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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 200 mg/28.5 mg/5 ml powder for oral suspension
Amoxicillin/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 (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
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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.
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.
Other medicines and Augmentin
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 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 can 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
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 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’.

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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 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.
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.

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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 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.

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
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.

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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
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 national reporting
system in Appendix V. 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 in order to protect from moisture.
Do not store above 25°C.
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.
Liquid suspension
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Once made up, the suspension should be used within 7 days.
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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 amoxicillin 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 off-white 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
[To be completed nationally]
This medicinal product is authorised in the Member States of the EEA under the following
names:
Lithuania – Augmentin
United Kingdom – Augmentin Duo
This leaflet was last approved in {MM/YYYY}.
[To be completed nationally]

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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.
2.
3.
4.
5.

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.
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.
You should not take antibiotics that have been prescribed for other people even if they had
an infection that was similar to yours.
You should not give antibiotics that were prescribed for you to other people.
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
200 mg/28.5 mg/5 ml

Volume of water to be added
at reconstitution (ml)
64

Final volume of reconstituted oral
suspension (ml)
70

Additional text for markets that have a fill line on the bottle or label:
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.

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Additonal text for markets which are supplied with a dosing syringe:
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 cleanliness of syringe and adaptor before use, rinse with clean water if required.
1. Shake the bottle well before each dose.
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.

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

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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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