Phaesidapa M Extended Release Tablet 10/500 mg (Dapagliflozin Propanediol Hydrate, Metformin Hydrochloride)

Adult dose

The usual dosage is once daily with the evening meal. The maximum dose is 10 mg of dapagliflozin/2000 mg of extended-release metformin once daily, administered as two tablets of 5 mg/1000 mg. The recommended starting dose when used as initial therapy is one tablet of 5 mg/500 mg or 10 mg/500 mg once daily. This medication should be swallowed whole and should not be broken, cut, or chewed.

This medication helps to control blood glucose levels. However, it can rarely cause a serious condition called lactic acidosis, which requires caution. Be careful, as hypoglycemia can occur when taken with other diabetes medications. It should not be used in patients with significantly impaired kidney function or in conditions such as severe infection, dehydration, or acute myocardial infarction. Pregnant and breastfeeding women should also not take this medication. Elderly patients or those with weakened kidney function should ensure that kidney function is monitored prior to and during use of this medication. This medication can increase the risk of genital infections and urinary tract infections, so treatment should be sought promptly if symptoms appear. Dehydration or hypotension symptoms due to reduced fluid volume may also occur, requiring caution. Vitamin B12 deficiency may occur, so regular blood tests are recommended if taken for an extended period. Excessive alcohol consumption can increase risks, and it is advisable to avoid drinking alcohol. Before surgery or radiographic examinations with contrast agents, the medication should be discontinued for a period and resumed only after confirming normal kidney function. During treatment with this medication, be vigilant for hypoglycemic symptoms, and dosage adjustments may be necessary if taken with insulin or other hypoglycemic agents. In case of overdose, seek medical attention immediately for proper treatment. This medication is not used in children or pregnant women as its safety has not been established. This medication does not significantly affect the ability to drive or operate machinery, but dizziness may occur, so caution is advised. Store the medication out of reach of children and in its original container to maintain quality.

Serious side effects

Lactic acidosis, mortality due to severe lactic acidosis, severe hypoglycemia, severe allergic reactions (hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor), severe skin adverse reactions (severe rash with high fever, blisters, skin peeling, pain in mouth/eye mucous membranes), difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, liver abnormalities (jaundice, yellowing of the skin or eyes)

Mild side effects

Vulvovaginitis, balanitis, and related genital infections, urinary tract infections, fungal infections, hypoglycemia (when combined with insulin or sulfonylureas), reduced fluid volume (including dehydration, hypovolemia, hypotension), thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, pruritus of the vulva, pruritus of the genitalia, increased hematocrit, decreased renal creatinine clearance at the start of treatment, dyslipidemia, elevated serum creatinine,

This medication is sensitive to air and moisture, so it must be stored in a well-sealed container. It is important to maintain the storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Pink rectangular extended release film-coated tablet

Package unit

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