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AMOXIL 500MG CAPSULES

Active substance(s): AMOXICILLIN

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Package leaflet: Information for the user
®

AMOXIL 500mg CAPSULES
(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 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.
The name of your medicine is AMOXIL 500mg CAPSULES but
will be referred to as Amoxil throughout the leaflet.
Please note that the leaflet also contains information about other
strength such as AMOXIL 250mg CAPSULES.
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
What
Amoxil is
is and
it isitused
for
1 1What
Amoxil
andwhat
what
is us
What Amoxil is
Amoxil is an antibiotic. The active ingredient is amoxicillin.
This belongs to a group of medicines called ‘penicillins’.
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.
2

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

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.
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.
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 40kg
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 40mg to 90mg for each kilogram of body
weight a day, given in two or three divided doses.
The maximum recommended dose is 100mg for each
kilogram of body weight a day.
Adults, elderly patients and children weighing 40kg or more
The usual dose of Amoxil is 250mg to 500mg three times a day
or 750mg to 1g every 12 hours, depending on the severity and
type of infection.
Severe infections: 750mg to 1g three times a day.
Urinary tract infection: 3g twice daily for one day.
Lyme disease (an infection spread by parasites called
ticks): Isolated erythema migrans (early stage – red or pink
circular rash): 4g a day, Systemic manifestations (late stage
– for more serious symptoms or when the disease spreads
around your body): up to 6g a day.
Stomach ulcers: one 750mg or one 1g 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
also be given at the same time. Your doctor, pharmacist or
nurse can give you more details.
The maximum recommended dose is 6g per day.

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

Kidney problems
If you have kidney problems the dose might be lower than the
usual dose.

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.

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

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.

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.
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.

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

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)
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 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.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. 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.

If any of the above happens stop taking the medicine and
see your doctor straight away.

Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.

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 affects 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 clotting
the blood may take longer to clot than it normally would. You
may notice this if you have a nosebleed or cut yourself

5

How to store Amoxil

Keep out of the sight and reach of children.
Store in a dry place, below 25°C.
Do not take the medicine after the expiry date which is stated
on the carton and blister label after the ‘Exp’. The expiry date
refers to the last day of that month.
If the capsules become discoloured or show any signs of
deterioration, seek the advice of your pharmacist.
Remember if your doctor tells you to stop taking this
medicine, return any unused tablets to your pharmacist for
safe disposal. Only keep this medicine if your doctor tells you
to.
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.
. 6

Contents of the pack and other information

What Amoxil contains:
The active ingredient in Amoxil is amoxicillin (as trihydrate).
Each capsule contains 500mg Amoxicillin (as trihydrate).
The other ingredients are: magnesium stearate, erythrosine
(E127), indigo carmine (E132), titanium dioxide (E171), yellow
iron oxide (E172) and gelatin.
What Amoxil looks like and contents of the pack:
Amoxil is maroon and gold, hard gelatin capsule marked
‘GS JVL’ on the cap and on the body.
Amoxil is available as blister packs of 24 capsules.
Manufactured by: Glaxo Wellcome Production, Mayenne,
France.

AMOXIL® 500mg CAPSULES;

PL 18799/2493

Leaflet date: 04.07.2016

POM
AMOXIL is a registered trademark of the Glaxo Group Ltd.
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.

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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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