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AUGMENTIN 375MG TABLETS

Active substance(s): AMOXICILLIN / CLAVULANIC ACID

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PHARMA CODE N° 4247

3
10000000137186

1000000
0137186

Package leaflet: Information for the user

GSK-GBR-Worthing-UKWOR

Augmentin® 375 mg Tablets

co-amoxiclav (amoxicillin and clavulanic acid)
United Kingdom-GBR

1 What Augmentin is and what it
is used for

Augmentin
N/A
LF035

Read all of this leaflet carefully before you
start taking this medicine because it
contains important information for you.

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• K
 eep 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 signs
of illness are the same as yours.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

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.

What is in this leaflet:

1 What Augmentin is and what it is used for
2 What you need to know before you take
Augmentin
3 How to take Augmentin
4 Possible side effects
5 How to store Augmentin
6 Contents of the pack and other information

Other medicines and Augmentin

2 What you need to know before
you take Augmentin
Do not take Augmentin:

• if you are allergic to amoxicillin, clavulanic
acid, penicillin or any of the other ingredients
of this medicine (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.

Warnings and Precautions

Talk to your doctor or pharmacist before taking
Augmentin 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.

Tell your doctor or pharmacist if you are using,
have recently used or might use any other
medicines.
• If you are taking allopurinol (used for gout)
with Augmentin, it may be more likely that
you will have an allergic skin reaction.
• If you are taking probenecid (used for gout),
your doctor may decide to adjust your 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 you are pregnant or breast-feeding, think
you may be pregnant or are planning to have a
baby, ask your 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.

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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3 How to take Augmentin

4 Possible side effects

Always take Augmentin 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 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

• Swallow the tablets whole with a glass of
water 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 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. Do not take a double dose to
make up for a forgotten 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 medicine, ask your doctor or pharmacist.

Like all medicines, this medicine 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.

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.

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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 your
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).

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.

Reporting of side effects

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.

5 How to store Augmentin
• K
 eep this medicine out of the sight and
reach of children.
• 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.
• Do not store above 25°C.
• Tablets supplied in pouches should be used
within 30 days of opening the pouch.
• Store in the original package in order to
protect from moisture.
• Do not use if the tablets are chipped or
damaged.
• 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 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 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. The pouch contains a
desiccant sachet. The desiccant must be kept
inside the pouch and must not be eaten. Each
pack contains 21 tablets.

Marketing Authorisation Holder and
Manufacturer

Marketing Authorisation Holder:
Beecham Group plc, Stockley Park West,
Uxbridge, Middlesex UB11 1BT
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:

➔ 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

0800 198 5000 (UK Only)
Please be ready to give the following
information:
Product name
Augmentin 375 mg Tablets
Reference number 00038/0270

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.

This is a service provided by the Royal National
Institute of Blind People.
This leaflet was last revised in January 2016.
Augmentin is a registered trade mark of the
GSK group of companies.
© 2016 GSK group of companies. All rights
reserved.

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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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