Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The list of the following adverse effects relates to those experienced with 2,4- dichlorobenzyl alcohol and amylmetacresol at OTC doses, in short term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.

Adverse events which have been associated with 2,4-dichlorobenzyl alcohol and amylmetacresol are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

System Organ Class                          Frequen       Adverse Events Immune System Disorders                     cy
Not           Hypersensitivity1 known
Gastrointestinal Disorders                  Not           Abdominal pain, nausea, oral known         discomfort2
Skin and Subcutaneous Tissue                Not           Rash
Disorders                                   known


Description of Selected Adverse Reactions
1
Hypersensitivity reactions may present in the form of rash, angioedema, urticaria, bronchospasms and hypotension with syncope.
2
Oral discomfort may present in the form of throat irritation, oral paraesthesia, oedema of the mouth and glossodynia .

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/