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AUGMENTIN 125/31 SF SUSPENSION

Active substance(s): AMOXICILLIN / CLAVULANIC ACID

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PHARMA CODE N° 703

3

1000000
0098982

10000000098982
Package Leaflet: Information for the Parent or Carers of Children

GSK-GBR-Worthing-UKWOR

AUGMENTIN 125/31 SF Suspension
®

co-amoxiclav (amoxicillin and clavulanic acid)

United Kingdom-GBR






middle ear and sinus infections
respiratory tract infections
urinary tract infections
skin and soft tissue infections including
dental infections
• bone and joint infections.

Augmentin
N/A

Read all of this leaflet carefully before
you start giving your child this medicine
because it contains useful information for
them.

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• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor, pharmacist or nurse.
• This medicine is usually prescribed for a baby
or child. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as your child’s.
• If your child gets any side effects, talk to
their doctor, pharmacist or nurse. This
includes any possible side effects not listed in
this leaflet. See section 4.

What is in this leaflet:
1 What Augmentin is and what it is used for
2 What you need to know before you
give Augmentin
3 How to give Augmentin
4 Possible side effects
5 How to store Augmentin
6 Contents of the pack and other 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:

2 What you need to know
before you give Augmentin
Do not give your child Augmentin:
• if they are allergic to amoxicillin,
clavulanic acid, penicillin or any of
the other ingredients of this medicine
(listed in section 6)
• if they have ever had a severe allergic
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

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.
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.
Tell your doctor or pharmacist if your child is
taking, has recently taken or might take any
other medicines. This includes medicines that
can be bought without a prescription and
herbal medicines.

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.

Driving and using machines

Conditions you need to look out for
Augmentin can make some existing
conditions worse, or cause serious side effects.

PAGE 1

Adults and children weighing 40 kg or
over

Children weighing less than 40 kg

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 you are not sure if any of the above apply to
your child, talk to their doctor or pharmacist
before giving Augmentin.

Always give this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.

• This suspension is not usually recommended
for adults and children weighing 40 kg and
over. Ask your doctor or pharmacist for advice.

Other medicines and Augmentin

Pregnancy, breast-feeding and fertility

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.

3 How to give Augmentin

Blood or urine tests

Check with their doctor, pharmacist or nurse
before giving your child this medicine if they:
• have glandular fever
• are being treated for liver or kidney
problems
• are not passing water regularly.

• 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.

If your child who is about to take this medicine
is pregnant or breast-feeding, thinks they
may be pregnant or are planning to have a
baby, ask their doctor or pharmacist for advice
before taking this medicine.
Augmentin can have side effects and the
symptoms may make you unfit to drive.
Do not drive or operate machinery unless you
are feeling well.

Augmentin contains aspartame and
maltodextrin:
• Augmentin contains aspartame (E951) which
is a source of phenylalanine. This may be
harmful for children born with a condition
called ’phenylketonuria’.

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 measuring
spoon or cup. You should use this to give the
correct dose to your baby or child.
• Recommended dose - 20 mg/5 mg to
60 mg/15 mg for each kilogram of body
weight a day, given in three divided doses.

If you forget to give Augmentin
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.

If your child stops taking 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 medicine, ask your doctor, pharmacist
or nurse.

Like all medicines, this medicine 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:

• 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.

How to give Augmentin

Inflammation of large intestine

• 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.

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.

If you give more Augmentin than you
should

Common side effects

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.

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Uncommon side effects
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.

Rare side effects

4 Possible side effects

• 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
• 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.

Patients with kidney and liver problems

• vomiting
• diarrhoea (in children).

Very common side effects
These may affect more than 1 in 10 people
• diarrhoea (in adults).
• 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

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)
➜ if you notice any of these symptoms contact
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)
• Inflammation of the protective membrane
surrounding the brain (aseptic meningitis)
• 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

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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.

10000000098982
GSK-GBR-Worthing-UKWOR
United Kingdom-GBR

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.

Augmentin
N/A

Reporting of side effects

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If your child gets 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.

6 Contents of the pack and
other information
What Augmentin contains
• The active substances are amoxicillin and
clavulanic acid. Each ml of suspension
contains amoxicillin trihydrate equivalent to
25 mg amoxicillin and potassium clavulanate
equivalent to 6.25 mg of clavulanic acid.
• The other ingredients are aspartame (E951),
xanthan gum, silicon dioxide, colloidal
anhydrous silica, succinic acid, hypromellose,
orange dry flavour 1* & 2*, raspberry
dry flavour*, golden syrup dry flavour*
(*including maltodextrin).
• See “Augmentin contains aspartame and
maltodextrin” in section 2.

What Augmentin looks like and contents
of the pack
Augmentin 125/31 SF Suspension is an off-white
powder supplied in a clear glass bottle. Once
made up, the bottle contains 100 ml of an
off-white liquid mixture called a suspension.

Marketing authorisation holder and
manufacturer

Keep this medicine out of the sight and reach
of children.

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

Dry powder

Other formats

Store in the original package in order to
protect from moisture.
Do not store above 25°C.

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

Do not use this medicine after the expiry date
which is stated on the carton. The expiry date
refers to the last day of that month.

0800 198 5000 (UK Only)

5 How to store Augmentin

Liquid suspension

Please be ready to give the following
information:
Product name

Augmentin 125/31 SF
Suspension
Reference number 00038/0298

Store in a refrigerator (2°C - 8°C).
Do not freeze.
Once made up, the suspension should be used
within 7 days.

This is a service provided by the Royal National
Institute of Blind People.

Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help you to
protect the environment.

Leaflet date: November 2014
Augmentin is a registered trade mark of the
GlaxoSmithKline group of companies
© 2014 GlaxoSmithKline group of companies.
All rights reserved.

Advice/medical education
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.

Strength Volume of water Final volume of
to be added at
reconstituted
reconstitution oral suspension
(ml)
(ml)
125 mg/
92
100
31.25 mg/
5 ml
Shake the bottle well before each dose.

Bacteria can become resistant to antibiotics
for many reasons. Using antibiotics carefully
can help to reduce the chance of bacteria
becoming resistant to them.
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.

Instructions for reconstitution
Check the cap seal is intact before using. Shake
bottle to loosen powder. Add volume of water
(as indicated below) invert and shake well.
Alternatively, shake bottle to loosen powder
then fill the bottle with water to just below
the line on the bottle or label. Invert and shake
well, then top up with water exactly to the
line. Invert and again shake well.

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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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