ROXIN norfloxacin 400 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

norfloxacin, Quantity: 400 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; magnesium stearate; microcrystalline cellulose; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin

Administration route:

Oral

Units in package:

6 tablets, 2 tablets, 14 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of adults with complicated and uncomplicated urinary tract infections that are caused by susceptible strains of microorganisms. Treatment of adults with gastrointestinal infections, in particular shigellosis and traveller's diarrhoea. Note. Specimens for culture and susceptibility testing should be obtained prior to and during treatment if clinical response warrants. Suppression in adults of chronic, recurrent urinary tract infection.

Product summary:

Visual Identification: WHITE, CONVEX, OVAL SCORED FILM-COATED TABLET WITH "N" &"F" INTERSPERSED WITH A BREAK LINE EMBOSSED ON ONE SIDE AND THE ARROW SYMBOL ON THE OTHER SIDE.; Container Type: Bottle; Container Life Time: 18 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2003-03-26

Patient Information leaflet

ROXIN – CONSUMER MEDICINE INFORMATION
PAGE 1 of 4
Roxin
_norfloxacin _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Roxin. It does not
contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Roxin against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ROXIN IS USED FOR
Roxin contains norfloxacin as the
active ingredient. It belongs to a
group of antibiotics called
quinolones. These medicines work
by killing the bacteria that is causing
infection.
Roxin is an antibiotic used to treat:
•
urinary tract infections
•
gastrointestinal infections.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ROXIN HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
this medicine for another reason.
Roxin is available only with a
doctor's prescription.
There is no evidence that it is
addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ROXIN IF YOU ARE
ALLERGIC TO MEDICINES CONTAINING:
•
norfloxacin
•
other quinolone antibiotics
including nalidixic acid
•
any of the ingredients listed at
the end of this leaflet.
DO NOT TAKE ROXIN IF YOU ARE
PREGNANT, OR INTEND TO BECOME
PREGNANT.
Roxin may affect your developing
baby if you take it during
pregnancy.
DO NOT TAKE THIS MEDICINE IF YOU
ARE BREASTFEEDING OR INTEND TO
BREASTFEED.
The active ingredient in Nufloxib
may pass into breast milk and may
affect your baby.
DO NOT GIVE ROXIN TO CHILDREN AND
TO PRE-PUBERTAL ADOLESCENTS, AS
THERE HAVE BEEN NO STUDIES OF ITS
EFFECTS IN THIS AGE GROUP.
DO NOT TAKE ROXIN IF THE EXPIRY
DATE (EXP.) PRINTED ON THE PACK
HAS PASSED.
DO NOT TAKE ROXIN IF THE
PACKAGING SHOWS SIGNS OF
TAMPERING OR THE TABLETS DO NOT
LOOK QUITE RIGHT.
_BEFORE YOU START TO TAKE I

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – ROXIN (NORFLOXACIN)
TABLETS
1
NAME OF THE MEDICINE
Norfloxacin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ROXIN tablets contain 400mg of norfloxacin.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ROXIN tablets are white, film-coated, convex, oval shaped scored
tablet, embossed with "N

F" on
one side and ">" on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of adults with complicated and uncomplicated urinary tract
infections that are caused by
susceptible strains of microorganisms.
Treatment of adults with gastrointestinal infections, in particular
shigellosis and traveller's
diarrhoea.
Note. Specimens for culture and susceptibility testing should be
obtained prior to and during
treatment if clinical response warrants.
Consideration should be given to available official guidance on the
appropriate use of antibacterial
agents.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Norfloxacin tablets should be taken one hour before or two hours after
a meal with a glass of water.
Patients receiving norfloxacin should be well hydrated. Multivitamins,
other products containing
iron or zinc, antacids containing magnesium and aluminium, sucralfate
or Videx (didanosine),
chewable/ buffered tablets or the paediatric powder for oral solution,
should not be taken within
2
two hours of administration of norfloxacin (see SECTION 4.4 SPECIAL
WARNINGS AND PRECAUTION FOR
USE).
_Urinary tract infection:_ Normal renal function. The recommended
dosage of norfloxacin for the
treatment of urinary tract infection is 400 mg twice daily for seven
to ten days.
For uncomplicated lower urinary tract infections, the recommended
dosage is 400 mg twice daily for
three days. In one study of uncomplicated lower urinary tract
infections, treatment for seven days
resulted in somewhat better eradication rates than treatment for three
days.
Maximum total daily dosage should not exceed 800 mg per day.
_Impaired renal function:_ Norfloxacin may be used f