Dapagliflozin Propanediol Hydrate / Metformin Hydrochloride Extended Release Tablets 10/1000 mg

Adult dose

This medication is typically administered once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin/2000 mg of extended-release metformin once daily, which can be taken as 2 tablets of 5 mg/1000 mg. For initial therapy, the recommended starting dose is 1 tablet of 5 mg/500 mg or 10 mg/500 mg once daily. The dosage should be adjusted gradually to reduce gastrointestinal side effects associated with metformin.

This medication is used to treat type 2 diabetes and assists in managing blood sugar levels. However, it should not be administered to certain patients. For example, patients who are allergic to any of the components of this medication, those with severe renal impairment, those who are dehydrated or have severe infections, patients with type 1 diabetes, pregnant women or breastfeeding women, and those with certain genetic disorders should not take this medication. Additionally, patients with mildly reduced kidney function or decreased fluid volume should be particularly cautious when using this medication and should regularly monitor kidney function and blood pressure due to potential symptoms of hypotension or dehydration. When this medication is used with other antidiabetic agents, the risk of hypoglycemia may increase, so dose adjustments may be necessary when used with insulin or sulfonylureas. While taking this medication, there is a risk of a rare but serious side effect known as lactic acidosis. Therefore, if symptoms such as fatigue, muscle pain, difficulty breathing, or abdominal pain occur, immediate consultation with a doctor is necessary. Moreover, this medication may increase the risk of genital or urinary tract infections, so prompt treatment should be sought if symptoms of infection occur. This medication may lower vitamin B12 levels, so for long-term use, it is recommended to regularly check vitamin B12 levels. Women who are pregnant or planning to become pregnant should not take this medication, and breastfeeding women should also avoid it. Excessive alcohol consumption may increase the risk of side effects associated with this medication, so caution is advised. This medication does not significantly affect driving or operating machinery; however, dizziness may occur, so caution is advised. Finally, this medication should be kept out of the reach of children and stored safely in its original container.

Serious side effects

Severe lactic acidosis (metformin-related), severe hypoglycemia, renal dysfunction, acute kidney injury, severe allergic reactions, severe skin reactions, liver dysfunction (jaundice), serious neurological symptoms (Guillain-Barré syndrome, headaches, facial paralysis, etc.), atrial fibrillation, perineal necrosis, urosepsis, pyelonephritis, acute cholecystitis, diabetic ketoacidosis, fluid volume reduction (including dehydration and hypotension).

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, so it should be stored in a tightly closed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the effectiveness and safety of the medication for an extended period.

Appearance

Yellow, double-sided, convex oval extended-release film-coated tablet

Package unit

Bottle packaging - 30 tablets/bottle