Description
Manufacturer
AstraZeneca Pharmaceuticals LP
Registraction Number
MAL16045043AZ
Content (Composition)
- Active Ingredients: Each extended-release tablet contains 5 mg dapagliflozin propanediol monohydrate (equivalent to 5 mg dapagliflozin) and 1000 mg metformin hydrochloride extended-release.
Indications (Uses)
- Type 2 Diabetes Mellitus: As an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.
- Cardiovascular Risk Reduction: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors.
Instructions for Use
- Administration: Take one tablet (5 mg/1000 mg) orally once daily, preferably with the evening meal.
- Swallow Whole: Do not crush, chew, or cut the tablet.
- Renal Function Monitoring: Assess renal function prior to initiating treatment and periodically thereafter.
Important Warnings
- Lactic Acidosis Risk: This medication may cause a rare but serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
- Dehydration: Risk of dehydration may increase with conditions such as vomiting, diarrhea, fever, or excessive alcohol intake.
- Renal Impairment: Not recommended for use in patients with severe renal impairment (eGFR <30 mL/min/1.73 m²).
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