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Package leaflet: Information for the user

Amoxicillin (as amoxicillin trihydrate)
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 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.

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



What Amoxicillin Capsules are
Amoxicillin Capsules are antibiotics. The active
ingredient is amoxicillin. This belongs to a group
of medicines called ‘penicillin’.
What Amoxicillin Capsules are used for
Amoxicillin Capsules are used to treat infections
caused by bacteria in different parts of the body.
Amoxicillin Capsules may also be used in
combination with other medicines to treat
stomach ulcers.



Do not take Amoxicillin Capsules:
- if you are allergic to amoxicillin, penicillin or
any of the other ingredients of this medicine
(listed in section 6).
- if you have ever had an allergic reaction to
any antibiotic. This can include a skin rash or
swelling of the face or throat.
Do not take Amoxicillin Capsules if any of the
above apply. If you are not sure, talk to your
doctor or pharmacist before taking Amoxicillin
Warnings and precautions
Talk to your doctor or pharmacist before taking
Amoxicillin Capsules if you:
• have glandular fever (fever, sore throat,
swollen glands and extreme tiredness)
• have kidney problems
• are not urinating regularly.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking Amoxicillin Capsules.
Blood and urine tests
If you are having:
• Urine tests (glucose) or blood tests for liver
• Oestriol tests (used during pregnancy to
check the baby is developing normally)
Tell your doctor or pharmacist that you are taking
Amoxicillin. This is because Amoxicillin Capsules
can affect the results of these tests.
Other medicines and Amoxicillin Capsules
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
• If you are taking allopurinol (used for gout)
with Amoxicillin Capsules, it may be more
likely that you will have an allergic skin
• If you are taking probenecid (used for gout),
your doctor may decide to adjust your dose of
Amoxicillin Capsules.
• 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) Amoxicillin Capsules may be less
• If you are taking methotrexate (used for the
treatment of cancer and severe psoriasis)
Amoxicillin Capsules may cause an increase
in side effects.
• If you are taking oral typhoid vaccine (may not
work if taken with amoxicillin)
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.
Driving and using machines
Amoxicillin Capsules 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.



Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
• Swallow with water without opening capsule.
• Space the doses evenly during the day, at
least 4 hours apart.
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
Amoxicillin Capsules 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.
Adults, elderly patients and children
weighing 40 kg or more
The usual dose of Amoxicillin Capsules is 250
mg to 500 mg three times a day or 750 mg to 1 g
every 12 hours, depending on the severity and
type of infection.
• Severe infections: 750 mg to 1 g three times
a day
• Urinary tract infections: 3 g twice daily for
one day.
• Lyme disease (an infection spread by
parasites called ticks): Isolated erythema
migrans (early stage – red or pink circular
rash): 4 g a day, Systemic manifestations (late
stage – for more serious symptoms or when
the disease spreads around your body): up to
6 g a day.
• Stomach ulcers: one 750 mg or one 1 g dose
twice a day for 7 days with other antibiotics
and medicines to treat stomach ulcers.
• To prevent heart infection during surgery:
the dose will vary according to the type of
surgery. Other medicines may be given at the
same time. Your doctor, pharmacist or nurse
can give you more details.
• The maximum recommended dose is 6 g per
Kidney problems
If you have kidney problems the dose might be
lower than the usual dose.
If you take more Amoxicillin Capsules than
you should
If you have taken too much Amoxicillin Capsules,
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 Amoxicillin Capsules
• 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 Amoxicillin for?
• Keep taking Amoxicillin Capsules 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 the doctor.
Thrush (a yeast infection of moist areas of the
body which can cause soreness, itching and
white discharge) may develop if Amoxicillin is
used for a long time. If this occurs tell your
If you take Amoxicillin Capsules for a long time,
your doctor may perform additional tests to
check your kidneys, liver and blood are working
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 them.
Stop taking Amoxicillin Capsules 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)
• 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
• 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 Amoxicillin Capsules,
some signs include: rashes, fever, joint pains
and enlargement of the lymph nodes
especially under the arms

DIMENSIONS 148 x 450 mm

• 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
• flu-like symptoms with a rash, fever, swollen
glands, and abnormal blood test results
(including increased white blood cells
(eosinophilia) and liver enzymes) (Drug
Reaction with Eosinophilia and Systemic
Symptoms (DRESS)).
• 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 Amoxicillin Capsules 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 your
medicine and see your doctor straight away.
Sometimes you may get less severe skin
reaction 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
Amoxicillin Capsules will need to be stopped.
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
• 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
• the blood may take longer to clot than it
normally would. You may notice this if you
have a nosebleed or cut yourself

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
This leaflet was last revised August 2017.
General advice regarding the use of
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
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.

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.
Do not store above 25ºC. Protect from light and
Do 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



What Amoxicillin Capsules contain
- The active substance in each capsule is
250 mg or 500 mg amoxicillin.
- The other ingredients are Magnesium
stearate, Maize starch, Gelatin, Erythrosin
(E127), Quinoline yellow (E104), Titanium
dioxide (E171) and Red iron oxide (E172).


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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.