Adverse reactions : תופעות לוואי

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

Nervous system disorders:
Very common: extrapyramidal symptoms may occur: tremor, rigidity, hypokinesia, hypersalivation, akathisia, dyskinesia.
These symptoms are generally mild at optimal dosages and partially reversible without discontinuation of amisulpride upon administration of antiparkinsonian medication. The incidence of extrapyramidal symptoms which is dose related, remains very low in the treatment of patients with predominantly negative symptoms with doses of 50 – 300 mg/day.
Common: somnolence, acute dystonia (spasm torticollis, oculogyric crisis, trismus) may appear. This is reversible without discontinuation of amisulpride upon treatment with an antiparkinsonian agent.
Uncommon: seizures, tardive dyskinesia characterized by rhythmic, involuntary movements primarily of the tongue and/or face have been reported, usually after long term administration. Antiparkinsonian medication is ineffective or may induce aggravation of the symptoms.
Rare: Neuroleptic Malignant Syndrome (see section 4.4), which is a potentially fatal complication.
Not known: restless legs syndrome.

Eye disorders:
Common: blurred vision (see section 4.7).

Psychiatric disorders:
Common: insomnia, anxiety, agitation, orgasmic dysfunction
Uncommon: confusion
Gastrointestinal disorders:
Common: constipation, nausea, vomiting, dry mouth.

Endocrine disorders:
Common: amisulpride causes an increase in plasma prolactin levels which is reversible after drug discontinuation. This may result in galactorrhoea, amenorrhoea, gynaecomastia, breast pain, and erectile dysfunction.
Rare: benign pituitary tumor such as prolactinoma (see sections 4.3 and 4.4) 
Metabolism and nutrition disorders:
Uncommon: hyperglycaemia (see section 4.4), hypertriglyceridemia and hypercholesterolaemia.
Rare: hyponatraemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Immune system disorders:
Uncommon: allergic reaction.

Blood and lymphatic system disorders:
Uncommon: leukopenia, neutropenia (see section 4.4).
Rare: agranulocytosis (see section 4.4).
Cardiac disorders:
Uncommon: bradycardia.
Rare: QT interval prolongation, ventricular arrhythmias such as torsade de pointes, ventricular tachycardia, ventricular fibrillation, cardiac arrest, sudden death (see section 4.4).

Vascular disorders:
Common: hypotension.
Uncommon: increase in blood pressure.
Rare: venous thromboembolism, including pulmonary embolism,
sometimes fatal, and deep vein thrombosis (see section 4.4).
Respiratory, thoracic and mediastinal disorders:
Uncommon: nasal congestion, pneumonia aspiration (mainly in association with other antipsychotics and CNS depressants).

Hepatobiliary disorders:
Uncommon: hepatocellular injury.

Skin and subcutaneous tissue disorders:
Rare: angioedema, urticaria.
Not known: photosensitivity reaction.
Musculoskeletal and connective tissue disorders:
Uncommon: osteopenia, osteoporosis.
Not known: rhabdomyolysis.

Renal and urinary disorders:
Uncommon: urinary retention.

Pregnancy, puerperium and perinatal conditions:
Not known: drug withdrawal syndrome neonatal (see section 4.6).
Injury, poisoning and procedural complications:
Not known: Fall as a consequence of adverse reactions compromising body balance.

Investigations:
Common: weight gain.
Uncommon: elevations of hepatic enzymes, mainly transaminases.
Not known: blood creatine phosphokinase increased.

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. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form.
http://forms.gov.il/globaldata/getsequence.aspx?formType=AdversEffectMedic@mo h.gov.il