HEMIDAONIL

Non-insulin-dependent diabetes, in combination with an appropriate diet, when this diet alone is not sufficient to restore glycemic balance.

Pregnancy

Risk related to diabetes

Diabetes (gestational or permanent), when not controlled, is at the origin of an increase in congenital malformations and perinatal mortality. In the periconceptional period, as good a control of diabetes as possible must be achieved, in order to reduce the malformative risk.

Risk related to glibenclamide

Sulfonylureas are teratogenic in animals at high doses.

Clinically, there are currently no relevant or sufficient data to evaluate a possible malformative or foetotoxic effect of glibenclamide when administered during pregnancy.

Management

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

It imperatively requires the use of 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 planned or in case of accidental discovery of a pregnancy exposed to this medicine: in this case, this does not constitute a systematic argument to advise an interruption of pregnancy but leads to an attitude of caution and targeted prenatal monitoring.

Neonatal monitoring of blood glucose is recommended.

Breastfeeding

In the absence of data concerning the 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 made aware of 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 frequent (≥ 1/10), frequent (≥ 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), unknown frequency (cannot be estimated on the basis of available data).

Metabolism and nutrition disorders

· Very frequent: hypoglycaemia (see sections 4.4 and 4.9);

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

· Unknown frequency: cases of hyponatraemia (isolated cases).

Skin and subcutaneous tissue disorders

· Frequent: mucocutaneous eruptions;

· Unknown frequency: pruritus, maculopapular eruption, bullous reactions, erythema multiforme, exfoliative dermatitis, some cases of photosensibilisation have been reported.

Immune system disorders

· Unknown frequency: hypersensitivity manifestations, allergic or pseudo-allergic reactions.

· Unknown frequency: isolated cases of urticaria-type reactions which may evolve into life-threatening reactions with bronchospasm, dyspnoea, hypotension, or even shock.

Gastrointestinal disorders

· Frequent: nausea, diarrhoea.

· Uncommon: epigastric discomfort.

Hepatobiliary disorders

· Unknown frequency: hepatic impairments: an increase in hepatic enzymes has been noted with the possibility of occurrence of cytolytic or cholestatic hepatitis requiring discontinuation of treatment. These impairments may evolve towards hepatic failure which is life-threatening.

Blood and lymphatic system disorders

Haematological impairments generally reversible on discontinuation of treatment:

· Unknown frequency: hypereosinophilia, leucopenia, moderate or severe thrombocytopenia which may manifest as purpura, agranulocytosis, haemolytic anaemia, aplastic anaemia and pancytopenia.

Investigations

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

· Unknown frequency: occasional medium to moderate elevations of uraemia and creatinine.

Eye disorders

· Unknown frequency: transient visual disturbances such as blurred vision or accommodation disorders, especially at the start of treatment, with or without glycaemic variation.

General disorders and administration site conditions

· Unknown frequency: antabuse effect in case of alcohol ingestion during meals,

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

· Unknown frequency: exceptionally, cutaneous or visceral allergic vasculitis which may be life-threatening.

Reporting of suspected adverse effects

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