Adverse reactions : תופעות לוואי

4.8    Undesirable effects

In clinical studies approximately 50% of patients experienced some type of skin irritation adverse reaction at the site of application. Burning sensation and pruritus were very common, usually mild to moderate in severity and tended to resolve within one week of starting treatment. Erythema was a common skin irritation adverse reaction. Sensation of warmth, pain, paraesthesia and rash at the site of application were also commonly observed. Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage) was common.

Patients may be at an increased risk of folliculitis, acne and herpes viral infections.

Adverse reactions with suspected relationship to treatment are listed below by system organ class. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.


System Organ          Very Common          Common                              Uncommon   Not known Class                 ≥1/10                ≥1/100,                             ≥1/1000,   (cannot be <1/10                               <1/100     estimated from the available data)
Infections and                             Local skin infection                           Ophthalmic infestations                               regardless of specific                         Herpes aetiology including but not                    Infection* limited to:
Eczema herpeticum,
Folliculitis,
Herpes simplex,
Herpes virus infection,
Kaposi’s varicelliform eruption*
Metabolism and                             Alcohol intolerance (facial nutrition disorders                        flushing or skin irritation after consumption of an alcoholic beverage)
Nervous system                             Paraesthesias and disorders                                  dysaesthesias (hyperaesthesia, burning sensation)
Skin and                                   Pruritus                            Acne*      Rosacea* subcutaneous tissue                                                                       Lentigo* disorders
General disorders     Application site     Application site warmth,                       Application site and administration    burning,             Application site erythema,                     oedema* site conditions       Application site     Application site pain,
pruritus             Application site irritation,
Application site paraesthesia,
Application site rash

Investigations                                                                            Drug level increased* (see section 4.4)
*The adverse reaction has been reported during post-marketing experience 
Maintenance treatment
In a study of maintenance treatment (twice weekly treatment) in adults and children with moderate and severe atopic dermatitis the following adverse events were noted to occur more frequently than in the control group: application site impetigo (7.7% in children) and application site infections (6.4% in children and 6.3% in adults).

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