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AUGMENTIN 375 MG TABLETS

Active substance(s): AMOXICILLIN / CLAVULANIC ACID

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Patient Information Leaflet

Augmentin® 375 mg Tablets
co-amoxiclav(amoxicillin and clavulanic acid)
The name of your medicine is Augmentin 375mg Tablets, but will
be referred to as Augmentin throughout the remainder of the
leaflet.
Your medicine is also available in the following strength 625mg
Tablets.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
• 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
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.
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
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. What you need to know before you take Augmentin
Do not take Augmentin:
• if you are allergic to amoxicillin, clavulanic acid, penicillin or
any 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.

Other medicines and Augmentin
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’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, 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.
3. How to take Augmentin to take Augmentin
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.

➔ 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.

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.

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.

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.

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.

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, 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.
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).
➔ 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.
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
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.
6. Further information
Augmentin 375mg tablets are white to off-white, oval shaped
tablets debossed with “Augmentin” on one side and plain on the
other.
The active substances are amoxicillin and clavulanic acid.
Each tablet contains amoxicillin trihydrate equivalent to 250 mg
amoxicillin with potassium clavulanate equivalent to 125 mg of
clavulanic acid.
Also contains:
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).
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.
Manufactured by: SmithKline Beecham Pharmaceuticals,
Worthing, West Sussex, United Kingdom. Procured from within
the EU. Product Licence Holder: Quadrant Pharmaceuticals Ltd,
Lynstock House, Lynstock Way, Lostock, Bolton, BL6 4SA.
Repackaged by Maxearn Ltd, Bolton, BL6 4SA.
PL 20774/1441 Augmentin 375 mg Tablets
th
Leaflet revision Date: 10 September 2015

POM

Augmentin is a registered trade mark of the Glaxo Group Limited
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.

PP1/1441/V2

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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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