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CO-AMOXICLAV 500/125 MG FILM-COATED TABLETS

Active substance(s): AMOXYCILLIN TRIHYDRATE / POTASSIUM CLAVULANATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

CO-AMOXICLAV 500 mg/125 mg
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
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).
Clavulanic acid stops this from happening.
Co-Amoxiclav is used in adults and children to treat the
following infections:
• respiratory infections
• middle ear and sinus infections
• urinary tract and kidney infections
• skin and soft tissue infections including animal bites
and dental infections
• bone and joint infections
You must talk to a doctor if you do not feel better or if
you feel worse after 14 days.
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, lips, tongue, throat or neck.
• if you have ever had liver problems or jaundice
(yellowing of the skin) when taking an antibiotic.
Warnings and precautions
Talk to your doctor or pharmacist before taking Coamoxiclav if you:
• have glandular fever
• have 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 must look out for while taking
Co-amoxiclav
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. If you experience an allergic reaction,
you must stop taking Co-amoxiclav and your doctor
will change your medicine. See 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 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 will 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.
• If you are taking methotrexate (a medicine used to
treat cancer or rheumatic diseases), Co-amoxiclav can
affect how it works and may cause side effects.
• Co-amoxiclav can affect how mycophenolate mofetil
(a medicine used after an organ transplant) 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.
You should only use Co-amoxiclav whilst pregnant if
your doctor tells you to. This medicine may be harmful to
the baby.
Amoxicillin and clavulanic acid can pass into breast milk.
If you breast-feed while taking this medicine, your baby
may be more likely to get diarrhoea or an infection. You
should only use Co-amoxiclav whilst breast-feeding if
your doctor tells you to.
Driving and using machines
Co-amoxiclav can have side effects such as allergic
reactions, dizziness or fits that may make you unfit to drive.
Do not drive or use 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.
Use in children weighing less than 40 kg
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.
Other forms of this medicine may be more suitable for
children under 25 kg; ask your doctor or pharmacist.
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.
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 (fits). Talk to your doctor as soon as
possible. Take the medicine carton 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 then 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.

Date: 25 Nov 2014
Description Amoxcillin / Clavulanic Acid 500/125mg 21
Component Type Leaflet

Pharma Code N/A

Affiliate Item Code 428803

SAP No. N/A

Superceded Affiliate Item Code 10004884

Vendor Job No. 230282

TrackWise PR No. 428803

Proof No. 6

MA No.

04569/0449,
04569/0459

Client Market UK

No. of colours
Colours

Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Main Font

Supplier Code TBC

Barcode Info N/A

Dimensions

Sign-offs

1

Time: 11:12

Myriad Pro
175 x 315mm

Body Text Size

9 pt

4. Possible side effects

5. How to store Co-amoxiclav

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

Keep this medicine out of the sight and reach
of children.

Stop taking Co-amoxiclav, contact a doctor
immediately or go directly to your nearest hospital
emergency department if you get any of the following:

Do not store tablets above 25°C. Store in the original
package in order to protect from moisture.

Rare (may affect up to 1 in 1,000 people)
• frequent infections causing fever, severe chills, sore
throat or mouth ulcers (these may be signs of a low
number of white blood cells).
Not known (cannot be estimated from the available data)
• signs of a serious allergic reaction which can include:
• sudden itching, red skin rash or swelling of
the face, lips, tongue, throat or neck, difficulty
breathing or swallowing.
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.
• tiredness, headaches, shortness of breath when
exercising, dizziness, pale or yellowing of the skin or eyes
(these may be signs of a low number of red blood cells).
• sensitivity to light, stiff neck, body aches, sore throat,
severe headache, flu-like symptoms (these may
indicate you have a type of meningitis that cannot be
passed on to others).
• diarrhoea, possibly with blood or mucus, stomach
pain or fever.
• yellowing of the skin or whites of the eyes, dark
urine, pale stools, tiredness, fever, nausea, weakness,
drowsiness and abdominal pain, with blood test
results showing abnormal liver function. (These may
be signs of serious problems with your liver).
• serious skin reactions such as a widespread rash with
blisters, bleeding and peeling skin, particularly around
the mouth, nose, eyes or genitals (Steven's-Johnson
syndrome) or 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).
• pain passing urine, lower back pain or fever.
These may be signs of a serious kidney problem
(interstitial nephritis).
• fits (especially if you take high doses of Co-amoxiclav
or if you have kidney problems).
Other side effects
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 if you take high doses.
If affected take Co-amoxiclav before food.
• being sick (vomiting).
Uncommon (may affect up to 1 in 100 people)
• indigestion.
• dizziness.
• headache.
• increase in some substances (enzymes) produced by
the liver that may show up in blood tests.
Rare (may affect up to 1 in 1,000 people)
• unexplained bruising or bleeding more easily or for
longer than normal. (These may be signs of a low
number of cells involved in blood clotting).
Not known (cannot be estimated from the available data)
• hyperactivity.
• black tongue which looks hairy.
• other infections that are difficult to treat (over growth
of non-susceptible organisms).
• crystals in urine (seen as cloudy urine or in a urine test).
Reporting 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.

Do not use this medicine after the expiry date which is
stated on the carton 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
(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) and
croscarmellose sodium. The tablet coating includes
triethyl citrate, ethylcellulose, sodium laurylsulfate, cetyl
alcohol, hypromellose, talc and titanium dioxide (E171).
What Co-amoxiclav looks like and contents of the pack
Your medicine comes as an off-white, capsule shaped
film-coated tablet with sides that curve out, marked with
'AXC625' on one side and 'GG' on the other. 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.
Manufacturer
Generics [UK] Limited, Potters Bar, Herts, EN6 1TL, United
Marketing Authorisation Holder
Mylan, Station Close, Potters Bar, Herts, EN6 1TL.
This leaflet was last revised in
11/2014
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.

428803

Date: 25 Nov 2014
Description Amoxcillin / Clavulanic Acid 500/125mg 21
Component Type Leaflet

Pharma Code N/A

Affiliate Item Code 428803

SAP No. N/A

Superceded Affiliate Item Code 10004884

Vendor Job No. 230282

TrackWise PR No. 428803

Proof No. 6

MA No.

04569/0449,
04569/0459

Client Market UK

No. of colours
Colours

Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Main Font

Supplier Code TBC

Barcode Info N/A

Dimensions

Sign-offs

1

Time: 11:12

Myriad Pro
175 x 315mm

Body Text Size

9 pt

Expand view ⇕

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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