Pizotifen 1.5mg Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pizotifen 1.5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.175mg Pizotifen hydrogen malate equivalent to 1.5mg Pizotifen base
For excipients: see section 6.1
3 PHARMACEUTICAL FORM
Film coated tablets
White coloured film-coated tablets with P15 embossed on one side.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Prophylactic treatment of recurrent vascular headaches, including classical migraine, common migraine and cluster headache (periodic migrainous neuralgia).
Adults: 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 patient requirements up to a maximum of 4.5mg daily. Up to 3mg may be given as a single dose.
Children: Up to 1.5 mg daily in divided dose. Use of 1.5mg tablets is not recommended. The appropriate paediatric doses may be given using 0.5mg tablets. Although up to 1mg has been given as a single dose at night.
Use in Elderly: Clinical work has not shown elderly patients to require different dosage from younger patients.
4.3 Contraindications
Known hypersensitivity to pizotifen or any of the excipient of the formulation.
4.4 Special warnings and precautions for use
Although the anticholinergic activity of pizotifen is relatively weak, caution is required in the presence of closed angle glaucoma and in patients with a predisposition to urinary retention. Dosage adjustment may be necessary in patients with kidney insufficiency.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
The central effects of sedatives, hypnotics, antihistamines (including certain common cold preparations) and alcohol may be enhanced by pizotifen.
As clinical data in pregnancy is very limited, it should only be administered under compelling circumstances.
Although the concentration of pizotifen in milk is not likely to affect the infants, its use in nursing mothers is not recommended.
4.7 Effects on ability to drive and use machines
Patients should be cautioned about the possibility of drowsiness and informed of its significance in the driving of vehicles and the operation of machinery.
4.8 Undesirable effects
The most commonly occurring side-effects are drowsiness and an increased appetite, which may lead to an increase in body weight. Other side effects such as dizziness, dry mouth, nausea and constipation have been reported infrequently. Rare instances of sleep disorders, depression and other mood disturbances have occurred. In children CNS stimulation may occur.
4.9 Overdose
Symptoms of overdosage may include drowsiness, dizziness, hypotension, dryness of mouth, confusion, excitatory states (in children), ataxia, nausea, vomiting, dyspnoea, cyanosis, convulsions (particularly in children), coma and respiratory paralysis.
Treatment: Administration of activated charcoal is recommended; in case of very recent intake, gastric lavage may be considered. Severe hypotension must be corrected (CAVE: adrenaline may produce paradoxical effects). If necessary, symptomatic treatment including monitoring of the cardiovascular and respiratory systems. Excitory states or convulsions may be treated with short acting benzodiazepines.
5.1 Pharmacodynamic properties
Pharmacodynamic studies demonstrate pizotifen to have powerful anti-serotonin and anti-tryptaminic properties, marked anti-histaminic effects and some antagonistic activity against kinins. It also possesses weak anti-cholinergic effects and sedative properties.
Pizotifen also possesses appetite- stimulating properties. The prophylactic effect of pizotifen in migraine is associated with its ability to modify humoral mechanisms of headache.
It inhibits the permeability-increasing effect of serotonin and histamine on the affected cranial vessels, thereby checking the transudation of plasmakinin so that the pain threshold of the receptors is maintained at ‘normal’ levels. In the sequence of events leading to migraine attack, depletion of plasma serotonin contributes to loss of tone in the extracranial vessels. Pizotifen inhibits serotonin re-uptake by the platelets, thus maintaining plasma serotonin and preventing the loss of tone and passive distension of the extracranial arteries.
5.2 Pharmacokinetic properties
The absorption of pizotifen is fast (absorption half-life 0.5 to 0.8 hours) and nearly complete (80%). Pizotifen is metabolised with a half-life of about lhour. The main metabolite (N- glucuronide) is eliminated with a half-life of approximately 23 hours. Protein binding amounts to about 91% and distribution volume is 485 litres. Less than 1% of the administered dose is excreted unchanged in the urine, whereas 55% is excreted as metabolites.
5.3 Preclinical safety data
None stated
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose monohydrate, Microcrystalline cellulose (E460), Maize starch,
Povidone K-30 (E1201), Magnesium stearate (E572), Colloidal silicon dioxide (E551). Hypromellose (E464), Polyethylene glycol,
Talc (E553b)
Titanium dioxide (E 171)
6.2 Incompatibilities
None
6.3 Shelf life
48 months
6.4 Special precautions for storage
Do not store above 25 °C. Protect the tablets from direct light.
6.5 Nature and contents of container
PVC/PVdC Aluminium blisters in cardboard carton. Each blister contains 14 tablets and there are two blisters per carton.
None
7
MARKETING AUTHORISATION HOLDER
The Co-operative Pharmacy National Distribution Centre Limited
Enterprise Way
Meir Park
Stoke on Trent
ST3 7UN
UK
8
9
21/11/2007
10
15/03/2011