Local symptoms such as pruritus, skin exfoliation, application site pain, application site irritation, pigmentation disorder, skin burning sensation, erythema and scab may occur at the site of application.
These minor symptoms must be distinguished from hypersensitivity reactions such as widespread pruritis, rash, bullous eruptions and hives which are reported in sporadic cases but require discontinuation.
In case of accidental contact with the eyes terbinafine hydrochloride may be irritating to the eyes.
In rare cases, the underlying fungal infection may be aggravated.
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), or not known (can not to be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Immune system disorders
Not known: Hypersensitivity
Eye disorders
Rare: Eye irritation
Skin and subcutaneous tissue disorders
Common: Skin exfoliation, pruritus
Uncommon: Skin lesion, scab, skin disorder, pigmentation disorder, erythema, skin burning sensation
Rare: Dry skin, dermatitis contact, eczema
Not known: Rash
General disorders and administration site conditions
Uncommon: Pain,application site pain,irritation
Rare: condition aggravated
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 the Yellow Card Scheme (www.mhra.gov.uk/yellowcard).