Each film coated tablet contains Dapagliflozin 10 mg and Linagliptin 5 mg Tablets.

It should be given orally once daily

No interaction studies have been performed for Dapagliflozin and Linagliptin tablets.

Patients with Renal impairment -Results of study, supported by results of population pharmacokinetic analyses, indicate that no dose adjustment is recommended in patients with renal impairment.

Hepatic Impairment- Patients with severe hepatic impairment (Child-Pugh class C) had comparable exposure of linagliptin in terms of AUC0-24 and approximately 23% lower Cmax compared with healthy subjects. Reductions in the pharmacokinetic parameters seen in patients with hepatic impairment did not result in reductions in DPP-4 inhibition. No dose adjustment of linagliptin is necessary in patients with hepatic impairment. Gender No dose adjustment is necessary based on gender.

Gender- had no clinically meaningful effect on the pharmacokinetics of linagliptin based on a population pharmacokinetic analysis.

Pregnant Women- There are no data from the use of drug in pregnant women. There are no adequate data from the use of linaliptin in pregnant women.

Race -No dose adjustment is necessary based on race. Race had no clinically meaningful effect on the pharmacokinetics of linagliptin based on available pharmacokinetic pharmacokinetic analysis,data, including subjects of White, Hispanic, Black, and Asian racial groups.

Lactating Women It is unknown whether dapagliflozin (and/or its metabolites) are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of dapagliflozin/metabolites in milk, as well as pharmacologically-mediated effects in nursing offspring. It is unknown whether linagliptin is excreted in human milk. It should not be used during breast-feeding.

Talk to your doctor, pharmacist or nurse before taking linagliptin/Dapagliflozin: -

• if you have type 1 diabetes (i.e. your body does not produce insulin) or if you have a condition called diabetic ketoacidosis.
• if you are taking an anti-diabetic medicine known as sulphonylurea (your doctor may want to reduce your dose of the sulphonylurea when you take it together with linagliptin in order to avoid low blood glucose [hypoglycaemia]).
• if you have moderate or severe kidney disease (you will need to take a lower dose of this combination).
• if you are on dialysis.
• if you have liver disease.
• if you suffer from heart failure.
• if you have or have had a disease of the pancreas.
• if you have headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heart beat, sweating and feeling jittery. - if you have stuffy or runny nose and sore throat.