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AUGMENTIN 625 MG TABLETS

Active substance(s): AMOXICILLIN / CLAVULANIC ACID

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Package leaflet: Information for the user

Augmentin® 625 mg Tablets
co-amoxiclav (amoxicillin and clavulanic acid)
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
Your medicine is called Augmentin® 625 mg Tablets but throughout
this leaflet will be referred to as Augmentin.





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






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
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

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:
• middle ear and sinus infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections including dental infections
• bone and joint 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 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.
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.
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 will have an allergic skin reaction.

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. 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.
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.

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.
Store in the original package. Store in a dry place. Do not store
above 25°C.
Use all tablets within 30 days of opening the aluminium wrapper
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.

 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).

6. Contents of the pack and other information

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.

What Augmentin contains
• The active substances in each tablet are 500 mg amoxicillin (as
trihydrate) and 125 mg clavulanic acid (present as potassium
clavulanate)
• The other ingredients are magnesium stearate, sodium starch
glycollate type A, colloidal anhydrous silicon dioxide, cellulose
microcrystalline, titanium dioxide (E171), hypromellose 5 CPS,
hypromellose 15 CPS, macrogol 4000, macrogol 6000, dimeticone
500.
What Augmentin looks like and contents of the pack
Augmentin 625 mg Tablets are white to off-white oval-shaped,
film-coated tablets debossed with ‘AC’ and a score line one side and
plain on the other side. They are packaged in blister packs, enclosed
in a carton containing 14 or 21 tablets.
Manufacturer: SmithKline Beecham Pharmaceuticals, UK

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 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

Procured within the EU by Product Licence Holder: Ecosse
Pharmaceuticals Limited, 3 Young Place, East Kilbride, G75 0TD.
Re-packaged by: Munro Wholesale Medical Supplies Limited,
3 Young Place, East Kilbride, G75 0TD.
PL 19065/0305
This leaflet was revised 05/01/2016

POM

E0305/5
Augmentin ® is a registered trade mark of the 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.

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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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