CO-AMOXICLAV TABLETS BP 500/125 MG

Active substance: POTASSIUM CLAVULANATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

CO-AMOXICLAV TABLETS BP
500/125 mg
(amoxicillin/clavulanic acid)

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) only. 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.
What is in this leaflet:
1. What Co-Amoxiclav is and what it is used for.
2. What you need to know before you take Co-Amoxiclav.
3. How to take Co-Amoxiclav.
4. Possible side effects.
5. How to store Co-Amoxiclav.
6. Contents of the pack and other information.
1. WHAT CO-AMOXICLAV IS AND WHAT IT IS USED FOR
Co-Amoxiclav 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.

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 Co-Amoxiclav. This is because
Co-Amoxiclav can affect the results of these types of tests.
Other medicines and Co-Amoxiclav
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines:
• If you are taking allopurinol (used for gout) with
Co-Amoxiclav, 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 Co-Amoxiclav.
• If medicines to help stop blood clots (such as warfarin)
are taken with Co-Amoxiclav then extra blood tests
may be needed.
• Co-Amoxiclav can affect how methotrexate (a medicine
used to treat cancer or rheumatic diseases) works.
Pregnancy and breast-feeding
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
Co-Amoxiclav 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 CO-AMOXICLAV
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Use in adults and children weighing 40 kg and over
The recommended dose is 1 tablet three times a day

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
CO-AMOXICLAV

Patients with kidney or 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 check how your liver is working.

Do not take Co-Amoxiclav:
• 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 Co-Amoxiclav if any of the above apply to
you. If you are not sure, talk to your doctor or pharmacist
before taking Co-Amoxiclav.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Co-Amoxiclav 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 Co-Amoxiclav.
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 Co-Amoxiclav or a different medicine.
Conditions you need to look out for
Co-Amoxiclav 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 Co-Amoxiclav, to reduce the risk of
any problems. See 'Conditions you need to look out for'
in Section 4.

Use in children weighing less than 40 kg
Children aged 6 years or less should preferably be
treated with Co-Amoxiclav suspension. Ask your doctor
or pharmacist for advice when giving Co-Amoxiclav
tablets to children weighing less than 40 kg. The tablets
are not suitable for children weighing less than 25 kg.

How to take Co-Amoxiclav:
• 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 Co-Amoxiclav for more than 2 weeks. If you
still feel unwell you should go back to see the doctor.
If you take more Co-Amoxiclav than you should
If you take too much Co-Amoxiclav, 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 Co-Amoxiclav
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 4 hours before taking the next dose. Do not take
a double dose to make up for a forgotten dose.
If you stop taking Co-Amoxiclav
Keep taking your medicine 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.

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Contact a doctor immediately if you get any of these
symptoms. Stop taking Co-Amoxiclav.

Also you can help to make sure that medicines remain
as safe as possible by reporting any unwanted side
effects via the internet at www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone 0808 100 3352
(available from 10 a.m. to 2 p.m. Mondays to Fridays) or
fill in a paper form available from your local pharmacy.

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.

5. HOW TO STORE CO-AMOXICLAV

Serious skin reactions:
• 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 – called erythema
multiforme)
• 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).

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Contact your doctor as soon as possible for advice if
you get these symptoms:
• inflammation of the large intestine, causing watery
diarrhoea usually with blood and mucus, stomach pain
and/or fever.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is
stated on the carton after 'EXP'. The expiry date refers to
the last date of the month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help to protect the environment.

What Co-Amoxiclav contains – The active substances
are amoxicillin trihydrate (corresponding to 500 mg
amoxicillin) and potassium clavulanate (corresponding
to 125 mg clavulanic acid). The other ingredients
are magnesium stearate (E572), talc, povidone,
microcrystalline cellulose (E460), croscarmellose sodium,
triethyl citrate, ethyl cellulose, sodium lauryl sulphate,
cetyl alcohol, hypromellose and titanium dioxide (E171).
What Co-Amoxiclav looks like and contents of the pack
Your medicine comes as an off-white oblong convex tablet.
The tablets are scored on both sides. Co-Amoxiclav is
available in blisters of 10, 15, 20, 21, or 100 tablets. Not all
pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
This leaflet was last revised
03/2013

Other side effects
Very common: may affect more than 1 in 10 people:
• diarrhoea (in adults).
Common: 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 Co-Amoxiclav before food.
• vomiting
• diarrhoea (in children).
Uncommon: may affect up to 1 in 100 people:
• skin rash, itching
• raised itchy rash (hives)
• indigestion
• dizziness
• headache
• increase in some substances (enzymes) produced by
the liver that may show up in your blood tests.
Rare: may affect up to 1 in 1,000 people:
• low number of cells involved in blood clotting
• low number of white blood cells.
These may show up in your blood tests.
Not known: frequency cannot be estimated from the
available data:
• 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
Co-Amoxiclav 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.

Other sources of information
Detailed information on this medicine is available on
the website of the Medicines and Healthcare products
Regulatory Agency (MHRA).
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.

If you get side effects, talk to your doctor or pharmacist.
This includes any side effects not listed in this leaflet.

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05-APR-2013

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10004984

03-MAY-2013

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Co-Amoxiclav is used in adults and children to treat the
following infections:
• respiratory infections
• middle ear and sinus infections
• urinary tract infections
• skin and soft tissue infections including dental
infections
• bone and joint infections.

4. POSSIBLE SIDE EFFECTS

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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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