8 Undesirable effects Adverse effects have been ranked under headings of frequency using the following convention ( ≥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).
4). Rare: agranulocytosis. ● Immune system disorders: Uncommon: allergic reaction ● 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.
4). ● Metabolism and nutrition disorders: Uncommon: hyperglycemia, hypertriglyceridemia and hypercholesterolemia. Rare: hyponatraemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH). ● Psychiatric disorders: Common: insomnia, anxiety, agitation, orgasmic dysfunction.
Uncommon: confusion. ● 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: acute dystonia (spasm torticollis, oculogyric crisis, trismus) may appear.
This is reversible without discontinuation of amisulpride upon treatment with an antiparkinsonian agent. Somnolence. Uncommon: 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. Seizures. 4), which is a potentially fatal complication. Not known: restless legs syndrome. ● Eye disorders: Common: blurred vision. ● Cardiac disorders: Uncommon: bradycardia.
4). ● Vascular disorders: Common: hypotension. Uncommon: increase in blood pressure. Rare: venous thromboembolism, including pulmonary embolism, sometimes fatal, and deep vein thrombosis ● Respiratory, thoracic and mediastinal disorders: Uncommon: nasal congestion, aspiration pneumonia (mainly in association with other antipsychotics and CNS depressants).
● Gastrointestinal disorders: Common:constipation, nausea, vomiting, dry mouth. ● Hepatobilary disorders: Uncommon: hepatocellular injury ● Skin and subcutaneous tissue disorders: Rare: angioedema, urticaria. Not known: photosensitivity reaction .
● Musculoskeletal and connective tissue disorders: Uncommon: osteopenia, osteoporosis. 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. 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.
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