Summary of the safety profile
The most commonly reported adverse reaction during treatment is pruritus. Contact dermatitis and hypersensitivity reactions like rash, eczema, erythema, skin irritation and angioedema may occur rarely.
Use near the eyes may produce inflammation of the conjunctiva.
Tabulated list of adverse reactions
Adverse reactions are listed below by system organ class and by 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) and very rare (<1/10,000), or not known (cannot be estimate from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Skin and subcutaneous tissue disorders:
contact dermatitis, hypersensitivity (like rash, eczema, erythema, skin irritation, angioedema)
Treatment should be discontinued if severe irritation occurs.
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. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: firstname.lastname@example.org.