Glyfloam Sustained-release Tablet 10/1000 mg

Adult dose

This medicine is generally administered once daily with the evening meal. The maximum dose is once daily dapagliflozin 10 mg/sustained-release metformin 2000 mg, given as 2 tablets of 5 mg/1000 mg. When used as initial therapy, the recommended starting dose is 1 tablet once daily of either 5 mg/500 mg or 10 mg/500 mg. For patients already under treatment with metformin, the recommended dose of dapagliflozin is 10 mg once daily.

This medicine can very rarely cause a dangerous condition called lactic acidosis, so patients with poor kidney function or serious infections, dehydration, etc., should not use it. Additionally, caution is needed as hypoglycemia may occur when taken in combination with insulin or sulfonylurea medications. Patients with moderate to severe kidney impairment, liver dysfunction, or significant heart disease should not take this medicine. This medicine should not be used by pregnant or breastfeeding women, nor by patients with hereditary lactose intolerance. Patients with reduced fluid volume or at risk of low blood pressure should consult a doctor before taking this medicine and monitor blood pressure and kidney function consistently during treatment. During treatment with this medicine, genital and urinary tract infections may occur, so medical personnel should be notified immediately if symptoms of infection arise. There may be a risk of vitamin B12 deficiency, so regular blood tests to check vitamin B12 levels are advisable during long-term use. Alcohol consumption may increase the risk of lactic acidosis, so excessive drinking should be avoided while taking this medicine. If undergoing surgery or iodine contrast tests, the use of this medicine should be halted for a certain period, and it should only be resumed after ensuring normal kidney function. In case of overdose, appropriate treatment is needed, and particularly for the metformin component, blood dialysis may be helpful. Elderly patients commonly experience decreased kidney function, so dosage should be adjusted and kidney function regularly monitored. This medicine does not significantly affect driving or operating machinery, but caution is advised as dizziness may occur. Store out of reach of children and keep in the original container to prevent misuse or degradation of medicine quality.

Serious side effects

• Lactic acidosis
• severe hypoglycemia
• serious allergic reactions
• acute kidney injury and renal impairment
• severe edema or urination abnormalities
• ketoacidosis
• urinary sepsis and pyelonephritis
• necrotizing fasciitis
• Guillain-Barré syndrome
• acute cholecystitis

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, hypoglycemia, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, decreased early treatment renal creatinine clearance, dyslipidemia, elevated serum creatinine, elevated serum urea, weight loss, diarrhea, nausea/vomiting, reduced/vitamin B12 deficiency, upper abdominal pain, indigestion, abdomen

This medicine should be stored in a tightly sealed container that protects it from air and moisture at a temperature between 1 to 30 degrees Celsius. This helps maintain the efficacy and safety of the medicine.

Appearance

Yellow, biconvex, oval-shaped sustained-release film-coated tablet

Package unit

30 tablets/box [(6 tablets/PTP*5)], 30 tablets/bottle