KELFIZINE W 2 Grams Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
28-04-2024
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Active ingredient:
SULFALENE
Available from:
Farmitalia Carlo Erba Ltd
INN (International Name):
SULFALENE
Dosage:
2 Grams
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Authorised
Authorization date:
0000-00-00
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kelfizine W Tablets, 2g
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sulfalene (sulfametopyrazine) 2g.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Tablet
White, flat, uncoated tablets marked ‘LONGUM’ on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of infections due to micro-organisms sensitive to this anti-infective, including chronic bronchitis and
urinary tract infections.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children over the age of 12 years
The usual dose is 2 grams (i.e. one tablet) weekly. Each tablet should be stirred into half a tumbler full of water or
orange squash.
Elderly
As hepatic conjugation and renal clearance occur at a reduced rate in the elderly, caution is advised when prescribing
the drug for long periods of time to avoid accumulation.
Children under 12 years of age
Kelfizine W tablets are contra-indicated for use in children under 12.
4.3 CONTRAINDICATIONS
Kelfizine W Tablets are contra-indicated in:
Children aged 12 years and less.
Lactating women who are breast feeding infants.
Patients hypersensitive to sulphonamides.
Patients suffering from porphyria, jaundice, intestinal obstruction or renal failure.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/07/2006_
_CRN 2025394_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This drug should only be used with great caution in patients with hepatic or renal dysfunction, dehydration or blood
dyscrasias.
Absorption of this sulphonamide may be increased in patients with ulcerative lesions of the bowel.
Adequate fluid intake should be ensured during administration.
Prolonged use of any anti-infe
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