AUGMENTIN 250/62 SF SUSPENSION

Active substance: CLAVULANIC ACID

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PHARMA CODE N° 5503

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10000000117424
GSK-GBR-Worthing-UKWOR
United Kingdom-GBR

6 Further information
What Augmentin contains

• The active substances are 250 mg amoxicillin
and 62.5 mg clavulanic acid (present as
potassium clavulanate) in every 5 ml of
suspension
• The other ingredients are xanthan gum
(E415), hydroxypropyl methylcellulose (E464),
aspartame (see section 2), silicon dioxide,
colloidal silica, succinic acid, raspberry, orange
and golden syrup flavours and water.
• Augmentin does not contain sugar.

What Augmentin looks like and contents
of the pack

A clear glass bottle containing 100 ml of an
off-white liquid mixture called a suspension.
The bottle is supplied in a carton.

Augmentin
1

Marketing authorisation holder and
manufacturer

Marketing Authorisation Holder:
GlaxoSmithKline UK, Stockley Park West,
Uxbridge, Middlesex UB11 1BT
Manufacturer: SmithKline Beecham, Worthing,
West Sussex BN14 8QH

K

Other formats:

When your doctor prescribes a course of an
antibiotic it is intended to treat only your
current illness. Paying attention to the
following advice will help prevent the
emergence of resistant bacteria that could stop
the antibiotic working.
1. It is very important that you take the
antibiotic at the right dose, at the right
times and for the right number of days. Read
the instructions on the label and if you do
not understand anything ask your doctor or
pharmacist to explain.
2. You should not take an antibiotic unless it
has been prescribed specifically for you and
you should use it only to treat the infection
for which it was prescribed.
3. You should not take antibiotics that have
been prescribed for other people even if
they had an infection that was similar to
yours.
4. You should not give antibiotics that were
prescribed for you to other people.
5. If you have any antibiotic left over when you
have taken the course as directed by your
doctor you should take the remainder to a
pharmacy for appropriate disposal.

To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free of
charge:

0800 198 5000 (UK Only)
Please be ready to give the following
information:
Product name
Augmentin
250/62 SF Suspension
Reference number 00038/0337
This is a service provided by the Royal National
Institute of Blind People.
Leaflet date: July 2013
Augmentin is a registered trademark of the
GlaxoSmithKline group of companies
© 2013 GlaxoSmithKline group of companies.
All rights reserved

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Advice/medical education

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Antibiotics are used to treat infections caused
by bacteria. They have no effect against
infections caused by viruses.
Sometimes an infection caused by bacteria
does not respond to a course of an antibiotic.
One of the commonest reasons for this to occur
is because the bacteria causing the infection
are resistant to the antibiotic that is being
taken. This means that they can survive and
even multiply despite the antibiotic.
Bacteria can become resistant to antibiotics for
many reasons. Using antibiotics carefully can
help to reduce the chance of bacteria
becoming resistant to them.

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Package Leaflet: Information for the Parent or Carers of Children

AUGMENTIN® 250/62 SF Suspension
co-amoxiclav (amoxicillin and clavulanic acid)

2 Before you give Augmentin
Do not give your child Augmentin:

Read all of this leaflet carefully before you
start giving your child this medicine.

• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine is usually prescribed for a baby
or 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 doctor or pharmacist.

In this leaflet:

1 What Augmentin is and what it is used for
2 Before you give Augmentin
3 How to give Augmentin
4 Possible side effects
5 How to store Augmentin
6 Further information

1 What Augmentin is and what it
is used for
Augmentin is an antibiotic and works by killing
bacteria that cause infections. It contains two
different medicines called amoxicillin and
clavulanic acid. Amoxicillin belongs to a group
of medicines called “penicillins” that can
sometimes be stopped from working (made
inactive). The other active component
(clavulanic acid) stops this from happening.
Augmentin is used in babies and children to
treat the following infections:
• middle ear and sinus infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections including
dental infections
• bone and joint infections.

• if they are allergic (hypersensitive) to
amoxicillin, clavulanic acid or any of the
other ingredients of Augmentin (listed in
section 6)
• if they have ever had an allergic
(hypersensitive) reaction to any other
antibiotic. This can include a skin rash or
swelling of the face or neck
• if they have ever had liver problems or
jaundice (yellowing of the skin) when taking
an antibiotic.
➔ Do not give Augmentin to your child if any
of the above apply to your child. If you are
not sure, talk to their doctor or pharmacist
before giving Augmentin.

Take special care with Augmentin

Check with their doctor or pharmacist before
giving your child this medicine if they:
• have glandular fever
• are being treated for liver or kidney
problems
• are not passing water regularly.
If you are not sure if any of the above apply to
your child, talk to their doctor or pharmacist
before giving Augmentin.
In some cases, your doctor may investigate the
type of bacteria that is causing your child’s
infection. Depending on the results, your child
may be given a different strength of
Augmentin or a different medicine.

Conditions you need to look out for

Augmentin can make some existing conditions
worse, or cause serious side effects. These
include allergic reactions, convulsions (fits) and
inflammation of the large intestine. You must
look out for certain symptoms while your child
is taking Augmentin, to reduce the risk of any
problems. See ‘Conditions you need to look out
for’ in section 4.

Blood or urine tests

If your child is having blood tests (such as red
blood cell status tests or liver function tests) or
urine tests, let the doctor or nurse know that
they are taking Augmentin. This is because
Augmentin can affect the results of these types
of tests.

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Augmentin
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Using other medicines

Please tell your doctor or pharmacist if your
child is taking or has recently taken any other
medicines. This includes medicines that can be
bought without a prescription and herbal
medicines.
If your child is taking allopurinol (used for
gout) with Augmentin, it may be more likely
that they will have an allergic skin reaction.
If your child is taking probenecid (used for
gout), your doctor may decide to adjust the
dose of Augmentin.
If medicines to help stop blood clots (such as
warfarin) are taken with Augmentin then extra
blood tests may be needed.
Augmentin can affect how methotrexate
(a medicine used to treat cancer or rheumatic
diseases) works.
Augmentin may affect how mycophenolate
mofetil (a medicine used to prevent the rejection
of transplanted organs) works.

Pregnancy and breast-feeding

If your child who is about to take this medicine
is pregnant or breast-feeding, please tell your
doctor or pharmacist.
Ask your doctor or pharmacist for advice
before taking any medicine.

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Important information about some of the
ingredients of Augmentin

• Augmentin contains aspartame (E951) which
is a source of phenylalanine. This may be
harmful for children born with a condition
called ’phenylketonuria’.
• Augmentin contains maltodextrin (glucose).
If you have been told by your doctor that
your child has an intolerance to some sugars,
contact your doctor before taking this
medicinal product.

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3 How to give Augmentin

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Always give Augmentin exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.
Adults and children weighing 40 kg or over
• This suspension is not usually recommended
for adults and children weighing 40 kg and
over. Ask your doctor or pharmacist for advice.
Children weighing less than 40 kg
All doses are worked out depending on the
child’s bodyweight in kilograms.
• Your doctor will advise you how much
Augmentin you should give to your baby or
child.
• You may be provided with a plastic
measuring spoon or measuring cup. You
should use this to give the correct dose to
your baby or child.
• Usual dose - 20 mg/5 mg to 60 mg/15 mg for

each kilogram of body weight a day, given
in three divided doses.

Patients with kidney and liver problems

• If your child has kidney problems the dose
might be lowered. A different strength or a
different medicine may be chosen by your
doctor.
• If your child has liver problems they may
have more frequent blood tests to see how
their liver is working.

• fever, joint pain, swollen glands in the neck,
armpit or groin
• swelling, sometimes of the face or mouth
(angioedema), causing difficulty in breathing
• collapse.
➔ Contact a doctor immediately if your child
gets any of these symptoms. Stop taking
Augmentin.

Inflammation of large intestine

Inflammation of the large intestine, causing
watery diarrhoea usually with blood and
mucus, stomach pain and/or fever.
➔ Contact your doctor as soon as possible for
advice if your child gets these symptoms.

Very common side effects
How to give Augmentin

• Always shake the bottle well before each
dose
• Give at the start of a meal or slightly before
• Space the doses evenly during the day, at least
4 hours apart. Do not take 2 doses in 1 hour.
• Do not give your child Augmentin for more
than 2 weeks. If your child still feels unwell
they should go back to see the doctor.

If you give more Augmentin than you should
If you give your child too much Augmentin,
signs might include an upset stomach (feeling
sick, being sick or diarrhoea) or convulsions .
Talk to their doctor as soon as possible. Take
the medicine bottle to show the doctor.

These may affect more than 1 in 10 people
• diarrhoea (in adults).

Common side effects

• These may affect up to 1 in 10 people
• thrush (candida - a yeast infection of the
vagina, mouth or skin folds)
• feeling sick (nausea), especially when taking
high doses
➔ if affected take Augmentin before food
• vomiting
• diarrhoea (in children).

Uncommon side effects

If you forget to give your child a dose, give it
as soon as you remember. You should not give
your child the next dose too soon, but wait
about 4 hours before giving the next dose.

These may affect up to 1 in 100 people
• skin rash, itching
• raised itchy rash (hives)
• indigestion
• dizziness
• headache.
Uncommon side effects that may show up in
blood tests:
• increase in some substances (enzymes)
produced by the liver.

If your child stops taking Augmentin

Rare side effects

If you forget to give Augmentin

Keep giving your child Augmentin until the
treatment is finished, even if they feel better.
Your child needs every dose to help fight the
infection. If some bacteria survive they can
cause the infection to come back.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, Augmentin can cause side
effects, although not everybody gets them. The
side effects below may happen with this
medicine.

Conditions you need to look out for
Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis)
which may be visible as red or purple raised
spots on the skin, but can affect other parts
of the body

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• Serious skin reactions:
- a widespread rash with blisters and peeling
skin, particularly around the mouth, nose,
eyes and genitals (Stevens-Johnson
syndrome), and a more severe form, causing
extensive peeling of the skin (more than
30% of the body surface - toxic epidermal
necrolysis)
- widespread red skin rash with small
pus-containing blisters (bullous exfoliative
dermatitis)
- a red, scaly rash with bumps under the skin
and blisters (exanthemous pustulosis).
➔ Contact a doctor immediately if your child
gets any of these symptoms.
• inflammation of the liver (hepatitis)
• jaundice, caused by increases in the blood of
bilirubin (a substance produced in the liver)
which may make your child’s skin and whites
of the eyes appear yellow
• inflammation of tubes in the kidney
• blood takes longer to clot
• hyperactivity
• convulsions (in people taking high doses of
Augmentin or who have kidney problems)
• black tongue which looks hairy
• stained teeth (in children), usually removed
by brushing.
Side effects that may show up in blood or urine
tests:
• severe reduction in the number of white
blood cells
• low number of red blood cells (haemolytic
anaemia)
• crystals in urine.

If your child gets side effects

These may affect up to 1 in 1000 people
• skin rash, which may blister, and looks like
small targets (central dark spots surrounded
by a paler area, with a dark ring around the
edge - erythema multiforme)
➔ f you notice any of these symptoms contact
i
a doctor urgently.
Rare side effects that may show up in blood
tests:
• low number of cells involved in blood clotting
• low number of white blood cells.

Other side effects
Other side effects have occurred in a very small
number of people but their exact frequency is
unknown.
• Allergic reactions (see above)
• Inflammation of the large intestine
(see above)
• nflammation of the protective membrane
I
surrounding the brain (aseptic meningitis)

➔ Tell your doctor or pharmacist if any of the
side effects become severe or troublesome,
or if you notice any side effects not listed in
this leaflet.

5 How to store Augmentin
• Keep out of the reach and sight of children.
• Do not use Augmentin after the expiry date
which is stated on the carton. The expiry
date refers to the last day of that month.
• The expiry date which is stated on the bottle
label is for the pharmacist’s use. The
pharmacist will have made up your
medicine. It should be used within 7 days.
• Store in the fridge, but do not freeze.
• 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.

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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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