AUGMENTIN 500/125MG TABLETS

Active substance: CLAVULANIC ACID

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227 Augmentin LEAFLET 20131106

PACKAGE LEAFLET: INFORMATION FOR USER

AUGMENTIN 500/125mg TABLETS
AUGMENTIN 625mg TABLETS/
CO- AMOXICLAV 500/125 TABLETS
(co-amoxiclav)

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.



Your medicine is known as any of the above names but will be
referred to as Augmentin throughout the following leaflet.

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



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

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.



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.

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
The usual dose is:


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.

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.

1 tablet three times a day

Children weighing less than 40 kg

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

If you get side effects



swelling, sometimes of the face or mouth (angioedema),
causing difficulty in breathing



collapse.

➜ 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.

➜ 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)



Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
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


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not use after the expiry date printed the carton or blister
strip.



Keep your tablets in their pack and store them in a dry place
o
below 25 C



If your tablet appears to be discoloured or shows any signs of
deterioration check with your pharmacist who will tell you what
to do.



If your doctor tells you to stop using the tablets, take any which
you have left back to your pharmacist for safe disposal. Only
keep them if the doctor tells you to.



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.

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.

6. FURTHER INFORMATION
What Augmentin contains


Each tablet contains 500mg amoxicillin (as amoxillin trihydrate)
and 125mg clavulanic acid (as potassium clavulanate) as the
active ingredients.



The other ingredients are: magnesium stearate, crospovidone,
macrogol 4000, macrogol 6000, colloidal hydrated silica,
colloidal anhydrous silica, titanium dioxide (E171),
hypromellose and dimeticone.

What Augmentin looks like and contents of the pack
The tablets are white, oval and marked ‘A/C’ on one side.
Augmentin tablets are available in packs of 12 tablets.
Product Licence holder



low number of cells involved in blood clotting

Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, HA0 1DX.



low number of white blood cells.

Manufacturer

Rare side effects that may show up in your blood tests:

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 (StevensJohnson 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.

This product is manufactured by Glaxo Wellcome Production, Zl de
la Payenniere, 53101 Maynne, France.
POM

PL No: 08747/0227

Leaflet revision date: 06 November 2013
Augmentin is a registered trade mark of 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.
227 Augmentin LEAFLET 20131106

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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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