Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The following adverse reactions from clinical investigations were based on experience with glimepiride and other sulfonylureas, were listed below by system organ class and in order of decreasing incidence: 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, granulocytopenia, agranulocytosis, erythropenia, hemolytic anemia and pancytopenia, which are in general reversible upon discontinuation of medication.
Not known: severe thrombocytopenia with platelet count less than 10,000/μl and thrombocytopenic purpura.
Immune system disorders
Very rare: leukocytoclastic vasculitis, mild hypersensitivity reactions that may develop into serious reactions with dyspnea, fall in blood pressure and sometimes shock.
Not known: cross-allergenicity with sulfonylureas, sulfonamides or related substances is possible.
Metabolism and nutrition disorders
Rare: hypoglycemia
These hypoglycemic reactions mostly occur immediately, may be severe and are not always easy to correct. The occurrence of such reactions depends, as with other hypoglycemic therapies, on individual factors such as dietary habits and dose (see further under section 4.4).
Eye disorders
Not known: visual disturbances, transient, may occur especially on initiation of treatment, due to changes in blood glucose levels.
Gastrointestinal disorders
Rare: dysgeusia.
Very rare: nausea, vomiting, diarrhea, abdominal distension, abdominal discomfort and abdominal pain, which seldom lead to discontinuation of therapy.
Hepatobiliary disorders
Very rare: hepatic function abnormal (e.g., with cholestasis and jaundice), hepatitis and hepatic failure.
Not known: hepatic enzymes increased.
Skin and subcutaneous tissue disorders
Rare: alopecia.
Not known: hypersensitivity reactions of the skin may occur such as pruritus, rash, urticaria and photosensitivity.
Investigations
Rare: weight gain.
Very rare: blood sodium decrease.
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.