AUGMENTIN 375MG TABLETS

Active substance: POTASSIUM CLAVULANATE

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PHARMA CODE N° 6663

4
10000000104958
GSK-GBR-Worthing-UKWOR
United Kingdom-GBR

Advice/medical education

6 Further information
What Augmentin contains

• The active substances are amoxicillin and
clavulanic acid. Each tablet contains
amoxicillin trihydrate equivalent to 250 mg
amoxicillin and potassium clavulanate
equivalent to 125 mg of clavulanic acid.
• The other ingredients are:
Tablet core - magnesium stearate, sodium
starch glycolate type A, colloidal anhydrous
silica, microcrystalline cellulose.
Film-coat - titanium dioxide (E171),
hypromellose, macrogol (4000, 6000) and
silicone oil (dimeticone).

What Augmentin looks like and contents of
the pack

Augmentin
1

Augmentin 250 mg/125 mg film-coated tablets
are white to off-white, oval shaped tablets
debossed with “Augmentin” on one side. They
are packaged in blister packs inside a pouch,
enclosed in a carton. Each pack contains 21 tablets.

Marketing authorisation holder and
manufacturer

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

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Other formats

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

LF001

0800 198 5000 (UK Only)
Please be ready to give the following
information:
Product name
Augmentin 375 mg Tablets
Reference number 00038/0270
This is a service provided by the Royal National
Institute of Blind People.
Leaflet date: October 2013
Augmentin is a registered trademark of the
GlaxoSmithKline group of companies
© 2013 GlaxoSmithKline group of companies.
All rights reserved

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.

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Package Leaflet: Information for the Patient

Augmentin® 375 mg Tablets

co-amoxiclav (amoxicillin and clavulanic acid)

2 Before you take Augmentin
Do not take Augmentin:

Read all of this leaflet carefully before you
start taking this medicine.

• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you
(or for your child). Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
• 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.

In this leaflet:

1 What Augmentin is and what it is used for
2 Before you take Augmentin
3 How to take Augmentin
4 Possible side effects
5 How to store Augmentin
6 Further 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 adults and children to
treat the following infections:
• sinus infections
• urinary tract infections
• skin infections
• dental infections.

• if you are allergic (hypersensitive) to
amoxicillin, clavulanic acid, penicillin or any
of the other ingredients of Augmentin (listed
in section 6)
• if you 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 you have ever had liver problems or
jaundice (yellowing of the skin) when taking
an antibiotic.
➔ Do not take Augmentin if any of the above
apply to you. If you are not sure, talk to your
doctor or pharmacist before taking
Augmentin.

Take special care with Augmentin

Talk to your doctor or pharmacist before taking
this medicine if you:
• 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
you, talk to your doctor or pharmacist before
taking Augmentin.
In some cases, your doctor may investigate the
type of bacteria that is causing your infection.
Depending on the results, you 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 you are
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 you are 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 you are taking Augmentin. This is because
Augmentin can affect the results of these types
of tests.

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Using other medicines

10000000104958

Please tell your doctor or pharmacist if you are
using or have recently used any other
medicines. This includes medicines that can be
bought without a prescription and herbal
medicines.

GSK-GBR-Worthing-UKWOR

• If you are taking allopurinol (used for gout)
with Augmentin, it may be more likely that
you’ll have an allergic skin reaction.

United Kingdom-GBR

• If you are taking probenecid (used for gout),
your doctor may decide to adjust your dose
of Augmentin.

Augmentin

• If medicines to help stop blood clots (such as
warfarin) are taken with Augmentin then
extra blood tests may be needed.

1

• 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 and breast-feeding

If you are pregnant, you think you might be
pregnant or if you are breast-feeding, please
tell your doctor or pharmacist.
Ask your doctor or pharmacist for advice before
taking any medicine.

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Driving and using machines

Augmentin can have side effects and the
symptoms may make you unfit to drive.
Don’t drive or operate machinery unless you are
feeling well.

LF001

3 How to take Augmentin
Always take 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 and
over
The usual dose is:
• 1 tablet three times a day

Children weighing less than 40 kg

Children aged 6 years or less should preferably
be treated with Augmentin oral suspension or
sachets. Augmentin tablets are not
recommended.

Patients with kidney and liver problems

• If you have kidney problems the dose might
be changed. A different strength or different
medicine may be chosen by your doctor.
• If you have liver problems you may have
more frequent blood tests to check your liver
is working.

How to take Augmentin

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• Space the doses evenly during the day, at
least 4 hours apart. Do not take 2 doses in
1 hour.
• Do not take Augmentin for more than
2 weeks. If you still feel unwell you should go
back to see the doctor.

If you take more Augmentin than you
should

If you take too much Augmentin, signs might
include an upset stomach (feeling sick, being
sick or diarrhoea) or convulsions. Talk to your
doctor as soon as
possible. Take the
medicine carton or
bottle to show the
doctor.

If you forget to take
Augmentin

• If you forget to take a dose take it as soon as
you remember.
• You should not take the next dose too soon,
but wait around 4 hours before taking the next
dose.

If you stop taking Augmentin

Keep taking Augmentin until the treatment is
finished, even if you feel better. You need
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.

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 you get 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 you get these symptoms.

• Swallow the tablets whole with a glass of
water at the start of a meal or slightly before

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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 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
your blood tests:
• increase in some substances (enzymes)
produced by the liver.

- red, scaly rash with bumps under the skin
a
and blisters (exanthemous pustulosis).
➔ Contact a doctor immediately if you get 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 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.
Side effects that may show up in your 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 side effects

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)
➔ f you notice any of these symptoms contact a
i
doctor urgently.
Rare side effects that may show up in your
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:
- widespread rash with blisters and peeling
a
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)
- idespread red skin rash with small
w
pus-containing blisters (bullous exfoliative
dermatitis)

➔ 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.
• Do not use Augmentin after the expiry date
which is stated on the carton. The expiry date
refers to the last day of that month.
• Do not store above 25°C.
• Store in the original package in order to
protect from moisture.
• Do not use if the tablets are chipped or
damaged.
• 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.

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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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