Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Pizotifen
Phoenix Labs
N02CX; N02CX01
Pizotifen
1.5 milligram(s)
Coated tablet
oral use
carton containing 28 tablets
Product subject to prescription which may be renewed (B)
antimigraine drug
Other antimigraine preparations; pizotifen
Prophylactic treatment of recurrent vascular headaches, including classical migraine, common migraine and cluster headache (periodic migrainous neuralgia). Sanomigran is not effective in relieving migraine attacks once in progress. 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.
Not marketed
1994-09-07
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sanomigran 1.5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1.5 mg pizotifen as malate. Excipients - contains Lactose Monohydrate 136.425mg and sucrose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablet Ivory/yellow, sugar-coated, bi-convex tablets, printed ‘SMG 1.5’ on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylactic treatment of recurrent vascular headaches, including classical migraine, common migraine and cluster headache (periodic migrainous neuralgia). Sanomigran is not effective in relieving migraine attacks once in progress. The International Classification of Headache Disorders 2 nd 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral administration. _Adults_ Starting with 0.5mg 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 patients' requirements up to a maximum of 4.5 mg daily. Up to 3 mg may be given as a single daily dose. _Children over 12 years:_ Starting with 0.5mg 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. _Use in the elderly_ Clinical work with Sanomigran has not shown that elderly patients require different dosages from younger patients. _Special populations_ Renal and hepatic impairment Caution is required in patients with renal or hepatic impairment and dosage adjustment may be necessary (see section 5.2 P Olvassa el a teljes dokumentumot