NOUMED CIPROFLOXACIN ciprofloxacin 500 mg (as hydrochloride) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ciprofloxacin hydrochloride, Quantity: 555 mg (Equivalent: ciprofloxacin, Qty 500 mg)

Available from:

AVALLON PHARMACEUTICALS PTY LTD

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; sodium starch glycollate type A; maize starch; purified talc; microcrystalline cellulose; colloidal anhydrous silica; titanium dioxide; hypromellose; macrogol 400

Administration route:

Oral

Units in package:

14 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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. 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 case 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 aetiological agents, additional therapy should be considered.

Product summary:

Visual Identification: WHITE TO OFF-WHITE, CAPLET-SHAPED, FILM-COATED TABLET, DEBOSSED WITH '500' ON ONE SIDE, PLAIN ON THE OTHER SIDE.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-12-17

Patient Information leaflet

NOUMED CIPROFLOXACIN TABLETS
1
NOUMED CIPROFLOXACIN
_ciprofloxacin hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Noumed
Ciprofloxacin.
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 risks and
benefits. Your doctor has weighed
the risks of you taking Noumed
Ciprofloxacin against the benefits it
is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
Noumed Ciprofloxacin is used to
treat certain bacterial infections such
as:
•
kidney and bladder infections
•
bowel infections
•
lung infections
•
skin infections
•
bone and joint infections
•
prostate infections.
Noumed Ciprofloxacin tablets
contain the active ingredient,
ciprofloxacin, which is an antibiotic
belonging to a group of medicines
called quinolones (pronounced
KWIN-a-lones).
This medicine works by killing the
bacteria which cause these infections.
This helps your body to fight the
infection.
This medicine will not work against
viral infections such as colds or flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY NOUMED
CIPROFLOXACIN HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor’s prescription.
There is no evidence that Noumed
Ciprofloxacin is addictive.
THIS MEDICINE IS NOT RECOMMENDED
FOR USE IN CHILDREN OR GROWING
TEENAGERS.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE NOUMED CIPROFLOXACIN
IF YOU HAVE AN ALLERGY TO:
•
ciprofloxacin, the active
ingredient in Noumed
Ciprofloxacin
•
any of the ingredients listed at the
end of this leaflet
•
any other medicines belonging to
the quinolone chemical family
such as moxifloxacin,
norfloxacin, or nalidixic acid.
Some of the symptoms of an allergic
reaction may inclu

Summary of Product characteristics

Product Information - Australia
Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION –
NOUMED CIPROFLOXACIN
(CIPROFLOXACIN (AS HYDROCHLORIDE))
1. NAME OF THE MEDICINE
Ciprofloxacin
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Noumed Ciprofloxacin is available as 500 mg and 750 mg film-coated
tablets for oral administration.
Each Noumed Ciprofloxacin tablet contains 500 mg or 750 mg of
ciprofloxacin as ciprofloxacin hydrochloride.
For the full list of excipients, see _section 6.1 List of excipients._
3. PHARMACEUTICAL FORM
Noumed Ciprofloxacin 500 mg tablets: white to off-white, caplet
shaped, film-coated tablets debossed with “500”
on one side and plain on the other side.
Noumed Ciprofloxacin 750 mg tablets: white to off-white, caplet
shaped, film-coated tablets debossed with “750”
on one side and plain on the 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 to moderate severity
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