CO-AMOXICLAV 400/57 ORAL SUSPENSION

Active substance: CLAVULANIC ACID

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S0319 LEAFLET Augmentin Duo Suspension 20110509

PACKAGE LEAFLET: INFORMATION FOR THE USER
AUGMENTIN DUO 400/57 SUSPENSION
(co-amoxiclav (amoxicillin and clavulanic acid))
Your medicine is known as Augmentin Duo 400/57 Suspension but
will be referred to as Augmentin throughout the following leaflet.

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.
Using other medicines
Please 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.

Read all of this leaflet carefully before you start giving your
child this medicine.


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





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

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





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 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.



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 give Augmentin
3. How to give Augmentin

Pregnancy and breast-feeding
If your child who is about to take this medicine is pregnant or
breast-feeding, please tell your doctor or pharmacist.
Ask your doctor or pharmacist for advice before taking any
medicine.
Important information about some of the ingredients of
Augmentin


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.

4. Possible side effects
5. How to store Augmentin
6. Further 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:

3. HOW TO TAKE AUGMENTIN
Always give 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 or over


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



middle ear and sinus infections

Children weighing less than 40 kg



respiratory tract infections



urinary tract infections

All doses are worked out depending on the child’s bodyweight in
kilograms.



skin and soft tissue infections including dental infections





bone and joint infections.

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



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



Usual 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.

2. BEFORE YOU TAKE AUGMENTIN
Do not give your child Augmentin:


if they are allergic (hypersensitive) 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.



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 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.

Patients with kidney and liver problems

How to give Augmentin
Take special care with Augmentin



Always shake the bottle well before each dose

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



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.



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.

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.
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 or pharmacist.

4. POSSIBLE SIDE EFFECTS



Like all medicines, Augmentin 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.



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

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

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



black tongue which looks hairy



collapse.



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

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
These may affect more than 1 in 10 people


diarrhoea (in adults).

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.

If your child gets 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 AUGMENTIN


Common side effects
These may affect up to 1 in 10 people


thrush (candida - a yeast infection of the vagina, mouth or skin
folds)



KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT
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.

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

6. FURTHER INFORMATION



skin rash, itching

What Augmentin contains



raised itchy rash (hives)





indigestion



dizziness



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.

headache.



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.

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)

What Augmentin looks like and contents of the pack
Augmentin Duo 400/57 is provided as a clear glass bottle
containing an off-white powder with a 2.5/5ml measuring spoon.
Augmentin Duo 400/57 is available in 70 ml bottles

if you notice any of these symptoms contact a doctor urgently.

Rare side effects that may show up in blood tests:

Product Licence holder



low number of cells involved in blood clotting



low number of white blood cells.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, Middlesex, HA0 1DX.

Other side effects

Manufacturer

Other side effects have occurred in a very small number of people
but their exact frequency is unknown.

This product is manufactured by Glaxo Wellcome Production,
Terras II, Mayenne, France.



Allergic reactions (see above)



Inflammation of the large intestine (see above)



Serious skin reactions:



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).

POM

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

Leaflet revision date: 09 May 2011
Augmentin is a registered trademark of the GlaxoSmithKline group
of companies

S0319 LEAFLET Augmentin Duo Suspension 20110509

S0319 LEAFLET Co-Amoxiclav Duo Suspension 20110509

PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-AMOXICLAV DUO 400/57 ORAL SUSPENSION
Your medicine is known as Co-amoxiclav Duo 400/57 Oral
Suspension but will be referred to as Co-amoxiclav throughout the
following leaflet.

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.
Using other medicines
Please 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.

Read all of this leaflet carefully before you start giving your
child this medicine.


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





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

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





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 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.



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 Co-amoxiclav is and what it is used for
2. Before you give Co-amoxiclav
3. How to give Co-amoxiclav

Pregnancy and breast-feeding
If your child who is about to take this medicine is pregnant or
breast-feeding, please tell your doctor or pharmacist.
Ask your doctor or pharmacist for advice before taking any
medicine.
Important information about some of the ingredients of Coamoxiclav


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.

4. Possible side effects
5. How to store Co-amoxiclav
6. Further 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:

3. HOW TO TAKE CO-AMOXICLAV
Always give 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 or over


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



middle ear and sinus infections



Children weighing less than 40 kg

respiratory tract infections



urinary tract infections

All doses are worked out depending on the child’s bodyweight in
kilograms.



skin and soft tissue infections including dental infections





bone and joint infections.

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



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



Usual 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.

2. BEFORE YOU TAKE CO-AMOXICLAV
Do not give your child Co-amoxiclav:


if they are allergic (hypersensitive) 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



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.
Take special care with Co-amoxiclav
Check with their doctor or pharmacist before giving your child this
medicine 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.

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 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 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.
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 or pharmacist.

4. POSSIBLE SIDE EFFECTS



Like all medicines, Co-amoxiclav 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.



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

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

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



black tongue which looks hairy



collapse.



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

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).

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.

If your child gets 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 CO-AMOXICLAV


Common side effects
These may affect up to 1 in 10 people


thrush (candida - a yeast infection of the vagina, mouth or skin
folds)



KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT
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.

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

6. FURTHER INFORMATION



skin rash, itching

What Co-amoxiclav contains



raised itchy rash (hives)





indigestion



dizziness



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.

headache.



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.

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)

What Co-amoxiclav looks like and contents of the pack
Co-amoxiclav Duo 400/57 is provided as a clear glass bottle
containing an off-white powder with a 2.5/5ml measuring spoon.
Co-amoxiclav Duo 400/57 is available in 70 ml bottles

if you notice any of these symptoms contact a doctor urgently.

Rare side effects that may show up in blood tests:

Product Licence holder



low number of cells involved in blood clotting



low number of white blood cells.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, Middlesex, HA0 1DX.

Other side effects

Manufacturer

Other side effects have occurred in a very small number of people
but their exact frequency is unknown.

This product is manufactured by Glaxo Wellcome Production,
Terras II, Mayenne, France.



Allergic reactions (see above)



Inflammation of the large intestine (see above)



Serious skin reactions:



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).

POM

PL No: 19488/0319

Co-amoxiclav Duo
400/57 Oral Suspension

Leaflet revision date: 09 May 2011

S0319 LEAFLET Co-Amoxiclav Duo Suspension 20110509

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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