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AUGMENTIN DISPERSIBLE TABLETS 375MG

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Approved text for Augmentin 375 mg Dispersible Tablets PIL
Reason for MHRA Submission: Article 30 national implementation
MHRA Submission Date:
MHRA Approval Date:
Version: Issue 1 Draft 1

[GlaxoSmithKline Logo]
Package leaflet: Information for the patient

Augmentin® Dispersible Tablets 375 mg
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 is usually 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

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.
* Only marketed pack size(s) will be shown

Do not take Augmentin if any of the above apply. 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.

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

* Only marketed pack size(s) will be shown

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
The usual dose is:
• 1 tablet three times a day
Children weighing less than 40 kg
Augmentin dispersible tablets are not recommended for children weighing less
than 40 kg. Ask your doctor or pharmacist for advice.

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
• Just before you need to take the tablet, stir it in a glass of water so that it
disperses,
• Swallow the mixture 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 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 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.

* Only marketed pack size(s) will be shown

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:

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.



* Only marketed pack size(s) will be shown

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)
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
stained teeth (in children), usually removed by brushing.

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.

* Only marketed pack size(s) will be shown

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.
Store in the original pack in a dry place.
Do not use Augmentin if the tablets are chipped or there are other visible
signs of deterioration.
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 in each tablet are 250 mg amoxicillin and 125 mg
clavulanic acid (present as potassium clavulanate).
• The other ingredients are polyvinylpyrrolidone (cross-linked), silica gel
(E551), saccharin sodium, pineapple, strawberry and blood orange
flavours, magnesium stearate (E572) and microcrystalline cellulose
(E460).
• See section 2 for further important information about one of the ingredients
of Augmentin.
What Augmentin looks like and contents of the pack
Augmentin Dispersible Tablets 375 mg are white, round tablets engraved
‘Augmentin’. They are packaged in blister packs, enclosed in a carton. Each
pack contains* 6, 21, 30, 90, 100 or 500 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
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 Dispersible Tablets 375 mg
Reference number 00038/0272
This is a service provided by the Royal National Institute of Blind People.
Leaflet Date: November 2009
Augmentin is a registered trademark of the GlaxoSmithKline group of
companies

* Only marketed pack size(s) will be shown

© [Year] GlaxoSmithKline group of companies
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]

* Only marketed pack size(s) will be shown

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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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