Each buccal tablet contains 3.0 mg prochlorperazine maleate Ph Eur

Buccal tablet.

For nausea and vomiting in previously diagnosed migraine, in adults aged 18 years and over.

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.

Duration of treatment: Two days maximum.

Adults aged 18 years and over: One or two tablets twice a day.

Children and young adults under 18 years: Not recommended.

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

In patients with impaired liver function, existing blood dyscrasias, epilepsy, Parkinsons Disease, prostatic hypertrophy, narrow angle glaucoma and known hypersensitivity to the active ingredient or any of the other ingredients of this product. In pregnancy.

Only use when migraine has previously been diagnosed by a doctor. Hypotension, usually postural, may occur, particularly in elderly or volume depleted patients. Tardive dyskinesia may occur occasionally, although this is normally associated with higher doses than are recommended for Buccastem M tablets. Nausea and vomiting as a sign of organic disease may be masked by the anti-emetic action of Buccastem M tablets.

Alcohol and CNS depressants should be used with caution – possible additive effect. Tricyclic antidepressants and antimuscarinic agents – possible enhanced antimuscarinic effect in the elderly although the risk is small. Oral anticoagulants – may have diminished effect. Thiazide diuretics – possible enhanced hypotensive effect. Propoanolol – levels of both drugs may increase. Anticonvulsants – efficacy may be diminished necessitating dosage adjustment. Alpha-adrenoreceptor blocking antihypertensives – levels of both drugs may change. The concomitant use of lithium may result in severe extrapyrimidal side effects or severe neurotoxicity. The concurrent use of desferrioxamine and prochlorperazine should be avoided. Prochlorperazine opposes the effects of levadopa.

Drowsiness, dizziness, dry mouth, insomnia, agitation and mild skin reactions may occur. Extrapyramidal reactions are very unlikely at the recommended dosage. Other effects which have occurred rarely with prochlorperazine and other phenothiazine neuroleptics include jaundice, blood dyscrasias and, very rarely, hyperprolactinaemic effects such as gynaecomastia. Neuroleptic malignant syndrome (hyperthermia, rigidity, autonomic dysfunction and altered consciousness) may occur with any neuroleptic. Use of Buccastem M tablets may occasionally result in local irritation to the gum and mouth.

Alliance Pharmaceuticals

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