Edaphar Tablet 10mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dose for this medication in both monotherapy and additional combination therapy is 10 mg once daily. In cases of initial combination therapy with metformin, the recommended dose is either 5 mg or 10 mg once daily. This medication can be taken orally once daily at any time, regardless of meals. The tablets must be swallowed whole.

Child dose

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

This medication should not be used in patients who have had an allergic reaction to the active ingredient or excipients. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Patients with lactose intolerance or specific genetic disorders should not take this medication. It is also unsuitable for patients undergoing dialysis. Administration should be cautious in patients with fluid volume deficiency or poor renal function as it may lead to hypotension or renal damage, necessitating careful monitoring. During treatment, there may be an increased risk of genital infections and urinary tract infections, so immediate consultation with healthcare professionals is warranted if any infection symptoms occur. There is a risk of hypoglycemia when taken with insulin or sulfonylureas, so patients should be aware of hypoglycemic symptoms and may need dosage adjustments. Dehydration and hypotension may occur due to reduced fluid volume, so adequate hydration and careful monitoring of symptoms are necessary. Diabetic ketoacidosis may occur rarely, so if symptoms such as vomiting, abdominal pain, or shortness of breath arise, immediate medical attention should be sought. Patients with poor liver function, the elderly, or those taking diuretics should closely monitor their renal function and fluid status. Pregnant or breastfeeding women should avoid this medication, and if pregnancy is confirmed, discontinue use immediately. There is no specific antidote for overdose, so appropriate treatment should be administered based on symptoms, per a doctor’s guidance. This medication does not significantly affect driving or machinery operation, but caution is advised in cases of potential hypoglycemia. The product should be stored out of reach of children and kept in its original container for safety.

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucous membranes, shortness of breath or difficulty breathing, asthmatic attacks, abnormal breathing with cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden severe headache, thunderclap headache, seizures, consciousness disturbances, visual disturbances, paralysis, urination

Mild side effects

• Vulvovaginitis
• balanitis and related genital infections
• urinary tract infections
• fungal infections
• hypoglycemia
• dry mouth
• dizziness
• constipation
• back pain
• dysuria

This medication may be sensitive to air or moisture; it should be stored in a sealed container. The recommended storage temperature is room temperature between 1 degree and 30 degrees Celsius. This helps maintain the medication's effectiveness for a longer time.

Appearance

Yellow, double-convex, diamond-shaped film-coated tablets

Package unit

PTP - 28 tablets/box [7 tablets/PTP x 4], Bottle - 30 tablets/bottle