GLEMA

glimépiride is indicated in the treatment of type 2 diabetes mellitus, when diet, exercise and weight reduction alone are not sufficient.

Pregnancy

Risk related to diabetes

Abnormal blood glucose levels during pregnancy are associated with an increased incidence of congenital malformations and perinatal mortality. Blood glucose levels must be closely monitored during pregnancy to reduce the teratogenic risk. Diabetes in pregnant women requires insulin therapy. Patients planning a pregnancy should inform their doctor.

Risk related to glimépiride

There are currently no sufficient data on the use of glimépiride in pregnant women. Studies in animals have shown toxicity likely related to the pharmacological action (hypoglycemia) of glimépiride (see section 5.3).

Consequently, glimépiride must not be used during the entire duration of pregnancy.

If a pregnancy is planned or in case of accidental discovery of a pregnancy during treatment with glimépiride, the treatment must be replaced as soon as possible by insulin.

Breastfeeding

In humans, no data concerning the passage of glimépiride into breast milk is available. In rats, glimépiride is excreted in breast milk. Given that other sulfonylureas are excreted in breast milk and taking into account the risk of neonatal hypoglycemia, breastfeeding is not recommended in case of treatment with this medicine.

Fertility

No data on fertility is available.

The effects on the ability to drive vehicles and use machines have not been studied.

Concentration abilities and reflexes may be decreased in case of hypoglycemia or hyperglycemia or, for example, visual disturbances. This may represent a risk in situations where these faculties are of primary importance (for example driving a car or using machines).

Patients must be informed of the precautions to take before driving to avoid hypoglycemia, particularly if the precursor symptoms of hypoglycemia are absent or decreased or if episodes of hypoglycemia are frequent. It is not recommended to drive a vehicle or use machines in these circumstances.

The following adverse effects during clinical trials were based on experience with glimepiride and other sulfonylureas, and have been listed below by organ system and in decreasing order of frequency (very common: ≥ 1/10; common: ≥ 1/100 to < 1/10; uncommon: ≥ 1/1 000 to < 1/100; rare: ≥ 1/10 000 to < 1/1 000; very rare: < 1/10 000), not known (cannot be estimated from the available data).

Blood and lymphatic system disorders

Rare: thrombocytopenia, leukopenia, agranulocytosis, erythrocytopenia, hemolytic anemia and pancytopenia, generally reversible upon discontinuation of treatment.

Frequency not known: severe thrombocytopenia with platelet count less than 10 000/µl and thrombocytopenic purpura.

Immune system disorders

Very rare: leukocytoclastic vasculitis, moderate hypersensitivity reactions which may progress to more serious reactions with dyspnea, fall in blood pressure or even shock.

Frequency not known: cross-allergy with sulfonylureas, sulfonamides and their derivatives is possible.

Metabolism and nutrition disorders

Rare: hypoglycemia.

These hypoglycemic episodes appear most often immediately, and can be severe and sometimes difficult to correct. The occurrence of these hypoglycemic episodes depends, as with any hypoglycemic treatment, on individual factors such as dietary habits and the dose of the hypoglycemic agent (see section 4.4).

Eye disorders

Frequency not known: glycemic changes may lead to transient visual disturbances, especially at the start of treatment.

Gastrointestinal disorders

Very rare: nausea, vomiting, diarrhea, abdominal distension, abdominal discomfort and abdominal pain, which may exceptionally lead to discontinuation of treatment.

Rare: dysgeusia.

Hepatobiliary disorders

Very rare: impairment of liver function (e.g. with cholestasis and jaundice), or even hepatitis which may progress to liver failure.

Frequency not known: elevation of liver enzymes.

Skin and subcutaneous tissue disorders

Frequency not known: hypersensitivity reactions (pruritus, urticaria, skin rashes and photosensitivity) may occur.

Rare: alopecia.

Investigations

Very rare: hyponatremia.

Rare: weight gain.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals report any suspected adverse reaction via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr .