STEMETIL Suppositories 25 Milligram

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

PROCHLORPERAZINE MALEATE

Available from:

Sanofi-Aventis Ireland Limited

Dosage:

25 Milligram

Pharmaceutical form:

Suppositories

Authorization date:

1997-04-01

Summary of Product characteristics

                                PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Stemetil 25 mg Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains Prochlorperazine base equivalent to 25 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.
Menier’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 04/11/2006_
_CRN 2029694_
_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
theref
                                
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