Ibilex

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Cephalexin; Cefalexin

Available from:

Alphapharm Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

IBILEX

_contains the active ingredient cephalexin (as 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:
•
cephalexin 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 m

Summary of Product characteristics

IBILEX 
_Cephalexin _

PRODUCT INFORMATION 

NAME OF DRUG 

Ibilex (cephalexin) is a semisynthetic cephalosporin antibiotic for
oral administration.  It is 7-(D-α-amino-α-
phenyl-acetamido)-3-methyl-3-cephem-4-carboxylic acid, monohydrate. 
Cephalexin has the following structural formula. 

DESCRIPTION 

The nucleus of cephalexin is
related to that of other cephalosporin antibiotics.  The
compound is a zwitterion; i.e. 
the molecule contains both a basic and an acidic group.  The
isoelectric point of cephalexin in water is 
approximately 4.5 to 5. 

The crystalline form of cephalexin which is available
is a monohydrate.  It is a white crystalline solid having a 
bitter taste.  Solubility in water is low at room temperature; 1 or
2 mg/mL may be dissolved readily, but higher 
concentrations are obtained with increasing difficulty. 

The cephalosporins differ from penicillins in the structure of the
bicyclic ring system. Cephalexin has a 
D-phenylglycyl group as substituent at the 7-amino position and
an unsubstituted methyl group at the 3-position. 

Each capsule (pulvule) contains cephalexin monohydrate equivalent to
250 mg or 500 mg of cephalexin. They 
also contain Microcrystalline cellulose, Carmellose Sodium,
Dimethicone 350, Magnesium Stearate, Patent Blue 
V (CI42051), Quinoline Yellow (CI47005), Titanium Dioxide and
Gelatin.  

Powder for Suspensions in bottles contains cephalexin monohydrate
equivalent to 125 mg or 250 mg of 
cephalexin per 5 mL upon reconstitution.  They also contain
Sodium Lauryl Sulphate, Allura Red AC CI16035, 
Methylcellulose 15, Dimeticone 350, Xanthan Gum, Pregelatinised
Starch, Imitation Guarana Flavour 51880T 
and Sucrose. 

PHARMACOLOGY 

HUMAN PHARMACOLOGY.
  Ibilex is acid stable and may be given without regard to
meals.  It is rapidly absorbed 
after oral administration.  Following doses of 250 mg, 500 mg,
and 1 g, average peak serum levels of 
approximat