AMISULPRIDE

For acute psychotic episodes:

Oral doses between 4 ml/day (400 mg/day) and 8 ml/day (800 mg/day) are recommended. In individual cases, the daily dose may be increased up to 12 ml/day (1200 mg/day). Doses above 12 ml/day (1200 mg/day) have not been extensively evaluated for safety and therefore should not be used.

No specific titration is required when initiating the treatment with Amisulpride. Doses should be adjusted according to individual response. For patients with mixed positive and negative symptoms, doses should be adjusted to obtain optimal control of positive symptoms.

Maintenance treatment should be established individually with the minimally effective dose. 5 ml/day (50 mg/day) and 3 ml/day (300 mg/day) are recommended. Doses should be adjusted individually. Amisulpride can be administered once a day at oral doses up to 400mg, higher dose should be split into two separate doses.

Elderly:

The safety of amisulpride has been examined in a limited number of elderly patients. Amisulpride should be used with particular caution because of a possible risk of hypotension and sedation. Reduction in dosage may also be required because of renal insufficiency.

Children:

The efficacy and safety of amisulpride from puberty to the age of 18 years have not been established. There are limited data available on the use of amisulpride in adolescents in schizophrenia. 3).

Renal insufficiency:

Amisulpride is eliminated by the renal route. In renal insufficiency, the dose should be reduced to half in patients with creatinine clearance (CRCL) between 30-60 ml/min and to a third in patients with CRCL between 10-30 ml/min. As there is no experience in patients with severe renal impairment (CRCL < 10 ml/min) particular care is recommended in these patients (see section

). 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).

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: hyperglycaemia, 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.

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. 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 authorisation 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.

4 Special Warnings and Special Precautions for Use). Hepatic insufficiency: since the drug is weakly metabolised a dosage reduction should not be necessary. Method of administration For oral use only. The oral solution should be drunk with a liquid, which does not contain alcohol.

3 Contraindications • Hypersensitivity to the active ingredient or to other ingredients of the product. g. 8). • Phaeochromocytoma. • Children up to puberty. • Combination with levodopa (see section

• Hypersensitivity to the active ingredient or to other ingredients of the product. g. 8). • Phaeochromocytoma. • Children up to puberty. • Combination with levodopa (see section