Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Approximately one third of patients experience adverse reactions, usually transient, during the first few days after chip insertion. These may also be due to the mechanical placement of the periodontal insert in the periodontal pocket or as a result of the preceding scaling procedure. The most commonly reported are gastrointestinal system disorders: dental, gingival or oral soft tissue reactions or are otherwise described as application site reactions.

Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); frequency not known (cannot be estimated from the available data):


System Organ Class          Very Common         Common             Uncommon              Not Known (≥1/10)             (≥1/100 to         (≥1/1,000 to          (cannot be <1/10)             <1/100)               estimated

from the available data)
Infections and                                                  Upper respiratory infestations                                                    tract infection Blood and lymphatic                                             Lymphadenopathy system disorders
Immune disorders                                                                       Hypersensitivity including anaphylactic shock* (see sections 4.3 and 4.4.)
Nervous system                                                  Dizziness, disorders                                                       neuralgia Gastrointestinal           Toothache          Gingival          Gingival disorders                                     swelling,         hyperplasia, gingival pain,    gingival recession,
gingival          gingival pruritus,
bleeding          mouth ulceration,
sensitivity of teeth
Skin disorders                                                                         Allergic skin reactions such as dermatitis,
pruritus,
erythema,
eczema, rash,
urticaria, skin irritation, and blisters
General disorders                                               Malaise, influenza and administration                                              like illness, site conditions                                                 pyrexia 
* Patients should be instructed to seek immediate medical attention if they develop allergic symptoms such as skin rash, itch, generalised swelling, breathing difficulties, light headedness, rapid heart rate, upset stomach or diarrhoea after exposure to chlorhexidine.

The following adverse reactions have been derived from post-marketing reports on PerioChip: systemic hypersensitivity, anaphylactoid reaction, soft tissue necrosis, cellulitis and abscess related to the application site, loss of taste and gingival discoloration.

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