Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
Prophylactic treatment of recurrent vascular headaches, including classical migraine, common migraine and cluster headache (periodic migrainous neuralgia).
The International Classification of Headache Disorders 2nd edition (ICHD-II) are standard classifications of headache used by health professionals and describe the above-mentioned disorders as follows: prophylactic treatment of recurrent migraine headache with or without aura and of cluster headache.
Pizotifen is not effective in relieving a migraine attack once in progress.
Usually 1.5mg daily. This may be taken as a single dose at night or in three divided doses. Dosage should be adjusted to individual patients' requirements up to a maximum of 4.5mg daily. Up to 3mg may be given as a single daily dose.
Up to 1.5mg daily, usually as a divided dose, although up to 1mg has been given as a single dose at night.
Clinical work with pizotifen has not shown elderly patients to require different dosages from younger patients.
Caution is required in patients with renal or hepatic impairment and dosage adjustment may be necessary (see section 5.2).
For oral use.
Symptoms: drowsiness, dizziness, pyrexia, hypotension, dryness of the mouth, confusion, excitatory states (in children), ataxia, nausea, vomiting, dyspnoea, cyanosis, tachycardia, convulsions (particularly in children), coma and respiratory paralysis.
Treatment: Administration of activated charcoal is recommended; in case of very recent uptake, gastric lavage may be considered.
Severe hypotension must be corrected (cave: adrenaline (epinephrine) may produce paradoxical effects).
If necessary, symptomatic treatment should be given including monitoring of the cardiovascular and respiratory symptoms.
Excitatory states or convulsions may be treated with short-acting barbiturates or benzodiazepines. General surveillance measures are indicated.
Shelf-life: Two years from date of manufacture.
Shelf-life after dilution/reconstitution: Not applicable.
Shelf-life after first opening: Not applicable.
Do not store above 25°C.
The product containers are rigid injection moulded polypropylene tablet containers with snap-on polyethylene lids.
The product may also be supplied in blister packs in cartons:
a) Carton: Printed carton manufactured from white folding box board.
b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-7g/M2 PVC compatible heat seal lacquer on the reverse side.
Pack sizes: 28, 30, 56, 60, 84, 90, 100, 112, 120, 168, 180.
Not applicable.
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