Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of the safety profile
The most frequently reported adverse reactions are changes in blood glucose levels, i.e.
hypoglycaemia. The occurrence of such reactions depends on individual factors, such as dietary habits, dosage, exercise and stress.

Tabulated list of adverse reactions

Based on the experience with repaglinide and with other hypoglycaemic medicinal products the following adverse reactions have been seen: Frequencies are defined as: 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) and not known (cannot be estimated from the available data).

Immune system disorders               Allergic reactions*         Very rare Metabolism and nutrition              Hypoglycaemia               Common disorders
Hypoglycaemic coma and      Not known hypoglycaemic unconsciousness
Eye disorders                         Refraction disorder*        Very rare Cardiac disorders                     Cardiovascular disease      Rare Gastrointestinal disorders            Abdominal pain, diarrhoea   Common Vomiting, constipation      Very rare
Nausea                      Not known
Hepatobiliary disorders               Abnormal hepatic            Very rare function, increased liver enzymes*


Skin and subcutaneous tissue         Hypersensitivity*             Not known disorders
* see section Description of selected adverse reactions below

Description of selected adverse reactions

Allergic reactions
Generalised hypersensitivity reactions (e.g. anaphylactic reaction), or immunological reactions such as vasculitis.

Refraction disorders
Changes in blood glucose levels have been known to result in transient visual disturbances, especially at the commencement of treatment. Such disturbances have only been reported in very few cases after initiation of repaglinide treatment. No such cases have led to discontinuation of repaglinide treatment in clinical trials.

Abnormal hepatic function, increased liver enzymes
Isolated cases of increased liver enzymes have been reported during treatment with repaglinide. Most cases were mild and transient, and very few patients discontinued treatment due to increased liver enzymes. In very rare cases, severe hepatic dysfunction has been reported.

Hypersensitivity
Hypersensitivity reactions of the skin may occur as erythema, itching, rashes and urticaria. There is no reason to suspect cross-allergenicity with sulphonylurea due to the difference in chemical structure.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form
(https://sideeffects.health.gov.il).