EMPIGET EMPAGLIFLOZIN 10MG 14’S

It is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise

– as monotherapy when metformin is considered inappropriate due to intolerance

– in addition to other medicinal products for the treatment of diabetes

Dosage

Type 2 diabetes mellitus

The recommended starting dose is 10 mg empagliflozin once daily for monotherapy and add-on combination therapy with other medicinal products for the treatment of diabetes. In patients tolerating empagliflozin 10 mg once daily who have an eGFR ?60 ml/min/1.73 m² and need tighter glycaemic control, the dose can be increased to 25 mg once daily. The maximum daily dose is 25 mg.

Heart failure

The recommended dose is 10 mg empagliflozin once daily.

All indications

When empagliflozin is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia.

If a dose is missed, it should be taken as soon as the patient remembers; however, a double dose should not be taken on the same day.

Pregnancy

There are no data from the use of empagliflozin in pregnant women. Animal studies show that empagliflozin crosses the placenta during late gestation to a very limited extent but do not indicate direct or indirect harmful effects with respect to early embryonic development. However, animal studies have shown adverse effects on postnatal development . As a precautionary measure, it is preferable to avoid the use of Jardiance during pregnancy.

Breast-feeding

No data in humans are available on excretion of empagliflozin into milk. Available toxicological data in animals have shown excretion of empagliflozin in milk. A risk to the newborns/infants cannot be excluded. Empiget should not be used during breast-feeding.