Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PROCHLORPERAZINE MALEATE
Sanofi-Aventis Ireland Limited
5 Milligram
Suppositories
1997-04-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Stemetil 5mg Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains Prochlorperazine base equivalent to 5 mg of the Maleate. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Suppository Cream-coloured, smooth torpedo shaped suppositories. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Stemetil suppositories are recommended in the management of acute vertigo such as is associated with Meniere’s syndrome, nausea and vomiting, migraine and anxiety states. The course of treatment should not normally exceed 2 weeks duration. In the management of Phobias, Schizophrenia, Acute Mania and similar psychotic reactions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Rectal. _Recommended Dosage:_ Adults: For the management of nausea and vomiting due to migraine: One 5mg suppository three times a day. In acute cases, an intramuscular injection may be administered followed by the use of suppositories. Prevention of post-operative vomiting: Two 5mg suppositories just before the operation, followed by two every five hours, for up to 20 hours thereafter. Meniere’s syndrome, nausea and vomiting: 25mg followed by oral medication 6 hours later, if necessary. Schizophrenia and psychotic disorders: 25 mg b.d. (twice a day) or t.d.s. (three times a day) until oral treatment becomes possible. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 03/11/2006_ _CRN 2029692_ _page number: 1_ Elderly: Stemetil should be used cautiously in the elderly owing to their susceptibility to drugs acting centrally on the nervous system. There is an increased risk of drug-induced Parkinsonism in the elderly particularly after prolonged use therefore Read the complete document