Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Epiduo may cause the following adverse reactions at the site of application: 
System Organ Class (MedDRA)              Frequency                                 Adverse Drug Reaction Not known (cannot be estimated from the
Eye disorders                                                                    Eyelid oedema available data)*
Not known (cannot be estimated from the
Immune system                                                                    Anaphylactic reaction available data)*

Respiratory, thoracic and mediastinal    Not known (cannot be estimated from the Throat tightness, dyspnoea disorders                                available data)*

Skin and subcutaneous tissue disorders   Common (>1/100 to <1/10)                  Dry skin, irritative contact dermatitis, skin irritation, skin burning sensation,
erythema, skin exfoliation (scaling)

Uncommon (>1/1000 to <1/100)              Pruritus, sunburn

Not known (cannot be estimated from the Allergic contact dermatitis, swelling face, available data)*                        pain of skin (stinging pain), blisters (vesicles), skin discolouration
(hyperpigmentation and hypopigmentation), urticaria, application site burn **


*Post marketing surveillance data
**Most of the cases of "application site burn" were superficial burns but cases with second degree burn or severe burn reactions have been reported.

If skin irritation appears after application of Epiduo, the intensity is generally mild or moderate, with local tolerability signs and symptoms (erythema, dryness, scaling, burning and pain of skin (stinging pain) peaking during the first week and then subsiding spontaneously.

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/