Buccastem M Buccal Tablets

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 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.

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 M tablets 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 M tablets are not licensed for the treatment of dementia-related behavioural disturbances.

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.

Contraindicated in pregnancy.

Neonates exposed to antipsychotics (including prochlorperazine) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.

Since data from animal studies shows that prochlorperazine may be found in breast milk, Buccastem M tablets should not be used during lactation.

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. Use of Buccastem M tablets may occasionally result in local irritation to the gum and mouth.

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 also occur. Treatment is essentially symptomatic and supportive. 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. The site of action is thought to be the chemoreceptor trigger zone.

Buccastem 3 tablets are placed in the buccal cavity where they form a gel from which the prochlorperazine is released and absorbed. The plasma levels achieved at steady-state on a dosage regimen of one 3 mg buccal tablet twice daily are similar to those observed with the standard oral dosage of one 5 mg tablet taken three times daily. 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 and riboflavin sodium phosphate.

None.

Three years.

Protect from light.

250 micron PVC aluminium foil blister packs.

Pack size: Blister packs of eight tablets.

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

Alliance Pharmaceuticals Ltd

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

PL 16853/0102

16^th February 2010

December 2011