CIPROL 750 ciprofloxacin 750mg (as hydrochloride) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ciprofloxacin hydrochloride, Quantity: 873.32 mg (Equivalent: ciprofloxacin, Qty 750 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; pregelatinised maize starch; crospovidone; maize starch; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3000

Administration route:

Oral

Units in package:

2 tablets, 10 tablets, 14 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CIPROL is indicated for the treatment of infections caused by susceptible organisms in the conditions listed: urinary tract infections, gonorrhoeal urethritis and cervicitis, gastroenteritis, bronchial infections, skin and skin structure infections, bone and joint infections, chronic bacterial prostatitis of mild to moderate severity. Note: 1. Typhoid and paratyphoid infections and infections due to multiresistant 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 Neisseria gonorrhoea resistant to ciprofloxacin have been reported in Australia. Appropriate culture and susceptibility tests should be preformed 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 beforeresults 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-postitive aerobic bacteria. If anaerobic organisms are suspected as accompanying agents, additional therapy should be considered.

Product summary:

Visual Identification: White to off-white, oblong, biconvex, unscored film-coated tablet, debossed CR 750 on one face and plain on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2002-04-19

Patient Information leaflet

CIPROL CMI-
1
CIPROL
TABLETS
_Ciprofloxacin _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about Ciprol 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 Ciprol
tablets 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 Ciprol is used for
Ciprol tablets are used for the
treatment of infections of the
lungs, skin, bones, joints, kidneys,
bladder, prostate and bowel.
Ciprol 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.
Ciprol will not work against
infections caused by viruses such
as colds or the flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed it
for another reason
Before you take Ciprol
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CIPROL IF YOU HAVE
AN ALLERGY TO:
•
ciprofloxacin, the
active ingredient in
Ciprol
•
any of the ingredients
listed at the end of this
leaflet
•
other medicines belonging
to the quinolone chemical
family (e.g. moxifloxacin,
norfloxacin, nalidixic acid).
Some of the symptoms of
an allergic reaction may
include:
•
shortness of breath
•
wheezing or difficulty
breathing
•
swelling of the face,
lips, tongue or other
parts of the body
•
rash, itching or hives on
the skin.
DO NOT TAKE CIPROL IF YOU ARE
ALSO TAKING A MEDICINE CALLED
TIZANIDINE, A MUSCLE RELAXANT
USED TO TREAT SPASTICITY
ASSOCIATED WITH MULTIPLE
SCLEROSIS, INJURY OR DISEASES OF
THE SPINAL CORD.
Ciprol can interfere with
tizanidine and can lead
to undesirable side
effects.
DO NO

Summary of Product characteristics

CIPROL PI v- Dec 19
1
AUSTRALIAN PRODUCT INFORMATION
CIPROL (CIPROFLOXACIN HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Ciprofloxacin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ciprol tablets come in three strengths and contain 250 mg, 500 mg or
750 mg of ciprofloxacin (as the
hydrochloride).
Ciprofloxacin hydrochloride is a synthetic carboxyquinolone derivative
with broad spectrum
antimicrobial activity.
Ciprofloxacin hydrochloride is a faintly yellowish to yellow
crystalline substance that is sparingly
soluble to soluble in water.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
CIPROL 250,
Tablets, 250 mg (White to off white, round, convex, scored film-coated
tablet,
debossed CR/250 on one face and plain on the other side)
CIPROL 500,
Tablets, 500 mg (White to off white, oblong, biconvex, scored film
coated tablet,
debossed CR/500 on one face and plain on the other side)
CIPROL 750,
Tablets, 750 mg (White to off white, oblong, biconvex, unscored
film-coated tablet,
debossed CR 750 on one face and plain on the other side)
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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 to moderate severity.
CIPROL PI v- Dec 19
2
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_