INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ESPIRIDE CAPSULES
ESPIRIDE ELIXIR
SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

ESPIRIDE CAPSULES
ESPIRIDE ELIXIR

COMPOSITION:
Espiride Capsules: Each capsule contains sulpiride 50 mg 
Espiride Elixir: Each 5 mL of elixir contains sulpiride 25 mg. 
Preservatives: Methylparaben         0,08% m/v
  Propylparaben         0,02% m/v
  Contains Ethanol (100%)         5,0% v/v

PHARMACOLOGICAL CLASSIFICATION:
A 2.6.5 Tranquillisers: Miscellaneous structure.

PHARMACOLOGICAL ACTION:
Sulpiride is a substituted benzamide used chiefly in the management of schizophrenia. It exerts antipsychotic action, antiemetic actions and has an effect on gastrin secretion.
It is absorbed with oral administration and the plasma half-life is about 7-9 hours.

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Schizophrenia particularly with the symptoms of hallucination, autism, aggressiveness and with withdrawn-inhibited types of schizophrenia.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.

CONTRA-INDICATIONS:
Sensitivity to sulpiride or phenothiazines.
Espiride should not be administered to patients with phaeochromocytoma, with bone-marrow depression and only with caution to patients with hypertension.
Contra-indicated in hypomanic patients, in the manic or premanic phase of manic-depressive psychosis and in patients with acute mania as it may exacerbate symptoms.
Sulpiride is considered to be unsafe in patients with acute porphyria.
The safety in pregnancy has not been established.

WARNING:
Slow decrease in dosages before total withdrawal.
This medicine may lead to drowsiness and impaired concentration which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents. Patients should not operate hazardous machinery or drive motor vehicles or perform potentially hazardous tasks where loss of concentration may lead to accidents.

DOSAGE AND DIRECTIONS FOR USE:
For the treatment of schizophrenia:
Adults:                        Initial dose of 200 - 400 mg twice daily, increasing if necessary to a maximum of 1,2 g twice daily.
Maintenance dose 600 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 to 200 mg daily up to 300 mg per day in divided doses. For maintenance treatment, reduce or increase as necessary.
Children: (6-12 years) 3 - 5 mg/kg body mass per day in divided doses.
For gastro-enterology:
Adults:                        150 to 300 mg daily in divided doses. Maintenance and duration of treatment according to patients requirements.
For the treatment of vertigo:
Adults:                        150 to 300 mg daily in divided doses depending upon the intensity of the vertigo.Slowly decrease the dosage before totally withdrawing sulpiride.
Sulpiride should be given in reduced doses to elderly patients.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The side-effects of sulpiride and mild sedation and extrapyramidal disorders which include acute dystonia, a Parkinsonism-like syndrome, akathisia, and the neuroleptic malignant syndrome; tardive dyskinesia and perioral tremor may subsequently develop. Sleep disturbances, overstimulation and agitation may occur. Hypertension, fatigue, impotence, amenorrhoea, galactorrhoea, gynaecomastia and mass gain have been reported. Minor abnormalities in liver function tests may occur.
Other adverse effects of sulpiride therapy may include minimal antimuscarinic effects such as dry mouth, constipation, urinary retention, and mydriasis, as well as insomnia, depression, convulsions, nasal congestion, tachycardia, cardiac arrhythmias, electrocardiographic changes, postural hypotension, miosis, blurred vision, and inhibition of ejaculation.
Allergic reactions include urticaria, exfoliative dermatitis, erythema multiforme and contact sensitivity. Jaundice has occurred, and is probably allergic in origin. Prolonged therapy may lead to deposition of pigment in the skin, or more frequently the eyes; corneal and lens opacities have been observed. Photosensitivity reactions also occur.
Various haematological disorders, including haemolytic anaemia, aplastic anaemia, aplastic anaemia, thrombocytopenic purpura and a potentially fatal agranulocytosis have occurred in patients receiving sulpiride. Most cases of agranulocytosis have occurred within 4 to 10 weeks of starting treatment, and symptoms such as sore throat or fever should be watched for and white cell counts instituted should they appear.
Sulpiride alters endocrine and metabolic functions. Patients have experienced hyperglycaemia and altered glucose tolerance and increased serum-cholesterol concentrations. Body temperature regulation is impaired and may result in both hypo- or hyperthermia depending on environment.
Following the abrupt discontinuation of large doses, withdrawal symptoms may include nausea, vomiting, gastritis and tremors.
Espiride should be used with caution in patients with cardiovascular or respiratory disease, or other conditions in which a sudden drop in blood pressure would be undesirable. If it is used in conjunction with other medicine, likely to cause postural hypotension, an adjustment of dosage may be necessary. It should be used with caution in patients with existing tachycardia or cardiac insufficiency and in patients with liver dysfunction or a history of jaundice. It should be used with care in patients with Parkinsonism, the anti-Parkinsonian actions of agents such as levodopa may be diminished by concurrent administration of sulpiride. Patients receiving long term therapy should have regular examinations for abnormal pigmentation or ocular changes.
The bioavailability of Espiride is reduced when given together with sucralfate or an antacid containing aluminium and magnesium hydroxides. It is recommended that if used concurrently that sulpiride be given before rather than with or after sucralfate or antacids.
Espiride may enhance the anticholinergic properties of atropine and tricyclic anti-depressants.
Espiride should not ge given in conjunction with other medicine that might cause leucopenia such as phenylbutazone and the thiouracil derivatives. The anti-emetic actions of sulpiride may mask the symptoms of disorders such as gastro-intestinal obstruction. The antihypertensive action of adrenergic neurone blocking medicines, such as guanethidine, is reduced by Espiride.
It enhances the activity of central nervous system depressants including alcohol, anaesthetics, hypnotics and narcotic analgesics and doses of these agents may need to be reduced.
The anticonvulsant properties of diazepam, phenobarbitone, phenytoin, or other anticonvulsants, are not enhanced by sulpiride, but sulpiride may conversely, lower the convulsive threshold. Care is required in patients receiving anticonvulsant therapy.
Espiride should be used with care in elderly and debilitated patients.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special Precautions".
In severe overdosage the stomach should be emptied by aspiration and lavage. Emetics should not be used.
Treatment is symptomatic and supportive.

IDENTIFICATION:
Espiride Capsules: A white powder encapsulated in a no. 3 off-white, opaque capsule, printed with a mortar and pestle and 'Lennon' in blue ink.
Espiride Elixir: A clear, bright yellowish-green solution.

PRESENTATION:
Espiride Capsules:         Securitainers of 100 capsules.
Espiride Elixir:         Bottles of 100 mL.

STORAGE INSTRUCTIONS:
Store below 25°C and protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
Espiride Capsules:         Y/2.5/386
Espiride Elixir:         W/2.5/36

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited, 7 Fairclough Road, Korsten, PORT ELIZABETH 6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
19/06/1991
                Lennon Medicines logo
                D007
                A & S PRINTERS

Updated on this site: December 1999
Current: April 2005
Source: Community Pharmacy

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