Emparilduo Extended-Release Tablets 10/1000 mg (Empagliflozin, Metformin)

Adult dose

To reduce gastrointestinal adverse effects associated with metformin, this medication should be taken once daily in the evening with meals. The 10/1000 mg extended-release tablets or the 25/1000 mg extended-release tablets should be taken once daily, one tablet at a time. Patients taking 5/1000 mg extended-release tablets or 12.5/1000 mg extended-release tablets should take two tablets simultaneously once a day. The maximum recommended daily dose for each active ingredient is 25 mg of empagliflozin and 2000 mg of extended-release metformin hydrochloride, and should be determined based on the current treatment plan, effectiveness, and tolerability of each patient. To reduce gastrointestinal adverse reactions related to metformin, the dosage increase of metformin hydrochloride should be done gradually. For maintaining the extended-release properties, this medication must be swallowed whole without breaking, crushing, grinding, or chewing. It may be excreted incompletely in the stool. There is no known information regarding the presence of active substances in the stool. If a patient repeatedly reports finding this medication in the stool, healthcare professionals should evaluate whether blood glucose is adequately controlled (refer to cautions in usage section 5. General precautions). • For patients who are unable to achieve sufficient blood glucose control through metformin alone or in combination with other medications like insulin, the initial recommended dosage is once daily with a total amount of 10 mg of empagliflozin and the current dose of metformin. If the patient tolerates 10 mg of empagliflozin well and further blood glucose control is needed, it can be increased to 25 mg of empagliflozin. • For patients switching from combination therapy using empagliflozin and metformin, the previous doses of empagliflozin and metformin should be used. When converting from immediate-release metformin to an extended-release formulation, blood glucose control should be closely monitored, and dosing adjustments should be made appropriately. • When this medication is used in combination with sulfonylureas or insulin, a dosage reduction of sulfonylureas or insulin may be considered to reduce the risk of hypoglycemia (refer to cautions in usage section 4. Adverse reactions and 6. Interactions). Special groups Renal impairment Since dosage adjustments are needed based on renal function, periodic assessment of kidney function is recommended before and after administration of this medication. In patients with mild renal impairment (creatinine clearance (CrCl) ≧ 60 mL/min or estimated glomerular filtration rate (eGFR) ≧ 60 mL/min/1.73 m2), dosage adjustment is not necessary. For 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/1.73m2 and <60 mL/min/1.73m2), this medication can be used with dosage adjustments based on the use of metformin hydrochloride if the tolerability is good and there are no other symptoms that could increase the risk of lactic acidosis. The starting dose of extended-release metformin hydrochloride is once daily at 500 mg or 750 mg, hence initiation of treatment with this medication should not occur. The maximum daily dose of metformin hydrochloride is 1000 mg. If creatinine clearance (CrCl) falls below 45 ml/min or the estimated glomerular filtration rate (eGFR) drops below 45 ml/min/1.73m2, this medication should be discontinued immediately. Elderly patients Patients aged 75 and older must consider potential risks regarding kidney function and fluid volume reduction.

This medication is primarily used for diabetes treatment and helps in controlling blood sugar levels. However, there are several precautions to take while using this medicine. Firstly, this medication can rarely cause a serious condition called lactic acidosis, which is more likely to occur in patients with reduced kidney function or those who are dehydrated or have severe infections. Additionally, symptoms of hypoglycemia may occur when taken with insulin or sulfonylureas, so blood glucose levels should be monitored closely. This medication should not be administered to patients with moderate to severe kidney function impairment, acute heart failure, acute infections, dehydration, or pregnant women. Before and after undergoing tests involving iodine contrast agents, the administration of this medication should be temporarily halted until kidney function returns to normal. During treatment, side effects such as hypoglycemia, urinary tract infections, genital infections, increased urination, nausea, vomiting, diarrhea, abdominal pain, loss of appetite, constipation, reduced vitamin B12, taste disturbances, itching, rash, erythema, hives, angioedema, diagnostic test abnormalities (increased serum creatinine, decreased glomerular filtration rate), thirst, increased serum lipids, weight loss, headache, dizziness, weakness, chest discomfort, chest pain, insomnia, vulvar pruritus, and genital discomfort may occur, so immediate consultation with medical staff is necessary if any of these symptoms arise. Furthermore, as vitamin B12 levels may decrease, it is advisable to regularly check blood levels. Alcohol consumption may increase the risk of lactic acidosis; therefore, it is important to avoid excessive drinking during treatment. Elderly patients may have a higher risk of decreased kidney function, so kidney function tests should be conducted before treatment, followed by regular monitoring. This medication should be swallowed whole without crushing or chewing, and it may sometimes pass through the stool intact, which is considered normal. Finally, this medication can interact with various other drugs, so if other medications are being taken, it is necessary to inform medical personnel.

Serious side effects

Hives, angioedema, severe rash accompanied by fever, blisters, peeling skin, mucosal pain in the mouth/eyes, necrotizing fasciitis (Fournier's gangrene), severe allergic reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough + fever, jaundice (yellowing of skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden and severe headaches, lightning headaches, seizures, confusion of consciousness, vision issues

Mild side effects

Hypoglycemia, urinary tract infections, genital infections, increased urination, nausea, vomiting, diarrhea, abdominal pain, loss of appetite, constipation, decreased and deficient vitamin B12, taste disturbance, itching, rash, erythema, hives, angioedema, diagnostic test abnormalities (increased serum creatinine, decreased glomerular filtration rate), thirst, increased serum lipids, weight loss, headache, dizziness, weakness, chest discomfort, chest pain, insomnia, vulvar pruritus, genital discomfort

This medication can be sensitive to air or moisture and should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. This will help preserve the medication's effectiveness.

Appearance

Yellow rectangular extended-release film-coated tablet

Package unit

Bottle packaging - 30 tablets/bottle