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AUGMENTIN 1G TABLETS

Active substance(s): AMOXICILLIN / CLAVULANIC ACID

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Reason for Submission: Update to section 4.5 of the SPC following PSUR assessment of generic
Text date: July 2013
Date of MHRA Submission: 17/07/2013
Date of MHRA Approval:
Version: Issue 4 Draft 3
SPC Version number: Issue 5 Draft 1
CO Number: N/A (not marketed)

[GlaxoSmithKline Logo]
Package leaflet: Information for the patient

Augmentin® 1 g Tablets
co-amoxiclav (amoxicillin and clavulanic acid)
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
What Augmentin is
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:
• middle ear and sinus infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections including dental infections
• bone and joint infections.

2 Before you take Augmentin

Do not take Augmentin:
• 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 type of
tests.
Using other medicines
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.
• If you are taking allopurinol (used for gout) with Augmentin, it may be more
likely that you’ll 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 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.
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.

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
• Usual dose – 1 tablet two times a day
• Higher dose – 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.
Ask your doctor or pharmacist for advice when giving Augmentin tablets to
children weighing less than 40 kg. The tablets are not suitable for children
weighing less than 25 kg.
Patients with kidney and liver problems
• If you have kidney problems the dose might be changed. A different strength
or a different medicine may be chosen by your doctor.
• If you have liver problems you may have more frequent blood tests to see
how 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. Tablets can be broken along the score line to make them
easier to swallow. You must take both pieces of the tablet at the same time.
• 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 have 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 about 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.

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.
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.
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 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
 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.
Tablets supplied in pouches should be used within 30 days of opening the
pouch.
Store in the original pack 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.

6 Further information
What Augmentin contains
• The active substances are amoxicillin and clavulanic acid. Each tablet
contains amoxicillin trihydrate equivalent to 875 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 875 mg/125 mg film-coated tablets are white to off-white, capsule
shaped tablets debossed with “AC” and a scoreline on one side.
They are packaged in:


blister packs, enclosed in a carton. Each pack contains 2, 4, 10, 12, 14,
16, 20, 24, 30, 100 or 500 tablets;



blister packs inside a pouch, enclosed in a carton. Each pack contains 14
tablets.

Not all pack sizes may be marketed
Marketing authorisation holder and manufacturer
Beecham Group Ltd, 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 1 g Tablets
Reference number 00038/0368
This is a service provided by the Royal National Institute of Blind People.**
(**Service not provided if product is non marketed)
Leaflet Date: July 2013
Augmentin is a registered trademark of the GlaxoSmithKline group of companies
© 2013 GlaxoSmithKline group of companies. All rights reserved
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.
[GlaxoSmithKline Logo]

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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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