Zadiglyemmet Tablet 12.5/500 mg (Empagliflozin 2L-Proline, Metformin)

Adult dose

The recommended dose of this medication is 1 tablet, taken twice a day. The maximum recommended daily doses for empagliflozin and metformin should not exceed 25 mg and 2000 mg, respectively, based on each patient’s current treatment regimen, efficacy, and tolerability. For patients not able to achieve sufficient glycemic control with monotherapy using metformin or other medications, the recommended dose is 5 mg of empagliflozin taken twice daily and the currently prescribed dose of metformin.

This medication is used for the treatment of diabetes, acting with two components to help control blood sugar. While taking this medication, a rare side effect known as severe lactic acidosis may occur, with symptoms including malaise, muscle pain, difficulty breathing, and abdominal pain; immediate consultation with a physician is advised if these symptoms arise. Additionally, caution should be exercised as hypoglycemia may occur when taken with insulin or other diabetes medications, characterized by symptoms such as dizziness, cold sweats, and severe fatigue. Patients with poor kidney function, acute infection, dehydration, heart disease, or liver dysfunction should avoid using this medication. Especially before and after examinations that utilize iodinated contrast agents, this medication should be temporarily discontinued and resumed only after confirming normal kidney function. It is recommended that women who are pregnant or breastfeeding do not take this medication, and those planning pregnancy should consult with a physician. This medication may cause reduced fluid volume, so patients with a risk of dehydration or hypotension should use it with caution, and older adults should adjust the dosage while regularly monitoring kidney function. The risk of genital infections and urinary tract infections may increase during use, so any infection symptoms should be reported to healthcare personnel immediately. Vitamin B12 levels may decrease, so it is advisable to check through blood tests during long-term use. Overdosage can lead to serious side effects such as hypoglycemia or lactic acidosis, so adhering to the prescribed dosage is crucial, and if side effects are suspected, immediate medical attention should be sought. This medication's safety and efficacy have not been established in children, and it is recommended not to use it for those under 18 years of age.

Serious side effects

Hives, severe swelling (edema), angioedema, tightness of the chest, difficulty breathing, lactic acidosis, ketoacidosis, severe rash with fever, blisters, skin peeling, pain in oral/conjunctival mucosa, severe adverse skin reactions, asthma attacks, respiratory abnormalities with coughing and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances.

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 must be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 to 30 degrees Celsius (room temperature). Proper storage will help maintain the medication's efficacy and safe use.

Appearance

Light brownish-purple, convex, oval film-coated tablet

Package unit

30 tablets/bottle