AUGMENTIN 625 MG TABLETS

Active substance: CLAVULANIC ACID

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PACKAGE LEAFLET: INFORMATION FOR THE USER
AUGMENTIN® 625 mg Tablets
co-amoxiclav (amoxicillin and clavulanic acid)
The name of your medicine was Augmentin® 625 mg Tablets but
will be referred to as Augmentin throughout the remainder of
this 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.
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. 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.

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
 swelling, sometimes of the face or mouth (angioedema),
causing difficulty in breathing
 collapse.

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.

Contact a doctor immediately if you get any of these symptoms.
Stop taking Augmentin.

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.

Inflammation of large intestine
Inflammation of the large intestine, causing watery diarrhoea usually
with blood and mucus, stomach pain and/or fever.

Ask your doctor or pharmacist for advice before taking any medicine.

Contact your doctor as soon as possible for advice if you get
these symptoms.

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.

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.
5.

Very common side effects
These may affect more than 1 in 10 people
 diarrhoea (in adults).

How to store Augmentin

 Keep out of the sight and reach of children.
 Do not use Augmentin after the expiry date which is stated on the
carton. The expiry date refers to the last day of that month.

 Do not store above 25°C. Store in a dry place.
 Do not use Augmentin if the tablets are chipped or there are

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).

6.

Uncommon side effects
These may affect up to 1 in 100 people
 skin rash, itching
 raised itchy rash (hives)
 indigestion
 dizziness
 headache.

What Augmentin contains
 The active substances in each tablet are 500 mg amoxicillin and
125 mg clavulanic acid (present as potassium clavulanate).
 The other ingredients are crospovidone, colloidal anhydrous
silica, magnesium stearate, macrogol 4000, macrogol 6000,
hypromellose, titanium dioxide (E171), dimethicone 500.
 See section 2 for further important information about one of the
ingredients of Augmentin.

Uncommon side effects that may show up in your blood tests:
 increase in some substances (enzymes) produced by the liver.

What Augmentin looks like and contents of the pack
Augmentin tablets are white to off-white, oval-shaped, film-coated
tablets engraved with ‘A/C’ one side and plain on the other side.
They are packaged in blister packs, enclosed in a carton. Each pack
contains 12 or 21 tablets.

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.

other visible signs of deterioration. Medicines should not be
disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
Further information

Manufacturer
Augmentin tablets are made by Glaxo Wellcome Production, Z.I. de
la Peyenniere, 53101 Mayenne Cedex, France. Procured from within
the EU and repackaged by the Parallel Import Product Licence
holder: G. Pharma Ltd., Dakota Avenue, Salford M50 2PU.

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).

PL 16369/1227 Augmentin 625 mg Tablets

POM

Date of revision of this leaflet: 2nd April 2013

To listen to, or request a copy of this leaflet in Braille, large print or
audio please call 0161 877 8999.
Please be ready to give the following information:
Product Name
Augmentin 625 mg Tablets

Reference Number
16369/1227

PACKAGE LEAFLET: INFORMATION FOR THE USER
AUGMENTIN® 625 mg Tablets
co-amoxiclav (amoxicillin and clavulanic acid)
The name of your medicine was Augmentin® 625 mg Tablets but
will be referred to as Augmentin throughout the remainder of
this 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.
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. 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.

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
 swelling, sometimes of the face or mouth (angioedema),
causing difficulty in breathing
 collapse.

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.

Contact a doctor immediately if you get any of these symptoms.
Stop taking Augmentin.

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.

Inflammation of large intestine
Inflammation of the large intestine, causing watery diarrhoea usually
with blood and mucus, stomach pain and/or fever.

Ask your doctor or pharmacist for advice before taking any medicine.

Contact your doctor as soon as possible for advice if you get
these symptoms.

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.

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.
5.

Very common side effects
These may affect more than 1 in 10 people
 diarrhoea (in adults).

How to store Augmentin

 Keep out of the sight and reach of children.
 Do not use Augmentin after the expiry date which is stated on the
carton. The expiry date refers to the last day of that month.

 Do not store above 25°C. Store in a dry place.
 Do not use Augmentin if the tablets are chipped or there are

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).

6.

Uncommon side effects
These may affect up to 1 in 100 people
 skin rash, itching
 raised itchy rash (hives)
 indigestion
 dizziness
 headache.

What Augmentin contains
 The active substances in each tablet are 500 mg amoxicillin and
125 mg clavulanic acid (present as potassium clavulanate).
 The other ingredients are crospovidone, colloidal anhydrous
silica, magnesium stearate, macrogol 4000, macrogol 6000,
hypromellose, titanium dioxide (E171), dimethicone 500.
 See section 2 for further important information about one of the
ingredients of Augmentin.

Uncommon side effects that may show up in your blood tests:
 increase in some substances (enzymes) produced by the liver.

What Augmentin looks like and contents of the pack
Augmentin tablets are white to off-white, oval-shaped, film-coated
tablets engraved with ‘A/C’ one side and plain on the other side.
They are packaged in blister packs, enclosed in a carton. Each pack
contains 12 or 21 tablets.

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.

other visible signs of deterioration. Medicines should not be
disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
Further information

Manufacturer
Augmentin tablets are made by Glaxo Wellcome Production, Z.I. de
la Peyenniere, 53101 Mayenne Cedex, France. Procured from within
the EU and repackaged by the Parallel Import Product Licence
holder: G. Pharma Ltd., Dakota Avenue, Salford M50 2PU.

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).

PL 16369/1227 Augmentin 625 mg Tablets

POM

Date of revision of this leaflet: 2nd April 2013

To listen to, or request a copy of this leaflet in Braille, large print or
audio please call 0161 877 8999.
Please be ready to give the following information:
Product Name
Augmentin 625 mg Tablets

Reference Number
16369/1227

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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