SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Buccastem M Buccal Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each buccal tablet contains 3.0 mg prochlorperazine maleate.

Excipients with known effect:

Compressible sugar (contains sucrose) 49.493 mg

3    PHARMACEUTICAL FORM

Buccal tablet.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

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

4.2    Posology and method of administration

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.

4.3 Contraindications

•    Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

•    Impaired liver function

•    Existing blood dyscrasias

•    Epilepsy

•    Parkinsons Disease

•    Prostatic hypertrophy

•    Narrow angle glaucoma

•    Pregnancy.

4.4 Special warnings and precautions for use

Only use when migraine has previously been diagnosed by a doctor.

Buccastem M tablets should be avoided in patients with stroke risk factors and myasthenia gravis.

Agranulocytosis has been reported with phenothiazines. The occurrence of unexplained infections or fever may be evidence of blood dyscrasia (see section 4.8), and requires immediate haematological investigation.

It has been reported that patients with AIDS may be particularly susceptible to antipsychotic-induced extrapyramidal effects

Because of the risk of photosensitisation, patients should be advised to avoid exposure to direct sunlight and use sunscreen (see section 4.8).

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 antiemetic action of Buccastem M 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. It is imperative that treatment be discontinued in the event of NMS (characterised by unexplained fever, hyperthermia, autonomic dysfunction, altered consciousness, muscle rigidity) (see section 4.8).

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 (see section 4.8).

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.

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

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

4.5 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 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 opposes the effects of levadopa.

Fertility, pregnancy and lactation

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

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

Undesirable effects are listed by MedDRA System Organ Classes. Assessment of undesirable effects is based on the following frequency groupings:

Very common: >1/10 Common: >1/100 to <1/10 Uncommon: >1/1,000 to <1/100 Rare: >1/10,000 to <1/1,000 Very rare: <1/10,000

Not known: cannot be estimated from the available data

Tabulated list of adverse reactions

System organ class	Undesirable effect and frequency
Blood and lymphatic	Rare:
system disorders	Blood dyscrasia
Immune system disorders	Not known:
	Hypersensitivity reactions such as rash and angioedema
Endocrine disorders	Very rare: Hyperprolactinaemia which may result in gynaecomastia, galactorrhoea and amenorrhoea

Metabolism and nutrition disorders	Not known: Hyponatraemia Syndrome of inappropriate antidiuretic hormone secretion Hyperglycaemia Glucose tolerance impaired
Psychiatric disorders	Not known: Insomnia Agitation
Nervous system disorders	Not known: Convulsion Drowsiness Dizziness Extrapyramidal reactions including acute dystonia, akathisia, parkinsonism and tardive dyskinesia
Vascular disorders	Not known: Hypotension (usually orthostatic)
Gastrointestinal disorders	Not known: Dry mouth Irritation gum Mouth irritation
Hepatobiliary disorders	Rare: Jaundice
	Not known: Cholestasis
Skin and subcutaneous tissue disorders	Not known: Skin reaction Photosensitivity (see section 4.4)
Pregnancy, puerperium and perinatal conditions	Not known: Drug withdrawal syndrome neonatal (see Section 4.6)

Description of selected adverse reactions

Impotence, ejaculation disorder, priapism, and agranulocytosis (see section

4.4)    are class effects associated with phenothiazines.

Neuroleptic malignant syndrome may occur with any neuroleptic (see section

4.4) .

Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs- Frequency unknown (see section 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. Healthcare professionals are asked to report

any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

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. 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 or orphenadrine 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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Phenothiazines with piperazine structure ATC code: N05AB

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.

5.2 Pharmacokinetic properties

Buccastem M 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.

Preclinical safety data

No preclinical findings of relevance have been reported.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Compressible sugar, povidone K30, xanthan gum, locust bean gum, talc, magnesium stearate and riboflavin sodium phosphate.

6.2 Incompatibilities

None.

6.3 Shelf life

Three years.

6.4 Special precautions for storage

Protect from light.

6.5 Nature and contents of container

250 micron PVC/PVdC aluminium foil blister packs. Pack size:

Blister packs of 8tablets.

6.6 Special precautions for disposal and other handling

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Alliance Pharmaceuticals Ltd

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

8    MARKETING AUTHORISATION NUMBER(S)

PL 16853/0102

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

16^th February 2010

10 DATE OF REVISION OF THE TEXT

16/02/2016