Skip to Content

AUGMENTIN DUO 400/57

Active substance(s): AMOXICILLIN TRIHYDRATE / POTASSIUM CLAVULANATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PHARMA CODE N° 6661

3

1000000
0141561

10000000141561
Package Leaflet: Information for the User

GSK-GBR-Worthing-UKWOR

AUGMENTIN DUO® 400/57
co-amoxiclav (amoxicillin and clavulanic acid)

United Kingdom-GBR

2 What you need to know before
you give Augmentin

Augmentin

Do not give your child Augmentin:

N/A

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

LF035

• 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.

N/A
N/A
1
K

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

0

1 What Augmentin is and what it is
used for

0

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 8.3pt

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.

• 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.

Take special care with Augmentin

Check with their doctor, pharmacist or nurse
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 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.

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

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

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

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 How to 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.

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 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

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, 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:

Other side effects

• 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.
➜➜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).

Common side effects

These may affect up to 1 in 10 people
• thrush (candida - a yeast infection of the
vagina, mouth or skin folds)
• feeling sick (nausea), especially when taking
high doses
- if affected take Augmentin before food
• vomiting
• diarrhoea (in children).

Uncommon side effects

These may affect up to 1 in 100 people
• skin rash, itching
• raised itchy rash (hives)
• indigestion
• dizziness
• headache.
Uncommon side effects that may show up in
blood tests:
• increase in some substances (enzymes)
produced by the liver.

Rare side effects

➜➜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 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 (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

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

Leading: 9pt
Horizontal Scale: 90%

PAGE 1

PAGE 2

PAGE 3

Smallest text size: 8.3pt
Microtext: No

Page 1 of 2

3
10000000141561

Other formats

5 How to store Augmentin
Keep this medicine out of the sight and reach
of children.

GSK-GBR-Worthing-UKWOR

Dry Powder

Store in the original package in order to
protect from moisture.
Do not store above 25°C.
Do not use this medicine after the expiry date
which is stated on the carton. The expiry date
refers to the last day of that month.

United Kingdom-GBR
Augmentin

Liquid suspension

Store in a refrigerator (2°C - 8°C)
Do not freeze.
Once made up, the suspension should be used
within 7 days.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away any medicines you no longer use.
These measures will help protect the environment.

N/A
LF035

N/A

6 Contents of the pack and other
information

N/A

What Augmentin contains

• The active substances are amoxicillin and
clavulanic acid. Each millilitre (ml) of
suspension contains amoxicillin trihydrate
equivalent to 80 mg amoxicillin and
potassium clavulanate equivalent to 11.4 mg
of clavulanic acid.
• The other ingredients are magnesium
stearate, aspartame (E951), crospovidone,
xanthan gum, silicon dioxide, colloidal
anhydrous silica, sodium benzoate,
carboxymethyl cellulose sodium, strawberry
flavour (including maltrodextrin).
• See also section 2.

1
K

0

What Augmentin looks like and contents
of the pack

0

Augmentin 400 mg/57 mg/5 ml (strawberry
flavour) powder for oral suspension is an
off-white powder supplied in a clear glass
bottle 147, 190 or 200 ml with an aluminium
roll-on pilfer proof (ROPP) cap with an internal
lacquer and polyvinyl chloride (PVC) or
polyolefin liner. Once made up, the bottle
contains 35 ml, 70 ml or 140 ml of an off-white
liquid mixture called a suspension.
Not all pack sizes may be marketed.

Marketing authorisation holder and
manufacturer

TEXT SIZE CONTAINED IN THIS ARTWORK

Marketing Authorisation Holder: SmithKline
Beecham Ltd, Stockley Park West, Uxbridge,
Middlesex UB11 1BT
Manufacturer: SmithKline Beecham, Worthing,
West Sussex BN14 8QH

To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free of
charge:

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
Augmentin Duo 400/57
Reference number
10592/0070
This is a service provided by the Royal National
Institute of Blind People.
This leaflet was last revised in June 2016.
Augmentin Duo is a registered trade mark of
the GSK group of companies.
© 2016 GSK group of companies. All rights
reserved.

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
64
127

5. Place bottle upright and remove syringe.
6. To give the dose, carefully put the tip of the syringe into the mouth and slowly push down on
the plunger of the syringe (repeat steps 4, 5 and 6 if more than one syringe is needed to
deliver the dose).

Final volume of reconstituted oral
suspension (ml)
35
70
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.
Instructions for using the syringe
A syringe is supplied to administer Augmentin
The syringe is only for use with Augmentin and must not be used to administer any other
medicines, because the markings are specific to this product. The syringe is supplied with an
adaptor which allows it to attach to the bottle.
The dose is indicated on the oral dosing syringe in millilitres (ml). You should give your child the
dose recommended by their doctor.
Check cleanliness of syringe and adaptor before use, rinse with clean water if required.
1. Shake the bottle well before each dose.
2. Remove the bottle cap.

3. Remove adaptor from syringe. Hold the bottle firmly and insert the adaptor into the neck of
the bottle (the adaptor should remain in place).
Insert the syringe into the adaptor ensuring it is secure.

7. Rinse syringe thoroughly in clean water. Allow the syringe to
dry completely before next use.

8. Replace the bottle cap.

Store in a refrigerator and always shake before use.
Once made up, the suspension should be used within 7 days.

4. Invert bottle holding the syringe in place and withdraw the required dose as indicated by your
doctor.

1000000
0141561

Body text size: 8.3pt
Leading: 9pt
Horizontal Scale: 90%

PAGE 4

PAGE 5

PAGE 6

Smallest text size: 8.3pt
Microtext: No

Page 2 of 2

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.

Hide