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CO-AMOXICLAV 400/57 ORAL SUSPENSION

Active substance(s): AMOXICILLIN / CLAVULANIC ACID

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S0319 LEAFLET Augmentin Duo Suspension 20140203

PACKAGE LEAFLET: INFORMATION FOR THE USER
AUGMENTIN DUO 400/57 SUSPENSION
(co-amoxiclav (amoxicillin and clavulanic acid))

Pregnancy and breast-feeding
If your child who is about to take this medicine is pregnant or
breast-feeding, thinks they 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

Your medicine is known as Augmentin Duo 400/57 Suspension but
will be referred to as Augmentin throughout the following leaflet.

Augmentin can have side effects and the symptoms may make you
unfit to drive. Do not drive or operate machinery unless you are
feeling well.

Read all of this leaflet carefully before you start giving your
child this medicine because it contains important information
for them.

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



Keep this leaflet. You may need to read it again.



Augmentin contains aspartame and maltodextrin:

If you have any further questions, ask your doctor, pharmacist,
or nurse.





This medicine is usually prescribed for a baby or child. Do not
pass it on to others. It may harm them, even if their symptoms
are the same as your child’s.

Augmentin contains aspartame (E951) which is a source of
phenylalanine. This may be harmful for children born with a
condition called ’phenylketonuria’.



Augmentin contains maltodextrin (glucose). If you have been
told by your doctor that your child has an intolerance to some
sugars, contact your doctor before taking this medicinal
product.

3

HOW TO GIVE AUGMENTIN



If your child gets any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side effects not
listed in this leaflet. See section 4

What is in this leaflet:
1

What Augmentin is and what it is used for

2

What you need to know before you give Augmentin

Always give Augmentin exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

3

How to give Augmentin

Adults and children weighing 40 kg or over

4

Possible side effects



5

How to store Augmentin

6

Contents of the pack and other information

1

WHAT AUGMENTIN IS AND WHAT IT IS USED FOR

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 babies 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 GIVE
AUGMENTIN

Children weighing less than 40 kg
All doses are worked out depending on the child’s body weight in
kilograms.


Your doctor will advise you how much Augmentin you should
give to your baby or child.



You may be provided with a plastic measuring spoon or plastic
measuring cup or dosing syringe. You should use this to give
the correct dose to your baby or child.



Recommended dose - 25 mg/3.6 mg to 45 mg/6.4 mg for each
kilogram of body weight a day, given in two divided doses.



Higher dose - up to 70 mg/10 mg for each kilogram of body
weight a day, given in two divided doses.

Patients with kidney and liver problems


If your child has kidney problems the dose might be lowered. A
different strength or a different medicine may be chosen by your
doctor.



If your child has liver problems they may have more frequent
blood tests to see how their liver is working.

Do not give your child Augmentin:


if they are allergic to amoxicillin, clavulanic acid or any of the
other ingredients of Augmentin (listed in section 6)



if they 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 they have ever had liver problems or jaundice (yellowing of
the skin) when taking an antibiotic.

 Do not give Augmentin to your child if any of the above
apply to your child. If you are not sure, talk to their doctor or
pharmacist before giving Augmentin.

This suspension is not usually recommended for adults and
children weighing 40 kg and over. Ask your doctor or
pharmacist for advice.

How to give Augmentin


Always shake the bottle well before each dose



Give 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 give your child Augmentin for more than 2 weeks. If your
child still feels unwell they should go back to see the doctor.

If you give more Augmentin than you should
Take special care with Augmentin
Check with their doctor, pharmacist or nurse before giving your
child this medicine if they:

If you give your child too much Augmentin, signs might include an
upset stomach (feeling sick, being sick or diarrhoea) or convulsions.
Talk to their doctor as soon as possible. Take the medicine bottle to
show the doctor.



have glandular fever



are being treated for liver or kidney problems

If you forget to give Augmentin



are not passing water regularly.

If you forget to give your child a dose, give it as soon as you
remember. You should not give your child the next dose too soon,
but wait about 4 hours before giving the next dose.

If you are not sure if any of the above apply to your child, talk to
their doctor or pharmacist before giving Augmentin.
In some cases, your doctor may investigate the type of bacteria that
is causing your child’s infection. Depending on the results, your
child 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 your child is taking Augmentin, to reduce
the risk of any problems. See ‘Conditions you need to look out for’
in section 4.
Blood or urine tests
If your child is having blood tests (such as red blood cell status tests
or liver function tests) or urine tests, let the doctor or nurse know
that they are taking Augmentin. This is because Augmentin can
affect the results of these types of tests.

If your child stops taking Augmentin
Keep giving your child Augmentin until the treatment is finished,
even if they feel better. Your child needs 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, pharmacist or nurse.
4

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.

Other medicines and Augmentin
Tell your doctor or pharmacist if your child is taking or has recently
taken any other medicines. This includes medicines that can be
bought without a prescription and herbal medicines.


If your child is taking allopurinol (used for gout) with Augmentin,
it may be more likely that they will have an allergic skin
reaction.



If your child is taking probenecid (used for gout), your doctor
may decide to adjust the 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.



Augmentin may affect how mycophenolate mofetil (a medicine
used to prevent the rejection of transplanted organs) works.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although
not everybody gets them. The side effects below may happen with
this medicine.

 Contact a doctor immediately if your child gets 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 your
child gets these symptoms.

Very common side effects

6

These may affect more than 1 in 10 people

What Augmentin contains





Each 5ml contains amoxicillin trihydrate equivalent to 400mg
amoxicillin and potassium clavulanate equivalent to 57mg
clavulanic acid. Both of these ingredients are antibiotics and
together they are known as co-amoxiclav.



Augmentin Duo 400/57 also contains the following inactive
ingredients: xanthan gum, crospovidone, aspartame, silicon
dioxide, colloidal silica, magnesium stearate, sodium benzoate,
strawberry flavour and carmellose sodium.

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


CONENTS OF THE PACK AND OTHER INFORMATION

if affected take Augmentin before food



vomiting

What Augmentin looks like and contents of the pack



diarrhoea (in children).

Augmentin Duo 400/57 is provided as a clear glass bottle
containing an off-white powder with a 2.5/5ml measuring spoon.

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 blood tests:


Augmentin Duo 400/57 is available in 70 ml bottles
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, Middlesex, HA0 1DX.
Manufacturer
This product is manufactured by Glaxo Wellcome Production,
Terras II, Mayenne, France and/or SmithKline Beecham
Pharmaceuticals, Worthing, United Kingdom.

increase in some substances (enzymes) produced by the liver.
POM

PL No: 19488/0319 Augmentin Duo 400/57 Suspension

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)

Leaflet revision date: 03 February 2014
Augmentin is a registered trademark of the GlaxoSmithKline group
of companies

 if you notice any of these symptoms contact a doctor urgently.
Advice/medical education
Rare side effects that may show up in 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)



Inflammation of the protective membrane surrounding the brain
(aseptic meningitis)



Serious skin reactions:


a widespread rash with blisters and peeling skin, particularly
around the mouth, nose, eyes and genitals (StevensJohnson 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 your child gets any of
these symptoms.

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.



inflammation of the liver (hepatitis)



jaundice, caused by increases in the blood of bilirubin (a
substance produced in the liver) which may make your child’s
skin and whites of the eyes appear yellow



inflammation of tubes in the kidney



blood takes longer to clot

Instructions for reconstitution



hyperactivity



convulsions (in people taking high doses of Augmentin or who
have kidney problems)

Check cap seal is intact before using. Shake bottle to loosen
powder. Add volume of water (as indicated below). Invert and shake
well.



black tongue which looks hairy



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

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.

Alternatively, shake the bottle to loosen powder then fill the bottle
with water to just below the line on the bottle or label. Invert and
shake well, then top up with water exactly to the line.
Invert again and shake well.

Side effects that may show up in blood or urine tests:


severe reduction in the number of white blood cells



low number of red blood cells (haemolytic anaemia)



crystals in urine.

Strength

Volume of water to
be added at
reconstitution (ml)

Final volume of
reconstituted oral
suspension (ml)

400 mg/57 mg/5 ml

32

35

Reporting of side effects

64

70

If you get any side effects, talk to your doctor, pharmacist or nurse.
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

127

140

Shake the bottle well before each dose.

By reporting side effects you can help provide more information on
the safety of this medicine.
5

HOW TO STORE AUGMENTIN



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Store reconstituted suspensions in a refrigerator (2-8°C) but do
not freeze. Discard any remaining suspension after 7days and
return it to your pharmacist.



Do not use after the expiry date printed on the carton or bottle
label.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

S0319 LEAFLET Augmentin Duo Suspension 20140203

S0319 LEAFLET Co-Amoxiclav Duo Suspension 20140203

PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-AMOXICLAV DUO 400/57 ORAL SUSPENSION

Pregnancy and breast-feeding
If your child who is about to take this medicine is pregnant or
breast-feeding, thinks they may be pregnant or are planning to have
a baby, ask your doctor or pharmacist for advice before taking this
medicine.

Your medicine is known as Co-amoxiclav Duo 400/57 Oral
Suspension but will be referred to as Co-amoxiclav throughout the
following leaflet.

Driving and using machines

Read all of this leaflet carefully before you start giving your
child this medicine because it contains important information
for them.

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



Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor, pharmacist,
or nurse.



This medicine is usually prescribed for a baby or child. Do not
pass it on to others. It may harm them, even if their symptoms
are the same as your child’s.



What Co-amoxiclav is and what it is used for

2

What you need to know before you give Co-amoxiclav

3

How to give 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). The other active component (clavulanic
acid) stops this from happening.
Co-amoxiclav is used in babies 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

Co-amoxiclav contains aspartame and maltodextrin:


Co-amoxiclav contains aspartame (E951) which is a source of
phenylalanine. This may be harmful for children born with a
condition called ’phenylketonuria’.



Co-amoxiclav contains maltodextrin (glucose). If you have been
told by your doctor that your child has an intolerance to some
sugars, contact your doctor before taking this medicinal
product.

3

HOW TO GIVE CO-AMOXICLAV

If your child gets any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side effects not
listed in this leaflet. See section 4

What is in this leaflet:
1

Co-amoxiclav can have side effects and the symptoms may make
you unfit to drive. Do not drive or operate machinery unless you are
feeling well.

WHAT YOU NEED TO KNOW BEFORE YOU GIVE COAMOXICLAV

Always give Co-amoxiclav exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
Adults and children weighing 40 kg or over


Children weighing less than 40 kg
All doses are worked out depending on the child’s body weight in
kilograms.


Your doctor will advise you how much Co-amoxiclav you should
give to your baby or child.



You may be provided with a plastic measuring spoon or plastic
measuring cup or dosing syringe. You should use this to give
the correct dose to your baby or child.



Recommended dose - 25 mg/3.6 mg to 45 mg/6.4 mg for each
kilogram of body weight a day, given in two divided doses.



Higher dose - up to 70 mg/10 mg for each kilogram of body
weight a day, given in two divided doses.

Patients with kidney and liver problems


If your child has kidney problems the dose might be lowered. A
different strength or a different medicine may be chosen by your
doctor.



If your child has liver problems they may have more frequent
blood tests to see how their liver is working.

Do not give your child Co-amoxiclav:


if they are allergic to amoxicillin, clavulanic acid or any of the
other ingredients of Co-amoxiclav (listed in section 6)



if they 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

This suspension is not usually recommended for adults and
children weighing 40 kg and over. Ask your doctor or
pharmacist for advice.

How to give Co-amoxiclav


Always shake the bottle well before each dose



Give 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 give Co-amoxiclav to your child if any of the above
apply to your child. If you are not sure, talk to their doctor or
pharmacist before giving Co-amoxiclav.



Do not give your child Co-amoxiclav for more than 2 weeks. If
your child still feels unwell they should go back to see the
doctor.

Take special care with Co-amoxiclav

If you give more Co-amoxiclav than you should

Check with their doctor, pharmacist or nurse before giving your
child this medicine if they:

If you give your child too much Co-amoxiclav, signs might include
an upset stomach (feeling sick, being sick or diarrhoea) or
convulsions. Talk to their doctor as soon as possible. Take the
medicine bottle to show the doctor.



if they have ever had liver problems or jaundice (yellowing of
the skin) when taking an antibiotic.



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 your child, talk to
their doctor or pharmacist before giving Co-amoxiclav.
In some cases, your doctor may investigate the type of bacteria that
is causing your child’s infection. Depending on the results, your
child 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 your child is taking Co-amoxiclav, to reduce
the risk of any problems. See ‘Conditions you need to look out for’
in section 4.
Blood or urine tests
If your child is having blood tests (such as red blood cell status tests
or liver function tests) or urine tests, let the doctor or nurse know
that they 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 your child is taking or has recently
taken any other medicines. This includes medicines that can be
bought without a prescription and herbal medicines.


If your child is taking allopurinol (used for gout) with Coamoxiclav, it may be more likely that they will have an allergic
skin reaction.

If you forget to give Co-amoxiclav
If you forget to give your child a dose, give it as soon as you
remember. You should not give your child the next dose too soon,
but wait about 4 hours before giving the next dose.
If your child stops taking Co-amoxiclav
Keep giving your child Co-amoxiclav until the treatment is finished,
even if they feel better. Your child needs 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, pharmacist or nurse.
4

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although
not everybody gets them. The side effects below may happen with
this medicine.
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.



If your child is taking probenecid (used for gout), your doctor
may decide to adjust the dose of Co-amoxiclav.

 Contact a doctor immediately if your child gets any of these
symptoms. Stop taking Co-amoxiclav.



If medicines to help stop blood clots (such as warfarin) are
taken with Co-amoxiclav then extra blood tests may be needed.

Inflammation of large intestine



Co-amoxiclav can affect how methotrexate (a medicine used to
treat cancer or rheumatic diseases) works.

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



Co-amoxiclav may affect how mycophenolate mofetil (a
medicine used to prevent the rejection of transplanted organs)
works.

 Contact your doctor as soon as possible for advice if your
child gets these symptoms.

Very common side effects

6

These may affect more than 1 in 10 people

What Co-amoxiclav contains





Each 5ml contains amoxicillin trihydrate equivalent to 400mg
amoxicillin and potassium clavulanate equivalent to 57mg
clavulanic acid. Both of these ingredients are antibiotics and
together they are known as co-amoxiclav.



Co-amoxiclav Duo 400/57 also contains the following inactive
ingredients: xanthan gum, crospovidone, aspartame, silicon
dioxide, colloidal silica, magnesium stearate, sodium benzoate,
strawberry flavour and carmellose sodium.

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


CONENTS OF THE PACK AND OTHER INFORMATION

if affected take Co-amoxiclav before food



vomiting

What Co-amoxiclav looks like and contents of the pack



diarrhoea (in children).

Co-amoxiclav Duo 400/57 is provided as a clear glass bottle
containing an off-white powder with a 2.5/5ml measuring spoon.

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 blood tests:


Co-amoxiclav Duo 400/57 is available in 70 ml bottles
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, Middlesex, HA0 1DX.
Manufacturer
This product is manufactured by Glaxo Wellcome Production,
Terras II, Mayenne, France and/or SmithKline Beecham
Pharmaceuticals, Worthing, UK.

increase in some substances (enzymes) produced by the liver.
POM

PL No: 19488/0319

Rare side effects

Co-amoxiclav Duo
400/57 Oral Suspension

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 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)



Inflammation of the protective membrane surrounding the brain
(aseptic meningitis)



Serious skin reactions:


a widespread rash with blisters and peeling skin, particularly
around the mouth, nose, eyes and genitals (StevensJohnson 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).

Leaflet revision date: 03 February 2014
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.

 Contact a doctor immediately if your child gets any of
these symptoms.

4. You should not give antibiotics that were prescribed for you to
other people.



inflammation of the liver (hepatitis)



jaundice, caused by increases in the blood of bilirubin (a
substance produced in the liver) which may make your child’s
skin and whites of the eyes appear yellow

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.



inflammation of tubes in the kidney

Instructions for reconstitution



blood takes longer to clot



hyperactivity

Check cap seal is intact before using. Shake bottle to loosen
powder. Add volume of water (as indicated below). Invert and shake
well.



convulsions (in people taking high doses of Co-amoxiclav or
who have kidney problems)



black tongue which looks hairy

Alternatively, shake the bottle to loosen powder then fill the bottle
with water to just below the line on the bottle or label. Invert and
shake well, then top up with water exactly to the line.



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

Invert again and shake well.

Strength

Volume of water to
be added at
reconstitution (ml)

Final volume of
reconstituted oral
suspension (ml)

400 mg/57 mg/5 ml

32

35

64

70

127

140

Side effects that may show up in blood or urine tests:


severe reduction in the number of white blood cells



low number of red blood cells (haemolytic anaemia)



crystals in urine.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
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

Shake the bottle well before each dose.

By reporting side effects you can help provide more information on
the safety of this medicine.
5

HOW TO STORE CO-AMOXICLAV



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Store reconstituted suspensions in a refrigerator (2-8°C) but do
not freeze. Discard any remaining suspension after 7days and
return it to your pharmacist.



Do not use after the expiry date printed on the carton or bottle
label.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

S0319 LEAFLET Co-Amoxiclav Duo Suspension 20140203

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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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