Zadimet Tablet 5/1000 mg (Empagliflozin, Metformin Hydrochloride)

Adult dose

The recommended dosage is 1 tablet per dose, twice a day. The maximum recommended daily dosage is 25 mg of empagliflozin and 2000 mg of metformin. If blood glucose control is insufficient with metformin alone or in conjunction with other medications such as insulin, 5 mg of empagliflozin can be administered twice a day while maintaining the current dosage of metformin.

This medication is used for the treatment of type 2 diabetes and acts to lower blood glucose through its two components. It can cause a rare side effect called severe lactic acidosis, so it should not be used in cases of impaired kidney function, severe infections, dehydration, or heart failure. Additionally, caution is needed when taken with insulin or sulfonylureas as there is an increased risk of hypoglycemia. Patients with moderate or severe impairment of kidney function should not take this medication, and regular kidney function tests should be performed before and during treatment. In the case of acute illnesses, upcoming surgery, or severe infections or dehydration, the use of this medication should be temporarily discontinued. Pregnant or breastfeeding women should not use this medication, and especially women with potential for pregnancy should consult a physician before taking it. This medication may increase the risk of urinary tract infections and genital infections, so immediate medical attention is needed if symptoms of infection appear. During usage, it is important to watch for signs of hypoglycemia, particularly when taken with insulin or other glucose-lowering agents. Vitamin B12 deficiency may occur, so patients using this medication for long periods should regularly check their vitamin B12 levels. Alcohol consumption can increase the risk of lactic acidosis, so excessive drinking should be avoided while taking this medication. This medication can lead to fluid loss and a decrease in blood pressure, so elderly patients or those at risk of fluid loss should use it with caution. Throughout treatment, blood glucose control, kidney function, and infection status should be closely monitored, and immediate consultation with healthcare providers is necessary if any abnormal symptoms arise. This medication has not been established as safe and effective for children, therefore it should not be used in individuals under 18 years of age. In the event of an overdose, serious side effects such as lactic acidosis may occur, so adherence to the prescribed dosage is crucial, and immediate hospital visit is required if side effects arise. This medication should be stored in its original container, out of reach of children.

Serious side effects

Hives, erythema, angioedema, necrosis of the perineum, ketoacidosis, lactic acidosis, acute kidney injury, acute pyelonephritis, urosepsis, liver abnormalities (hepatitis, liver damage, autoimmune hepatitis), severe allergic reactions, severe swelling, myocardial infarction, cerebral infarction, severe headache (thunderclap headache), seizures, consciousness disturbance, visual disturbances, paralysis, severe skin adverse reactions (severe rash, blisters, skin peeling, pain in oral/ocular mucosa)

Mild side effects

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

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is also recommended to avoid extremely hot or cold places, and to keep it at room temperature between 1°C and 30°C.

Appearance

Yellow, biconvex, oval-shaped film-coated tablet with a brown tint

Package unit

10 tablets/box [10 tablets/PTP×1], 60 tablets/box [10 tablets/PTP×6], 60 tablets/bottle, 30 tablets/bottle