Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Immune disorders
Frequency not known:
- Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4).
Skin disorders
Frequency not known:
- Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticarial, skin irritation, and blisters.
- Chemical burns in neonates and infants.

Eye Disorder
Frequency not known:
- Corneal erosion, epithelium defect/corneal injury, significant permanent visual impairment*


Septol SPC MW Minor updates Aug 2024
Not known
Rare
Very      Common       Uncommon                    Very Rare      (cannot System Organ                                                  (≥
Common      (≥ 1/100 <   (≥ 1/1,000 <                    (<       be estimated Class                                                  1/10,000
(≥ 1/10)      1/10)        1/100)                   1/10,000)        from < 1/1,000) available data)
Hypersensitivity
Immune
System
Anaphylactic
Disorders shock
Allergic skin
Skin and                                                                           reactions Subcutaneous
Tissue                                                                          Chemical Burns Disorders                                                                         (Neonates and infants)
Corneal erosion,
epithelium defect/corneal injury,
Eye Disorder significant permanent visual impairment*


*Cases of severe corneal erosion and permanent significant visual impairment due to inadvertent ocular exposure have been reported post-marketing, leading to some patients requiring corneal transplant (see section 4.4).

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