APO-CEPHALEXIN (as monohydrate) 250mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefalexin monohydrate, Quantity: 275 mg (Equivalent: cefalexin, Qty 250 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: sunset yellow FCF; lactose monohydrate; iron oxide yellow; titanium dioxide; magnesium stearate; Gelatin; brilliant blue FCF; purified water; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

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 micro-organisms. Respiratory tract infections - caused by S. pneumoniae and group A B-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: A dark green/white, self-locked hard gelatin capsules of size '2' imprinted with 'RX656' in black edible ink, containing white to off white granular powder/pellets; Container Type: Blister Pack; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2000-09-15

Patient Information leaflet

APO- CEPHALEXIN CAPSULES
1
APO-CEPHALEXIN
CAPSULES
_Contains the active ingredient cefalexin 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 this medicine. 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 this medicine
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 THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Cephalexin. It contains the active
ingredient cefalexin monohydrate.
It is used to treat infections in
different parts of the body caused by
bacteria, such as:
•
respiratory tract (chest, lungs,
tonsils or throat)
•
sinuses
•
ears (middle ear infection)
•
skin
•
genitourinary tract (kidney,
bladder or prostate).
Cefalexin belongs to a group of
antibiotics called cephalosporins that
are closely related to penicillins.
It works by killing the bacteria
causing your infection or by stopping
its growth.
Cefalexin 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
cefalexin for another reason.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
cefalexin
•
other cephalosporins
•
any of the ingredients listed at the
end of this leaflet.
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
�

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO- CEPHALEXIN (CEFALEXIN MONOHYDRATE)
CAPSULES
1
NAME OF THE MEDICINE
Cefalexin monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains cefalexin monohydrate equivalent to 250 mg or
500 mg cefalexin
anhydrous as the active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Contains sugars as lactose.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
250 MG CAPSULES:
Dark green and white, self-locked hard gelatin capsules of size 2,
imprinted with RX656 in
black ink, containing white to off-white granular powder/pellets.
500 MG CAPSULES:
Dark green and light green, self-locked hard gelatin capsules of size
0, imprinted with RX657
in black ink, containing white to off-white granular powder/pellets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cefalexin is indicated for the 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

-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.
2
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 conditions.
Note:_ _Appropriate culture and susceptibility tests