Amilia 50 mg tablets, Amilia 200 mg tablets, Amilia 400 mg coated tablets

Basic information

Composition

Amisulpride 50 mg, 200 mg or 400 mg in 1 tablet

Pharmacotherapeutic group

Antipsychotics, benzamides (ATC code: N05AL05)

Therapeutic indications

The preparation is indicated for treatment of acute and chronic schizophrenia. It is efficient in treatment of positive symptoms with delusions, hallucinations and thought disorders. It primarily treats negative symptoms with blunted affect, emotional and social withdrawal which accompany schizophrenia.

Pharmacological properties

Amisulpride is an atypical antipsychotic agent with a benzamide structure, an analogue of sulpiride. It acts as a potent antagonist at D2 and D3 receptors. Its mechanism of action is biphasic — at low doses it blocks presynaptic dopamine receptors (which induces dopamine release responsible for disinhibitory effect) and at higher doses it blocks postsynaptic receptors. It does not act on serotonin, adrenergic, histamine or muscarinic receptors. It has a mild sedative and hypotensive effect, mild extrapyramidal symptoms and it has no anticholinergic effect.

Pharmaceutical form

Tablets, film-coated tablets

More information

Posology and method of administration

In patients with positive symptoms 400–800 mg/day, in individual cases 1,200 mg/day. In patients with negative symptoms 50–300 mg/day. If given at a dose of up to 400 mg, amisulpride can be administered once daily, higher doses should be given as 2 divided doses. Dosage must be reduced in patients with renal insufficiency.

Contraindications

Known hypersensitivity to amisulpride or any of the excipients, prolactin-dependent cancer, pheochromocytoma, patients with severe renal impairment, children under 18 years of age, lactation. Combination with drugs that may induce severe arrhythmias, and combination with levodopa.

Interactions

Contraindicated combinations: Dopamine agnoists (such as levodopa, bromocriptine, ropinirol). Not recommended combinations: alcohol. Combinations requiring precautions: CNS depressants, antihypertensives. Caution is recommended when combining amisulpride with medicinal products that extend the QT interval, such as class IA antiarrhythmics (such as quinidine, disopyramide) and class III antiarrhythmics (such as amiodarone, sotalol), certain antihistamines, certain other antipsychotics and certain antimalarials (such as mefloquine).

Undesirable effects

Increased plasma prolactin levels, insomnia, anxiety, agitation, extrapyramidal symptoms (such as tremor, rigidity, hypokinesia, hypersalivation, akathisia, dyskinesia), acute dystonia, hypotension, constipation, nausea, vomiting, dry mouth, weight gain.

Special warnings and precautions for use

Amisulpride may cause neuroleptic malignant syndrome, increase the risk of cerebrovascular accident, prolong the QT interval and worsen Parkinson’s disease. Amisulrpide may increase the effect of alcohol on the CNS and therefore alcohol must not be consumed during treatment. It is advised not to use the product during pregnancy. In newborns who were exposed to amisulpride use in the 3rd trimester there is a risk of development of extrapyramidal or withdrawal symptoms. Decreased fertility in women was observed. Ability to drive vehicles or operate machinery can be impaired.

For more detailed product information, see the Summary of Product Characteristics

Availability

The medicinal product is available on prescription only and is partly covered by health insurance.

Contents of container

12 and 60 tablets of 50 mg; packaging for hospital use contains 600 tablets.

20, 30, 50, 60, 100, 150 tablets of 200 mg; packaging for hospital use contains 600 tablets.

20, 30, 50, 60, 100, 150 coated tablets of 400 mg; packaging for hospital use contains 600 tablets.

Package available in the Czech Republic

60 tablets of 50 mg;

30 a 150 tablets of 200 mg.

SPC and PIL

Marketing authorisation holder

PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic

Date of revision of the text

18 June 2020

Product images

Amilia 50 mg coated tablets
Amilia 50 mg coated tablets
Amilia 50 mg coated tablets
Amilia 50 mg coated tablets
Amilia 200 mg coated tablets
Amilia 200 mg coated tablets
Amilia 200 mg coated tablets
Amilia 200 mg coated tablets
Amilia 200 mg coated tablets
Amilia 400 mg coated tablets
Amilia 400 mg coated tablets
Amilia 400 mg coated tablets
Amilia 400 mg coated tablets
Amilia 50 mg coated tablets