Sanomigran 500 microgram Tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Pizotifen

Tilgængelig fra:

Phoenix Labs

ATC-kode:

N02CX; N02CX01

INN (International Name):

Pizotifen

Dosering:

500 microgram(s)

Lægemiddelform:

Coated tablet

Indgivelsesvej:

oral use

Enheder i pakken:

carton containing 60 tablets

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk gruppe:

antimigraine drug

Terapeutisk område:

Other antimigraine preparations; pizotifen

Terapeutiske indikationer:

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 healthcare professionals and describe the above-mentioned disorders as follows: prophylactic treatment of recurrent migraine headache with or without aura and of cluster headache. Sanomigran is not effective in relieving migraine attacks once in progress.

Autorisation status:

Not marketed

Autorisation dato:

1994-09-07

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sanomigran 500 microgram Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 micrograms of pizotifen as malate.
Excipients - Contains Lactose Monohydrate 45.475mg 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’ 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).
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.
Sanomigran is not effective in relieving migraine attacks once in
progress.
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