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AUGMENTIN DUO 400/57 SUSPENSION

Active substance(s): AMOXICILLIN / CLAVULANIC ACID

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Ref: 1186/260218/1/F

®

Augmentin-Duo 400/57 Suspension
Co-amoxiclav (amoxicillin and clavulanic acid)
Patient Information Leaflet
Read all of this leaflet carefully before you start giving your child this
medicine because it contains important information for them.
* 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.
* 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.
Your medicine is called Augmentin-Duo 400/57 Suspension, but will be
referred to as Augmentin throughout this leaflet.
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

3

How to give Augmentin

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

Do not give your child Augmentin:
* if they are allergic to amoxicillin, clavulanic acid, penicillin or any of the
other ingredients of Augmentin (listed in section 6).
* if they have ever had a severe allergic reaction to any other antibiotic.
This can include a skin rash or swelling of the face or throat.
* 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.
Warnings and Precautions
Check with their doctor, pharmacist or nurse before giving your child
Augmentin if they:
* 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 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.

Pregnancy, breast-feeding and fertility
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
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.
Augmentin contains aspartame and maltodextrin
* 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

Always give Augmentin 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
* This suspension is not usually recommended for adults and children
weighing 40 kg and over.
Ask your doctor or pharmacist for advice.
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. Instructions on how to use the dosing syringe are
provided at the end of this leaflet.
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.
How to give Augmentin
* Always shake the bottle well before each dose
* Give with a meal
* 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
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.
If you forget to give Augmentin
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. Do not take a double dose to make up for a
forgotten dose.
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 medicine, ask your
doctor, pharmacist or nurse.

4
Blood and urine tests
If your child is 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 they are taking Augmentin. This is because Augmentin can affect
the results of these types of tests
Other medicines and Augmentin
Tell your doctor or pharmacist if your child is taking, has recently taken or
might take any other 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 can affect how mycophenolate mofetil (a medicine used to
prevent the rejection of transplanted organs) works.

How to give Augmentin

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 throat (angioedema), causing difficulty
in breathing
* collapse.
Contact a doctor immediately if your child gets any of these symptoms.
Stop taking Augmentin.

Ref: 1186/260218/1/B

®

Augmentin-Duo 400/57 Suspension
Co-amoxiclav (amoxicillin and clavulanic acid)
Patient Information Leaflet (continued)
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
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 give Augmentin with a meal
* 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 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 blood tests:
* low number of cells involved in blood clotting
* low number of white blood cells.
Frequency not known
Frequency cannot be estimated from the available data.
* 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 (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 your child gets 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 child’s 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 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 or by searching for MHRA Yellow Card in the
Google Play or Apple App Store.
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.
Dry Powder
in the original package in order to protect from moisture.
* Store
not store above 25°C.
* Do
not use this medicine after the expiry date which is stated on the
* Do
carton. The expiry date refers to the last day of that month.
Liquid suspension
in a refrigerator (2°C-8°C).
* Store
Do
not
freeze.
* Once made
up, the suspension should be used within 7 days.
* If this medicine
becomes discoloured or shows any other signs of
* deterioration, consult
your pharmacist who will tell you what to do.
* 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.

*

6

Contents of the pack and other information

What Augmentin contains
Each ml of oral suspension contains amoxicillin trihydrate equivalent to
80mg amoxicillin and potassium clavulanate equivalent to 11.4mg of
clavulanic acid. Both of these ingredients are antibiotics and together they
are known as co-amoxiclav.
The other ingredients in this medicine are: magnesium stearate, aspartame
(E951), crospovidone, xanthan gum, silicon dioxide, colloidal anhydrous
silica, sodium benzoate, carboxymethyl cellulose sodium, strawberry flavour
(including Maltodextrin).
What Augmentin looks like and contents of the pack
Augmentin-Duo is a clear, glass bottle containing an off-white, dry powder
for reconstitution in water. When reconstituted, an off-white suspension is
formed. The bottle is supplied with a plastic 5ml measuring spoon.
The 70 ml bottle is supplied in a carton.
Powder for oral suspension
Manufacturer and Licence Holder
Augmentin-Duo is manufactured by SmithKline Beecham Pharmaceuticals,
Clarendon Road, Worthing, West Sussex, BN14 8QH and is procured from
within the EU and 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 15184/1186

Augmentin-Duo 400/57mg Suspension

Augmentin-Duo is a registered trademark of GlaxoSmithKline group of
companies
Revision date: 26/02/18

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you
Advice/medical education
Antibiotics are used to treat infections caused by bacteria. They have no
effect against infections caused by viruses.
Sometimes an infection caused by bacteria does not respond to a course of
an antibiotic. One of the commonest reasons for this to occur is because
the bacteria causing the infection are resistant to the antibiotic that is being
taken. This means that they can survive and even multiply despite the
antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Using
antibiotics carefully can help to reduce the chance of bacteria becoming
resistant to them.
When your doctor prescribes a course of an antibiotic it is intended to treat
only your current illness. Paying attention to the following advice
will help prevent the emergence of resistant bacteria that could stop the
antibiotic working.
1. It is very important that you take the antibiotic at the right dose, at the
right times and for the right number of days. Read the instructions on
the label and if you do not understand anything ask your doctor or
pharmacist to explain.
2. You should not take an antibiotic unless it has been prescribed specifically
for you and you should use it only to treat the infection for which it was
prescribed.
3. You should not take antibiotics that have been prescribed for other people
even if they had an infection that was similar to yours.
4. You should not give antibiotics that were prescribed for you to other
people.
5. If you have any antibiotic left over when you have taken the course as
directed by your doctor you should take the remainder to a pharmacy
for appropriate disposal.

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

400 mg/57 mg/5 ml

Volume of water to be added
at reconstitution (ml)

32

Final volume of
reconstituted oral
suspension (ml)
35

64

70

127

140

Alternatively, shake 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 and again shake well.

Ref: 1186/260218/2/F

Co-amoxiclav 400/57 Suspension
(amoxicillin and clavulanic acid)
Patient Information Leaflet
Read all of this leaflet carefully before you start giving your child this
medicine because it contains important information for them.
* 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.
* 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.

Driving and using machines
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.
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.

Your medicine is called Co-amoxiclav-Duo 400/57 Suspension, but will be
referred to as Co-amoxiclav throughout this leaflet.
What is in this leaflet:
1

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

What you need to know before you give
Co-amoxiclav

Do not give your child Co-amoxiclav:
* if they are allergic to amoxicillin, clavulanic acid, penicillin or any of the
other ingredients of Co-amoxiclav (listed in section 6).
* if they have ever had a severe allergic reaction to any other antibiotic.
This can include a skin rash or swelling of the face or throat.
* if they have ever had liver problems or jaundice (yellowing of the skin)
when taking an antibiotic.
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.
Warnings and Precautions
Check with their doctor, pharmacist or nurse before giving your child
Co-amoxiclav if they:
* 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 and urine tests
If your child is 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 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, has recently taken or
might take any other medicines.
* If your child is taking allopurinol (used for gout) with Co-amoxiclav, 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 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.
* Co-amoxiclav can affect how mycophenolate mofetil (a medicine used to
prevent the rejection of transplanted organs) works.
Pregnancy, breast-feeding and fertility
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.

3

How to give Co-amoxiclav

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
* This suspension is not usually recommended for adults and children
weighing 40 kg and over.
Ask your doctor or pharmacist for advice.
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. Instructions on how to use the dosing syringe are
provided at the end of this leaflet.
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.
How to give Co-amoxiclav
* Always shake the bottle well before each dose
* Give with a meal
* 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 Co-amoxiclav for more than 2 weeks. If your child
still feels unwell they should go back to see the doctor.
If you give more Co-amoxiclav than you should
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 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. Do not take a double dose to make up for a
forgotten 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 medicine, 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 throat (angioedema), causing difficulty
in breathing
* collapse.
Contact a doctor immediately if your child gets 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 your child gets
these symptoms.
Very common side effects
These may affect more than 1 in 10 people
* diarrhoea (in adults).

Ref: 1186/260218/2/B

®

Co-amoxiclav 400/57 Suspension
(amoxicillin and clavulanic acid)
Patient Information Leaflet (continued)
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 give Co-amoxiclav with a meal
* 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 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 blood tests:
* low number of cells involved in blood clotting
* low number of white blood cells.
Frequency not known
Frequency cannot be estimated from the available data.
* 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 (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 your child gets 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 child’s 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 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 or by searching for MHRA Yellow Card in the
Google Play or Apple App Store.
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.
Dry Powder
in the original package in order to protect from moisture.
* Store
Do
not
above 25°C.
* Do not store
this medicine after the expiry date which is stated on the
* carton. use
The expiry date refers to the last day of that month.
Liquid suspension
in a refrigerator (2°C-8°C).
* Store
not freeze.
* Do
made up, the suspension should be used within 7 days.
* Once
If this medicine becomes discoloured or shows any other signs of
* deterioration,
consult your pharmacist who will tell you what to do.
* 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.

6

Contents of the pack and other information

What Co-amoxiclav contains
Each ml of oral suspension contains amoxicillin trihydrate equivalent to
80mg amoxicillin and potassium clavulanate equivalent to 11.4mg of
clavulanic acid. Both of these ingredients are antibiotics and together they
are known as co-amoxiclav.
The other ingredients in this medicine are: magnesium stearate, aspartame
(E951), crospovidone, xanthan gum, silicon dioxide, colloidal anhydrous
silica, sodium benzoate, carboxymethyl cellulose sodium, strawberry flavour
(including Maltodextrin).
What Co-amoxiclav looks like and contents of the pack
Co-amoxiclav-Duo is a clear, glass bottle containing an off-white, dry powder
for reconstitution in water. When reconstituted, an off-white suspension is
formed. The bottle is supplied with a plastic 5ml measuring spoon.
The 70 ml bottle is supplied in a carton.
Powder for oral suspension
Manufacturer and Licence Holder
Co-amoxiclav-Duo is manufactured by SmithKline Beecham
Pharmaceuticals, Clarendon Road, Worthing, West Sussex, BN14 8QH and
is procured from within the EU and 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 15184/1186

Co-amoxiclav-Duo 400/57mg Suspension

Co-amoxiclav-Duo is a registered trademark of GlaxoSmithKline group of
companies
Revision date: 26/02/18

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Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you
Advice/medical education
Antibiotics are used to treat infections caused by bacteria. They have no
effect against infections caused by viruses.
Sometimes an infection caused by bacteria does not respond to a course of
an antibiotic. One of the commonest reasons for this to occur is because
the bacteria causing the infection are resistant to the antibiotic that is being
taken. This means that they can survive and even multiply despite the
antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Using
antibiotics carefully can help to reduce the chance of bacteria becoming
resistant to them.
When your doctor prescribes a course of an antibiotic it is intended to treat
only your current illness. Paying attention to the following advice
will help prevent the emergence of resistant bacteria that could stop the
antibiotic working.
1. It is very important that you take the antibiotic at the right dose, at the
right times and for the right number of days. Read the instructions on
the label and if you do not understand anything ask your doctor or
pharmacist to explain.
2. You should not take an antibiotic unless it has been prescribed specifically
for you and you should use it only to treat the infection for which it was
prescribed.
3. You should not take antibiotics that have been prescribed for other people
even if they had an infection that was similar to yours.
4. You should not give antibiotics that were prescribed for you to other
people.
5. If you have any antibiotic left over when you have taken the course as
directed by your doctor you should take the remainder to a pharmacy
for appropriate disposal.

*

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

400 mg/57 mg/5 ml

Volume of water to be added
at reconstitution (ml)

Final volume of
reconstituted oral
suspension (ml)

32

35

64

70

127

140

Alternatively, shake 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 and again shake well.

+ Expand Transcript

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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