ROFLO ciprofloxacin 500mg (as hydrochloride monohydrate) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ciprofloxacin, Quantity: 500 mg

Available from:

Ipca Pharma (Australia) Pty Ltd

INN (International Name):

Ciprofloxacin

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: maize starch; microcrystalline cellulose; sodium starch glycollate; colloidal anhydrous silica; magnesium stearate; hypromellose; purified talc; macrogol 4000; titanium dioxide

Administration route:

Oral

Units in package:

14 tablets, 8 tablets, 10 tablets, 20 tablets, 100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ciprofloxacin is indicated for treatment of infections caused by susceptible organisms in the conditions listed below: Urinary tract infections; Gonorrhoeal urethritis and cervicitis; Gastroenteritis; Bronchial infections; Skin and skin structure infections; Bone and joint infections; Chronic bacterial prostatitis of mild or moderate severity. Inhalational anthrax (post-exposure): To reduce the incidence or progression of disease following exposure to aerosolised Bacillus anthracis. Ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication. Note: 1. Typhoid and paratyphoid infections and infections due to multi-resistant Staphylococcus aureus are excluded from the above due to insufficient data. 2. Because gram-positive organisms are generally less sensitive to ciprofloxacin, it may not be the drug of choice in cases with Gram-positive infections, such as pneumonia due to Streptococcus pneumoniae. 3. Chronic bacterial prostatitis should be demonstrated by microbiological evidence localising infection to the prostate. Strains of Neisseria gonorrhoea resistant to ciprofloxacin have been reported in Australia. Appropriate culture and susceptibility tests should be performed before treatment in order to determine organism susceptibility to ciprofloxacin and after treatment as warranted by the clinical condition. Therapy with ciprofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. Ciprofloxacin is suitable to treat mixed infections caused by susceptible strains of both Gram-negative and Gram-positive aerobic bacteria. If anaerobic organisms are suspected as accompanying aetiologic agents, additional therapy should be considered.

Product summary:

Visual Identification: White to creamish white, capsule-shaped, film-coated tablets with "CPR 500" embossed and a break line on one side and "BL" embossed on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2006-08-28

Patient Information leaflet

ROFLO TABLETS
CONSUMER MEDICINE INFORMATION
COMMERCIAL-IN-CONFIDENCE
ROFLO TABLETS
Pronounced (sip-ro-flox-a-cin)
_Contains the active ingredient Ciprofloxacin hydrochloride _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common questions about ROFLO TABLETS.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking
ROFLO TABLETS
against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOU DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IS ROFLO TABLETS USED FOR
ROFLO TABLETS
are used for the treatment of infections of the lungs, skin,bones and
joints,
kidney and bladder, prostate and bowel. However, your doctor may
prescribe this medicine for
another use.
ROFLO TABLETS
contain the active ingredient ciprofloxacin which is an antibiotic
belonging
to a group of medicines called quinolones (pronounced kwin-o-lones).
These antibiotics work
by killing the bacteria that are causing your infection.
There are many different types of medicines used to treat
_infections _
Your doctor, however, may have prescribed ROFLO TABLETS
for another purpose.
ASK YOU DOCTOR IF YOU HAVE ANY QUESTIONS WHY ROFLO TABLETS HAS BEEN
PRESCRIBED
FOR YOU.
ROFLO TABLETS
are not addictive.
ROFLO TABLETS
CONSUMER MEDICINE INFORMATION
COMMERCIAL-IN-CONFIDENCE
This medicine is available only with a doctor’s prescription.
BEFORE YOU TAKE ROFLO TABLTS
_DO NOT TAKE ROFLO TABLETS IF: _
1.
YOU HAVE AN ALLERGY TO CIPROFLOXACIN, OTHER QUINOLONE ANTIBIOTIC
INCLUDING NALIDIXIC
ACID, OR ANY OF THE INGREDIENTS IN ROFLO TABLETS LISTED AT THE END OF
THIS
LEAFLET.
2.
THE PACKAGING IS TORN OR SHOWS SIGN OF TAMPERING
3.
THE EXPIRY DATE (EXP) PRINTED ON THE PACK HAS PASSED.
If you take this medicine after the expiry date has passed, it may not
work as well.
4.
YOU ARE BREAST-FEEDI

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION ROFLO ® (CIPROFLOXACIN) TABLETS
1.
NAME OF THE MEDICINE
CIPROFLOXACIN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Roflo is available as 250 mg, 500 mg and 750 mg film-coated tablets
for oral administration. Roflo 250
contains 250mg of active, Roflo 500 contains 500mg of active, and
Roflo 750 contains 750mg of active.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS
3.
PHARMACEUTCAL FORM
ROFLO 250 MG: White to creamish white, round film-coated tablets, with
“CPR 250” embossed on one
side and “BL” embossed on other side.
ROFLO 500MG: White to creamish white capsule shaped film-coated
tablets with “CPR 500” embossed &
break line on one side and “BL” embossed on the other side.
ROFLO 750MG: White to creamish white capsule shaped film-coated
tablets, with “CPR 750” embossed
on one side and “BL” embossed on other side
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ciprofloxacin is indicated for the treatment of infections caused by
susceptible organisms in the
conditions listed below:
Urinary tract infections
Gonorrhoeal urethritis and cervicitis
Gastroenteritis
Bronchial infections
Skin and skin structure infections
Bone and joint infections
Chronic bacterial prostatitis of mild or moderate severity
Inhalational anthrax (post-exposure): To reduce the incidence or
progression of disease following
exposure to aerosolised _ Bacillus anthracis_. Ciprofloxacin serum
concentrations achieved in humans
serve as a surrogate endpoint reasonably likely to predict clinical
benefit and provide the basis for this
indication.
NOTE:
1.
Typhoid
and
Paratyphoid
infections
and
infections
due
to
multi-resistant
_Staphylococcus _
_aureus_ are excluded from the above due to insufficient data
2.
Because Gram-positive organisms are generally less sensitive to
ciprofloxacin, it may not be
the
drug
of
choice
in
cases
with
Gram-positive
infections,
such
as
pneumonia
due
to
_Streptococcus pneumoniae_.
3.
Chronic bacterial prostatitis should be demonstrated by
microbi