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AMOXICILLIN 250MG/5ML ORAL SUSPENSION (SUGAR FREE)

Active substance: AMOXICILLIN TRIHYDRATE

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Package leaflet: Information for the patient

Amoxicillin 125mg/5ml & 250mg/5ml
Oral Suspension Sugar Free BP
code
area

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

What is in this leaflet
1  hat Amoxicillin is and what it is
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used for
2 
What you need to know before you
take Amoxicillin
3 
How to take Amoxicillin
4 
Possible side effects
5 
How to store Amoxicillin
6 
Contents of the pack and other
information
1  HAT AMOXICILLIN IS AND WHAT IT
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IS USED FOR

Amoxicillin is one of a group of antibiotic
medicines called penicillins. Amoxicillin works
by interfering with the bacteria that cause the
infection.
Amoxicillin can treat a wide range of infections
including those of the following:
•  hest (bronchitis or pneumonia)
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•  onsils (tonsillitis)
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•  kin
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•  ars (otitis media)
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•  inuses (sinusitis)
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•  idneys
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•  eeth
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•  ums (abscesses)
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•  eart (endocarditis)
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•  lood (septicaemia)
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•  one
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•  he bladder or the urethra (the tube which
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carries urine from the bladder)
•  he female reproductive system including
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infections caused by difficulties during
childbirth (puerperal sepsis and septic
abortion)
•  bdomen (intra-abdominal sepsis and
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peritonitis)
•  onorrhoea (a sexually transmitted infection)
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• nfections associated with pregnancy
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•  yphoid and paratyphoid (fevers caused by a
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group of bacteria called Salmonella)
Amoxicillin may also be used in combination
with other medicines to treat stomach ulcers.

2  HAT YOU NEED TO KNOW BEFORE
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YOU TAKE AMOXICILLIN
Do not take Amoxicillin if:

•  ou are allergic to amoxicillin or any of the
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other ingredients of this medicine (listed in
section 6)
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•  ou have ever had a bad reaction or allergy to
any penicillin-type antibiotic
•  ou have ever had a skin rash or swelling of the
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face or neck or shortness of breath when taking
any antibiotic

Warnings and precautions

Talk to your doctor or pharmacist before taking
Amoxicillin if:
•  ou suffer from kidney disease or kidney
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problems, as you may require a lower dose than
normal
•  ou have glandular fever
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•  ou are not passing water regularly
•  ou have an intolerance to some sugars as this
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medicine contains sorbitol
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Other medicines and Amoxicillin

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, even those not prescribed by a
doctor. In particular tell your doctor if you are
taking any of the following:
•  he contraceptive pill (in which case you will
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have to take extra contraceptive measures such
as using a condom)
•  nticoagulants e.g. warfarin, phenindione
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•  hemotherapy drugs e.g. methotrexate
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•  rugs used to treat gout e.g. probenecid,
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allopurinol, sulfinpyrazone
•  ome other antibiotics (e.g. neomycin
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and tetracyclines can reduce the effect of
amoxicillin)
•  ral typhoid vaccine (may not work if taken
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with amoxicillin)
•  ome penicillins may increase the effects of
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muscle-relaxing drugs given as part of an
anaesthetic for surgery. Tell the doctor you
are taking amoxicillin if you need to have an
anaesthetic.

Having urine or blood tests

If you or your child are having urine tests for
diabetes (sugar in the urine) or blood tests for
liver function, let the doctor know. Amoxicillin
can affect the results of these tests.

Pregnancy and breast-feeding

Check with your doctor before you take this
medicine if you are pregnant or 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.

Amoxicillin Oral Suspension Sugar Free
BP contains sorbitol

This medicinal product contains sorbitol. Sorbitol
may cause stomach upset and diarrhoea.
If you have been told by your doctor that you
have an intolerance to some sugars, contact your
doctor before taking this medicinal product.

3  OW TO TAKE AMOXICILLIN
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Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Try to give/take this medicine as part of the daily
routine, for example at mealtimes. You may give/
take amoxicillin before, with or after food, unless
the label advises a specific time.
You should make sure you/your child have
several more drinks of water each day unless told
otherwise by your doctor.

Dosage:

Adults (including the elderly):
The total daily dose should not exceed 6 g in
total, given in divided doses.
•  he usual dose for most infections is 5 ml of
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250 mg/5 ml suspension to be taken 3 times a day.
•  or more serious infections the dose may be
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doubled to 10 ml of 250 mg/5 ml suspension
3 times a day.
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•  he following doses may be given in the
following conditions:
•  evere or recurrent chest infections: 3 g twice
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daily
•  imple urinary tract infections: two 3 g doses
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with 10 to 12 hours between doses (short
course)
•  ental abscesses: two 3 g doses given orally
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with 8 hours between doses
•  onorrhoea: a single 3 g dose
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•  or stomach ulcers, the following may be
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prescribed with other antibiotics:
1 x 750 mg or 1 x 1 g twice a day for 7 days
•  he following are the usual adult dosages for
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preventing infection during dental or other
surgery:
•  f a general anaesthetic is not used, 3 g given
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orally one hour before surgery and another
dose six hours later if necessary
•  f a general anaesthetic is used, 3 g given orally
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four hours before anaesthesia and 3 g six hours
after the initial dose

Children:

•  hildren weighing more than 40 kg should be
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given the usual adult dosage.
•  hildren weighing less than 40 kg:
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•  ll doses are worked out depending on the
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child’s body weight in kilograms. Your doctor
will advise you how much medicine 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.

Patients with kidney problems

If you have kidney problems, the dose prescribed
by your doctor may be lower than the usual dose.

If you take more Amoxicillin than you
should

If you (or somebody else) accidentally take too
much of your medicine, speak to your doctor
or go to your nearest hospital immediately. You
should take this leaflet and any medicine you still
have to show the doctor.
Severe cases of nausea, vomiting and diarrhoea
can be treated with rehydration therapy, by
drinking fluids containing sodium, water and
sugar to prevent dehydration.

If you forget to take Amoxicillin

If you forget to take a dose, take it as soon as
you remember, unless it is within an hour of your
next dose, then carry on as before. Do not take
a double dose to make up for the dose you have
missed.

If you stop taking Amoxicillin

Keep taking this medicine until it is finished
or your doctor tells you to stop. Do not stop
taking it just because you feel better. If you stop
taking the medicine, some bacteria may survive
and cause the infection to come back, or your
condition may re-occur or get worse.
If you/your child, are still unwell after taking all
the medicine, go and see your doctor. Never
give/take more than the recommended dose
each day.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4  OSSIBLE SIDE EFFECTS
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Like all medicines, this medicine can cause side
effects, although not everybody gets them.

If you or your child experience any of
the following events STOP taking your
medicine and tell your doctor or go to
your nearest hospital immediately:

•  ypersensitivity – symptoms may include
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swollen face, mouth, lips, throat or tongue,
reddening of the skin, breathing problems,
joint pain and fever. If these symptoms occur,
STOP taking amoxicillin right away and tell your
doctor.
•  evere diarrhoea possibly with bleeding
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•  llergic skin reactions with itching e.g. hives,
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nettle rash, blistering or peeling of the skin.
If you start to itch or get a rash, STOP taking
amoxicillin and tell your doctor immediately.
•  onvulsions may occur in patients on high
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doses or with kidney problems
•  arker coloured urine, faeces becoming paler
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•  ellowing of the skin or the whites of your eyes
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(jaundice)
•  ifficulty or discomfort in passing urine or
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having blood in the urine

The following events are less serious
but you may wish to discuss them
with your doctor or pharmacist if
they become troublesome or last a
long time.
Common side effects (have been reported in
more than 1 in 100 people) include:
•  ausea (feeling sick) or diarrhoea
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Uncommon side effects (have been reported
in between 1 in 100 and 1 in 1000 people taking
amoxicillin) include:
•  omiting
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Very rare side effects (have been reported in
less than 1 in 10,000 people) include:
•  hrush (a yeast infection of the vagina, mouth
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or skin folds). You can get treatment for thrush
from your doctor or pharmacist.
•  ooth discolouration. The colour usually
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returns to normal with brushing.
•  lackening of the tongue
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•  nflammation of the kidney
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•  xcessive body movements (hyperkinesia) or
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dizziness
•  eduction (reversible) in blood cell counts
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which may cause anaemia (may be
characterised by feeling weak or light-headed)
or a longer time taken for blood to clot. Tell
your doctor that you are taking amoxicillin if
you are having blood tests.
•  rystalluria, forming of crystals in the urine
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Not known: frequency cannot be estimated from
available data
•  eningitis (signs may include stiff neck, fever
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and vomiting)

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  OW TO STORE AMOXICILLIN
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Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the label. The expiry date to be
followed is that included by the pharmacist after
the medicine is made up for you.
Store in original package. Keep the bottle tightly
closed.
Dry powder: Store in a dry place below 25°C.
Reconstituted suspension: Store up to 14 days at
2°C-8°C in a refrigerator.
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  ONTENTS OF THE PACK AND OTHER
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INFORMATION

What Amoxicillin Oral Suspension Sugar
Free BP contains

•  he active ingredient is amoxicillin. Amoxicillin
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Oral Suspension Sugar Free BP is available in
two strengths containing either 125 mg/5 ml
or 250 mg/5 ml of amoxicillin as amoxicillin
trihydrate.
•  he other ingredients are sodium benzoate
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(E211), disodium edetate, sodium citrate,
orange bramble flavour, quinoline yellow
(E104), citric acid monohydrate, colloidal
anhydrous silica, xanthan gum, sorbitol (E420)
and saccharin sodium.

What Amoxicillin Oral Suspension Sugar
Free BP looks like and contents of the
pack
The suspensions are pale yellow with a
characteristic odour.
Amoxicillin Oral Suspensions Sugar Free BP are
available in bottles of 100ml.

Marketing Authorisation Holder and
Manufacturer

Athlone Laboratories Limited, Ballymurray, Co.
Roscommon, Ireland.
The product is distributed by Actavis, Barnstaple,
EX32 8NS, UK
PL 06453/0049
PL 06453/0050

A
 moxicillin 125mg/5ml Oral
Suspension Sugar Free BP
A
 moxicillin 250mg/5ml Oral
Suspension Sugar Free BP

This leaflet was last revised in June 2014.

Actavis, Barnstaple, EX32 8NS, UK

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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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