AMOXIL PAEDIATRIC SUSPENSION

Active substance: AMOXYCILLIN TRIHYDRATE

View full screen / Print PDF » Download PDF ⇩

Transcript
PHARMA CODE REF: 809

• 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 form of anaemia. Signs include:
tiredness, headaches, shortness of breath,
dizziness, looking pale and yellowing of the skin
and the whites of the eyes
• the blood may take longer to clot than it
normally would. You may notice this if your child
has a nosebleed or cuts themself.
If any of the side effects gets serious, or if your
child has any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5 How to store Amoxil
• Keep out of the reach and sight of children.
• The expiry date which is stated on the label is
for the pharmacist’s use. The pharmacist will
have made up your medicine. It should be used
within 14 days.
• Do not store above 25°C.
• 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.

1000000
0083684

6 Further information
What Amoxil contains
• The active substance is 125 mg amoxicillin in
each 1.25 ml.
• The other ingredients are sodium benzoate (E211),
sodium carboxymethylcellulose (E466), peach,
strawberry and lemon dry flavours and sucrose.
The pharmacist will add water or syrup. Amoxil is
citrus flavoured.
• See also Important information about some
of the ingredients of Amoxil in section 2.

Package Leaflet: Information for the Parent or Carers of Children
®

Amoxil Paediatric Suspension 125 mg per 1.25 ml
amoxicillin

2 Before you give Amoxil
Do not give your child Amoxil if they:

What Amoxil looks like and contents of the
pack
Your child’s Amoxil comes in a bottle containing
20 ml of an off-white liquid mixture, called a
suspension. It also contains a syringe for giving this
medicine to your child.

Marketing authorisation holder and
manufacturer
Marketing Authorisation Holder: GlaxoSmithKline
UK, Stockley Park West, Uxbridge,
Middlesex UB11 1BT
Manufacturer: SmithKline Beecham, Worthing,
West Sussex BN14 8QH

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.
Leaflet date: September 2010
Amoxil is a registered trademark of the
GlaxoSmithKline group of companies
© 2010 GlaxoSmithKline group of companies

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.
• The medicine is usually prescribed for a child
under 10 years. Do not pass it on to others.
It may harm them, even if their symptoms are
the same as your child’s.
• 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 Amoxil is and what it is used for
2 Before you give Amoxil
3 How to give Amoxil
4 Possible side effects
5 How to store Amoxil
6 Further information

• are allergic (hypersensitive) to amoxicillin,
penicillin or any of the other ingredients of
Amoxil (listed in section 6)
• have ever had an allergic (hypersensitive)
reaction to any antibiotic. This can include
a skin rash or swelling of the face or neck.
Do not give Amoxil to your child if any of the above
apply. If you are not sure, talk to their doctor or
pharmacist before giving Amoxil.

Take special care with Amoxil
Check with their doctor or pharmacist before giving
your child this medicine if they:
• have glandular fever (a viral infection which
causes a sore throat, high temperature
(above 39°C) (102.2°F)), tiredness, muscle pains
and headache
• are being treated for 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 Amoxil.

Having urine or blood tests

1 What Amoxil is and
what it is used for
What Amoxil is
Amoxil Paediatric Suspension (called Amoxil in
this leaflet) is an antibiotic. It contains a medicine
called amoxicillin. This belongs to a group of
medicines called ‘penicillins’.

What Amoxil is used for
Amoxil is used to treat infections in different parts
of the body caused by bacteria. It is also used to
stop infections when you have a tooth removed or
other surgery.

If your child is having tests on their water (urine
glucose tests) or blood tests for liver function,
let the doctor or nurse know that they are on
Amoxil. This is because Amoxil can affect the
results of these tests.

Taking 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. This is because
Amoxil can affect the way some other medicines
work. Also some other medicines can affect the
way Amoxil works.

PAGE 1 OF 2
Page 4

Page 1

• If your child is taking allopurinol (used for gout)
with Amoxil, 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 their dose of
Amoxil.
• If medicines to help stop blood clots (such as
warfarin) are taken with Amoxil then extra blood
tests may be needed.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice if your
daughter who is about to take this medicine is
taking the contraceptive pill, pregnant or
breast-feeding.

To stop infection during surgery
• If your child is having Amoxil to stop infections,
the dose will be 50 mg for each kilogram body
weight in a single dose, given one hour before
the surgery. Other medicines may also be given
at the same time.
• Your doctor, pharmacist or nurse can give you
more details.

Adults and children weighing more
than 40 kg
This suspension is not
usually prescribed for
adults and children
weighing more than
40 kg. Ask your doctor or
pharmacist for advice.

Important information about some of
the ingredients of Amoxil
• Amoxil contains sucrose (0.6 g/1.25 ml dose).
If you have been told by your doctor that your
child has an intolerance to some sugars, see your
doctor before giving Amoxil to your child.
• Amoxil contains sodium (0.4 mg/1.25 ml dose).
This should be considered if your child is on a
controlled sodium diet.
• Amoxil contains sodium benzoate (E211).
Sodium benzoate may irritate the skin, eyes
and mucous membranes.

3 How to give Amoxil
Always give Amoxil exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.

Kidney problems
If your child has kidney problems the dose
might be lower than the usual dose.

How to give Amoxil
1 Shake the bottle well before each use
2 Unscrew the cap
3 Using the provided syringe draw up the required
dose
4 Put the medicine onto your child’s tongue using
the syringe until all the medicine in the syringe
has been pushed out
5 Wash out the syringe with water. Shake to
remove any drops of water.

If you give too much Amoxil

When giving Amoxil
• Always shake the bottle well before each dose.
• Use the syringe provided to measure the dose.
• Give at the start of a meal or slightly before
unless the label specifies particular times.
• Space the doses evenly during the day, at least
4 hours apart.
• Never give 2 doses in 1 hour.
• Do not give doses of Amoxil at night.
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.
• Usual dose – 40 mg to 90 mg for each kilogram
of body weight a day, given in two or three
divided doses.

If your child has 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 passing urine.
Talk to their doctor as soon as possible. Take the
medicine bottle to show the doctor.

If you forget to give Amoxil
• If you forget to give a dose don’t worry, give it
as soon as you remember.
• Don’t give your child the next dose too soon,
wait about 4 hours before giving the next dose.

How long should your child take Amoxil
for?
• Keep giving your child Amoxil 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. Treatment
should be continued for 2 to 3 days after the
symptoms have gone.

• Your child should not need to take Amoxil for
more than 2 weeks. If your child still feels unwell
they should go back to see the doctor.
Thrush (a yeast infection of moist areas of the body)
may develop if Amoxil is used for a long time. If this
occurs and your child has been taking Amoxil for
longer than recommended, tell your doctor.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, Amoxil can cause side effects,
although not everybody gets them. The following
side effects may happen with this medicine:
Stop giving your child Amoxil and see a
doctor straight away, if you notice any of
the following serious side effects – they may
need urgent medical treatment:
The following are very rare
(affects less than 1 in 10,000 people)
• allergic 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
• 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 your child 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 private parts.
Your child 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
• high temperature (fever), chills, a sore throat
or other signs of an infection, or if they bruise
easily. These may be signs of a problem with
their blood cells
• inflammation of the large bowel (colon) with
diarrhoea sometimes containing blood, pain
and fever

• serious liver side effects may occur which are
often reversible. They are mainly associated with
people having treatment over a long period,
males and the elderly. You must tell your doctor
urgently if your child gets:
- severe diarrhoea with bleeding
- blisters, redness or bruising of the skin
- darker urine or paler stools
- 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 happen to your child
stop giving them the medicine and see your
doctor straight away.
Sometimes your child may get less severe
skin reactions such as:
• a mildly itchy rash (round, pink-red patches),
‘hive-like’ swollen areas on their forearms,
legs, palms, hands or feet. This is uncommon
(affects less than 1 in 100 people).
If your child has any of these talk to their
doctor as Amoxil will need to be stopped.
The other possible side effects are:
Common (affects less than 1 in 10 people)
• skin rash
• feeling sick (nausea)
• diarrhoea.
Uncommon (affects less than 1 in 100 people)
• being sick (vomiting).
Very rare (affects less than 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 your child drinks
plenty of fluids to
reduce the chance of
these symptoms

1000000
0083684

PAGE 2 OF 2
Page 2

Page 3

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
(web5)