SOLIAN TABLET 200 mg

THERAPEUTIC INDICATIONS

Treatment of schizophrenia, particularly acute or chronic schizophrenic disorders, characterised by positive symptoms (e.g. delirium, hallucinations, thought disorders) and/or negative symptoms (e.g. blunted emotions, emotional and social withdrawal), including when the negative symptoms predominate.

CONTRAINDICATIONS

This medicinal product MUST NOT BE USED in the following situations:

• Hypersensitivity to amisulpride or any of the excipients
• Serious hypertensive events have been reported in patients with pheochromocytoma using anti-dopaminergic drugs, including some benzamides. This medicinal product should therefore not be prescribed to known or suspected pheochromocytoma carriers.
• Children under 15 years of age, because no clinical data are available
• Known or suspected prolactin-dependent tumour, e.g., pituitary gland prolactinomas and breast cancer (see sections Special warnings and special precautions for use and Undesirable effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
• In combination with:
  • non-antiparkinsonian dopamine agonists (cabergoline, quinagolide),
  • citalopram, escitalopram, domperidone, hydroxyzine, piperaquine (see section Interaction with other medicinal products and other forms of interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

DOSAGE AND ADMINISTRATION

Usually, if the daily dose is ≤ 400 mg, it will be administered as a once-daily intake. If the daily dose exceeds 400 mg, it will be administered as two daily intakes.

Predominantly negative episodes

The recommended dosage is 50 to 300 mg/day. Dosage should be adjusted on an individual basis. The optimum dosage is about 100 mg/day.

Mixed episodes with positive and negative symptoms

At the beginning of treatment, the dosage should be that which enables the control of positive symptoms, i.e. 400 to 800 mg/day. The dosage should then be adjusted individually as a function of the patient’s response, so as to obtain the minimum effective dose.

Acute psychotic episodes

At the beginning of treatment:

• it is possible to start via the IM route for a few days, at a maximum dose of 400 mg/day, replaced thereafter with oral treatment,
• the recommended dosage via the oral route is 400 to 800 mg; the maximum dosage should never exceed 1200 mg.

Thereafter:

• the dosage should be maintained or adjusted as a function of the patient’s response.

In all cases, the dosage of maintenance therapy should be established individually using the minimum effective dose.

Elderly subjects

Amisulpride should be used with particular caution in this patient population due to the risk of hypotension and sedation (see SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal insufficiency

Because amisulpride is excreted via the kidneys, the dosage should be reduced by half in patients with renal insufficiency whose creatinine clearance (CrCl) is between 30 and 60 ml/min, and to one third if the creatinine clearance is between 10 and 30 ml/min.

In the absence of relevant data on patients with serious renal insufficiency (CrCl < 10 ml/min), amisulpride is contraindicated (see CONTRAINDICATIONS).

Hepatic insufficiency

Amisulpride is poorly metabolised, so it is not necessary to reduce the dose in patients with hepatic insufficiency.