APO-CEFACLOR CD cefaclor 375mg (as monohydrate) tablets blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

cefaclor monohydrate

Διαθέσιμο από:

Sun Pharma ANZ Pty Ltd

Καθεστώς αδειοδότησης:

Registered

Φύλλο οδηγιών χρήσης

APO-CEFACLOR CD
TABLETS
_Cefaclor monohydrate_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about cefaclor. 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 using this medicine
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 THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Cefaclor is used to treat infections
caused by bacteria in different parts
of the body, including:
•
chest and lungs (lower respiratory
tract)
•
nose, throat, sinuses and tonsils
(upper respiratory tract)
•
bladder (lower urinary tract)
•
skin
Cefaclor belongs to a group of
medicines called cephalosporin
antibiotics. These are closely related
to penicillin antibiotics.
It works by killing the bacteria
causing your infection or by stopping
its growth.
It 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 this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend the use of this medicine
in children under 12 years of age.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
cefaclor
•
other cephalosporins
•
any of the ingredients listed at the
end of this leaflet.
DO NOT TAKE CEFACLOR IF YOU HAVE
HAD A SERIOUS ALLERGIC REACTION TO
PENICILLIN.
SOME OF THE SYMPTOMS OF AN
ALLERGIC REACTION MAY INCLUDE:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue,
throat or other pa

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1
AUSTRALIAN PRODUCT INFORMATION
APO-CEFACLOR CD (CEFACLOR MONOHYDRATE) 375 MG TABLETS
1
NAME OF THE MEDICINE
Cefaclor monohydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified release tablet contains cefaclor monohydrate equivalent
to 375 mg cefaclor.
EXCIPIENT WITH KNOWN EFFECT
Lactose monohydrate.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
375 MG MODIFIED RELEASE TABLET
Biconvex, capsule shape and coloured blue.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of the following infections caused by susceptible
organisms, in adults and
children 12 years and older:
•
Community acquired pneumonia of mild to moderate severity (excluding
atypical
pneumonia).
•
Acute bronchitis and acute exacerbations of chronic bronchitis.
•
Upper respiratory infections, including pharyngitis, tonsillitis and
acute bacterial
sinusitis.
•
Symptomatic lower urinary tract infections, including cystitis.
•
Skin and skin structure infections.
Note.
1.
Penicillin is the usual drug of choice in the treatment and prevention
of streptococcal
infections, including the prophylaxis of rheumatic fever. Cefaclor CD
is generally effective
in
the
eradication
of
Streptococci
from
the
oropharynx;
however,
substantial
data
establishing the efficacy of Cefaclor CD in the subsequent prevention
of rheumatic fever
are not available.
2.
Bacteriological studies to determine the causative organism and its
susceptibility to
cefaclor should be performed. Therapy may be started while awaiting
the results of these
studies. Once these results become available, antimicrobial therapy
should be adjusted
accordingly
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Cefaclor CD modified release tablets are intended for oral
administration.
Cefaclor CD can be taken with or without food; however absorption is
enhanced when
Cefaclor CD is administered with food (see section 5.2 –
PHARMACOKINETIC PROPERTIES).
The tablets should not be cut, crushed or chewed.
ADULTS
The usual adult dosage