Emparol-M

Empagliflozin & Metformin Hydrochloride

Composition : Each film coated tablet contains Empagliflozin INN 5 mg & Metformin Hydrochloride USP 500 mg.

Indication : Emparol-M is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with bothempagliflozin and metformin is appropriate. Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.

Dosage and Administration: Individualize the starting dose of Emparol-M based on the patient's current regimen. The maximum recommended dose is 12.5mg Empagliflozin/1000 mg Metformin twice daily. Take twice daily with meals, with gradual dose escalation to reduce the gastrointestinal side effects due to metformin. Assess renal function before initiating Emparol-M. Do not initiate or continue Emparol-M if creatinine levels > 1.5 mg/dL(males), > 1.4 mg/dL (females), or if eGFR is below 45

mL/min/1.73 m2.Or, as directed by the registerd physician.

Use in Pregnancy and Lactation : Pregnancy: There are no adequate and well-controlled studies of Empagliflozin& Metformin combination in pregnant women. This combination should be used duing pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation: It is not recommended when breastfeeding.

Packing : Each box contains 2 x 7's tablets in bilster pack.