CEPHALEX cefalexin (as monohydrate) 250 mg capsules blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefalexin monohydrate, Quantity: 262.94 mg (Equivalent: cefalexin, Qty 250 mg)

Available from:

Pharmacor Pty Ltd

INN (International Name):

cefalexin monohydrate

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: lactose; magnesium stearate; colloidal anhydrous silica; titanium dioxide; brilliant blue FCF; purified water; quinoline yellow; allura red AC; Gelatin; sodium lauryl sulfate

Administration route:

Oral

Units in package:

20 capsules)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Cephalexin is indicated in the 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 soft-tissue 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: Dark green size 2 hard gelatin capsules printed "250" on body and " CEP" on cap in black ink; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-10-02

Patient Information leaflet

CEPHALEX 250 MG
AND 500 MG
(Cephalexin BP 250 mg and
500 mg Capsules)
CONSUMER MEDICINE
INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cephalex 250 mg and
500 mg. It does not contain all the
available information. It does not take
the place of talking with your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Cephalex 250
mg and 500 mg 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 need to read it again.
WHAT CEPHALEX 250 MG
AND 500 MG IS USED FOR
Cephalex 250 mg and 500
mg contains cephalexin
monohydrate as the active
ingredient.
It is used to treat infections caused by
bacteria in different parts of the body,
including infections of the:
•
respiratory tract (throat, tonsils,
chest and lungs)
•
nose (sinusitis)
•
ears (otitis media)
•
skin and soft tissue
•
kidneys and bladder (genitourinary
tract).
This medicine belongs to a group of
medicines called cephalosporins.
These antibiotics work by killing the
bacteria that are causing your infection.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
THIS MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed it for
another reason.
This medicine is available only with a
doctor’s prescription.
There is no evidence that it is
addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CEPHALEX 250 MG AND
500 MG IF YOU HAVE AN ALLERGIC
REACTION TO:
•
any medicine containing
cephalexin monohydrate
•
other cephalosporins
•
any of the ingredients listed at the
end of this leaflet.
DO NOT TAKE THIS MEDICINE 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 or other parts of the body;
rash, itching or hives on the skin.
DO

Summary of Product characteristics

CEPHALEX PI
Ver: 02
1
AUSTRALIAN PRODUCT INFORMATION - CEPHALEX (CEPHALEXIN)
1.
NAME OF THE MEDICINE
Cephalexin monohydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CEPHALEX 250 MG CAPSULES
Each
capsule
contains
cephalexin
(as
monohydrate)
equivalent
to
250
mg
cephalexin
anhydrous
CEPHALEX 500 MG CAPSULES
Each
capsule
contains
cephalexin
(as
monohydrate)
equivalent
to
500
mg
cephalexin
anhydrous
EXCIPIENTS WITH KNOWN EFFECT:
Lactose
For the full list of excipients, see
SECTION 6.1 - LIST OF EXCIPIENTS
3.
PHARMACEUTICAL FORM
CEPHALEX 250 MG CAPSULES:
Hard Gelatin Capsules Size “2”, body dark green and cap
dark green with printing “220” on both body and cap in black ink
containing 250 mg
cephalexin.
CEPHALEX 500 MG CAPSULES:
Hard Gelatin Capsules Size “0”, body light green and cap
light green with printing “219” on both body and cap in black ink
containing 500 mg
cephalexin.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cephalexin
is
indicated
in
the
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
CEPHALEX PI
Ver: 02
2
Skin and soft-tissue 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 spina