BUCCASTEM M Buccal tablet Ref.[50140] Active ingredients: Prochlorperazine

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 anti-emetic 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.

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.

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.

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

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

None.