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AMOXIL CAPSULES 500MG

Active substance(s): AMOXYCILLIN TRIHYDRATE

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GSK-FRA-Mayenne (Terras 2)-FRMAY

PHARMA CODE
READING DIRECTION

5127783021

5127783021

Amoxil® Capsules 250 mg and 500 mg
amoxicillin

PHARMA CODE
READING DIRECTION

1

United Kingdom-GBR

Amoxil Capsules 250 mg and
500 mg
®

PHARMA CODE
READING DIRECTION

N/A
NPL170_315_40_C80

N/A
N/A
1
K

0

amoxicillin

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.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Amoxil is and what it is used for
What you need to know before you take Amoxil
How to take Amoxil
Possible side effects
How to store Amoxil
Contents of the pack and other information

1 What Amoxil is and what it is used for
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
0

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

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

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.

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 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.
• 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 Amoxil 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 infection: 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 also be given at the same time. Your doctor,
pharmacist or nurse can give you more details.
• The maximum recommended dose is 6 g per day.

Kidney problems

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

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 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.

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.

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

Amoxil can have side effects and the symptoms (such as
allergic reactions, dizziness and convulsions) may make you
unfit to drive.

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Package leaflet: Information for the user
Amoxil

1
4 Possible side effects

5127783021
GSK-FRA-Mayenne (Terras 2)-FRMAY
United Kingdom-GBR
Amoxil
N/A
NPL170_315_40_C80

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0

0

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.

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

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 How to store Amoxil
• 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 carton. The expiry date refers to the last
day of that month.
• Do not store above 25°C.
• 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 environment.

6 Contents of the pack and other information
What Amoxil contains

• The active substance in each capsule is 250 mg or 500 mg
amoxicillin.
• The other ingredients are: Magnesium stearate (E572) ,
Gelatin , Erythrosine (E127), Titanium dioxide (E171),
Indigotine (E132), Iron oxide yellow (E172), and
Shellac (E904)

What Amoxil looks like and contents of the pack
Amoxil 250 mg Capsules are yellow and red capsules printed
with “GS LEX”. They are packaged in blister packs enclosed
in a carton. Available in packs of 3, 6, 12, 21, 50, 100, 500
and 50,000 capsules.
Amoxil 500 mg Capsules are yellow and red capsules printed
with “GS JVL”. They are packaged in blister packs enclosed
in a carton. Available in packs of 3, 6, 8, 10, 12, 16, 18, 20,
21, 24, 30, 32, 50, 100 and 500 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Beecham Group plc,
Stockley Park West, Uxbridge, Middlesex UB11 1BT
Manufacturer: Glaxo Welcome Production, Terras 2, Zone
Industrielle de la Peyenniere, 53100 Mayenne, France

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 Capsules 250 mg
Amoxil Capsules 500 mg

Reference number 00038/0103
This is a service provided by the Royal National Institute of
Blind People.
This leaflet was last revised in September 2015.
Amoxil is a registered trade mark of the GSK group of
companies.
© 2015 GSK group of companies. All rights reserved.

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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