Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Undesirable effects are listed hereunder in accordance with the MedDRA System Organ Class and in decreasing frequency. Assessment of frequency of the undesirable effects is based on the following categories: 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); unknown (frequency unable to be assessed from available data).

System organ class Frequency Side effect General diseases and complaints at Very common Appearing at the the site of application administration site: erythema, inflammations, irritations (including burning), pain, pruritus
Common Appearing at the administration site: bleeding, skin erosion,
crusting
Uncommon Appearing at the administration site: dermatitis, edema,
ulceration
Diseases of the skin and Common Skin exfoliation subcutaneous tissue
Diseases of the nervous system Common Headaches
Eye diseases Uncommon Dry eyes, eye itching, increased tear secretion 
In rare cases, severe burning may lead to treatment being stopped.
Due to the effect of the severe softening of the corneal layer there may be whitish discolorations or exfoliation of the skin, particularly in the area around the wart.

As a result of the salicylic acid content slight irritation such as dermatitis or contact-allergic reactions which may also manifest themselves by itching, reddening and blisters beyond the area of contact (so- called spreading reactions) may occur with accordingly susceptible patients when using this medicinal product.

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/ and emailed to the Registration Holder’s Patient Safety Unit at: drugsafety@neopharmgroup.com