Adverse reactions : תופעות לוואי

4.8   Undesirable effects

In clinical studies of RET-AVIT, the majority of adverse events were associated with the system organ class Skin and Subcutaneous Tissues. The majority of these events (such as erythema, burning, stinging, dryness and peeling) were mild in intensity occurred early during therapy and generally decreased over the course of therapy.

Common (>1/100):
Skin: Erythrema, reddening, peeling, scaling, exfoliative dermatitis, dry skin, pruritus, warmth, burning, rashes, stinging reaction or pain.
Temporary hypo- and hyper-pigmentation.

Uncommon (1/100–1/1000):
Skin: Blistering and crusting of the skin, oedema
Eyes: Eye irritation.
True contact allergy to cutaneous tretinoin is rare. Increased susceptibility to sunlight or other UVB sources has been reported. Studies of RET-AVIT in volunteers indicate a low potential for the induction of allergic contact dermatitis, photoallergy or phototoxicity.

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/