Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Throughout this section adverse reactions are reported. Adverse reactions are adverse events that were considered to be reasonably associated with the use of Vermox based on the comprehensive assessment of the available adverse event information. A causal relationship with Vermox cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of Vermox was evaluated in 6276 subjects who participated in 39 clinical trials for the treatment of single or mixed parasitic infestations of the gastrointestinal tract. In these 39 clinical trials, no adverse drug reactions (ADRs) occurred in ≥1% of Vermox-treated subjects.

ADRs identified from clinical trials and post-marketing experience with Vermox are included in Table 1. The displayed frequency categories use the following convention: 
Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (≥1/10,000 to <1/1000); Very rare (<1/10,000), Not known (cannot be estimated from the available data).


Table 1: Adverse Drug Reactions Reported in Clinical Trials and Post-marketing Experience for Vermox


Adverse Drug Reactions


System Organ Class
Frequency Category
Common                    Uncommon                   Rare
( 1/100 to < 1/10)       ( 1/1000 to < 1/100)      (≥1/10,000 to <1/1000) 
Blood and                                                               Neutropeniab Lymphatic                                                               Agranulocytosisb * System
Disorders
Immune System                                                           Hypersensitivity Disorders                                                               including anaphylactic reaction and anaphylactoid reactionb
Nervous System                                                          Convulsionsb Disorders                                                               Dizzinessa Gastrointestinal   Abdominal paina           Abdominal discomforta;
Disorders                                    Diarrhoeaa;
Flatulencea
Nauseaa, Vomitinga
Hepatobiliary                                                           Hepatitis; b Disorders                                                               Abnormal liver function testsb
Skin and                                                                Rasha Subcutaneous                                                            Toxic epidermal Tissue Disorders                                                        necrolysis b; Stevens-Johnson syndrome b;
Exanthema b;
Angioedema b;
Urticaria b;
Alopecia b
Renal and                                                               Glomerulonephritisb * Urinary
Disorders a
ADR frequency data derived from Clinical Trials or Epidemiological Studies b
ADRs not observed in clinical trials and frequency calculated based on 6276 patients exposed in clinical trials and epidemiological studies, divided by 3 (Frequency = 1/2092).
* Observed in patients treated for Echinococcosis


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