Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Adverse reactions listed by System Organ Class. Frequencies are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 , <1 /10); uncommon (≥1/1000 , <1/100); rare(≥ 1/10,000 , <1/1000); very rare (<1/10,000); not known (cannot be estimated from the available data).
System Organ Class              Frequency           Adverse reactions Blood and lymphatic system disorders
Not known           Methemoglobinemia, which could be related to
NADH cytochrome-b5 reductase deficiency,
particularly in neonates in whom the use is contraindicated (see section 4.4).
Sulfhemoglobinemia, mainly with concomitant administration of high doses of sulfur-releasing medicinal products
Cardiac disorders
Uncommon            Bradycardia, particularly with intravenous formulation.
Not known           Cardiac arrest, occurring shortly after injectable use, and which can be subsequent to bradycardia
(see section 4.4); Atrioventricular block, Sinus arrest particularly with intravenous formulation;
Electrocardiogram QT prolonged; Torsade de pointes
Endocrine disorders*
Uncommon            Amenorrhea, Hyperprolactinemia
Rare                Galactorrhea
Not known           Gynecomastia
Gastrointestinal disorders
Common             Diarrhea
General disorders and administration site conditions
Common              Asthenia
Not Known           Injection site inflammation and local phlebitis
Immune system disorders
Uncommon            Hypersensitivity
Not known           Anaphylactic reaction (including anaphylactic shock) particularly with intravenous formulation.
Nervous system disorders
Very common         Somnolence
Common              Extrapyramidal disorders (particularly in children and young adults and/or when the recommended dose is exceeded, even following administration of a single dose of the drug) (see section 4.4),
Parkinsonism, Akathisia
Uncommon            Dystonia (including visual disturbances and oculogyric crisis), Dyskinesia, Depressed level of consciousness
Rare                Convulsion especially in epileptic patients
Not known           Tardive dyskinesia which may be persistent, during or after prolonged treatment, particularly in elderly patients (see section 4.4), Neuroleptic malignant syndrome (see section 4.4)
Psychiatric disorders
Common              Depression
Uncommon            Hallucination
Rare                Confusional state
Vascular disorders
Common              Hypotension, particularly with intravenous formulation
Not known           Shock, syncope after injectable use. Acute hypertension in patients with pheochromocytoma
(see section 4.3)
Transient increase in blood pressure
Skin disorders
Not known           Skin reactions such as rash, pruritus, angioedema and urticaria
* Endocrine disorders during prolonged treatment in relation with hyperprolactinemia (amenorrhea, galactorrhea, gynecomastia).



The following reactions, sometimes associated, occur more frequently when high doses are used: -   Extrapyramidal symptoms: acute dystonia and dyskinesia, parkinsonian syndrome, akathisia, even following administration of a single dose of the medicinal product, particularly in children and young adults (see section 4.4).
-   Drowsiness, decreased level of consciousness, confusion, hallucinations.
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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