GLIDIABET

Non-insulin-dependent diabetes, in association with an appropriate diet, when this diet is not sufficient to restore glycemic balance on its own.

Pregnancy

Risk related to diabetes

Diabetes (gestational or permanent), when not balanced, is the cause of an increase in congenital malformations and perinatal mortality. In the peri-conception period, as good a balance of diabetes as possible must be achieved, in order to reduce the malformation risk.

Risk related to glibenclamide

Sulfonylureas are teratogenic in animals at high doses.

In clinical practice, there are currently no relevant or sufficient data to evaluate any potential malformative or foetotoxic effect of glibenclamide when administered during pregnancy.

Management

Rebalancing diabetes allows for normalizing the course of pregnancy in this category of patients.

It imperatively requires insulin, regardless of the type of diabetes I or II, gestational or permanent.

In the latter case, it is recommended to switch from oral treatment to insulin as soon as a pregnancy is envisaged or in case of incidental discovery of a pregnancy exposed to this medicine: in this case, this does not constitute the systematic argument to advise an interruption of pregnancy but leads to a cautious attitude and to oriented prenatal surveillance.

Neonatal blood glucose monitoring is recommended.

Breastfeeding

In the absence of data concerning passage into breast milk and given the risk of neonatal hypoglycemia, breastfeeding is contraindicated in case of treatment with this medicine.

Fertility

Not applicable.

Patients should be sensitized to the symptoms of hypoglycemia and should be cautious when driving and using machines.

The classification of adverse events according to their frequency is as follows: very common (≥ 1/10), common (≥ 1/100 and < 1/10), uncommon (≥ 1/1 000 and < 1/100), rare (≥ 1/10 000 and < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data).

Metabolism and nutrition disorders

· Very common: hypoglycemia (see sections 4.4 and 4.9);

These hypoglycemic episodes can be prolonged and severe and are not always easy to correct.

· Not known: cases of hyponatremia (isolated cases).

Skin and subcutaneous tissue disorders

· Common: mucocutaneous eruptions;

· Not known: pruritus, maculopapular rash, bullous reactions, erythema multiforme, exfoliative dermatitis, some cases of photosensitization have been reported.

Immune system disorders

· Not known: manifestations of hypersensitivity, allergic or pseudo-allergic reactions.

· Not known: isolated cases of urticaria-like reactions that may progress to life-threatening reactions with bronchospasm, dyspnea, hypotension, or even shock.

Gastrointestinal disorders

· Common: nausea, diarrhea.

· Uncommon: epigastric discomfort.

Hepatobiliary disorders

· Not known: hepatic disorders: an increase in liver enzymes has been noted with the possibility of the occurrence of cytolytic or cholestatic hepatitis requiring discontinuation of treatment. These disorders can progress to life-threatening liver failure.

Blood and lymphatic system disorders

Hematological disorders generally reversible upon discontinuation of treatment:

· Not known: hyper eosinophilia, leukopenia, moderate or severe thrombocytopenia which may manifest as purpura, agranulocytosis, hemolytic anemia, aplastic anemia and pancytopenia.

Investigations

· Common: glibenclamide, like all sulfonylureas, can lead to weight gain.

· Not known: occasional mild to moderate elevations of urea and creatinine.

Eye disorders

· Not known: transient visual disturbances such as blurred vision or accommodation disorders, especially at the start of treatment, with or without glycemic variation.

General disorders and administration site conditions

· Not known: disulfiram-like effect in case of alcohol ingestion during meals,

clinical expression of porphyria (hepatic or cutaneous) in porphyric patients (see section 4.3).

· Not known: exceptionally, allergic cutaneous or visceral vasculitis which may be life-threatening.

Reporting of suspected adverse reactions

Reporting suspected adverse effects after authorization of the medicine is important. It allows continuous monitoring of the benefit/risk ratio of the medicine. Healthcare professionals report any suspected adverse effect via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and network of Regional Pharmacovigilance Centres - Website: www.signalement-sante.gouv.fr .