Glyance Tablet 25 mg (Empagliflozin)

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and additional combination therapy with insulin or other blood glucose-lowering agents. For patients exhibiting excellent tolerance but requiring additional blood sugar control, the dose may be increased to 25 mg once daily. This medication can be taken without regard to meals and tablets should be swallowed whole. If a dose is missed, it should be taken as soon as the patient remembers, and double dosing should be avoided.

This medication should not be used in patients who are hypersensitive to the active substance or any excipients. It should also not be administered to patients with type 1 diabetes or diabetic ketoacidosis. It is contraindicated in patients with severely impaired kidney function, i.e., those with a glomerular filtration rate (GFR) of less than 30 mL/min/1.73m², those with end-stage renal disease, or those undergoing dialysis. This drug contains lactose and should not be given to patients with inherited conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Caution should be exercised when using this medication in patients with slightly impaired kidney function, and especially in those with a GFR of less than 60 mL/min/1.73m², where dose adjustment or discontinuation may be necessary. It is recommended to use with caution in patients with heart failure classified as NYHA class I-II, and it should not be used in patients classified as class III-IV. There is an increased risk of hypoglycemia when taken with medications like insulin or sulfonylureas, so dosage adjustments may be necessary. This medication can cause various adverse effects, including hypoglycemia, genital infections, increased urination, urinary tract infections, and decreased blood volume, so symptoms should be monitored closely. A serious metabolic acidosis called ketoacidosis may occur, so if symptoms like vomiting, abdominal pain, or dyspnea appear, immediate consultation with a healthcare professional is required. Elderly patients or those at high risk of dehydration or hypotension should be monitored for dehydration or low blood pressure and may need to temporarily discontinue the medication if necessary. Serious urinary infections such as urosepsis or pyelonephritis can occur, so rapid treatment is required upon the onset of infection symptoms. There is also an increased risk of genital fungal infections with this medication, so patients with a history of such infections should be particularly cautious. Caution is advised when driving or operating machinery due to the risk of hypoglycemia, especially when used in conjunction with insulin. The use of this medication is not recommended during pregnancy, and it should be discontinued immediately if pregnancy is confirmed. If breastfeeding, it is advisable to discontinue nursing as this medication may be excreted in breast milk. Its safety and efficacy have not been established for patients under 18 years of age, so it should not be used. No specific toxic reactions have been reported in cases of overdose, but appropriate treatment is necessary depending on the clinical condition. This medication should be stored out of reach of children and care should be taken not to transfer it to other containers as this may compromise its quality.

Serious side effects

Urticaria, angioedema, ketoacidosis, urosepsis, pyelonephritis, perineal necrosis, rash, headache, cerebrovascular accident, intracranial aneurysm, severe edema accompanied by increased blood pressure, acute cholecystitis, autoimmune hepatitis, cholelithiasis, hepatitis, deep vein thrombosis, asthma attack, difficulty breathing, dyspnea, cold sweat, pallor.

Mild side effects

• Hypoglycemia
• vulvar candidiasis
• vulvitis
• balanitis and other genital infections
• increased urination
• decreased blood volume
• increased serum creatinine
• decreased glomerular filtration rate
• rash
• itching

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is best kept at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the drug's efficacy and ensures safe use.

Appearance

Pale yellow, oval-shaped, biconvex film-coated tablet

Package unit

30 tablets/box [(*10 tablets/PTP*3)]