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CO-AMOXICLAV 250/125MG FILM-COATED TABLETS

Active substance: POTASSIUM CLAVULANATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

CO-AMOXICLAV 250 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.
•  eep this leaflet. You may need to read it again.
K
•  f you have any further questions, ask your doctor
I
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.
•  f you get any side effects, talk to your doctor or
I
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:
• sinus infections
• urinary tract and kidney infections
• skin infections
• infections from animal bites
• dental 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:
•  you are allergic to amoxicillin, clavulanic acid, penicillin
if
or any of the other ingredients of this medicine (listed in
section 6).
•  you have ever had a severe allergic reaction to any
if
other antibiotic. This can include a skin rash or swelling
of the face, lips, tongue, throat or neck
•  you have ever had liver problems or jaundice
if
(yellowing of the skin) when taking an antibiotic.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Co-amoxiclav 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.

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
or use machinery.
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:
Co-Amoxiclav tablets should not be taken by children less
than 40 kg.
Other forms of this medicine may be more suitable for
children; ask your doctor or pharmacist.
Patients with kidney or liver problems
•  you have kidney problems the dose might be changed.
If
A different strength or a different medicine may be
chosen by your doctor.
•  you have liver problems you may have more frequent
If
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.
•  not take Co-amoxiclav for more than 2 weeks. If you
Do
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.

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.

Date: 25 Nov 2014
Description Amoxcillin / Clavulanic Acid 250/125mg 21
Component Type Leaflet

Pharma Code N/A

Affiliate Item Code 428801

SAP No. N/A

Superceded Affiliate Item Code 10005019

Vendor Job No. 230268

TrackWise PR No. 428801

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: 11:19

Myriad Pro
175 x 315mm

Body Text Size

9 pt

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.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Stop taking Co-amoxiclav, contact a doctor immediately
or go to your nearest hospital emergency department if
you get any of the following:
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)
•  red, scaly rash with bumps under the skin and blisters
a
(exanthemous pustulosis)
• 
pain passing urine, lower back pain or fever. These
may be signs of a serious kidney problem (interstitial
nephritis).
•  (especially if you take high doses of Co-amoxiclav or
fits
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.
5. How to store Co-amoxiclav
Keep this medicine out of the sight and reach of children.
Do not store tablets above 25°C. Store in the original
package in order to protect from moisture.
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 250 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
'AXC375' on one side and 'GG' on the other. The tablets are
scored on both sides. Co-amoxiclav is available in blisters of
15, 21, or 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Station Close, Potters Bar, Herts, EN6 1TL.
Manufacturer
Generics [UK] Limited, Potters Bar, Herts, EN6 1TL,
United Kingdom.
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.  t is very important that you take the antibiotic at the
I
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.  ou should not take an antibiotic unless it has been
Y
prescribed specifically for you and you should use it only
to treat the infection for which it was prescribed.
3.  ou should not take antibiotics that have been prescribed
Y
for other people even if they had an infection that was
similar to yours.
4.  ou should not give antibiotics that were prescribed for
Y
you to other people.
5.  f you have any antibiotic left over when you have taken
I
the course as directed by your doctor you should take the
remainder to a pharmacy for appropriate disposal.
428801

Date: 25 Nov 2014
Description Amoxcillin / Clavulanic Acid 250/125mg 21
Component Type Leaflet

Pharma Code N/A

Affiliate Item Code 428801

SAP No. N/A

Superceded Affiliate Item Code 10005019

Vendor Job No. 230268

TrackWise PR No. 428801

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: 11:19

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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