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.

• General disorders and administration site conditions (frequency not known): Pain at application site, oedema peripheral (at the application site) 
• Skin and subcutaneous tissue disorders (frequency not known):
Dermatitis contact, dermatitis allergic, redness, pruritus, rash, urticaria, blisters, skin exfoliation, eczema, dry skin, skin irritation, skin maceration, skin burning sensation 
These side effects are reversible after discontinuation of the treatment.
Benzyl alcohol 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 www.perrigo-pharma.co.il