Empaanduo Tablet 12.5/1000 mg (Empagliflozin, Metformin Hydrochloride)

Adult dose

The recommended dosage of this medicine is one tablet, twice daily. The dosage should be determined within the limits of the maximum recommended daily dose of empagliflozin 25 mg and metformin 2000 mg, considering the treatment regimen, effectiveness, and tolerability for each patient. If blood sugar control is insufficient, 5 mg of empagliflozin may be taken twice daily (total of 10 mg per day) along with the current dose of metformin, considering its excellent tolerability.

This medicine includes two components, empagliflozin and metformin hydrochloride, that help control blood sugar. It is important to be cautious as this medicine may cause a rare but serious side effect known as lactic acidosis. Lactic acidosis is a condition where lactic acid builds up excessively in the body, and symptoms may include fatigue, muscle pain, difficulty in breathing, and abdominal pain. If any of these symptoms occur, consult a doctor immediately. Moreover, when taken in conjunction with other diabetes medications such as insulin or sulfonylureas, the risk of hypoglycemic symptoms may increase, so blood sugar levels should be monitored frequently and medication doses adjusted in consultation with a doctor if necessary. Patients with decreased kidney function, acute infections, dehydration, heart problems, or severe liver disease should not take this medicine as it may increase the risk of side effects due to drug accumulation in such conditions. During the course of taking this medicine, regular monitoring of kidney function is required, and special care is necessary for elderly patients or those with slightly reduced kidney function. If undergoing tests or surgeries involving iodine contrast agents, this medicine should be discontinued 48 hours prior to the procedure and can be resumed only after kidney function has normalized. This medicine may cause urinary tract infections or genital infections, so prompt treatment should be sought if related symptoms occur. Due to the metformin component, there may be a decrease in vitamin B12 levels, so it is advisable to monitor vitamin B12 levels during prolonged use. Pregnant women or women who may become pregnant, as well as those who are breastfeeding, should not take this medicine, and if currently taking it, they should consult a doctor. Furthermore, alcohol can increase the risk of side effects from this medicine, so it is crucial to avoid excessive drinking during treatment. This medicine is not recommended for children under 18 years of age, and special caution is needed for elderly patients over 75 years due to changes in body fluid status and decreased kidney function. In cases of overdose, there is a particular risk of lactic acidosis, so immediate medical attention should be sought if suspected. Finally, it is safest to store this medicine out of reach of children, and to keep it in its original container.

Serious side effects

Hives, angioedema, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty in breathing, asthma attack, cough with fever and respiratory distress, yellowing of skin or eyes (jaundice), profound lethargy, sudden and severe headache, lightning-like headache, seizure, confusion, visual disturbances,

Mild side effects

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

This medicine should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius to ensure the medication’s effectiveness is preserved for a longer time.

Appearance

Dark brownish to purplish, oval, biconvex film-coated tablet

Package unit

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