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Package leaflet: Information for the patient



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 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.
• 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.

What is in this leaflet
1. What Amoxicillin is and what it is 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



Amoxicillin is one of a group of antibiotic
medicines called penicillins. Amoxicillin works by
interfering with the bacteria that cause the
Amoxicillin can treat a wide range of infections
including those of the following:
• chest (bronchitis or pneumonia)
• skin
• tonsils (tonsillitis)
• bone
• ears (otitis media)
• teeth
• sinuses (sinusitis)
• heart (endocarditis)
• kidneys
• gums (abscesses)
• blood (septicaemia)
• abdomen (intra-abdominal sepsis and
• the bladder or the urethra (the tube which
carries urine from the bladder)
• the female reproductive system including
infections caused by difficulties during
childbirth (puerperal sepsis and septic
Amoxicillin can also be used to treat:
• gonorrhoea (a sexually transmitted infection)
• infections associated with pregnancy
• typhoid and paratyphoid (fevers caused by a
group of bacteria called Salmonella)
Amoxicillin may also be used in combination with
other medicines to treat stomach ulcers.



Do not take Amoxicillin if
• You are allergic to amoxicillin or any of the
other ingredients of this medicine (listed in
section 6)
• You have ever had a bad reaction or allergy to
any penicillin-type antibiotic
• You have ever had a skin rash or swelling of
the face or neck or shortness of breath when
taking any antibiotic
Warnings and precautions
Talk to your doctor or pharmacist before taking
Amoxicillin if:
• You suffer from kidney disease or kidney
problems, as you may require a lower dose
than normal
• You are not passing urine regularly
• You have glandular fever
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:
• The contraceptive pill (in which case you will
have to take extra contraceptive measures
such as using a condom)
• Anticoagulants e.g. warfarin, phenindione
• Chemotherapy drugs e.g. methotrexate
• Drugs used to treat gout (which can be
caused by the build up of uric acid)
e.g. probenecid, allopurinol, sulfinpyrazone

• Some other antibiotics (e.g. neomycin and
tetracyclines can reduce the effect of
• Oral typhoid vaccine (may not work if taken
with amoxicillin)
• Some penicillins may increase the effects of
muscle-relaxing drugs given as part of an
anaesthetic for surgery. Tell the doctor you are
taking amoxicillin if you need to have an
Having urine or blood tests
If you 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
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.



Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
The maximum daily dose is 6g given in divided
Adults including the elderly:
• The usual dose of Amoxicillin Capsules is
250mg three times a day
• For more severe infections this may be
doubled to 500mg three times a day
• High doses may be used in the following
- For severe or recurrent chest infections a
dose of 3g twice daily given orally is usually
- For simple urinary tract infections an adult
dose of two 3g doses given orally with 10 to
12 hours between doses (short course)
- For the treatment of dental abscesses two 3g
doses given orally with 8 hours between
doses is recommended
- For gonorrhoea a single 3g dose given orally
is recommended
- For stomach ulcers, the following may be
prescribed with other antibiotics: 1 x 750mg
or 1 x 1g twice a day for 7 days
The following are the usual adult dosages for
preventing infection during dental
procedures and other surgery:
• If a general anaesthetic is not used, 3g given
orally one hour before surgery and another
dose six hours later if necessary
• If a general anaesthetic is used, 3g given
orally four hours before anaesthesia and 3g
six hours after the initial dose
It is recommended that children be given
amoxicillin as a suspension instead of as
• Children weighing more than 40kg should be
given the usual adult dosage.
• Children weighing less than 40kg who are
able to swallow capsules:
All doses are worked out depending on the
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
40mg to 90mg for each kilogram of body
weight a day, given in two or three divided
Patients with kidney problems
If you have kidney problems, the dose prescribed
by your doctor may be lower than the usual
When to take your medicine
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. It is not
normally necessary to arrange to have a dose in
the middle of the night, unless your doctor has
told you to do so. But remember, space the
doses as evenly as possible throughout the day.
Do not give/take more than one dose every four
If you take more Amoxicillin than you should
If you take more capsules than you should, tell
your doctor immediately or go to the nearest
hospital. You should take this leaflet and any
capsules 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 Amoxicllin
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 a forgotten dose.
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.
You should make sure you have several more
drinks of water each day unless told otherwise by
your doctor.
If you 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.



Like all medicines, this medicine can cause
side effects, although not everybody gets
If you experience any of the following events
STOP taking your medicine and tell your
doctor or go to your nearest hospital
• Hypersensitivity or severe allergic reaction
including swollen face or breathing problems.
If these symptoms occur, STOP taking
amoxicillin right away and tell your doctor.
• Severe diarrhoea with bleeding
• Allergic skin reactions with itching e.g. hives,
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.
• Convulsions may occur in patients on high
doses or with kidney problems
• Notice your urine becoming darker or your
faeces becoming paler
• Notice your skin or the white of your eyes
turning yellow (jaundice)
• Difficulty or discomfort in passing urine or
having cloudy urine
The following symptoms are less serious but
you may wish to discuss them with your
doctor if they become troublesome or last a
long time.
Common side effects of amoxicillin (i.e. have
been reported in more than 1 in 100 people
taking it) include:
• Nausea (feeling sick) or diarrhoea
Uncommon side effects (i.e. have been
reported in between 1 in 100 and 1 in 1,000
people taking amoxicillin) include:
• Vomiting

Very rare side effects (i.e. reported in less than
1 in 10,000 people) include:
• Thrush (a yeast infection of the vagina, mouth
or skin folds). You can get treatment for
thrush from your doctor or pharmacist.
• Tooth discolouration. The colour usually
returns to normal with brushing.
• Blackening of the tongue
• Inflammation of the kidney
• Excessive body movements (hyperkinesia) or
• Reduction (reversible) in blood cell counts
including anaemia (a reduction in the body’s
red blood cells or haemoglobin which 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.
• Crystalluria (forming of crystals in the urine)
Not known: frequency cannot be estimated from
available data
• Meningitis (signs may include stiff neck, fever
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 By
reporting side effects you can help provide more
information on the safety of this medicine.



Keep this medicine out of the sight and reach of
Do not use this medicine after the expiry date
which is stated on the label after EXP. The expiry
date refers to the last day of that month.
Store below 25ºC and protect from light and
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



What Amoxicillin Capsules contain
• The active ingredient is amoxicillin. Each
capsule contains either 250 mg or 500 mg of
amoxicillin as amoxicillin trihydrate.
• The other ingredients are magnesium
stearate, maize starch, gelatin, erythrosin
(E127), quinoline yellow (E104), titanium
dioxide (E171) and red iron oxide (E172).
What Amoxicillin Capsules look like and
contents of the pack
• Amoxicillin Capsules are scarlet and ivory
opaque hard gelatin capsules, each capsule is
marked with the characters “AMOX 250” or
“AMOX 500”.
• Securitainers are available in pack sizes of 15,
18, 20, 21, 28, 30, 50, 100, 500 & 1000
capsules, the pack size of 1000 is available for
the 250 mg strength only.
Blister packs are available in pack sizes of 15,
16, 18, 20, 21, 28, 30, 50, 100, 500 & 1000
capsules, the pack size of 1000 is available for
the 250 mg strength only and the pack size of
16 is available for the 500 mg strength only.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Athlone Laboratories Limited, Ballymurray,
Co.Roscommon, Ireland
The Product is distributed by:
Almus Pharmaceuticals,
43 Cox Lane, Chessington, KT9 1SN, UK
PL 06453/0017
PL 06453/0018
Date of revision June 2014


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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.