Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The majority of side effects have been dose related, transient, and have responded to dose reduction or withdrawal of the medication. However, clinical experience thus far has shown that, as with other sulphonylureas, some side effects associated with hypersensitivity may be severe and deaths have been reported in some instances.
The reported adverse reactions, which may possibly be associated with glipizide, are listed in the following table by system organ class and frequency group: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10,000 to < 1/1000), Very rare (< 1/10,000), Not known (cannot be estimated from available data).
Blood and lymphatic system disorders:
Not known - Leukopenia, agranulocytosis, thrombocytopenia, haemolytic anaemia, pancytopenia
Metabolism and nutrition disorders:
Common – Hypoglycaemia
Not known – Hyponatraemia
Psychiatric disorders:
Not known – Confusional state1
Nervous system disorders:
Uncommon – Dizziness1, somnolence1, tremor1
Not known – Headache1
Eye disorders:
Uncommon – Vision blurred1
Not known – Diplopia1, visual impairment1, visual acuity reduced1 Gastrointestinal disorders:
Common – Nausea2, diarrhoea2, abdominal pain and upper2 abdominal pain Uncommon – Vomiting
Not known – Constipation2
Hepatobiliary disorders:
Uncommon – Jaundice cholestatic3
Not known – Hepatic function abnormal, hepatitis
Skin and subcutaneous tissue disorders:
Uncommon – Eczema4
Not known – Dermatitis allergic4, erythema4, rash morbilliform4, rash maculopapular4, urticaria4, pruritus4, photosensitivity reaction Congenital, familial and genetic disorders:
Not known – Porphyria non-acute
General disorders and administration site conditions:

Not known – Malaise1.

Investigations:
Not known – Aspartate aminotransferase increased5, blood lactate dehydrogenase (BLT) increased5, blood alkaline phosphatase increased5, blood urea increased (BUN)5, blood creatinine increased5.
1They are This is usually transient and do not require discontinuance of therapy; however, they may also be symptoms of hypoglycaemia.
2Appear to be dose related and usually disappear on division or reduction of dosage.
3   Discontinue treatment if cholestatic jaundice occurs.
4They frequently disappear with continued therapy. However, if they persist, the drug should be discontinued.
5The  relationship of these abnormalities to glipizide is uncertain, and they have rarely been associated with clinical symptoms.
Aplastic anaemia and disulfiram-like reactions have been reported with other sulphonylureas.
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.
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

Additionally, you can also report to www.perrigo-pharma.co.il.