Posiol Tablets 5 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dose for this medication is 10 mg once daily for monotherapy and additional combination therapy. For initial combination therapy, 5 mg once daily or 10 mg once daily may be administered. This medication can be taken orally at any time of the day, regardless of meals. The tablet should be swallowed whole.

Child dose

The efficacy and safety of dapagliflozin in patients under 18 years of age have not been established.

This medication should not be used in patients with hypersensitivity to the active ingredient or excipients, type 1 diabetes patients, patients with diabetic ketoacidosis, and those with lactose intolerance or related genetic disorders. It is also safer not to use in patients undergoing dialysis. Caution should be exercised when using this medication in patients with reduced fluid volume or impaired renal function, and blood pressure and renal function should be closely monitored before and after administration. Elderly patients or those taking diuretics are at higher risk of hypotension and reduced fluid volume, thus requiring careful attention. During the use of this medication, side effects such as genital infections, urinary tract infections, hypoglycemia, dizziness, thirst, constipation, back pain, etc., may occur; immediate consultation with medical personnel is required if unusual symptoms appear. Additionally, serious metabolic abnormalities such as diabetic ketoacidosis may occur, so symptoms of ketoacidosis must be carefully monitored during usage. This medication should be used with caution in patients with impaired liver function, and blood pressure and fluid status should be frequently checked in patients at risk of low blood pressure or reduced fluid volume. Pregnant or breastfeeding women should refrain from using this medication, and immediate discontinuation is necessary upon confirmation of pregnancy. The safety and efficacy of this medication in children have not been established, thus it should not be used. There is no specific antidote for overdose; appropriate treatment should be administered based on symptoms, and action should be taken as directed by medical personnel if necessary. This medication may increase the risk of hypoglycemia when used with insulin or sulfonylureas, so dose adjustment may be needed. Additionally, this medication can increase urination, leading to lower blood pressure, hence caution is advised in patients with low blood pressure or those on diuretics. Patients should be aware of symptoms of hypoglycemia while driving or operating machinery during the use of this medication, and should rest immediately if any abnormal symptoms occur. Finally, it is important to store this medication out of reach of children and in its original container to maintain its quality.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by fever, blisters, skin shedding, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, abnormal breathing coupled with cough and fever, yellowing of skin or eyes (jaundice), feeling very sluggish throughout the body, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis,

Mild side effects

Vulvitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, increased hematocrit, decreased renal creatinine clearance initially upon treatment, dyslipidemia, increased blood creatinine initially upon treatment, increased blood urea, weight loss, rash, chest pain, weakness, pain, swelling, foreign body sensation, facial swelling, facial pain, warmth,

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature.

Appearance

Yellow, round, double-convex film-coated tablet

Package unit

28 tablets/box [7 tablets/PTP X 4]