CEFALEXIN SANDOZ cefalexin (as monohydrate) 500mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefalexin monohydrate, Quantity: 525.76 mg (Equivalent: cefalexin, Qty 500 mg)

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; Gelatin; purified water; titanium dioxide

Administration route:

Oral

Units in package:

20 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections. Caused by S. pneumoniae and group A beta-haemolytic streptococci (penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present). Bacterial sinusitis. Caused by streptococci, S. pneumoniae and S. aureus (methicillin sensitive only). Otitis media. Due to S. pneumoniae, staphylococci. Skin and skin structure infections. Caused by staphylococci and/or streptococci. Genitourinary tract infections, including acute prostatitis. Caused by E. coli, P. mirabilis, and klebsiella sp. The effectiveness of cephalexin in the treatment of bacterial infections of the brain and spinal column has not been established and cephalexin is not indicated in these conditions. Note: appropriate culture and susceptibility tests should be initiated prior to and during therapy to determine susceptibility of the causative organism to cephalexin. Renal function studies should be performed when indicated.

Product summary:

Visual Identification: White opaque hard gelatine capsule, size 0 (500 mg); Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2002-03-05

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

210517-Cefalexin Sandoz-pi
Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION
CEFALEXIN SANDOZ (CEFALEXIN MONOHYDRATE) CAPSULES AND
POWDER FOR SUSPENSION
1.
NAME OF THE MEDICINE
Cefalexin monohydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefalexin Sandoz capsules contains cefalexin (as monohydrate)
equivalent to 500 mg of
cefalexin anhydrous.
Cefalexin Sandoz Powder for Oral Suspension contains cefalexin (as
monohydrate) equivalent
to 125 mg/5 mL or 250 mg/5 mL of cefalexin anhydrous.
_Excipients with known effect:_
Sucrose (Cefalexin Sandoz Powder for Oral Suspension)
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
_Capsules _
500 mg -The capsules are white opaque in colour, containing a white to
yellowish powder.
_Powder for Oral Suspension _
The suspension is orange-yellow in colour with a fruity flavour.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Treatment of the following infections when caused by susceptible
strains of the designated
micro-organisms.
_Respiratory tract infections._
Caused by
_S. pneumoniae_
and group A
_ _
ß-haemolytic Streptococci
(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; however, substantial
data establishing the
efficacy of cefalexin in the subsequent prevention of rheumatic fever
are not available at
present).
_Bacterial sinusitis_
. Caused by Streptococci
_, S. pneumoniae_
and
_S. aureus_
(methicillin sensitive
only).
_Otitis media_
. Due to
_S. pneumoniae, _
Staphylococci.
_Skin and skin structure infections_
. Caused by Staphylococci and/or Streptococci
_. _
Genitourinary tract infections, including acute prostatitis. Caused by
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 is not indicated in
these cond