ESPIRIDE Capsule Ref.[51228] Active ingredients: Sulpiride

Source: Health Products Regulatory Authority (ZA)  Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191

Therapeutic indications

Reactive depression, depression associated with psychoses of other origins. Prophylaxis and treatment of depressive psychoses.

Schizophrenia, particularly with the symptoms of hallucination, autism, aggressiveness and with withdrawn-inhibited types of schizophrenia. Acute delirium, acute hallucinatory and confused states. Behaviour disorders in all age groups where abnormal aggressive symptoms are in the forefront.

ESPIRIDE is a useful adjunct in the medical treatment of duodenal ulceration of psychosomatic origin.

For the treatment of vertigo. It also has an anti-emetic action.

Posology and method of administration

For the treatment of schizophrenia

Adults: Initial dose of 200 mg to 400 mg twice daily, increasing if necessary to a maximum of
1,2 g twice daily.

Maintenance dose 600 mg to 800 mg per day in divided doses for as long as necessary.

Common, milder psychiatric conditions of shorter duration and behavioural disorders

Adults: 100 mg to 200 mg daily up to 300 mg per day, in divided doses. For maintenance
treatment, reduce or increase as necessary.

Children (6 to 12 years): 3 to 5 mg/kg body mass per day in divided doses.

For gastro-enterology

Adults: 150 mg to 300 mg daily in divided doses. Maintenance and duration of treatment
according to patient’s requirements.

For the treatment of vertigo

Adults: 150 mg to 300 mg daily in divided doses depending upon the intensity of the vertigo.

Slowly decrease the dosage before totally withdrawing ESPIRIDE.

ESPIRIDE should be given in reduced doses to elderly patients.

Overdose

Symptoms

See SIDE EFFECTS.

Treatment

In severe overdosage the stomach should be emptied by aspiration and lavage. Emetics should not be used.

Treatment is symptomatic and supportive.

Special precautions for storage

Store at or below 25°C and protect from light and moisture.

Keep in original packaging until required for use.

KEEP OUT OF REACH OF CHILDREN.

Nature and contents of container

ESPIRIDE:

100 capsules are packed in a white cylindrical polypropylene securitainer with a white low density polyethylene cap with a tamper evident seal.

100 capsules are packed in a white hostalen polypropylene securitainer with a white low density polyethylene cap with a tamper evident seal.

100 capsules are packed in a white linear low density polyethylene securitainer with a white low density polyethylene cap with a tamper evident seal.

28 or 56 capsules are packed in a low density polyethylene Ziploc metallised lay-flat bags. The lay-flat bags are then grouped and packed into polyethylene bags.

ESPIRIDE ELIXIR:

100 ml is packed in an amber round polyvinyl chloride bottle together with a black urea formalin screw on cap with an expanded polyethylene liner. The bottle is placed in an outer cardboard carton.

100 ml is packed in an amber round glass bottle together with a black urea formalin screw on cap with an expanded polyethylene liner. The bottle is placed in an outer cardboard carton.

100 ml is packed in a clear high density polyethylene round bottle with a white low density polyethylene snap on cap. The bottle is placed in an outer cardboard carton.

100 ml is packed in a clear round polyvinylchloride bottle together with a white low density polyethylene snap on cap. The bottle is placed in an outer cardboard carton.

Not all packs and pack sizes are necessarily marketed.

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