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AMOXIL PAEDIATRIC SUSPENSION

Active substance(s): AMOXYCILLIN TRIHYDRATE

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PHARMA CODE READING DIRECTION

1
5127783031
GSK-FRA-Mayenne (Terras 2)-FRMAY

• D
 o not use this medicine if there are visible
signs of deterioration.
• Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help protect
the environment.

6 Contents of the pack and other
information

United Kingdom-GBR

What Amoxil contains
• The active substance in each suspension is
125 mg amoxicillin.
• The other ingredients are:
Carboxymethylcellulose Sodium 12,
Lemon-Peach-Strawberry Dry Flavour,
Crospovidone, Aspartame (E951), Sodium
Benzoate (E211), Xanthan Gum (E415), Silica
Hydrophobic Colloidal Magnesium Stearate.

Amoxil
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What Amoxil looks like and contents of the
pack
Amoxil 125 mg/1.25 ml Powder for Oral Suspension
is a white powder with yellowish grains filled into
clear glass bottles with a nominal volume of 45 ml
(for a 20 ml presentation). The bottles are packaged
in a carton with a dosing syringe.
Not all pack sizes may be marketed.

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Marketing authorisation holder and
manufacturer
Marketing Authorisation Holder: Beecham Group plc,
Stockley Park West, Uxbridge, Middlesex UB11 1BT
Manufacturer: Glaxo Wellcome Production, Z.I. de
la Peyenniere, 53100 Mayenne, France

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Other formats
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 Amoxil Paediatric
Suspension
Reference number 00038/0107
This is a service provided by the Royal National
Institute of Blind People.
This leaflet was last revised in September 2015.
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Amoxil is a registered trade mark of the GSK
group of companies.

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General advice regarding the use of
antibiotics
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 use.
Invert and shake bottle to loosen powder.
Fill the bottle with water to just below the mark
on the bottle label.
Invert and shake well, then top up with water to
the mark. Invert and shake again
Shake well before taking each dose.

© 2015 GSK group of companies. All rights
reserved.

Package leaflet: Information for the user

Amoxil® Paediatric Suspension 125 mg per 1.25 ml
amoxicillin

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you (or
for your child) only. Do not pass it on to others.
It may harm them, even if their signs of illness
are the same as yours.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

• if you have ever had an allergic reaction to any
antibiotic. This can include a skin rash or
swelling of the face or throat.

What is in this leaflet
1. What Amoxil is and what it is used for
2. What you need to know before you take Amoxil
3. How to take Amoxil
4. Possible side effects
5. How to store Amoxil
6. Contents of the pack and other information

If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking Amoxil.

1 
What Amoxil is and what it is
used for
What Amoxil is
Amoxil is an antibiotic. The active ingredient is
amoxicillin. This belongs to a group of medicines
called ‘penicillin’.
What Amoxil is used for
Amoxil is used to treat infections caused by
bacteria in different parts of the body. Amoxil may
also be used in combination with other medicines
to treat stomach ulcers.

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What you need to know before
you take Amoxil
Do not take Amoxil:
• if you are allergic to amoxicillin, penicillin or
any of the other ingredients of this medicine
(listed in section 6).

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Do not take Amoxil if any of the above apply. If
you are not sure, talk to your doctor or pharmacist
before taking Amoxil.
Warnings and Precautions
Talk to your doctor or pharmacist before taking
Amoxil if you:
• have glandular fever (fever, sore throat,
swollen glands and extreme tiredness)
• have kidney problems
• are not urinating regularly.

Blood and urine tests
If you are having:
• Urine tests (glucose) or blood tests for liver
function
• Oestriol tests (used during pregnancy to check
the baby is developing normally)
Tell your doctor or pharmacist that you are taking
Amoxil. This is because Amoxil can affect the
results of these tests.
Other medicines and Amoxil
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
• If you are taking allopurinol (used for gout)
with Amoxil, it may be more likely that you will
have an allergic skin reaction.
• If you are taking probenecid (used for gout),
your doctor may decide to adjust your dose of
Amoxil.
• If you are taking medicines to help stop blood
clots (such as warfarin), you may need extra
blood tests.
• If you are taking other antibiotics (such as
tetracycline) Amoxil may be less effective.
• If you are taking methotrexate (used for the
treatment of cancer and severe psoriasis)
Amoxil may cause an increase in side effects.

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Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.

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Driving and using machines
Amoxil can have side effects and the symptoms
(such as allergic reactions, dizziness and
convulsions) may make you unfit to drive.
Do not drive or operate machinery unless you are
feeling well.

GSK-FRA-Mayenne (Terras 2)-FRMAY
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Amoxil contains aspartame, maltodextrin and
sodium benzoate
• Aspartame (E951) is a source of phenylalanine.
This may be harmful for patients with a
condition called ’phenylketonuria’.
• Maltodextrin is absorbed as glucose. If you
have been told by your doctor that you have
an intolerance to some sugars, contact your
doctor before taking this medicinal product.
• S odium benzoate (E211) is a mild irritant to
the eyes, skin and mucous membrane and can
cause an increased risk of jaundice in new
born babies.

3 How to take Amoxil
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.

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• S hake bottle well before each dose.
• Space the doses evenly during the day, at least
4 hours apart
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If you take more Amoxil than you should
If you have taken too much Amoxil, signs might be
an upset stomach (feeling sick, being sick or
diarrhoea) or crystals in the urine, which may be
seen as cloudy urine, or problems urinating. Talk
to your doctor as soon as possible. Take the
medicine to show the doctor.
If you forget to take Amoxil
• If you forget to take a dose, take it as soon as
you remember.
• Do not take the next dose too soon, wait about
4 hours before taking the next dose.
• Do not take a double dose to make up for a
forgotten dose.
How long should you take Amoxil for?
• Keep taking Amoxil for as long as your doctor
has told you to, even if you feel better. You
need every dose to help fight the infection. If
some bacteria survive they can cause the
infection to come back.
• Once you finish treatment, if you still feel
unwell you should go back to see the doctor.
Thrush (a yeast infection of moist areas of the
body which can cause soreness, itching and white
discharge) may develop if Amoxil is used for a
long time. If this occurs tell your doctor.
If you take Amoxil for a long time, your doctor
may perform additional tests to check your
kidneys, liver and blood are working normally.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4 Possible side effects

The usual dose is:
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 Amoxil
you should give to your baby or child.
• The usual dose is 40 mg to 90 mg for each
kilogram of body weight a day given in two or
three divided doses.
• The maximum recommended dose is 100 mg
for each kilogram of body weight a day.

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Adults, elderly patients and children
weighing 40 kg or more
This suspension is not usually prescribed for adults
and children weighing more than 40 kg. Ask your
doctor or pharmacist for advice.
Kidney problems
If you have kidney problems the dose might be
lower than the usual dose.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop taking Amoxil and see a doctor straight
away, if you notice any of the following
serious side effects – you may need urgent
medical treatment:
The following are very rare (may affect up to 1 in
10,000 people)
• a llergic reactions, the signs may include: skin
itching or rash, swelling of the face, lips,
tongue, body or breathing difficulties. These
can be serious and occasionally deaths have
occurred
• rash or pinpoint flat red round spots under the
skin surface or bruising of the skin. This is due
to inflammation of blood vessel walls due to
an allergic reaction. It can be associated with
joint pain (arthritis) and kidney problems

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• a delayed allergic reaction can occur usually
7 to 12 days after having Amoxil, some signs
include: rashes, fever, joint pains and
enlargement of the lymph nodes especially
under the arms
• a skin reaction known as ‘erythema
multiforme’ where you may develop: itchy
reddish purple patches on the skin especially
on the palms of the hands or soles of the feet,
‘hive-like’ raised swollen areas on the skin,
tender areas on the surfaces of the mouth,
eyes and genitals. You may have a fever and be
very tired
• other severe skin reactions can include:
changes in skin colour, bumps under the skin,
blistering, pustules, peeling, redness, pain,
itching, scaling. These may be associated with
fever, headaches and body aches
• fever, chills, a sore throat or other signs of an
infection, or if you bruise easily. These may be
signs of a problem with your blood cells
• the Jarisch-Herxheimer reaction which occurs
during treatment with Amoxil for Lyme disease
and causes fever, chills, headache, muscle pain
and skin rash.
• inflammation of the large bowel (colon) with
diarrhoea (sometimes containing blood), pain
and fever
• serious liver side effects may occur. They are
mainly associated with people having treatment
over a long period, males and the elderly. You
must tell your doctor urgently if you get:
o severe diarrhoea with bleeding
o blisters, redness or bruising of the skin
o darker urine or paler stools
o yellowing of the skin or the whites of the
eyes (jaundice). See also anaemia below
which might result in jaundice.
These can happen when having the medicine or
for up to several weeks after.
If any of the above happens stop taking the
medicine and see your doctor straight away.
Sometimes you may get less severe skin
reactions such as:
• a mildly itchy rash (round, pink-red patches),
‘hive-like’ swollen areas on forearms, legs,
palms, hands or feet. This is uncommon (may
affect up to 1 in 100 people).
If you have any of these talk to your doctor
as Amoxil will need to be stopped.
The other possible side effects are:
Common (may affect up to 1 in 10 people)
• skin rash

• feeling sick (nausea)
• diarrhoea.
Uncommon (may affect up to 1 in 100 people)
• being sick (vomiting).
Very rare (may affect up to 1 in 10,000 people)
• thrush (a yeast infection of the vagina, mouth
or skin folds), you can get treatment for thrush
from your doctor or pharmacist
• kidney problems
• fits (convulsions), seen in patients on high
doses or with kidney problems
• dizziness
• hyperactivity
• crystals in the urine, which may be seen as
cloudy urine, or difficulty or discomfort in
passing urine. Make sure you drink plenty of
fluids to reduce the chance of these symptoms
• teeth may appear stained, usually returning to
normal with brushing (this has been reported
in children)
• the tongue may change to yellow, brown or
black and it may have a hairy appearance
• an excessive breakdown of red blood cells
causing a type of anaemia. Signs include:
tiredness, headaches, shortness of breath,
dizziness, looking pale and yellowing of the
skin and the whites of the eyes
• low number of white blood cells
• low number of cells involved with blood
clotting
• the blood may take longer to clot than it
normally would. You may notice this if you
have a nosebleed or cut yourself.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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.

5 How to store Amoxil
• K
 eep this medicine out of the sight and reach
of children.
• 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.
• Dry powder: Do not store above 25°C.
• Liquid suspension: Do not store above 25°C.
Once made up, the suspension should be used
within 14 days.

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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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