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CO-AMOXICLAV 500/125MG FILM-COATED TABLETS

Active substance(s): AMOXICILLIN TRIHYDRATE / POTASSIUM CLAVULANATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Co-amoxiclav 500/125mg, Film-coated Tablets
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 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. See section 4.
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

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 Coamoxiclav, it may be more likely that you will have an
allergic skin reaction.
If you are taking probenecid (used for gout), your
doctor may decide to adjust your dose of Coamoxiclav.
If medicines to help stop blood clots (such as warfarin)
are taken with Co-amoxiclav then extra blood tests
may be needed.

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.
Co-amoxiclav 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
CO-AMOXICLAV
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 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 this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Coamoxiclav. This is especially important 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 this
medicine.
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 this medicine, to
reduce the risk of any problems. See ‘Conditions you
need to look out for’ in section 4.

Co-amoxiclav can affect how methotrexate (a medicine
used to treat cancer or rheumatic diseases) and
mycophenolate mofetil (a medicine used after organ
transplants) work.
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 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 Amoxicillin/Clavulanic acid oral
suspension (in bottle or sachets).
Ask your doctor or pharmacist for advice when giving
Co-amoxiclav tablets to children weighing less than 40
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 check how your liver is
working.
How to take Co-amoxiclav
• 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 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 about 4 hours before taking the next
dose.
If you stop taking Co-amoxiclav
Keep taking Co-amoxiclav 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.

AAAI8121

Amoxicillin/Clavulanic acid 500mg/125mg tablet leaflet - UK

colours/plates:
1. Black

item no:

AAAI8121

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print proof no:

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pharmacode:

origination date: 02.03.16
approved for print/date

min pt size:

220 x 500

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3.
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11.5

5.
6.

originated by:

jh

revision date:

09.03.16

Technical Approval

revised by:

jh

date sent:

supplier:

Aurobindo

technically app. date: 03.03.16

02.03.16

Non Printing Colours
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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 Co-amoxiclav.
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 this applies to you, take Co-amoxiclav 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.
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 (buloous 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.

• black tongue which looks hairy
• stained teeth (in children), usually removed by
brushing
• inflammation of the brain membranes (aseptic
meningitis)
• inflammation of the bile duct (cholangitis).
• pain in the chest.
Side effects that may show up in your blood or urine
tests:
• severe reduction in the number of white blood cells
• lower 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 Yellow Card Scheme Website:
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 CO-AMOXICLAV
This medicinal product does not require any special
temperature storage conditions. Store in the original
package in order to protect from light and moisture.
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which is
stated on the carton and blister after ‘EXP’. The expiry
date refers to the last day of that 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 protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Co-amoxiclav contains
• The active substances are amoxicillin trihydrate
and potassium clavulanate. Each film-coated tablet
contains amoxicillin trihydrate corresponding to
500mg amoxicillin and potassium clavulanate
corresponding to 125mg clavulanic acid.
• The other ingredients are:
Core:
Microcrystalline cellulose (E460), colloidal silicon
dioxide, magnesium stearate (E470b), sodium starch
glycolate (Type A)
Film coating:
Hypromellose (E464), macrogol 400, titanium dioxide
(E171).
What Co-amoxiclav looks like and contents of the
pack
Film-coated Tablets.
Co-amoxiclav 500/125mg tablets are white, oval, filmcoated tablets inscribed with ‘A’ on one side and ‘64’ on
the other side.
Co-amoxiclav 500/125mg are available in blister packs
with 21 Film-coated Tablets.
Not all listed pack sizes will be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Milpharm Limited
Ares
Odyssey Business Park
West End Road
South Ruislip
HA4 6QD
United Kingdom
This leaflet was last revised in February 2016

If you would like a
leaflet with larger
text, please contact
01271 385257.

• 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
• seizures/convulsions (in people taking high doses
of amoxicillin/clavulanic acid or who have kidney
problems)

Actavis, Barnstaple, EX32 8NS, UK

AAAI8121

Amoxicillin/Clavulanic acid 500mg/125mg tablet leaflet - UK

colours/plates:
1. Black

item no:

AAAI8121

dimensions:

print proof no:

2

pharmacode:

origination date: 02.03.16
approved for print/date

min pt size:

220 x 500

2.
3.
4.

11.5

5.
6.

originated by:

jh

revision date:

09.03.16

Technical Approval

revised by:

jh

date sent:

supplier:

Aurobindo

technically app. date: 03.03.16

02.03.16

Non Printing Colours
1.
2.
3.

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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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