Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Approximately 16% of patients can be expected to experience adverse reactions. These are localised reactions due to the nature of the medicinal product.
The most commonly reported adverse reactions were administration site reactions (such as burning, dermatitis, erythema, pruritus, rash, skin irritation, and vesicles).
The table below lists adverse reactions that have been reported in studies of post herpetic neuralgia patients receiving the plaster. They are listed by system organ class and frequency. Frequencies are defined as very common (1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (1/10,000), not known (cannot be estimated from the available data).
Body system                                                      Adverse drug reaction Skin and subcutaneous tissues disorders uncommon                                                         Skin lesion Injury, poisoning and procedural complications uncommon                                                         Skin injury General disorders and administration site conditions
Very common                                                      Administration site reactions 
The following reactions have been observed in patients receiving the plaster under post-marketing conditions: Injury, poisoning and procedural complications
Very rare                                                        Open wound Immune system disorders
Very rare                                                        Anaphylactic reaction, hypersensitivity All adverse reactions were predominantly of mild and moderate intensity. Of those less than 5% lead to treatment discontinuation.
Systemic adverse reactions following the appropriate use of the plaster are unlikely since the systemic concentration of lidocaine is very low (see section 5.2). Systemic adverse reactions to lidocaine are similar in nature to those observed with other amide local anaesthetic agents (see section 4.9).

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 (http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.health.gov.il).