Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The application can cause local reactions such as erythema, pruritus or desquamation.
However, these benign symptoms must be distinguished from hypersensitivity reactions, which are reported in sporadic cases but require immediate discontinuation. These reactions can be accompanied by redness, papules, vesicles and pruritus, which can also occur beyond the contact zone (so-called dispersion reaction).
The following adverse effects are listed by system organ class and by frequency; they have been observed with the topical use of terbinafine. Frequencies are defined as follows: 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).
Immune system disorders
Very rare: hypersensitivity reactions such as urticaria, allergic exanthema (including dispersion reactions), papules, vesicular changes.
Isolated cases: angio-oedema, anaphylactic shock.
Eye disorders
Rare: irritation.
Skin and subcutaneous tissue disorders
Common: desquamation, pruritus.
Uncommon: skin lesions, scabs, other skin changes, pigmentation disorders, erythema, burning sensation.
Rare: dry skin, contact dermatitis, eczema.
Very rare: skin eruption or papula.
General disorders and administration site conditions
Uncommon: application site pain or irritation.
In rare cases, the underlying fungal infection may be aggravated.

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)