Source: Υπουργείο Υγείας (CY) Revision Year: 2016 Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Prophylactic treatment of recurrent vascular headaches, including classical migraine, common migraine and cluster headaches (periodic migrainous neuralgia).
The International Classification of Headache Disorders 2nd edition (ICHD-II) are standard classifications of headache used by healthcare professionals and describe the above-mentioned disorders as follows: prophylactic treatment of recurrent migraine headache with or without aura and of cluster headache.
Pizogran is not effective in relieving migraine attacks once in progress.
Starting with 0.5 mg daily, the dosage should be progressively increased. Dose is usually 1.5 mg daily. This may be taken as a single dose at night or in three divided doses, using 0.5 mg tablets or 1.5 mg tablets as appropriate. Dosage should be adjusted to individual patient requirements up to a maximum of 4.5 mg daily. Up to 3 mg may be given as a single daily dose.
Starting with 0.5 mg daily, the dosage should be progressively increased. Dose is up to 1.5 mg daily, usually as a divided dose. Use of the 1.5 mg tablets is not recommended but up to 1 mg has been given as a single daily dose at night. 0.5 mg tablets may be used.
Clinical work with pizotifen has not shown that elderly patients 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 Pharmacokinetic properties – Special population).
Oral administration.
Symptoms of overdosage may include drowsiness, dizziness, hypotension, dry mouth, confusion, excitatory states (in children), ataxia, nausea, vomiting, dyspnoea, cyanosis, tachycardia, pyrexia, convulsions (particularly in children), coma and respiratory paralysis.
Treatment should be directed to the elimination of the drug, administration of activated charcoal and diuresis is recommended. In case of very recent intake, gastric lavage may be considered. General surveillance measures are indicated, including monitoring of the cardiovascular and respiratory systems and symptomatic treatment may be required. Severe hypotension must be corrected (cave: adrenaline may produce paradoxical effects. Excitatory states or convulsions may be treated with short-acting barbiturates or benzodiazepines.
5 years.
Store below 25°C. Protect from light and moisture.
Pizogran 0.5 mg film-coated tablets:
PVC-PVDC/Aluminium blisters. Pack-sizes of 30, 60, 100 and 1000 film-coated tablets.
PP containers with PE closure. Pack-sizes of 100 film-coated tablets.
Pizogran 1.5 mg film-coated tablets:
PVC-PVDC/Aluminium blisters. Pack-sizes of 30, 100 and 1000 film-coated tablets.
PP containers with PE closure. Pack-sizes of 100 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements.
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