PROCHLORPERAZINE MALEATE

To be placed in the buccal cavity, high up along the top gum under the upper lip, until dissolved. Do not chew or swallow the tablet.

Adults and children aged 12 years and over:

One or two Prochlorperazine maleate 3 mg buccal tablets twice a day.

Children under 12 years:

Not recommended.

Elderly patients:

There is no evidence that dosage need be modified for the elderly.

Undesirable effects are listed by MedDRA System Organ Classes. 4) are class effects associated with phenothiazines. 4). 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Prochlorperazine maleate 3 mg buccal tablets should be avoided in patients with stroke risk factors and myasthenia gravis. Agranulocytosis has been reported with phenothiazines. 8), and requires immediate haematological investigation.

It has been reported that patients with AIDS may be particularly susceptible to antipsychotic-induced extrapyramidal effects. 8). Hypotension, usually postural, may occur, particularly in elderly or volume depleted patients. Nausea and vomiting as a sign of organic disease may be masked by the anti- emetic action of prochlorperazine maleate 3 mg buccal tablets.

Neuroleptic malignant syndrome (NMS) is a potentially fatal symptom complex associated with antipsychotic medicinal products. Alteration in mental status and other neurological signs often precede systemic signs of NMS. 8). Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs.

8). Increased Mortality in Elderly people with Dementia Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated.

There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known. Prochlorperazine maleate 3 mg buccal tablet is not licensed for the treatment of dementia-related behavioural disturbances.

Prochlorperazine maleate 3 mg buccal tablets contain sucrose Prochlorperazine maleate 3 mg buccal tablets contain sucrose. Hyperglycaemia or intolerance to glucose has been reported in patients treated with antipsychotic phenothiazines.

8). Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. 5 Interaction with other medicinal products and other forms of interaction Alcohol and CNS depressants should be used with caution due to the possible additive CNS depressant effect.

The hypotensive effect of antihypertensive drugs may be exaggerated. The mild anticholinergic effect of neuroleptics may be enhanced by other anticholinergic drugs. Oral anticoagulants – may have diminished effect. Anticonvulsants – efficacy may be diminished necessitating dosage adjustment, as prochlorperazine may lower the seizure threshold.

The hypotensive effect of antihypertensive drugs may be exaggerated. The concomitant use of lithium may result in severe extrapyramidal side effects or severe neurotoxicity. The concurrent use of desferrioxamine and prochlorperazine should be avoided.

Prochlorperazine maleate 3 mg buccal tablets oppose the effects of levodopa.

1 • Impaired liver function • Existing blood dyscrasias • Epilepsy • Parkinson’s Disease • Prostatic hypertrophy • Narrow angle glaucoma