KEFLEX cefalexin 250mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefalexin monohydrate, Quantity: 250 mg

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: dimeticone 350; magnesium stearate; patent blue V; quinoline yellow; titanium dioxide; Gelatin; microcrystalline cellulose; carmellose sodium; purified water; Shellac; industrial methylated spirit; iron oxide black; 2-ethoxyethanol; dimeticone 1000; lecithin

Administration route:

Oral

Units in package:

20, 2 sample pack

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 24 FEBRUARY 2004: KEFLEX 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. KEFLEX is generally effective in the eradication of streptococci from nasopharynx; however, substantial data establishing the efficacy of KEFLEX 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 staphlococci anr/or streptococci; Genitourinary tract infections, including acute prostatic caused by E. coli, P. mirabilis, and Klebsiella sp. The effectiveness of KEFLEX in the treatment of bacterial infections of the brain and spinal column has not been established and KEFLEX is not indicated in these conditions. NOTE: Appropriate culture and susceptibility test should be initiated prior to and during therapy to determine susceptibility of the causative organism to KEFLEX. Renal function studies should be performed when indicated.

Product summary:

Visual Identification: An opaque dark green and white capsule, size 1 marked with "GP1" on the cap and body.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2000-04-17

Patient Information leaflet

KEFLEX-CMI– oct19
Page 1 of 4
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Keflex. 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 Keflex
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 KEFLEX IS USED FOR
Keflex 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 IT
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE KEFLEX IF YOU HAVE AN
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 THIS MEDICINE AFTER
THE EXPIRY DATE PRINTED ON THE
PACK OR IF THE PACKAGING IS TORN OR
SHOWS SIGNS OF TAMPERING.
If it has expired or is damaged,
return it to your

Summary of Product characteristics

Keflex-pi-24oct19
AUSTRALIAN PRODUCT INFORMATION -
KEFLEX (CEFALEXIN MONOHYDRATE) CAPSULES AND POWDER FOR
ORAL LIQUID
1
NAME OF THE MEDICINE
Cefalexin monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
KEFLEX capsules contain the active cefalexin monohydrate equivalent to
250 mg or 500 mg of
cefalexin
.
KEFLEX powder for oral liquid in bottles contains the active cefalexin
monohydrate equivalent to
125 mg or 250 mg of cefalexin per 5 mL upon reconstitution.
Excipient with known effect: sucrose
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
KEFLEX is available in hard gelatin capsules and powder for oral
liquid in bottles.
_ _
KEFLEX CAPSULES
250 mg: An opaque dark green and white size 1 capsule marked with
“GP1” on the cap and body
containing 250 mg cefalexin.
500 mg: An opaque dark green and light green size 0 capsule marked
with “GP2” on the cap and
body containing 500 mg cefalexin.
KEFLEX POWDER FOR ORAL LIQUID
125 mg/5 mL: A white free flowing powder before reconstitution and a
red suspension after
reconstitution containing 125 mg cefalexin per 5 mL.
250 mg/5 mL: A white free flowing powder before reconstitution and a
red suspension after
reconstitution containing 250 mg cefalexin per 5 mL.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
KEFLEX 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,
Keflex-pi-24oct19
including the prophylaxis of rheumatic fever. KEFLEX is generally
effective in the eradication of
streptococci from the nasopharynx; however, substantial data
establishing the efficacy of KEFLEX
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)