CEFALEXIN SANDOZ cefalexin monohydrate 250 mg capsules blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefalexin

Available from:

Sandoz Pty Ltd

INN (International Name):

cefalexin

Authorization status:

Registered

Patient Information leaflet

CEFALEXIN SANDOZ
®
1
CEFALEXIN SANDOZ
®
_Cefalexin Monohydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cefalexin Sandoz.
It does not contain all the available
information. It does not take the
place of talking to your doctor and
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Cefalexin
Sandoz against the benefits they
expect it will 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 CEFALEXIN
SANDOZ IS USED FOR
The name of your medicine is
Cefalexin Sandoz. It contains the
active ingredient cefalexin
monohydrate.
Cefalexin Sandoz is an antibiotic
used to treat infections in different
parts of the body caused by bacteria.
Cefalexin Sandoz belongs to a group
of antibiotics called cephalosporins.
These antibiotics work by killing the
bacteria that are causing your
infection.
Cefalexin Sandoz can be used to treat
infections of the:
•
respiratory tract (throat, tonsils,
chest and lungs)
•
nose (sinusitis)
•
ears (otitis media)
•
skin and soft tissue
•
kidneys and bladder
(genitourinary tract).
Your doctor may have prescribed
Cefalexin Sandoz for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CEFALEXIN
SANDOZ HAS BEEN PRESCRIBED FOR
YOU.
Cefalexin Sandoz is available only
with a doctor's prescription. It is not
addictive.
BEFORE YOU TAKE
CEFALEXIN SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CEFALEXIN SANDOZ IF:
1.
YOU HAVE AN ALLERGY TO CEFALEXIN
MONOHYDRATE, OTHER
CEPHALOSPORINS OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include
asthma, wheezing, shortness of
breath; swelling of the face, lips
or tongue which may cause
difficulty in swallowing or
breathing; skin rash, itching or
hives.
2.
YOU HAVE HAD A SERIOUS ALLERGIC
REACTION TO ANY PENICILLINS.
You may be more likely to have
an al

Summary of Product characteristics

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AUSTRALIAN PRODUCT INFORMATION
CEFALEXIN SANDOZ
® (CEFALEXIN) CAPSULES
1.
NAME OF THE MEDICINE
Cefalexin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Cefalexin Sandoz
®
capsule contains 250 mg of cefalexin.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Cefalexin Sandoz 250 mg capsules are size ‘2’ capsules with dark
green cap imprinted with
“250” in black ink and white body.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Treatment of the following bacterial infections when caused by
susceptible strains of the
designated micro-organisms.
_RESPIRATORY TRACT INFECTIONS _
_Strep. pneumoniae_
and group A
β
-haemolytic streptococci. Although penicillin is the usual drug
of choice in the treatment and prevention of streptococcal infections
(including the prophylaxis of
rheumatic fever), cefalexin is generally effective in the eradication
of streptococci from the
nasopharynx. Substantial data establishing the efficacy of cefalexin
in the subsequent prevention
of rheumatic fever are not available at present.
_BACTERIAL SINUSITIS_
Streptococci,
_Strep. pneumoniae_
and
_Staph. aureus_
(methicillin sensitive only).
_OTITIS MEDIA _
_Strep. pneumoniae,_
staphylococci (methicillin sensitive only).
_SKIN AND SKIN STRUCTURE INFECTIONS _
Staphylococci (methicillin sensitive only) and/or streptococci.
_GENITOURINARY TRACT INFECTIONS, INCLUDING ACUTE PROSTATITIS _
_ E. coli, P. mirabilis_
, and
_Klebsiella_
sp.
The effectiveness of cefalexin in the treatment of bacterial
infections of the brain and spinal
column has not been established and Cefalexin Sandoz is not indicated
in these conditions (see
Section 4.3 Contraindications).
_Note:_
Appropriate culture and susceptibility tests should be initiated prior
to and during therapy
to determine susceptibility of the causative organism to Cefalexin
Sandoz. Renal function studies
should be performed when indicated.
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4.2.
D
OSE AND METHOD OF AD