a) Summary of the safety profile Adverse reactions following administration of articaine / adrenaline 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)”. , taste metallic, taste disturbance) Ageusia Allodynia Thermohyperesthesia Headache Uncommon Burning sensation Rare Facial nerve disorder2 (palsy, paralysis and paresis) Horner’s syndrome (eyelid ptosis, enophthalmos, miosis).
Somnolence (Drowsiness) Nystagmus Nervous system disorders Very rare Paresthesia3 (persistent hypoesthesia and gustatory loss) after mandibular or inferior alveolar nerve blocks Eye disorders Rare Diplopia (paralysis of oculomotor muscles)4 Visual impairment (temporary blindness)4 Ptosis Miosis Enophthalmos Ear and labyrinth disorders Rare Hyperacusis Tinnitus4 Cardiac disorders Common Bradycardia Tachycardia Rare Palpitations Not known Conduction disorders (atrioventricular block) Common Hypotension (with possible circulatory collapse) Uncommon Hypertension Rare Hot flush Vascular disorders Not known Local / Regional hyperaemia Vasodilatation Vasoconstriction Rare Bronchospasm / asthma Dyspnoea2 Respiratory, thoracic and mediastinal disorders Not known Dysphonia (Hoarseness)1 Common Swelling of tongue, lip, gums Uncommon Stomatitis, glossitis Nausea, vomiting, diarrhoea Rare Gingival / oral mucosal exfoliation (sloughing) / ulceration Gastrointestinal disorders Not known Dysphagia Swelling of cheeks Glossodynia Uncommon Rash (eruption) Pruritus Rare Angioedema (face / tongue / lip / throat / larynx / periorbital oedema) Urticaria Skin and subcutaneous tissue disorders Not known Erythema Hyperhidrosis Uncommon Neck pain Rare Muscle twitching4 Musculoskeletal and connective tissue disorders Not known Aggravation of the neuromuscular manifestations in Kearns-Sayre syndrome Trismus Uncommon Injection site pain Rare Injection site exfoliation / necrosis Fatigue, asthenia (weakness)/ Chills General disorders and administration site conditions Not known Local swelling Feeling hot, Feeling cold c) Description of selected adverse reactions 1 Allergic reactions should not be mistaken with syncopal episodes (cardiac palpitations due to adrenaline).
2 A 2 week delay in the onset of facial paralysis has been described following administration of articaine combined with adrenaline, and the condition was unchanged 6 months later. 3 These neural pathologies may occur with various symptoms of abnormal sensations.
, 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. 9 of SmPC). 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 authorization of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store