floxapen syrup - GSK Australia

FLOXAPEN® SYRUP
Flucloxacillin
Consumer Medicine Information
What is in this leaflet?
Please read this leaflet carefully
before you give FLOXAPEN.
This leaflet answers some
common questions about
FLOXAPEN. It does not contain
all of the available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Sometimes new risks
are found even when a medicine
has been used for many years.
Your doctor has weighed the
expected benefits of your child
taking FLOXAPEN against the risks
this medicine could have for your
child.
FLOXAPEN works by killing the
bacteria that cause these
infections. FLOXAPEN will not
work against infections caused by
viruses such as colds or the flu.
Your doctor may have prescribed
FLOXAPEN for another reason.
Ask your doctor if you have any
questions about why FLOXAPEN
has been prescribed for your
child.
There is no evidence that
FLOXAPEN is addictive.
Before you give
FLOXAPEN
Do not give FLOXAPEN if:
•
If you have any concerns about
your child taking this medicine,
ask your doctor or pharmacist.
Keep this leaflet until your child
has finished the course of
FLOXAPEN.
You may need to read it again.
What is FLOXAPEN
used for?
FLOXAPEN contains flucloxacillin
as the active ingredient.
FLOXAPEN belongs to a group of
medicines called penicillins.
FLOXAPEN is used to treat
infections caused by bacteria.
These infections may affect the
chest (pneumonia), the bones
(osteomyelitis), or the skin and
fleshy tissues. FLOXAPEN can
also be used to treat infected
burns or other infected wounds.
®
FLOXAPEN SYRUP
•
•
•
Your child has had an allergic
reaction to flucloxacillin, other
penicillins or similar types of
antibiotics (such as
cephalosporins) or any of the
ingredients contained in
FLOXAPEN. The ingredients
are listed at the end of this
leaflet. Some of the
symptoms of an allergic
reaction may include skin
rash, itching, difficulty in
breathing and swelling of the
face or tongue.
Your child has previously
experienced liver problems
after taking FLOXAPEN or
any other medicines.
the expiry date (EXP) printed
on the pack has passed.
the packaging is torn or shows
signs of tampering.
Tell your doctor if:
•
•
your child is allergic to foods,
dyes, preservatives or any
other medicines.
Your child has ever had an
allergic reaction (such as a
•
•
rash) to antibiotics or other
substances in the past.
your child has any kidney or
liver problems. The dose of
FLOXAPEN may need to be
changed or your child may
need to be given an
alternative medicine.
Your child is taking any other
medicines, including medicines
that you buy without a
prescription from your
pharmacy, supermarket or
health food shop. In particular
tell your doctor or pharmacist
if your child is taking any of
the following:
medicines which are used
to
treat
gout
(eg.
probenecid).
other antibiotics. These
may interfere with the
actions of FLOXAPEN.
Some medicines may affect the
way other medicines work. Your
doctor or pharmacist will be able
to tell you what to do when taking
FLOXAPEN with other medicines.
How do I give
FLOXAPEN?
Follow the directions given to you
by your doctor and pharmacist.
Their directions may differ from
the information contained in this
leaflet.
Please read the direction label
carefully. If you have any
concerns about how to give this
medicine talk to your doctor or
pharmacist.
How much FLOXAPEN to
give:
Give FLOXAPEN as directed by
your doctor or pharmacist.
The dose given depends on your
child’s weight.
[1]
A dose of FLOXAPEN is usually
given four times daily
How to give FLOXAPEN:
Shake the syrup well. Measure
the dose accurately with a marked
spoon, dropper or measure.
Make sure the whole dose is
swallowed each time.
FLOXAPEN should be given half
an hour to an hour before meals
or on an empty stomach.
Space the doses as evenly as
possible throughout the day. For
example, if your child is taking
FLOXAPEN four times a day, give
a dose about every six hours.
How long to give
FLOXAPEN for:
Keep giving FLOXAPEN until the
course is finished or for as long as
your doctor tells you. Do not stop
giving FLOXAPEN just because
your child feels better as the
infection can return
Do not stop giving FLOXAPEN, or
change the dose without first
checking with your doctor.
If you forget to give
FLOXAPEN:
Centre (telephone 131126)
for advice, if you think your
child or anyone else may have
taken too much FLOXAPEN,
even if there are no signs of
discomfort or poisoning.
If you are not sure what to do,
contact your doctor, pharmacist
or nearest hospital.
While you are giving
FLOXAPEN
Things you must do:
Tell your doctor if, for any reason,
you have not given the medicine
exactly as directed.
Otherwise, your doctor may think
that it was not working as it
should and change your child’s
treatment unnecessarily.
Tell your doctor, dentist or
pharmacist your child is taking
FLOXAPEN, before starting any
other medicines. Some medicines
may affect the way other
medicines work.
Tell your doctor if the symptoms
of your child’s infection become
worse, or do not improve within a
few days of starting FLOXAPEN.
Give the missed dose as soon as
you remember. Then give the
next dose at the time it is
normally due. Do not give two
doses within three hours of each
other.
Things you must not do:
Do not try to make up for missed
doses by giving more than one
dose at a time. Giving more than
the prescribed dose can increase
the chance of unwanted side
effects.
Do not use FLOXAPEN to treat any
other complaints unless your
doctor says to.
What do I do if I give
too much FLOXAPEN?
(Overdose)
Immediately telephone your
doctor or Poisons Information
®
FLOXAPEN SYRUP
Do not give this medicine to
anyone else, even if their
symptoms seem similar to your
child’s.
What are the sideeffects?
Check with your doctor as
soon as possible if you think
your child is experiencing any
side effects or allergic
reactions due to taking
FLOXAPEN, even if the
problem is not listed below.
Like other medicines, FLOXAPEN
can cause some side-effects. If
they occur, they are most likely to
be minor and temporary.
However, some may be serious
and need medical attention.
MILD EFFECTS
• Tell your doctor if you
notice any of the following
that are troublesome or
ongoing:
diarrhoea (several loose
bowel motions per day).
indigestion.
feeling sick or being sick.
white furry sore tongue
and mouth (oral thrush).
sore and itchy vagina
and/ or discharge (vaginal
thrush).
MORE SERIOUS EFFECTS
• Tell your doctor
immediately if you notice
any of the following
during or for up to several
weeks after taking
FLOXAPEN:
itching, rash.
dark urine or pale stools.
yellowing of the skin and
eyes (jaundice).
severe stomach cramps.
severe watery or bloody
diarrhoea.
These may be symptoms of
rare but serious side effects
and require urgent medical
attention.
•
Stop giving FLOXAPEN
and contact a doctor
immediately or take your
child to the emergency
department of your
nearest hospital if any of
the following happens:
Wheezing, swelling of the
limbs, lips/mouth or
throat, difficulty in
breathing, hayfever, lumpy
rash (hives) or severe skin
reactions or fainting.
These reactions are signs of a
severe allergic reaction to
FLOXAPEN. Allergy to
FLOXAPEN is rare.
[2]
• Other rare events that
-
have been reported with
FLOXAPEN include:
blood disorders.
inflammation of the liver
(hepatitis).
inflammation of the kidney
(nephritis).
FLOXAPEN can cause serious liver
damage which may be prolonged.
The reaction is more frequent in
the elderly and those who take it
for more than 14 days.
Remember, you should tell
the doctor or pharmacist as
soon as possible if any of
these, or any other unusual
events or problems occur
during or after treatment with
FLOXAPEN.
This is not a complete list of all
possible side-effects. Others may
occur in some people and there
may be some side-effects not yet
known.
Tell your doctor or pharmacist if
you notice any side effects from
your child’s medicine which are
not mentioned here.
Do not be alarmed by this list of
possible side-effects. Your child
may not experience any of them.
How do I store
FLOXAPEN?
Keep the bottle in the refrigerator
where the temperature stays
between 2 and 8°C.
Keep this medicine where children
cannot reach it, such as in a
locked cupboard.
Do not leave in a car, on a
window sill or in the bathroom.
Heat and dampness can destroy
some medicines.
Do not use any syrup left in the
bottle after it has been open for
14 days. Ask your pharmacist
®
FLOXAPEN SYRUP
what to do with any doses that
are left over.
Product description
What FLOXAPEN looks
like:
FLOXAPEN is available as syrups
containing;
-
125mg of flucloxacillin in 5mL
(FLOXAPEN syrup)
Pharmaceutical companies are not
in a position to give people an
individual diagnosis or medical
advice. Your doctor or pharmacist
is the best person to give you
advice on the treatment of your
condition.
FLOXAPEN syrups come in the
following packs:
-
FLOXAPEN syrup - (AUST
R11148).
FLOXAPEN forte syrup (AUST R11147).
or
250mg of flucloxacillin in 5mL
(FLOXAPEN forte syrup)
-
Ingredients:
The information provided applies
only to FLOXAPEN®.
FLOXAPEN contains the active
ingredient flucloxacillin.
FLOXAPEN syrups also contain the
following inactive ingredients:
xanthum gum, citric acid, sodium
benzoate and sodium citrate. The
syrups also contain sugar
(sucrose), sodium saccharin,
menthol dry 600061e, blood
orange 600001e and tutti-frutti
51.880/AP05.51 as flavourings.
FLOXAPEN is also available as
capsules.
®FLOXAPEN is a trademark of the
GlaxoSmithKline Group of
Companies.
This leaflet is subject to copyright.
FLOXAPEN Syrup Issue 2.
Prepared on 23rd June 2003.
Each 5mL of FLOXAPEN forte
syrup contains approximately
0.25mmoL of magnesium and
2.7g of sucrose. Each 5mL of
FLOXAPEN syrup contains
approximately 0.12mmoL of
magnesium and 2.9g of sucrose.
FLOXAPEN syrups do not
contain lactose, gluten,
tartrazine or any other azo
dyes.
Manufacturer:
Your FLOXAPEN is made by:
GlaxoSmithKline Australia Pty Ltd
1061 Mountain Highway
Boronia
Victoria, 3155
Australia.
Tel: (03) 9721 6000
Where to go for further
information:
[3]