INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo NICENE®-N Tablets
SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

NICENE®-N Tablets

COMPOSITION:
Each tablet contains:
Nitroxoline (8-Hydroxy-5-nitroquinoline)        100 mg

PHARMACOLOGICAL CLASSIFICATION:
A. 18.5 Urinary tract antiseptics.

PHARMACOLOGICAL ACTION:
Nitroxoline is a urinary antibacterial agent active against susceptible gram-positive and gram-negative organisms commonly found in urinary tract infections.
Following oral administration peak plasma concentrations are achieved in 2-3 hours and maximum urinary concentrations in 4-5 hours.

INDICATIONS:
Acute and chronic uncomplicated lower urinary tract infection.

CONTRA-INDICATIONS:
Anuria. Safety in pregnancy and during breast-feeding has not been established.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
Four to six tablets per day in divided doses, preferably after meals. Treatment should be continued for at least 7 days.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastrointestinal disturbances can occur. These can be minimised by administration after meals. The urine of patients taking NICENE®-N is coloured yellow and readily stains skin and clothing.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptomatic and supportive treatment should be given.

IDENTIFICATION:
NICENE®-N Tablets are round, light-green sugar-coated tablets.

PRESENTATION:
Containers of 42 and 500 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from moisture. Keep out of reach of children.

REGISTRATION NUMBER:
E/18.5/25

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue, Bryanston Ext. 77
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
10 May 1974

Under licence from:-
Laboratories Fournier, Paris

New addition to this site: April 2004
Source: Pharmaceutical Industry


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