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

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB

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.

4.9. 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.

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 eight tablets.

6.6. Special precautions for disposal and other handling

No special requirements.

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