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

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

ciprofloxacin hydrochloride, Quantity: 291.11 mg (Equivalent: ciprofloxacin, Qty 250 mg)

Dostopno od:

Arrotex Pharmaceuticals Pty Ltd

Farmacevtska oblika:

Tablet, film coated

Sestava:

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

Pot uporabe:

Oral

Enote v paketu:

14 tablets, 2 tablets, 10 tablets

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

APX-CIPROFLOXACIN 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 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 agents, additional therapy should be considered.

Povzetek izdelek:

Visual Identification: White to off-white, round, convex, scored film-coated tablet, debossed CR / 250 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

Status dovoljenje:

Registered

Datum dovoljenje:

2020-05-04

Navodilo za uporabo

APX-CIPROFLOXACIN CMI-
1
APX-CIPROFLOXACIN
TABLETS
_Ciprofloxacin _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about APX-
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 APX-
CIPROFLOXACIN 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 APX-CIPROFLOXACIN
is used for
APX-CIPROFLOXACIN tablets are
used for the treatment of
infections of the lungs, skin,
bones, joints, kidneys, bladder,
prostate and bowel.
APX-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.
APX-CIPROFLOXACIN 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 APX-
CIPROFLOXACIN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE APX-
CIPROFLOXACIN IF YOU HAVE AN
ALLERGY TO:
•
ciprofloxacin, the
active ingredient in
APX-CIPROFLOXACIN
•
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 APX-
CIPROFLOXACIN IF YOU ARE ALSO
TAKING A MEDICINE CALLED
TIZANIDINE, A MUSCLE RELAXANT
USED TO TREAT SPASTICITY
ASSOCIATED WITH MULTIP

Lastnosti izdelka

APX-CIPROFLOXACIN PI
1
AUSTRALIAN PRODUCT INFORMATION
APX-CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Ciprofloxacin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APX-CIPROFLOXACIN 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
APX-CIPROFLOXACIN 250MG,
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)
APX-CIPROFLOXACIN 500MG,
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)
APX-CIPROFLOXACIN 750MG,
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.
APX-CIPROFLOXACIN PI
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 localis