STEMETIL Suppositories 5 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:

5 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 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 
                                
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