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AUGMENTIN 250/62 SF SUSPENSION

Active substance(s): AMOXICILLIN / AMOXYCILLIN / CLAVULANIC ACID / AMOXICILLIN / CLAVULANIC ACID / AMOXICILLIN / CLAVULANIC ACID

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PHARMA CODE N° 6409

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1000000
0146454

10000000146454
Package leaflet: Information for the user

GSK-GBR-Worthing-UKWOR

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

United Kingdom-GBR

The other active component (clavulanic
acid) stops this from happening.

Augmentin

Augmentin is used in babies and children
to treat the following infections:

N/A






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

Read all of this leaflet carefully
before you start giving your child
this medicine because it contains
important 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

0

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).

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 throat.
• 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.

Warnings and Precautions
Check with their doctor, pharmacist or
nurse before giving your child Augmentin
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

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Driving and using machines

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

Other medicines and Augmentin
Tell your doctor or pharmacist if your child
is taking, has recently taken or might take
any other medicines.

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’.
• 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.

3 How to give 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.

Adults and children weighing 40 kg
or over

If your child is taking allopurinol
(used for gout) with Augmentin, it may be
more likely that they will have an allergic
skin reaction.

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

If your child is taking probenecid
(used for gout), your doctor may decide
to adjust the dose of Augmentin.

Children weighing less than 40 kg

Augmentin may affect how mycophenolate
mofetil (a medicine used to prevent the
rejection of transplanted organs) works.

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.
• Recomended dose - 20 mg/5 mg to
60 mg/15 mg for each kilogram of body
weight a day, given in three divided
doses.

Pregnancy, breast-feeding and
fertility

Patients with kidney and liver
problems

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.

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.

• 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.

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How to give Augmentin

• Always shake the bottle well before
each dose
• Give with a meal
• 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.

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. Do not take a double
dose to make up for a forgotten 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.

4 Possible side effects
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:
• 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
throat (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
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 with a
meal
• vomiting
• diarrhoea (in children).

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
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.

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Reporting of side effects

Rare side effects that may show up in
blood tests:
• low number of cells involved in blood
clotting
• low number of white blood cells.

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GSK-GBR-Worthing-UKWOR

Frequency not known

United Kingdom-GBR
Augmentin
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Frequency cannot be estimated from
available data.
• 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
• 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 you get any side effects, talk to your
doctor or pharmacist. 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.

What Augmentin looks like and
contents of the pack
Augmentin 250/62 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 the
month.

0800 198 5000 (UK Only)

Liquid suspension

Product name

5 How to store Augmentin

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

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 50 mg
amoxicillin and potassium clavulanate
equivalent to 12.5 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.

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Please be ready to give the following
information:
Augmentin 250/62 SF
Suspension
Reference number 00038/0337

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

This is a service provided by the Royal
National Institute of Blind People.
This leaflet was last revised in March 2017.
Trade marks are owned by or licensed to
the GSK group of companies.
© 2017 GSK group of companies or its
licensor.

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

Check cap seal is intact before using.
Shake bottle to loosen powder. Add
volume of water (as indicated below)
invert and shake well.
Alternatively, shake the 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.
Strength

Volume of
water to be
added at
reconstitution
(ml)

250 mg/
62.5 mg/
5 ml

90

Final
volume of
reconstituted
oral
suspension
(ml)
100

Shake the bottle well before each dose.

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Expand Transcript

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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