Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Undesirable effects include mild and passing skin reactions at the site of application.
In very rare instances, allergic reactions may occur.
Adverse reactions are listed below, by system organ class and frequency.
Frequencies are defined as: 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). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Infections and infestations
Very rare: Rash pustular
Immune system disorders
Very rare: Hypersensitivity (including urticaria), angioedema Respiratory, thoracic and mediastinal disorders
Very rare: Asthma
Skin and subcutaneous tissue disorders
Common: Dermatitis (including contact dermatitis), rash, erythema, eczema, pruritus.
Rare: Dermatitis bullous.
Very rare: Photosensitivity reaction
Not known: Desquamation, skin discolouration

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/
Additionally, please also report to GSK Israel (il.safety@gsk.com)