Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
PIZOTIFEN MALEATE
Novartis Pharmaceuticals UK Ltd
500 Microgram
Coated Tablets
1994-09-07
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). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral administration. _Adults_ Usually 1.5 mg daily. This may be taken as a single dose at night or in three divided doses, using 1.5 mg tablets, 0.5 mg tablets or elixir 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_ 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 or elixir may be used. _Use in the elderly_ Clinical work with Sanomigran has not shown that elderly patients require different dosages from younger patients. 4.3 CONTRAINDICATIONS Hypersensitivity to pizotifen or to any of the excipients (see section 6.1 List of excipients). Use in children under 12 years. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/08/2011_ _CRN 2104182_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE In view of the long half-life in the body and excretion in the Belgenin tamamını okuyun