AMOXICILLIN 500MG CAPSULES BP

Active substance: AMOXICILLIN TRIHYDRATE

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PATIENT INFORMATION LEAFLET

AMOXICILLIN 250mg CAPSULES
AMOXICILLIN 500mg CAPSULES

PHARMACODE
TO BE
INSERTED

Please read this leaflet carefully before you start to take your medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to
others. It may harm them even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in the leaflet,
please tell your doctor or pharmacist.

IN THIS LEAFLET
1. What your medicine is and what it is used for
2. Before you take your medicine
3. How to take your medicine
4. Possible side effects
5. How to store your medicine
6. Further information

1.

WHAT YOUR MEDICINE IS AND WHAT
IT 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:
• 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
peritonitis)
• 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
abortion)
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.

2.

BEFORE YOU TAKE YOUR MEDICINE

Do not take this medicine and consult your
doctor if the answer to any of the following is yes:
• 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
• You are allergic to any of the ingredients
contained in this medicine
Check with your doctor or pharmacist before
taking this medicine if:
• You suffer from kidney disease or kidney
problems, as you may require a lower dose
than normal
• You have glandular fever
Taking other medicines
Check with your doctor or pharmacist if you are
taking, or have recently taken 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
amoxicillin)
• 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
anaesthetic.
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
Check with your doctor before you take this
medicine if you are pregnant or breast-feeding.

3.

HOW TO TAKE YOUR MEDICINE

Follow all directions given to you by your doctor
or pharmacist. Their directions may differ from
the information contained in this leaflet. Your
doctor may advise you to take your medicine in a
different way, so you should always follow your
doctor's advice about when and how to take your
medicine and always read the label. Your
pharmacist may be able to help if you are not
sure.
The maximum daily dose is 6g given in divided
doses.
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
conditions:
- For severe or recurrent chest infections a
dose of 3g twice daily given orally is usually
recommended
- 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
Children
It is recommended that children be given
Amoxicillin as a suspension instead of as
capsules.
• Children weighing more than 40kg should be

DIMENSIONS 148 x 335 mm

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
doses.
Patients with kidney problems
If you have kidney problems, the dose prescribed
by your doctor may be lower than the usual
dose.
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
hours.
If you forget to take your medicine
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 take more of your medicine 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.
REMEMBER:
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.

4.

POSSIBLE SIDE EFFECTS

As with all medicines, some people may
experience side effects with amoxicillin
If you experience any of the following events
STOP taking your medicine and tell your
doctor or go to your nearest hospital
immediately:
• 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
dizziness
• 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
If you notice any side effects not mentioned in
this leaflet, please inform your doctor or
pharmacist.

5.

HOW TO STORE YOUR MEDICINE

Do not use your medicine after the expiry date
shown on the label.
Store your medicine below 25°C and protect it
from light and moisture.
Keep all medicines out of the reach and sight
of children.
If your doctor tells you to stop your treatment,
return any left over to the pharmacist. Only keep
it 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 protect the environment.

6.

FURTHER INFORMATION

The name of your medicine is Amoxicillin
Capsules. Amoxicillin Capsules are available
only on prescription from your doctor.
What Amoxicillin capsules contain
Each capsule contains either 250 mg or 500 mg
of Amoxicillin as Amoxicillin trihydrate. The
capsules also contain the following inactive
ingredients: magnesium stearate, maize starch,
gelatin, erythrosin (E127), quinoline yellow
(E104), titanium dioxide (E171), 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 250mg strength only.
Blister packs 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 250mg strength only.
The product is made by
Athlone Laboratories Limited, Ballymurray,
Co.Roscommon, Ireland. The product licence is
also held by Athlone Laboratories Limited.
The product is distributed by:
Almus Pharmaceuticals,
43 Cox Lane, Chessington, KT9 1SN, UK
PL 06453/0017
PL 06453/0018
Date of revision June 2013

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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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