ZENETIAMET

In adult patients with type 2 diabetes, SITAGLIPTINE/METFORMINE ZYDUS is indicated to improve glycemic control, in addition to diet and physical exercise:

· in patients inadequately controlled by metformin alone at the maximum tolerated dose or in patients already treated with the sitagliptin/metformin combination.

· in association with a hypoglycaemic sulfonylurea (triple therapy) when the maximum tolerated doses of metformin and sulfonylurea do not allow for adequate glycemic control.

· in triple therapy with a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (thiazolidinedione) when the maximum tolerated doses of metformin and the PPARγ receptor agonist do not allow for adequate glycemic control.

· in addition to insulin (triple therapy) when insulin and metformin, alone, at stable doses, do not allow for adequate glycemic control.

Pregnancy

There are no sufficient data on the use of sitagliptine in pregnant women. Studies conducted in animals have shown reproductive toxicity at high dose (see section 5.3).

Limited data suggest that the use of metformine in pregnant women is not associated with an increased risk of congenital malformation. Studies conducted in animals with metformine have not shown deleterious effects on gestation, embryonic or fetal development, parturition or post-natal development (see also section 5.3).

SITAGLIPTINE/METFORMINE ZYDUS must not be used during pregnancy. If a patient is planning a pregnancy or discovers she is pregnant, treatment should be discontinued and the patient should be treated with insulin as soon as possible.

Breastfeeding

No studies have been conducted in lactating animals with the combination of the active substances of this medicinal product. Studies conducted with each of the active substances have shown that sitagliptine and metformine are excreted in the milk of the lactating rat. Metformine is excreted in small quantities in human breast milk. It is unknown if sitagliptine is excreted in human breast milk. SITAGLIPTINE/METFORMINE ZYDUS must therefore not be used during breastfeeding (see section 4.3).

Fertility

Data in animals have not shown any effect of sitagliptine on male and female fertility. There are no data in humans.

SITAGLIPTINE/METFORMINE ZYDUS has no or negligible influence on the ability to drive and use machines. However, when driving or using machines, it should be taken into account that dizziness and somnolence have been reported with sitagliptin.

In addition, patients should be alerted to the risk of hypoglycaemia when SITAGLIPTINE/METFORMINE ZYDUS is used in combination with a sulphonylurea or with insulin.