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).
QT prolongation
Neuroleptic phenothiazines may potentiate QT interval prolongation which increases the risk of onset of serious ventricular arrhythmias of the torsade de pointes type, which is potentially fatal. Buccastem M tablets should be used with caution in patients with congenital or documented acquired QT prolongation and/or known risk factors for prolongation of the QT interval such as:
• cardiac disease e.g. heart failure, myocardial infarction
• proarrhythmic conditions e.g bradycardia (< 50 bpm)
• a history of ventricular dysrhythmias
• uncorrected hypokalemia and/or hypomagnesemia
• and during concomitant administration with QT interval prolonging drugs (see section 4.5).
If signs of cardiac arrhythmia occur during treatment with Buccastem M tablets, treatment should be stopped and an ECG should be performed.
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.