The following frequency categories are used for the evaluation of undesirable effects:
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) |
Not known | (frequency cannot be estimated from the available data) |
Skin and subcutaneous tissue disorders:
There may be rare cases of skin irritation in the form of erythema, burning, drying or peeling of the skin may be observed. In very rare cases the above symptoms may also be an expression of a hypersensitivity reaction (allergic contact eczema).There may be an apparent deterioration in acne with an increase in inflammatory symptoms at the commencement of treatment; this is a sign that the medicine is beginning to act and is usually transitory. If the above occurs, treatment should not be interrupted but the frequency of application reduced.
Rarely, a temporary hypopigmentation or hyperpigmentation has been reported in individuals treated with tretinoin. Temporary depigmentation in non-caucasians is possible.
Not known: acute generalised exanthematous pustulosis (AGEP).
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, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.