DEVODIL Tablet Ref.[28186] Active ingredients: Sulpiride

Source: Υπουργείο Υγείας (CY)  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

4.1. Therapeutic indications

Acute and chronic schizophrenia.

4.2. Posology and method of administration

Posology

Adults

A starting dose of 400 mg to 800 mg daily, given as one or two tablets daily (morning and early evening) is recommended.

Predominantly positive symptoms (formal thought disorder, hallucinations, delusions, incongruity of affect) respond to higher doses, and a starting dose of at least 400 mg twice daily is recommended, increasing if necessary up to a suggested maximum of 1200 mg twice daily. Increasing the dose beyond this level has not been shown to produce further improvement.

Predominantly negative symptoms (flattening of affect, poverty of speech, anergia, apathy), as well as depression, respond to doses below 800 mg daily; therefore, a starting dose of 400 mg twice daily is recommended. Reducing this dose towards 200 mg twice daily will normally increase the alerting effect of Devodil.

Patients with mixed positive and negative symptoms, with neither predominating, will normally respond to dosage of 400–600 mg twice daily.

Paediatric population

Clinical experience in children under 14 years of age is insufficient to permit specific recommendations.

Elderly

The same dose ranges are applicable in the elderly, but should be reduced if there is evidence of renal impairment.

Method of administration

Oral administration.

4.9. Overdose

Experience with sulpiride in overdosage is limited.

Experience with sulpiride in overdosage is limited. In the event of an overdose, dyskinetic manifestations with spasmodic torticollis, protrusion of the tongue, and trismus may occur. Some patients may develop life-threatening parkinsonian manifestations and coma.

Fatal outcomes have been reported mainly in combination with other psychotropic agents.

Sulpiride is partly removed by hemodialysis.

There is no specific antidote to sulpiride. Treatment is only symptomatic. Appropriate supportive measures should therefore be instituted, close supervision of vital functions and cardiac monitoring (risk of QT interval prolongation and subsequent ventricular arrhythmias) is recommended until the patient recovers.

If severe extrapyramidal symptoms occur, anticholinergics should be administered.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C.

Protect from light and moisture.

6.5. Nature and contents of container

Devodil 50 mg tablets:

PVC/Aluminium blisters. Pack sizes of 20 and 1000 tablets.

PP containers with PE closure. Pack size of 1000 tablets.

Devodil 200 mg tablets:

PVC/Aluminium blisters. Pack sizes of 20, 100 and 1000 tablets.

PP containers with PE closure. Pack size of 1000 tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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