Adverse reactions : תופעות לוואי

4.8.Undesirable Effects
When adverse reactions are evaluated, the following frequency categories are used: Very common       (>1/10)
Common           (>1/100 to <1/10)
Uncommon         (>1/1000 to <1/100)
Rare             (>1/10,000 to <1/1000)
Very rare         (<1/10,000)
Not known        (cannot be estimated from the available data)

The following adverse reactions have been identified during post-approval use of bifonazole. Because these reactions are reported voluntarily from patient groups of unknown size, the frequency cannot be estimated from the available data.
Organ classes            Frequency   Adverse effects
Skin and subcutaneous    Not known   Dry skin, skin irritation, maceration, skin tissue disorders                     exfoliation, redness, burning, pruritus, rash, eczema, blisters, urticaria, contact dermatitis, allergic dermatitis.
General illnesses and    Not known   Pain at the application site, peripheral local application site               oedema at the application site reactions


These side effects are reversible after discontinuation of the treatment.
Benzyl alcohol content in Agispor gel can cause allergic reactions.
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: http://sideeffects.health.gov.il Additionally, you may also report to Padagis via www.Padagis.co.il.