IBILEX 250 cefalexin 250mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefalexin monohydrate, Quantity: 263 mg (Equivalent: cefalexin, Qty 250 mg)

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: Gelatin; dimeticone 350; magnesium stearate; titanium dioxide; patent blue V; quinoline yellow; microcrystalline cellulose; carmellose sodium

Administration route:

Oral

Units in package:

20

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 24 FEBRUARY 2004: IBILEX 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. IBILEX is generally effective in the eradication of streptococci from nasopharynx; however, substantial data establishing the efficacy of IBILEX 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 IBILEX in the treatment of bacterial infections of the brain and spinal column has not been established and IBILEX 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 IBILEX. Renal function studies should be performed when indicated

Product summary:

Visual Identification: An opaque green and white capsule, size 1.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2000-04-28

Patient Information leaflet

IBILEX
_cefalexin monohydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ibilex.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Ibilex against the
benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT IBILEX IS USED FOR
Ibilex is used to treat infections in
different parts of the body caused by
bacteria. Ibilex can be used to treat
infections of the:
•
throat, tonsils, chest and lungs
(respiratory tract)
•
nose (sinusitis)
•
ears (otitis media)
•
skin
•
bladder and kidneys (urinary
tract).
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IBILEX HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Ibilex for another reason.
Ibilex is an antibiotic that belongs to
a group of medicines called
cephalosporins. These medicines
work by killing the bacteria that are
causing your infection.
Ibilex will not work against
infections caused by viruses, such as
colds or flu.
Ibilex is available only with a
doctor's prescription.
There is no evidence that Ibilex is
addictive.
BEFORE YOU TAKE IBILEX
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE IBILEX IF YOU ARE
ALLERGIC TO:
•
cefalexin or any other
cephalosporin antibiotic
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include skin rash,
itching; shortness of breath; swelling
of the face, lips, tongue or other parts
of the body.
DO NOT TAKE IBILEX IF YOU HAVE HAD
A SERIOUS ALLERGIC REACTION TO
PENICILLIN.
You may have an increased chance
of being allergic to Ibilex if you are
allergic to penicillins.
DO NOT TAKE IBILEX IF THE EXPIRY
DATE PRINTED ON THE PACK OR BOTTLE
HAS PASSED.
If you take this medicine after the
expiry date, it may not work as well

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
IBILEX
_Cefalexin monohydrate capsules and powder for oral liquid _
1 NAME OF THE MEDICINE
Cefalexin monohydrate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule (pulvule) contains cefalexin monohydrate equivalent to
250 mg or 500 mg of cefalexin.
Powder for oral liquid in bottle contains cefalexin monohydrate
equivalent to 125 mg or 250 mg of
cefalexin per 5 mL upon reconstitution.
Excipient with known effect: Powder for oral liquid contains sucrose.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3 PHARMACEUTICAL FORM
IBILEX 250
CAPSULES
:
An opaque green and white capsule, size 1 containing 250 mg cefalexin.
IBILEX 500
CAPSULES
:
An opaque dark green and light green capsule, size 0 containing 500 mg
cefalexin.
IBILEX 125
POWDER FOR ORAL
LIQUID
:
A white free-flowing powder before reconstitution and a red suspension
after
reconstitution containing 125 mg cefalexin per 5 mL.
IBILEX 250
POWDER FOR ORAL
LIQUID
:
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 THERAPEUTIC INDICATIONS
IBILEX 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. Cefalexin monohydrate is
generally effective in the
eradication of streptococci from the nasopharynx; however, substantial
data establishing the
efficacy of cefalexin monohydrate 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
strepto