Adverse reactions : תופעות לוואי

4.8) Undesirable effects:
Summary of the safety profile: Adverse reactions following administration of MEPIVACAINE HCI 3% INJECTION are similar to those observed with other local amide anaesthetics. These adverse reactions are, in general, dose- related and may result from high plasma levels caused by overdose, rapid absorption or unintended intra-vascular injection. They may also result from hypersensitivity, idiosyncrasy, or diminished tolerance by patient.
Serious adverse experiences are generally systemic.
Tabulated list of adverse reactions: The reported adverse effects come from spontaneous reporting 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).
Frequency “Not known”: “Not known (cannot be estimated from the available data)”.
MedDRA System Organ Frequency                     Adverse reactions Class
Hypersensitivity
Immune system
Rare                 Anaphylatic / anaphylactoid disorders reactions
Angioedema (Face / tongue
/ lip / throat / larynx 1 / periorbital oedema)
Bronchospasm / asthma 2
Urticaria

Euphoric mood
Psychiatric disorders   Not Known
Anxiety/Nervousness 3
Common      Headache
Neuropathy 4:
Neuralgia (Neuropathic pain)
Paresthesia (i.e., burning,
prickling, itching, tingling,
local sensation of heat or cold, with no apparent physical cause) of oral and perioral structures
Hypoesthesia / numbness
(oral and perioral)
Dysesthesia (oral and perioral), including dysgeusia (e.g., taste metallic, taste distorted),
ageusia
Nervous system
Rare        Dizziness (light disorders headedness)
Tremor 3
Deep CNS depression:
Loss of consciousness
Coma
Convulsion (including tonic- clonic seizure)
Presyncope, syncope;
Confusional state,
disorientation
Speech disorder 3 (e.g.,
dysarthria, logorrhea)
Restlessness / agitation 3
Balance disorder
(disequilibrium)
Somnolence
Not known   Nystagmus
Visual impairment
Rare        Vision blurred
Accommodation disorder
Eye disorders
Horner’s syndrome
Not known   Eyelid ptosis
Enophthalmos
Diplopia (paralysis of oculomotor muscles)
Amaurosis (blindness)
Mydriasis
Miosis
Rare        Vertigo
Ear and labyrinth                   Ear discomfort disorders               Not Known   Tinnitus
Hyperacusis
Cardiac arrest
Bradyarrhythmia
Bradycardia
Tachyarrhythmia (including ventricular extrasystoles
Rare        and ventricular fibrillation) 5
Cardiac disorders
Angina pectoris 6
Conduction disorders
(atrioventricular block)
Tachycardia
Palpitations
Not known   Myocardial depression
Hypotension (with possible
Rare circulatory collapse)
Very rare   Hypertension
Vascular disorders
Vasodilatation
Not known   Local / Regional hyperaemia
Respiratory depression
Bradypnoea
Apnoea (respiratory arrest)
Rare
Yawning
Respiratory, thoracic
Dyspnoea 2 and mediastinal
Tachypnea disorders
Hypoxia 7 (including cerebral)
Not known
Hypercapnia 7
Dysphonia (Hoarseness 1)
Nausea
Vomiting
Gingival / oral mucosal
Rare        exfoliation (sloughing) /
Gastrointestinal                    ulceration disorders                           Swelling 8 of tongue, lip, gums
Stomatitis, glossitis,
Not known   gingivitis
Salivary hypersecretion
Rash (eruption)
Skin and subcutaneous
Rare        Erythema tissue disorders
Pruritus
Swelling face
Hyperhidrosis (sweating or perspiration)
Musculoskeletal and
Muscle twitching connective tissue           Rare
Chills (shivering) disorders
General disorders and
Local swelling administration site         Rare
Injection site swelling conditions
Chest pain
Fatigue, asthenia
Not known           (weakness)
Feeling hot
Injection site pain
Injury, poisoning and procedural                  Not known           Nerve injury complications

Description of selected adverse reactions:
1 laryngo-pharyngeal oedema may characteristically occur with hoarseness  and/or dysphagia;
2 bronchospasm (bronchoconstriction) may characteristically occur with
 dyspnoea;
3 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.)
4 neural pathologies that may occur with the various symptoms of abnormal
 sensations (i.e., paresthesia, hypoesthesia, dysesthesia, hyperesthesia, etc) of the lips, tongue and oral tissues. These data originated in post-marketing reports, mostly following nerve blocks in mandible, involving various branches of the trigeminal nerve;
5 mostly in patients with underlying cardiac disease or those receiving certain  drugs;
6 in predisposed patients or those with risk factors of ischemic heart disease; 7 hypoxia and hypercapnia are secondary to respiratory depression and / or to  seizures and sustained muscular exertion;
8 by accidental biting or chewing of the lips or tongue while the anaesthesia  persists.

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.