CEPHALEXIN GENERICHEALTH cefalexin monohydrate 500 mg capsules blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefalexin, Quantity: 500 mg

Available from:

Generic Health Pty Ltd

INN (International Name):

cefalexin

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: Gelatin; titanium dioxide; patent blue V; sodium lauryl sulfate; magnesium stearate; microcrystalline cellulose; sunset yellow FCF; quinoline yellow; purified water; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; ethanol absolute

Administration route:

Oral

Units in package:

20 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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 GENERICHEALTH Capsules are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Cephalexin Capsules 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 GENERICHEALTH Capsules in the treatment of bacterial infections of the brain and spinal column has not been established and CEPHALEXIN GENERICHEALTH capsules are 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 GENERICHEALTH Capsule. Renal function studies should be performed when indicated.

Product summary:

Visual Identification: Size '0' capsules with dark green cap imprinted with "500" in black ink and light green body without imprint.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2009-06-10

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
CEPHALEXIN GENERICHEALTH
(CEFALEXIN MONOHYDRATE) CAPSULE
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Cephalexin generichealth. 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
Cephalexin generichealth
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 CEPHALEXIN
GENERICHEALTH IS USED FOR
Cephalexin generichealth
contains cefalexin 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
CEPHALEXIN GENERICHEALTH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CEPHALEXIN
GENERICHEALTH IF YOU HAVE
ALLERGIC REACTION TO:
•
any medicine containing
cefalexin 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 NOT TAKE

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – CEPHALEXIN GENERICHEALTH
(CEFALEXIN MONOHYDRATE) CAPSULE
1
NAME OF THE MEDICINE
Cefalexin monohydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 500 mg cefalexin (as monohydrate).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Cephalexin generichealth 500 mg capsules: Size ‘0’ capsules with
dark green cap imprinted with “500”
in black ink and light green body without imprint.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cephalexin generichealth capsules are 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 generichealth
capsules are generally
effective in the eradication of streptococci from the nasopharynx;
however, substantial data
establishing the efficacy of Cephalexin generichealth capsules 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 generichealth capsules in the
treatment of bacterial infections of the
brain and spinal column has not been established and Cephalexin
generichealth capsules are 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
generichealth capsules. Renal function
studies should