CO-AMOXICLAV 500MG/125MG TABLETS

Active substance: CLAVULANIC ACID

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Transcript
Ref: 1307/040413/1/F

®

Augmentin 625mg Tablets
(amoxicillin / clavulanic acid)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
* 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 symptoms are the same as
yours.
* If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Augmentin 625mg Tablets but will be referred to as
Augmentin throughout this Patient Information Leaflet.
In this leaflet:
1

What Augmentin is and what it is used for

2

Before you take Augmentin

3

How to take Augmentin

4

Possible side effects

5

How to store Augmentin

6

Using other medicines
Please tell your doctor or pharmacist if you are using or have recently used
any other medicines. This includes medicines that can be bought without a
prescription and herbal medicines.
* If you are taking allopurinol (used for gout) with Augmentin, 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 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.
Pregnancy and breast-feeding
If you are pregnant, you think you might be pregnant or if you are
breast-feeding, please tell your doctor or pharmacist.
Ask your doctor or pharmacist for advice before taking any medicine.

Further information

1

What Augmentin is and what it is used for?

What Augmentin is
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

Before you take Augmentin

Do not take Augmentin:
* if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin
or any of the other ingredients of Augmentin (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.
Take special care with Augmentin
Talk to your doctor or pharmacist before taking this medicine 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.

Driving and using machines
Augmentin 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 Augmentin

Always take Augmentin exactly as your doctor has told you. You should
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 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.

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 product, ask your doctor
or pharmacist.

4

Possible side effects

Like all medicines, Augmentin 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

Ref: 1307/040413/1/B

®

Augmentin 625mg Tablets
(amoxicillin / clavulanic acid)
Patient Information Leaflet (continued)
* 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.
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).
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.

5

How to store this medicine

SIGHT
* KEEP OUT OF THE25°C. AND REACH OF CHILDREN.
* Do notinstore above
a dry place.
* Store take this medicine after the expiry date shown on the carton label.
Do not
* If your doctor tells you to stop taking this medicine, take any remaining
medicine back to the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
If your medicine become
other signs
* deterioration, consult yourdiscoloured or show any you what to of
pharmacist who will tell
do.
Medicines should not be disposed
or household waste.
* Ask your pharmacist how to disposeof via wastewaterlonger required.
of medicines no
These measures will help protect the environment.

6

Further information

What this medicine contains:
Each tablet contains 500mg amoxicillin and 125 mg clavulanic acid.
The other ingredients are: magnesium stearate E572, sodium starch
glycollate, colloidal anhydrous silica, microcrystalline cellulose E460,
titanium dioxide E172, hypromellose E464, macrogol and dimeticone.
What this medicine looks like and contents of the pack
Augmentin Tablets are white to off-white, oval film-coated tablets debossed
with AC and a score line on one side and plain on the other.
Augmentin Tablets are available in blister packs of 21 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by SmithKline Beecham Pharmaceuticals,
Worthing, West Sussex, United Kingdom and is procured from within the EU.
Repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

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.

If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

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.

Augmentin is a registered trademark of the GlaxoSmithKline Group of
Companies.

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 (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
stained teeth (in children), usually removed by brushing.

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.
If you get side effects
* Tell your doctor or pharmacist if any of the side effects become severe
or troublesome, or if you notice any side effects not listed in this leaflet.

POM

PL 15184/1307

Augmentin 625mg Tablets

Revision date: 04/04/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 1307/040413/2/F

Co-amoxiclav 500mg/125mg Tablets
(amoxicillin / clavulanic acid)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
* 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 symptoms are the same as
yours.
* If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Co-amoxiclav 500mg/125mg mg Tablets but will be
referred to as Co-amoxiclav throughout this Patient Information Leaflet.
In this leaflet:
1

What Co-amoxiclav is and what it is used for

2

Before you take Co-amoxiclav

3

How to take Co-amoxiclav

4

Possible side effects

5

How to store Co-amoxiclav

6

Using other medicines
Please tell your doctor or pharmacist if you are using or have recently used
any other medicines. This includes medicines that can be bought without a
prescription and herbal 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, you think you might be pregnant or if you are
breast-feeding, please tell your doctor or pharmacist.
Ask your doctor or pharmacist for advice before taking any medicine.

Further information

1

What Co-amoxiclav is and what it is used for?

What Co-amoxiclav is
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

Before you take Co-amoxiclav

Do not take Co-amoxiclav:
* if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin
or any of the other ingredients of Co-amoxiclav (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.
Take special care with Co-amoxiclav
Talk to your doctor or pharmacist before taking this medicine 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.
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 type of tests.

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 Co-amoxiclav exactly as your doctor has told you. You should
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
Co-amoxiclav oral suspension or sachets.
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.
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 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 have 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.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4

Possible side effects

Like all medicines, Co-amoxiclav 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

Ref: 1307/040413/2/B

Co-amoxiclav 500mg/125mg Tablets
(amoxicillin / clavulanic acid)
Patient Information Leaflet (continued)
* 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 affected 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 (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 Co-amoxiclav or who have
kidney problems)
black tongue which looks hairy
stained teeth (in children), usually removed by brushing.

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.
If you get side effects
* Tell your doctor or pharmacist if any of the side effects become severe
or troublesome, or if you notice any side effects not listed in this leaflet.

5

How to store this medicine

SIGHT
* KEEP OUT OF THE25°C. AND REACH OF CHILDREN.
* Do notinstore above
a dry place.
* Store take this medicine after the expiry date shown on the carton label.
Do not
* If your doctor tells you to stop taking this medicine, take any remaining
medicine back to the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
If your medicine become
other signs
* deterioration, consult yourdiscoloured or show any you what to of
pharmacist who will tell
do.
Medicines should not be disposed
or household waste.
* Ask your pharmacist how to disposeof via wastewaterlonger required.
of medicines no
These measures will help protect the environment.

6

Further information

What this medicine contains:
Each tablet contains 500mg amoxicillin and 125 mg clavulanic acid.
The other ingredients are: magnesium stearate E572, sodium starch
glycollate, colloidal anhydrous silica, microcrystalline cellulose E460,
titanium dioxide E172, hypromellose E464, macrogol and dimeticone.
What this medicine looks like and contents of the pack
Co-amoxiclav Tablets are white to off-white, oval film-coated tablets
debossed with AC and a score line on one side and plain on the other.
Co-amoxiclav Tablets are available in blister packs of 21 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by SmithKline Beecham Pharmaceuticals,
Worthing, West Sussex, United Kingdom and is procured from within the EU.
Repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1307

Co-amoxiclav 500mg/125mg Tablets

Revision date: 04/04/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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