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SUPRAX POWDER 100MG/5ML PAEDIATRIC FOR ORAL SUSPENSION

Active substance(s): CEFIXIME ANHYDROUS

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Suprax Paediatric 100mg/5ml
Powder for Oral Suspension
Cefixime
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Phone 0845 372 7101 for help
Read all of this leaflet carefully before giving
your child this medicine.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
child’s doctor or your pharmacist.
• This medicine has been prescribed for your
child. Do not pass it on to others. It may harm
them, even if their symptoms are the same as
your child’s.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your child’s doctor or your
pharmacist.
In this leaflet:
1. What Suprax Powder is and what it is used for
2. Before you give Suprax Powder to your child
3. How to give Suprax Powder to your child
4. Possible side effects
5. How to store Suprax Powder
6. Further information
1. What Suprax Paediatric is and
what it is used for
Suprax Paediatric 100mg/5ml Powder for Oral
Suspension (called Suprax Paediatric in this
leaflet) contains a medicine called cefixime.
This belongs to a group of antibiotics called
‘cephalosporins’.
Suprax Paediatric is specially made for children.
The bottle contains powder which has been
mixed with water by your pharmacist. The
suspension is strawberry flavoured and is ready
to use.
Suprax is used to treat infections caused by
bacteria. These include infections of the:
• Ear
• Nose, sinuses (such as sinusitis)
• Throat (such as tonsillitis, pharyngitis)
• Chest and lungs (such as bronchitis and
pneumonia)
• Urinary system (such as cystitis and kidney
infections)
2. Before you give Suprax Paediatric to your
child
Do not give this medicine to your child
and tell their doctor if:
 Your child is allergic (hypersensitive) to
cefixime, any other cephalosporin antibiotics
including penicillin or to any of the other
ingredients of this medicine (see Section 6:
Further information).
Signs of an allergic reaction include:
a rash, swallowing or breathing problems,
swelling of the lips, face, throat and tongue.
Do not give this medicine to your child if the
above applies to them. If you are not sure, talk to
your child’s doctor or your pharmacist before
giving Suprax.

Take special care with Suprax Paediatric
Check with your child’s doctor or your
pharmacist before giving this medicine if
your child:
c Has ever had colitis
c Has severe kidney problems
c Is under 6 months
If you are not sure if any of the above apply to
your child, talk to your doctor or pharmacist
before giving this medicine.
Taking other medicines
Please tell your child’s doctor or your pharmacist
if your child is taking or has recently taken any
other medicines. This includes medicines you buy
without a prescription, including herbal
medicines. This is because Suprax Paediatric can
affect the way some other medicines work. Also
some medicines can affect the way Suprax
Paediatric works.
In particular, tell your child’s doctor if they are
taking:
• Medicines to thin the blood such as warfarin
Pregnancy and breast-feeding
This medicine is specially made for children.
However, if you are taking this medicine as an
adult, you should talk to your doctor before
taking this medicine if:
• You are pregnant, might become pregnant or
think you may be pregnant
• You are breast-feeding or planning to breast
feed
Ask your doctor or pharmacist for advice before
taking any medicine if you are pregnant or
breast-feeding.
Tests
If your child requires any tests (such as blood or
urine tests) while taking this medicine, please
make sure your child’s doctor knows that your
child is taking Suprax Paediatric.
Important information about some of
the ingredients of Suprax Paediatric
Suprax Paediatric contains:
• Sucrose: This is a type of sugar. If you have
been told by your doctor that you cannot
tolerate or digest some sugars talk to your
doctor before taking this medicine.

Brand: SUPRAX PAEDIATRICS 100MG5ML - MOCK-UP LEAFLET
Category:
Argus Code:
Spec No:
Supersedes:

LEAFLET
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1235773-E
1235773-D

Ticket No:
Date:
Issue No:
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Page:

410714
13-FEB-14
2
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1 of 2

Size:

150 X 197MM

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3. How to give Suprax Paediatric to your child
Having this medicine
Always use Suprax Paediatric exactly as your
child’s doctor has told you. You should check
with your doctor or pharmacist if you are not
sure.
The amount of medicine given will depend on
the weight and age of your child
• Give this medicine to your child by mouth
• Suprax comes with a measuring spoon that
can measure 3.75ml to 5ml. Use this spoon to
give your child the medicine
• The dose can be given in one go or the dose
can be divided into two and given at different
times
• If you feel the effect of the medicine is too
weak or too strong, do not change the dose
yourself, but ask your child’s doctor
Carefully read the label from the pharmacist. Ask
your pharmacist if you are not sure about the
dose to give. The medicine should be
Turn
Over
taken for the prescribed number of days.

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How much to give
The usual dose is:
Adults, Elderly and Children over
10 years or weighing more than 50kg
• 10ml to 20ml each day, depending on the
infection
Children 5 to 10 years old
• 10ml each day
Children 1 to 4 years old
• 5ml each day
Children 6 months to 1 year old
• 3.75ml each day
If your child has more Suprax Paediatric than
they should
If your child has too much of this medicine, talk
to your child’s doctor straight away.
If you forget to give Suprax Paediatric to your
child
If you forget to give your child a dose, give it as
soon as you remember it. However, if it is nearly
time for the next dose, skip the missed dose.
Do not give a double dose to make up for a
forgotten dose
If you stop giving Suprax Paediatric to your child
Do not stop giving your child the medicine
without talking to your doctor. Your child should
not stop taking Suprax just because he or she
feels better. This is because the infection may
come back or get worse again.
If you have any further questions on the use
of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Suprax Paediatric can cause
side effects, although not everybody gets them.
Tell your doctor straight away or go to the
nearest hospital casualty department if you
notice any of the following serious side effects –
your child may need urgent medical treatment:
• If your child has an allergic reaction. The signs
may include: a rash, joint pain, swallowing or
breathing problems, swelling of your lips,
face, throat or tongue
• Blistering or bleeding of the skin around the
lips, eyes, mouth, nose and genitals. Also
flu-like symptoms and fever. This may be
something called ‘Stevens-Johnson syndrome’.
• Severe blistering rash where layers of the skin
may peel off to leave large areas of raw
exposed skin over the body. Also a feeling of
being generally unwell, fever, chills and
aching muscles. This may be something called
‘Toxic epidermal necrolysis’
• If your child gets a skin rash or skin lesions with
a pink/red ring and a pale centre which may be
itchy, scaly or filled with fluid. The rash may
appear especially on the palms or soles of your
feet. These could be signs of a serious allergy to
the medicine called ‘erythema multiforme’
• If your child get infections more easily than
usual. This could be because of a blood
disorder. This normally gets better after
stopping the medicine
• If your child bruises or bleeds more easily
than normal. This could be because of a blood
disorder. This normally gets better after
stopping the medicine
• If your child gets nose bleeds, bleeding gums,
chills, tiredness, pale skin (often with a yellow
tinge), shortness of breath. This may be due to
haemolytic anaemia.
• Changes in the way the kidneys are working or
blood in your child's urine
Stop giving your child this medicine and contact
the child’s doctor without delay if they get:
• Severe watery diarrhoea that will not stop and
your child is feeling weak and has a fever. This
may be something called
‘Pseudomembranous colitis’

Tell your doctor or pharmacist if any of the
following side effects get serious or lasts
longer than a few days
• Feeling sick (nausea) or being sick (vomiting)
• Stomach pains, indigestion or wind
• Headaches
• Feeling dizzy
• Feeling itchy in the genital or vaginal area
Blood tests
Suprax Paediatric can cause blood clots or small
changes to the way the liver and kidney work.
This would be shown up in blood tests. This is not
common and goes back to normal after stopping
this medicine.
Reporting of side effects
If your child gets any side effects talk to your
doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Suprax Paediatric
Keep out of the reach and sight of children.
After the powder has been mixed with water by
the pharmacist, keep the bottles of medicine at
room temperature (below 25°C).
Do not freeze.
After being mixed with water, Suprax Paediatric
can be used for 14 days. Any liquid remaining after
14 days should be returned to your pharmacist.
Do not use this medicine after the expiry date
which is stated on the bottle.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

Brand: SUPRAX PAEDIATRICS 100MG5ML - MOCK-UP LEAFLET
Category:
Argus Code:
Spec No:
Supersedes:

LEAFLET
248
1235773-E
1235773-D

Ticket No:
Date:
Issue No:
Operator:
Page:

410714
13-FEB-14
2
CM
2 of 2

6. Further information

Size:

150 X 197MM

What Suprax Paediatric 100mg/5ml Powder
for Oral Suspension contains
• Each 5ml spoonful of liquid contains 100mg of
the active substance cefixime
• The other ingredients are sucrose, xantham
gum, sodium benzoate and strawberry flavour.
What Suprax Paediatric looks like and content
of the pack
Suprax Paediatric is available in 50ml and 100ml
bottles and comes with a measuring spoon that
can measure 3.75ml to 5ml. Not all pack sizes
may be marketed.
The bottle contains powder which will have been
mixed with water by your pharmacist, to form a
strawberry flavour medicine ready for use.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street
Guildford, Surrey, GU1 4YS, UK
Tel: 0845 372 7101
email:
uk-medicalinformation@sanofi.com
Manufacturer
Merck S.L., Poligono Merck, 08100 Mollet del
Valles (Barcelona), Spain.
This leaflet does not contain all the information about
your medicine. If you have any questions or are not
sure about anything, ask your doctor or pharmacist.

Barcode:
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N/A
BWR:
N/A
BWR to be assigned by printer.

This leaflet was last revised in 01/2014
©Sanofi, 1998 - 2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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