ESPIRIDE Capsule Ref.[51228] Active ingredients: Sulpiride

Slow decrease in dosages before total withdrawal.

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 (see INTERACTIONS). Patients receiving long term therapy should have regular examinations for abnormal pigmentation or ocular changes.

Care is required in patients receiving anticonvulsant therapy (see INTERACTIONS). ESPIRIDE should be used with care in elderly and debilitated patients.

Excipients

ESPIRIDE capsules contains lactose monohydrate which may have an effect on the glycaemic control of patients with diabetes mellitus. Patients with the rare hereditary conditions of galactose intolerance e.g. galactosaemia, Lapp lactase deficiency, glucose-galactose malabsorption or fructose intolerance should not take ESPIRIDE.

Patients with the rare hereditary condition of sorbitol intolerance should not take ESPIRIDE ELIXIR.

The anti-Parkinsonian actions of agents such as levodopa may be diminished by concurrent administration of ESPIRIDE (see WARNINGS AND SPECIAL PRECAUTIONS).

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 ESPIRIDE be given before rather than with or after sucralfate or antacids.

ESPIRIDE may enhance the anticholinergic properties of atropine and tricyclic antidepressants.

ESPIRIDE should not be given in conjunction with other medicine that might cause leucopenia such as phenylbutazone and the thiouracil derivatives. The anti-emetic actions of ESPIRIDE may mask the symptoms of disorders such as gastrointestinal obstruction. The antihypertensive action of adrenergic neuron blocking medicines, such as guanethidine, is reduced by ESPIRIDE.

ESPIRIDE 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 ESPIRIDE, but ESPIRIDE may conversely, lower the convulsive threshold (see WARNINGS AND SPECIAL PRECAUTIONS).

The safety in pregnancy has not been established.

ESPIRIDE 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.

The side effects of ESPIRIDE are 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 ESPIRIDE 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, thrombocytopenic purpura and a potentially fatal agranulocytosis have occurred in patients receiving ESPIRIDE. 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.

ESPIRIDE 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.