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).

Post-marketing
Cases of malignancies, including cutaneous and other types of lymphoma, and skin cancers, have been reported in patients using tacrolimus ointment (see section 4.4).

Paediatric population
Frequency, type and severity of adverse reactions in children are similar to those reported 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