Adverse reactions : תופעות לוואי

4.8     Undesirable effects

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (1/10), common (1/100, <1/10), uncommon (1/1000, <1/100), rare (1/10,000, <1/1000), very rare (<1/10,000), including isolated reports.

Common and uncommon adverse reactions were determined from pooled safety data from a clinical trial population of 1573 treated patients encompassing 12 clinical studies. Very rare adverse reactions were primarily determined from post-marketing experience data and therefore refer to reporting rate rather than true frequency.

Immune system disorders:
Very rare: Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema have been reported with Bactroban Dermal.

Skin and subcutaneous tissue disorders:
Common:      Burning localised to the area of application.

Uncommon: Itching, erythema, stinging and dryness localised to the area of application. Cutaneous sensitisation reactions to mupirocin or the ointment base.

Reporting of suspected adverse reactions
Reporting of 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
Additionally, you should also report to GSK Israel (il.safety@gsk.com).