IPC-CIPROFLOXACIN ciprofloxacin 250mg (as hydrochloride monohydrate) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ciprofloxacin hydrochloride (Equivalent: ciprofloxacin, Qty 250 mg)

Available from:

Ipca Pharma (Australia) Pty Ltd

INN (International Name):

ciprofloxacin hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

14 tablets, 20 tablets, 10 tablets, 100 tablets, 8 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, round, film-coated tablets with "CPR 250" embossed 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:

Registered

Authorization date:

2009-05-20

Patient Information leaflet

IPC-CIPROFLOXACIN tablets Consumer Medicine Information
IPC-CIPROFLOXACIN 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 IPC-CIPROFLOXACIN
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
IPC-CIPROFLOXACIN 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 IPC-CIPROFLOXACIN TABLETS IS USED FOR
IPC-CIPROFLOXACIN 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.
IPC-CIPROFLOXACIN 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 IPC-CIPROFLOXACIN TABLETS
for another
purpose.
ASK YOU DOCTOR IF YOU HAVE ANY QUESTIONS WHY IPC-CIPROFLOXACIN TABLETS
HAS BEEN PRESCRIBED FOR YOU.
IPC-CIPROFLOXACIN TABLETS are not addictive.
This medicine is available only with a doctor’s prescription.
BEFORE YOU TAKE IPC-CIPROFLOXACIN TABLETS
_ DO NOT TAKE IPC-CIPROFLOXACIN TABLETS IF: _
1.
YOU HAVE AN ALLERGY TO CIPROFLOXACIN, OTHER QUINOLONE ANTIBIOTIC
INCLUDING NALIDIXIC ACID, OR ANY OF THE INGREDIENTS IN IPC-CIPROFLOXACIN 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.
IPC-CIPROFLOXACIN tablets Consumer Medicine

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION IPC-CIPROFLOXACIN(CIPROFLOXACIN)
TABLETS
1.
NAME OF THE MEDICINE
CIPROFLOXACIN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
IPC-CIPROFLOXACIN 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
IPC-CIPROFLOXACIN 250 MG: White to creamish white, round film-coated
tablets, with “CPR 250”
embossed on one side and “BL” embossed on other side.
IPC-CIPROFLOXACIN 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.
IPC-CIPROFLOXACIN 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