Alliance Pharmaceuticals Ireland

Buccastem 3 mg Buccal Tablets

Each buccal tablet contains 3 mg prochlorperazine maleate.

Excipients: Each buccal tablet contains at least 47mg sucrose.

For a full list of excipients, see section 6.1.

Buccal tablet.

Pale yellow, round, biconvex, buccal tablet, with 'J1' on one face.

In the management of acute vertigo, such as is associated with Meniere's Syndrome, nausea and vomiting, and migraine.

To be placed in the buccal cavity.

Adults and children over 12 years: One tablet taken twice a day.

Children under 12 years: Not recommended.

The course of treatment should not exceed two weeks in duration.

Buccastem is contraindicated in patients with impaired liver function, existing blood dyscrasias and known hypersensitivity to the active ingredient.

Phenothiazines should only be used with great caution in patients with a history of jaundice.

Patients receiving phenothiazines over a prolonged period require regular and careful surveillance with particular attention to potential for inducing eye change, effects on haemopoiesis, liver dysfunction, myocardial conduction effects, particularly if other concurrently administered drugs also have potential effects on these symptoms.

Phenothiazines may induce drowsiness. Persons taking these drugs should not drive or operate machinery unless the drug has been shown not to interfere with physical or mental ability.

Use of phenothiazines at high (relative or absolute) doses may induce extrapyramidal side-effects, dyskinesia, akathisia, dystonia.

Prolonged administration of any phenothiazine may result in persistent or tardive dyskinesias, particularly in the elderly.

Phenothiazines should only be used with great caution in patients with coronary insufficiency or cardiac disease.

Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Buccastem and preventive measures undertaken

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.

Buccastem is not licensed for the treatment of dementia-related behavioural disturbances.

The concomitant administration of this product with medications such as central nervous system depressants (including alcohol and anaesthetics), or antihypertensives or anticholinergics will result in accentuation of their effect while potentiation of action will also occur with monoamine oxidase inhibitors, antidepressants and analgesics.

Phenothiazines should only be used in pregnancy if considered essential by the physician. The drug is excreted in breast milk, and breast feeding should cease during therapy.

Patients who drive or operate machinery should be warned of the possibility of drowsiness.

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.

Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs - frequency unknown.

The signs and symptoms will be predominantly extrapyramidal and may be accompanied either by restlessness and agitation or central nervous depression. Hypotension may occur. Treatment is essentially symptomatic and supportive. Rare Occurrence of cases of serious arrhythmias, including tachycardia and fibrillation, have also occurred after overdosage.

There is no specific antidote. Gastric lavage is helpful, particularly when carried out within 6 hours of ingestion. Do not induce vomiting. Particular attention must be directed to maintaining a clear airway since this may be threatened by extrapyramidal muscle dystonias. Severe dystonic reactions usually respond to procyclidine (5-10 mg) or orphenadrine (20-40 mg) given i.m. or i.v. If convulsions occur they should be treated using i.v. diazepam. If hypotension is present, strict attention to ventilation and posturing of the patient will often secure the desired effect, but failing this, consideration should be given to volume expansion by i.v. fluids. If this is insufficient, positive inotropic agents such as dopamine may be tried, but peripheral vasoconstrictor agents are not generally recommended. Adrenaline should NOT be used.

Prochlorperazine is a member of the phenothiazine group of neuroleptics which, in doses lower than those used in psychiatry, is usually employed for its anti-emetic properties.

Buccastem tablets contained in a buccal formulation which eliminates first pass hepatic metabolism. The elimination half-life of prochlorperazine in this formulation is 9.0 hours, similar to that observed with the oral formulation.

No preclinical findings of relevance have been reported.

Compressible sugar

Povidone K30

Xanthan gum

Locust bean gum

Talc

Magnesium stearate

Riboflavin sodium phosphate

Not applicable.

3 years.

This medicinal product does not require any special temperature storage conditions.

Keep the blisters in the outer carton.

PVC/PVDC/Aluminium foil blister packs containing 50 tablets.

Other packs not marketed: blisters in packs 8, 15, 30, or 60 tablets.

No special requirements.

Alliance Pharmaceuticals Ltd

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

PA 943/16/1

18^th December 2009

23^rd February 2010