FLAGYL Suppositories 0.5 Grams
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
METRONIDAZOLE
Available from:
Sanofi-Aventis Ireland Limited
Dosage:
0.5 Grams
Pharmaceutical form:
Suppositories
Authorization date:
1977-09-30
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flagyl Suppositories 0.5g
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 500 mg of Metronidazole.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suppository.
Cream-coloured, torpedo-shaped suppositories.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the prevention and treatment of infections due to anaerobic bacteria, particularly species of _Bacteroides_, anaerobic
_Streptococci, Fusobacteria, Clostridia_, etc.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Rectal.
Recommended Dosage:
Adults:
1g 8 hourly. Substitute oral medication as early as possible. If rectal administration is prolonged beyond 3
days reduce dose to 1g 12 hourly for remainder of course.
Children:
7.5 mg/kg 8 hourly.
Prophylaxis against anaerobic infection-chiefly in the context of abdominal (especially colorectal) and gynaecological
surgery:
Adults:
1g 8 hourly.
Children one half or a quarter of a 500mg suppository 8 hourly.
4.3 CONTRAINDICATIONS
Metronidazole should be used with caution in patients with active or chronic severe peripheral and central nervous
system disease due to the risk of neurological aggravation. Use in patients known to be hypersensitive to
metronidazole.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 06/12/2011_
_CRN 2093767_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The use of Flagyl for prolonged treatment duration should be carefully weighed
1.
If prolonged therapy is required, the physician should bear in mind the possibility of peripheral neuropathy or
leucopenia. Both effects are usually reversible. High dosage regimes have been associated with transient
epileptiform seizures. Caut
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