AUGMENTIN 250/62 SF SUSPENSION

Active substance: CLAVULANIC ACID

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AUGMENTIN® 250/62 SF Suspension
(amoxicillin/clavulanic acid)
Patient Information Leaflet
The name of your medicine is AUGMENTIN 250/62 SF Suspension but
will be referred to as Augmentin throughout the leaflet.
Read all of this leaflet carefully before you start giving your child this
medicine.
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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.

3. How to give Augmentin
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.
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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.
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Usual dose – 20 mg/5 mg to 60 mg/15 mg for each kilogram of body
weight a day, given in three divided doses.

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

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.

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.

How to give Augmentin
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Always shake the bottle well before each dose
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Give at the start of a meal or slightly before
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Space the doses evenly during the day, at least 4 hours apart. Do not
take 2 doses in 1 hour.
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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.

Augmentin is used in babies and children to treat the following infections:
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middle ear and sinus infections
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respiratory tract infections
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urinary tract infections
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skin and soft tissue infections including dental infections
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bone and joint infections.

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.

2. Before you give Augmentin
Do not give your child Augmentin:

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:
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have glandular fever
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are being treated for liver or kidney problems
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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.
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.
Pregnancy and breast-feeding
If your child who is about to take this medicine is pregnant or breastfeeding, please tell your doctor or pharmacist.
Ask your doctor or pharmacist for advice before taking any medicine.
Important information about some of the ingredients of Augmentin
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Augmentin does not contain sugar.
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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.

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 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:
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skin rash
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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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fever, joint pain, swollen glands in the neck, armpit or groin
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swelling, sometimes of the face or mouth (angioedema), causing
difficulty in breathing
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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
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These may affect up to 1 in 10 people
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thrush (candida - a yeast infection of the vagina, mouth or skin folds)
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feeling sick (nausea), especially when taking high doses
- if affected take Augmentin before food
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vomiting
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diarrhoea (in children).
Uncommon side effects
These may affect up to 1 in 100 people
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skin rash, itching
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raised itchy rash (hives)
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indigestion
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dizziness
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headache.
Uncommon side effects that may show up in blood tests:
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increase in some substances (enzymes) produced by the liver.
Rare side effects
These may affect up to 1 in 1000 people
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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:
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low number of cells involved in blood clotting
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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.
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Allergic reactions (see above)
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Inflammation of the large intestine (see above)
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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.
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inflammation of the liver (hepatitis)
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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
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blood takes longer to clot
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hyperactivity
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convulsions (in people taking high doses of Augmentin or who have
kidney problems)
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black tongue which looks hairy
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stained teeth (in children), usually removedby brushing.

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.

Side effects that may show up in blood or urine tests:

severe reduction in the number of white blood cells
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low number of red blood cells (haemolytic anaemia)
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crystals in urine.
If your child gets side effects
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.

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.

Do not store above 25oC. Store in the original container.

Once reconstituted store at 2o-8oC in a refrigerator.

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.
6. Further information

Augmentin sugar free suspension contains 250 mg amoxicillin and
62.5 mg clavulanic acid in every 5 mls of suspension.
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The other ingredients in this medicine are: xanthan gum,
hypromellose, aspartame, silicon dioxide, colloidal silica, succinic
acid, and raspberry, orange and golden syrup flavours.

Augmentin does not contain sugar.
What Augmentin looks like and contents of the pack
Augmentin is available as white to off-white dry powder for reconstitution
in water, comes in a 100ml glass bottle.
Product Licence Holder And Manufacturer
Augmentin is manufactured by SmithKline Beecham Pharmaceuticals,
Worthing, West Sussex UK. Procured from within the EU by Product
Licence holder Tenolol Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL No: 30900/1930

Leaflet revision and issue date (Ref) 13.09.10[5]
Augmentin is a registered trademark of the GlaxoSmithKline group of
companies.

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.

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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.

Watch this video series to learn about managing severe allergies (anaphylaxis).

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