or genital infections may occur; hence, consultation with healthcare providers should be sought if any infection symptoms appear. This medication may lead to fluid loss; therefore, vigilance is especially needed in cases of dehydration or among the elderly, as regular kidney function monitoring is necessary. Furthermore, vitamin B12 deficiency may occur, so regular blood tests are recommended. Alcohol consumption should be avoided while taking this medication, and attention is needed during sudden reductions in food intake or vigorous exercise. Patients scheduled for surgery should discontinue this medication 48 hours prior to the procedure and resume only after confirming normal kidney function post-surgery. Hypoglycemic symptoms may arise during treatment, so immediate blood sugar checks and necessary measures should be taken if symptoms like dizziness, cold sweat, and severe fatigue occur. Finally, this medication is not recommended for children, and elderly or frail patients should exercise extra caution when using it.

Serious side effects

Hives, severe swelling (angioedema), ketoacidosis, lactic acidosis, severe allergic reactions, severe skin reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowness of skin or eyes (jaundice), liver abnormalities, sudden and severe headaches, thunderclap headache, seizures, confusion, vision disturbances, paralysis, significant decrease in urine output, severe swelling or urination anomalies, perineal symptoms

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, so it should be stored in a tightly sealed container. The recommended storage temperature is between 1 and 30 degrees Celsius at room temperature to maintain its efficacy and safety over a long period.

Appearance

A white, oval, biphasic film-coated tablet with a pinkish hue

Package unit

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