ALMUS MIGRAINE RELIEF

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.

Undesirable effects are listed by MedDRA System Organ Classes. 4) are class effects associated with phenothiazines. 4). 4). QT prolongation, cardiac arrhythmias, including ventricular arrhythmias which may result in ventricular fibrillation or cardiac arrest have been reported during neuroleptic phenothiazine therapy.

Pre-existing cardiac disease, proarrhythmic conditions, hypokalaemia, hypomagnesemia, or concomitant administration with QT interval prolonging drugs may predispose. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 7 Effects on ability to drive and use machines Patients who drive or operate machinery should be warned of the possibility of drowsiness.

8 Undesirable effects Undesirable effects are listed by MedDRA System Organ Classes. 4) are class effects associated with phenothiazines. 4). 4). QT prolongation, cardiac arrhythmias, including ventricular arrhythmias which may result in ventricular fibrillation or cardiac arrest have been reported during neuroleptic phenothiazine therapy.

Pre-existing cardiac disease, proarrhythmic conditions, hypokalaemia, hypomagnesemia, or concomitant administration with QT interval prolonging drugs may predispose. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Only use when migraine has previously been diagnosed by a doctor. Almus Migraine Relief/ Prochlorperazine maleate Buccal Tablets should be avoided in patients with stroke risk factors and myasthenia gravis. Agranulocytosis has been reported with phenothiazines.

8), and requires immediate haematological investigation. 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 Almus Migraine Relief Tablets/ Prochlorperazine maleate Buccal 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. 8). Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs.

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. g. g. 5). If signs of cardiac arrhythmia occur during treatment with Almus Migraine Relief/ Prochlorperazine maleate Buccal 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. Almus Migraine Relief Tablets/ Prochlorperazine maleate Buccal Tablets are not licensed for the treatment of dementia-related behavioural disturbances.

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

1 • Impaired liver function • Existing blood dyscrasias • Epilepsy • Parkinsons Disease • Prostatic hypertrophy • Narrow angle glaucoma • Pregnancy