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AUGMENTIN-DUO 200/28

Active substance(s): AMOXICILLIN TRIHYDRATE / POTASSIUM CLAVULANATE

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Package leaflet: Information for the user
AUGMENTIN-DUO 200/28
co-amoxiclav (amoxicillin and clavulanic acid)
Read all of this leaflet carefully before you start giving your child this
medicine because it contains important information for them.
• 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:
• middle ear and sinus infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections including dental infections
• bone and joint 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 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 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..


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, breast-feeding and fertility
If your child who is about to take this medicine is pregnant or breast-feeding,
thinks they may be be pregnant or are planning to have a baby, ask their
doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Augmentin can have side effects and the symptoms may make you unfit to
drive. Do not 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
• 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 cup, spoon or syringe.
Instructions on how to use the dosing syringe are provided at the end
of this leaflet. You should use this to give the correct dose to your baby
or child.
• Recommended dose – 25 mg/3.6 mg to 45 mg/6.4 mg for each
kilogram of body weight a day, given in two divided doses.
• Higher dose – up to 70 mg/10 mg for each kilogram of body weight a
day, given in two 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.
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.
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 give 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.
Rare side effects that may show up in blood tests:

low number of cells involved in blood clotting

low number of white blood cells.
Frequency not known
Frequency cannot be estimated from the 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.
Reporting of side effects
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 or by searching for MHRA Yellow Card in the
Google Play or Apple App Store.
By reporting side effects you can help provide more information about the
safety of this medicine.

5 How to store Augmentin
Keep this medicine out of the sight and reach of children.
Dry Powder
Store in the original package to protect from moisture.
Do not store above 25°C.
Do not use this medicine after the expiry date (EXP) which is stated on the
carton. The expiry date refers to the last day of that month.
Liquid suspension
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 to 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 40 mg and
potassium clavulanate equivalent to 5.7 mg of clavulanic acid.
• The other ingredients are aspartame (E951), xanthan gum, silicon dioxide,
colloidal anhydrous silica, succinic acid, hypermellose, orange dry flavour



1* and 2*, raspberry dry flavour*, golden syrup dry flavour* (*including
maltodextrin) and water.
See also “Augmentin contains aspartame and maltodextrin” in section 2.

What Augmentin looks like and contents of the pack
Augmentin 200 mg/28.5 mg/5 ml powder for oral suspension is a white to offwhite powder supplied in a clear glass bottle. Once made up, the bottle
contains 70 ml of an off-white liquid mixture called a suspension.
Marketing authorisation holder and manufacturer
Marketing Authorisation Holder: SmithKline Beecham Ltd, Brentford, 980
Great West Road, Brentford, Middlesex TW8 9GS
Manufacturer: Smithkline Beecham, Worthing, West Sussex. BN14 8QH

Other formats
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 Duo 200/28
Reference number 10592/0072
This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in September 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.

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

Volume of water to be
added at reconstitution (ml)

200 mg/28.5 mg/5 ml

64

Final volume of
reconstituted oral
suspension (ml)
70

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.
Instructions for using the syringe
A syringe is supplied to administer Augmentin
The syringe is only for use with Augmentin and must not be used to
administer any other medicines, because the markings are specific to this
product. The syringe is supplied with an adaptor which allows it to attach to
the bottle.
The dose is indicated on the oral dosing syringe in millilitres (ml). You should
give your child the dose recommended by their doctor.
Check cap seal is intact before first use.
Check cleanliness of syringe and adaptor before use, rinse with clean water if
required.

1. Shake the bottle well before each dose.
Remove the bottle cap
Fill the bottle with 64 ml water. Close, invert and shake well.
2. Remove the bottle cap.

3. Remove adaptor from syringe. Hold the bottle firmly and insert the adaptor
into the neck of the bottle (the adaptor should remain in place).
Insert the syringe into the adaptor ensuring it is secure.

4. Invert bottle holding the syringe in place and withdraw the required dose
as indicated by your doctor.

5. Place bottle upright and remove syringe.
6. To give the dose, carefully put the tip of the syringe into the mouth and
slowly push down on the plunger of the syringe (repeat steps 4, 5 and 6 if
more than one syringe is needed to deliver the dose).

7. Rinse syringe thoroughly in clean water. Allow the syringe to dry
completely before next use.

8. Replace the bottle cap.

Store in a refrigerator and always shake before use.
Once made up, the suspension should be used within 7 days.

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