Adverse reactions : תופעות לוואי

4.8) Undesirable effects:
a) Summary of the safety profile: Adverse reactions following administration of articaine/epinephrine are similar to those observed with other local amide anaesthetics/vasoconstrictors. These adverse reactions are, in general, dose- related. They may also result from hypersensitivity, idiosyncrasy, or diminished tolerance by patient. Nervous system disorders, local injection site reaction, hypersensitivity, cardiac disorders and vascular disorders are the most frequently occurring adverse reactions. Serious adverse reactions are generally systemic.

b) Tabulated list of adverse reactions: The reported adverse reactions come from spontaneous reporting, clinical studies and literature.
The frequencies classification follows the convention: 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), and very rare (<1/10,000), Not known (cannot be estimated from the available data)”.

MedDRA
System Organ         Frequency          Adverse Reactions Class
Infections and
Common             Gingivitis
infestations
Allergic1, anaphylactic / anaphylactoid
Immune system
Rare               reactions
disorders
Psychiatric          Rare               Nervousness / anxiety4 disorders            Not known          Euphoric mood Nervous system                          Neuropathy:
Common
disorders                               Neuralgia (neuropathic pain) MedDRA
System Organ    Frequency   Adverse Reactions
Class
Hypoesthesia / numbness (oral and
perioral)4
Hyperesthesia
Dysesthesia (oral and perioral),
including
Dysgeusia (e.g., taste metallic,
taste disturbance)
Ageusia
Allodynia
Thermohyperesthesia
Headache
Uncommon    Burning sensation
Facial nerve disorder2 (palsy,
paralysis and paresis)
Horner’s syndrome (eyelid ptosis,
Rare
enophthalmos, miosis).
Somnolence (Drowsiness)
Nystagmus
Paresthesia3 (persistent hypoesthesia
Very rare   and gustatory loss) after mandibular or
inferior alveolar nerve blocks
Diplopia (paralysis of oculomotor
muscles)4
Visual impairment (temporary
Eye disorders   Rare        blindness)4
Ptosis
Miosis
Enophthalmos
Ear and
labyrinth       Rare        Hyperacusis Tinnitus4
disorders
Bradycardia
Common
Tachycardia
Cardiac
Rare        Palpitations
disorders
Conduction disorders
Not known
(atrioventricular block)
Hypotension (with possible circulatory
Common
collapse)
Uncommon    Hypertension
Vascular
Rare        Hot flush
disorders
Local / Regional hyperaemia
Not known   Vasodilatation
Vasoconstriction
Respiratory,    Rare        Bronchospasm / asthma Dyspnoea2 thoracic and
Not known   Dysphonia (Hoarseness)1
MedDRA
System Organ         Frequency         Adverse Reactions Class
mediastinal
disorders
Common            Swelling of tongue, lip, gums
Stomatitis, glossitis, nausea, vomiting,
Uncommon
diarrhoea
Gastrointestinal                       Gingival / oral mucosal exfoliation Rare
disorders                              (sloughing) / ulceration Dysphagia
Not known         Swelling of cheeks
Glossodynia
Rash (eruption)
Uncommon
Pruritus
Skin and                               Angioedema (face / tongue / lip / subcutaneous         Rare              throat / larynx / periorbital oedema) tissue disorders                       Urticaria
Erythema
Not known
Hyperhidrosis
Uncommon          Neck pain
Rare              Muscle twitching4
Musculoskeletal
Aggravation of the neuromuscular
and connective
manifestations in Kearns-Sayre
tissue disorders     Not known
syndrome
Trismus
Uncommon          Injection site pain
General                                Injection site exfoliation / necrosis Rare
disorders and                          Fatigue, asthenia (weakness) / Chills administration                         Local swelling site conditions      Not known         Feeling hot
Feeling cold

c) Description of selected adverse reactions:
1
Allergic reactions should not be mistaken with syncopal episodes (cardiac palpitations due to epinephrine).
2
A 2-week delay in the onset of facial paralysis has been described following administration of articaine combined with epinephrine, and the condition was unchanged 6 months later.
3
These neural pathologies may occur with various symptoms of abnormal sensations. Paresthesia can be defined as spontaneous abnormal usually non-painful sensation (e.g., burning, pricking, tingling or itching) well beyond the expected duration of anesthesia. Most cases of paresthesia reported following dental treatment are transient and resolve within days, weeks or months. Persistent paresthesia, mostly following nerve blocks in the mandible, is characterized by slow, incomplete, or lack of recovery.
4
Several adverse events, like agitation, anxiety / nervousness, tremor, speech disorder may be warning signs before CNS depression. In attendance of these signs, patients should be requested to hyperventilate and surveillance should be instituted (see Section 4.9).

d) Paediatric population: The safety profile was similar in children and adolescents from 4 to 18 years old compared to adults. However, accidental soft tissue injury was observed more frequently, especially in 3 to 7 year old children, due to the prolonged soft tissue anaesthesia.

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