JANUVIA

In adult patients with type 2 diabetes, SITAGLIPTINE TEVA is indicated to improve glycemic control:

as monotherapy

· in patients inadequately controlled by diet and exercise alone and for whom metformin is contraindicated or not tolerated.

as oral dual therapy, in combination with

· metformin, when used as monotherapy with diet and exercise, does not allow for adequate glycemic control.

· a sulfonylurea, when used as monotherapy, at the maximum tolerated dose, with diet and exercise, does not allow for adequate glycemic control and when metformin is contraindicated or not tolerated.

· a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (thiazolidinedione), when appropriate and when its use as monotherapy with diet and exercise does not allow for adequate glycemic control.

as oral triple therapy, in combination with

· a sulfonylurea and metformin, when dual therapy with these two medicines with diet and exercise does not allow for adequate glycemic control.

· a PPARγ receptor agonist and metformin, when the PPARγ receptor agonist is appropriate and dual therapy with these two medicines with diet and exercise does not allow for adequate glycemic control.

SITAGLIPTINE TEVA is also indicated in addition to insulin (with or without metformin) when a stable dose of insulin with diet and exercise does not allow for adequate glycemic control.

Pregnancy

There are no sufficient data on the use of sitagliptine in pregnant women. Animal studies have shown reproductive toxicity at high dose (see section 5.3). The potential clinical risk is unknown. Due to the absence of data in humans, sitagliptine should not be used during pregnancy.

Breastfeeding

It is unknown if sitagliptine is excreted in human breast milk. Animal studies have shown that sitagliptine is found in breast milk. Sitagliptine should not be used during breastfeeding.

Fertility

Animal data have not shown an effect of sitagliptine on male and female fertility. There are no data in humans.

Sitagliptine has no effect, or a negligible effect, on the ability to drive vehicles and use machines. However, when driving vehicles or using machines, account must be taken of the fact that dizziness and somnolence have been reported.

In addition, patients should be warned of the risk of hypoglycemia when sitagliptine is administered in association with a hypoglycemic sulfonylurea or insulin.