AMOXICILLIN 500MG CAPSULE

Active substance: AMOXICILLIN TRIHYDRATE

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394165

Amoxicillin 250 mg
Capsules
Amoxicillin 500 mg
Capsules (amoxicillin)

PACKAGE LEAFLET:
INFORMATION FOR THE USER

TBC

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Amoxicillin 250 mg Capsules
Amoxicillin 500 mg Capsules
(amoxicillin)

Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information for you.
•  eep this leaflet. You may need
K
to read it again.
• f you have any further questions,
I
ask your doctor or pharmacist.
•  his medicine has been
T
prescribed for you only. Do
not pass it on to others. It may
harm them, even if their signs
of illness are the same as yours.
•  f you get any side effects talk
I
to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet.
What is in this leaflet:
1.  hat Amoxicillin is and what it is
W
used for
2.  hat you need to know before
W
you take Amoxicillin
3.  ow to take Amoxicillin
H
4.  ossible side effects
P
5.  ow to store Amoxicillin
H
6.  ontents of the pack and
C
other information
1. WHAT AMOXICILLIN IS AND
WHAT IT IS USED FOR
The name of your medicine is
Amoxicillin. It contains the active
ingredient amoxicillin trihydrate.
Amoxicillin belongs to the
penicillin group of medicines called
antibiotics. Antibiotics are used to
kill the bacteria that cause infections
in many different parts of the body.
Amoxicillin can be used to treat a
variety of bacterial infections of:
•  he respiratory tract (ear, nose,
t
throat and lungs)
•  he urinary system
t
•  he reproductive system
t
•  he digestive system
t
•  he skin and soft tissue
t
•  he gums and teeth
t
•  he blood and abdomen.
t
Amoxicillin can also be used in
combination with other medicines
to treat stomach ulcers, as well as in
patients with heart valve problems
or other damaged heart tissue who
need protection from infection
during the dental treatment.
2. what you need to
know BEFORE YOU
TAKE AMOXICILLIN
Do not take Amoxicillin if:
•  ou are allergic (hypersensitive)
y
to amoxicillin or any of the other
ingredients of this medicine
(listed in section 6 of this leaflet).
•  ou are allergic (hypersensitive)
y
to the penicillin group of
antibiotics e.g. Penicillin,
Ampicillin, Flucloxacillin.
•  ou have ever had an allergic
y
(hypersensitive) reaction to any
antibiotic. This can include a skin
rash, itching, shortness of breath
or swelling of the face or neck.
Do not take this medicine if any of
the above apply to you. 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 this medicine:
• f you suffer from kidney
i
problems: your doctor may have
to lower your dose
• f you have glandular fever
i
• f you are not passing urine regularly
i
• f you are taking drugs to prevent
i
blood clots forming (anticoagulant).
If you are not sure if any of the
above apply to you, talk to your
doctor or pharmacist before taking
Amoxicillin.
Taking other medicines
Please tell your doctor or
pharmacist if you are taking,
have recently taken or might take
any other medicines, including
medicines obtained without a
prescription and herbal medicines.

This is because Amoxicillin can
affect the way some medicines
work. Also some medicine can
affect the way Amoxicillin works.
In particular, tell your doctor or
pharmacist if you are taking any
of the following:
•  edicines to thin the blood
m
(anticoagulants) e.g Warfarin. Extra
blood tests may be needed as the
tendency to bleed may be increased
•  ethotrexate, used to treat cancer
M
•  robenecid and Allopurinol, used
P
to prevent gout. Your doctor
may decide to adjust the dose
of Amoxicillin as levels may be
increased in your blood
•  ral contraceptives (the pill).
o
Amoxicillin may reduce the
effectiveness of the contraceptive
pill; additional contraceptive
precautions should be taken. If
you need any advice, talk to your
doctor or pharmacist.
Having urine or blood tests
If you are having blood tests or
urine tests to check your sugar
levels or liver function, tell the
doctor you are taking Amoxicillin
as it may interfere with the results.
Driving and machinery
Amoxicillin should not affect your
ability to drive or operate machinery.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may be pregnant
or are planning to have a baby, ask
your doctor or pharmacist for advice
before taking this medicine.
3. HOW TO TAKE AMOXICILLIN
Always take Amoxicillin exactly
as your doctor has told you. You
should check with your doctor or
pharmacist if you are not sure. It is
important that you complete the
course of treatment.
When taking Amoxicillin:
•  wallow the capsules whole with
S
a glass of water
•  pace the doses evenly during
S
the day, at least 4 hours apart
•  ever take 2 doses in 1 hour.
N
Dosage
Your doctor will decide your dose
and length of treatment, as it
depends on your condition.
Adults (including the Elderly) and
Children who weigh more than
40 kg: The usual dose is 250 mg
three times a day. For more severe
infections, the dose may be increased
to 500 mg three times a day. The
maximum recommended dose
is 6 grams daily (e.g 12 x 500 mg
capsules) given in divided doses.
For the following conditions your
doctor may prescribe these doses:
Severe or recurrent chest infection,
one 3 gram dose may be given twice
a day (6 x 500 mg capsules).
To treat a urinary tract infection,
one 3 gram dose may be given,
followed 12 hours later by a further
3 gram dose (6 x 500 mg capsules).
To treat a dental abscess, one
3 gram dose may be given,
followed 8 hours later by a further
3 gram dose (6 x 500 mg capsules).
To treat gonorrhoea, a single
3 gram dose may be given (6 x
500 mg capsules).
To prevent infection in heart
patients needing dental surgery,
your doctor may give you one
3 gram dose one hour before the
dental procedure and if necessary,
a further 3 gram dose 6 hours later.
If you need a general anaesthetic
and/or need to be admitted to
hospital, it may be necessary to
give you the appropriate dose of
Amoxicillin by injection.
Stomach ulcers, 1x 750 mg dose
(3 x 250 mg capsules or 1 x 500 mg
capsule and 1 x 250 mg capsule) or
1 x 1 g dose (2 x 500 mg capsules)
twice a day for 7 days with
other antibiotics.
Children weighing under 40 kg
who are able to swallow capsules:
The usual dose for children under
40 kg is 40-90 mg/kg/day two or
three times daily. (not exceeding
3 g/day).
Oral suspensions containing
Amoxicillin are recommended for
infants, as well as for children who
cannot swallow capsules.
If you suffer from kidney
problems your doctor may
prescribe a lower dose than that
stated above.

Date: 28 Mar 2014
Description Amoxicillin 250/500mg ALL
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 394165

SAP No. N/A

Superceded Affiliate Item Code 10004819

Vendor Job No. 227142

TrackWise PR No. 394165

Proof No. 1

MA No. 04569/0092, 0093

Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code TBC

Barcode Info N/A

Sign-offs

Time: 10:58
Page Count 1/2

No. of colours 1
Colours

Black

Non-Print
Colours

Text
Free

Equate CMYK
with
Main Font Myriad Pro
Dimensions 110 x 395mm

Body Text Size 9 pt

To stop 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.
If you take more Amoxicillin than
you should
Contact your doctor or nearest
hospital emergency department
immediately. Take the container
and any remaining tablets with
you. Signs of an overdose may
include feeling sick, being sick,
diarrhoea or crystals in the urine,
which may be seen as cloudy urine,
or difficulty in passing urine.
If you forget to take Amoxicillin
Take the next dose as soon as you
remember unless it is almost time
for your next dose. Do not take
a double dose to make up for a
forgotten dose.
If you stop taking Amoxicillin
Do not suddenly stop taking your
medicine as the infection may
come back again. Keep taking
your medicine until the course is
finished even if you feel better.
If you have any further questions
on the use of this medicine, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Amoxicillin can
cause side effects, although not
everybody gets them.
If any of the following happen,
stop taking Amoxicillin and tell
your doctor immediately or go
to your nearest hospital
emergency department:
•  llergic skin reactions which may
a
cause an itchy skin rash, swelling
of the face, lips, tongue or throat,
difficulty in breathing, speaking
or swallowing, dizziness or
collapse. These can be serious and
occasionally deaths have occurred
•  lat red spots under the skin
f
surface or bruising of the skin. This
is a result of an allergic reaction
caused by the inflammation
of blood vessel walls. It can be
associated with joint pain (arthritis)
and kidney problems
•  delayed allergic reaction can
a
usually occur 7 to 12 days after
having Amoxicillin. Some signs
include rashes, fever, joint pains
and enlargement of lymph nodes
especially under the arms
• tchy reddish purple patches on
i
the skin especially on the palm
of the hands and on the soles of
the feet, 'hive-like' raised swollen
areas on the skin, tender areas on
the surfaces of the mouth, eyes
and private parts. You may have
fever and feel tired
•  ther severe skin reactions such
o
as changes in the skin colour,
bumps under the skin, blistering,
pustules, peeling, redness, pain,
itching, scaling. These may be
associated with fever, headaches
and body aches
•  lood disorders, causing fever,
b
chills, sore throat, easy bruising or
signs of an infection
• nflammation of the large
i
intestine (colitis), which may
cause aches and pain in the
stomach area, severe diarrhoea
with blood in the stools and fever
•  idney problems, which may
k
cause a change in the amount of
urine passed, blood on the urine,
swollen ankles, feeling sick or
being sick, or confusion
• iver problems which may cause
l
yellowing of the skin or whites
of the eyes, dark urine and pale
faeces, severe diarrhoea with
bleeding, blisters, redness or
bruising of the skin. These can
happen when having the medicine
or for several weeks after.
These side effects are rare
but serious. You may need
medical attention.

Very rare (affects
less than 1 in
10,000 people):
• fits (convulsions),
seen in patients
on high doses
or with kidney
problems
• dizziness
• feeling unusually
excitable
(hyperactivity)
•  rystals in the urine, which
c
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
•  eeth may appear stained
t
(this has been reported in
children). This is usually
removed by regular brushing
•  he tongue may change to yellow,
t
brown or black and it may have a
'hairy' appearance
•  lood may take longer to clot,
b
you may notice this if you have a
nose bleed or if you cut yourself
•  hrush (a yeast infection of the
t
vagina, mouth or skin folds
causing soreness and discharge).
Your doctor or pharmacist can
give you treatment for thrush.
If you get any side effect talk to
your doctor or pharmacist. This
includes any 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 AMOXICILLIN
Keep this medicine out of the sight
and reach of children.
Store in a dry place below 25°C and
protect from light.
Do not use Amoxicillin after the
expiry date which is stated on the
carton after 'EXP'. The expiry date
refers to the last day of that month.
Do not use Amoxicillin if there are
visible signs of deterioration.
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. FURTHER INFORMATION
What Amoxicillin contains:
The active substance is amoxicillin
trihydrate.
The other ingredients are talc,
magnesium stearate, sodium starch
glycollate with microcrystalline
cellulose in the 250 mg product
only and colloidal silicon dioxide
in the 500 mg product only. The
capsule shell contains erythrosine
(E127), quinoline yellow (E104),
titanium dioxide (E171), red iron
oxide (E172) and gelatine. The
printing ink contains black iron
oxide (E172), shellac, isopropyl
alcohol, n-butyl alcohol, propylene
glycol and ammonium hydroxide.
What Amoxicillin looks like and
contents of the pack:
Your medicine comes as a hard
capsule with a yellow body and
a red cap. The 250 mg capsule is
marked 'AX250' and 'G'. The 500 mg
capsule is marked 'AX500' and 'G'.
Amoxicillin Capsules are available
in blisters or bottles of 5, 7, 10, 14,
15, 20, 21, 25, 28, 30, 56, 60, 84,
90, 100, 250 and 500 capsules. The
250 mg capsules are also available
in blisters or bottles of 50 capsules.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom
Manufacturer
Generics [UK] Ltd, Potters Bar,
Herts., EN6 1TL, United Kingdom

If you get any of the following side
effects, talk to your doctor as soon
as possible.
Common (affects less than 1 in
10 people):
•  ild skin rash
m
• diarrhoea
•  eeling sick (nausea).
f
Uncommon (affects less than 1 in
100 people):
•  eing sick (vomiting)
b
•  ildly itchy rash (pink-red
m
patches).

This leaflet was last revised
394165
in: March 2014
00000000

Date: 28 Mar 2014
Description Amoxicillin 250/500mg ALL
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 394165

SAP No. N/A

Superceded Affiliate Item Code 10004819

Vendor Job No. 227142

TrackWise PR No. 394165

Proof No. 1

MA No. 04569/0092, 0093

Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code TBC

Barcode Info N/A

Sign-offs

Time: 10:58
Page Count 2/2

No. of colours 1
Colours

Black

Non-Print
Colours

Text
Free

Equate CMYK
with
Main Font Myriad Pro
Dimensions 110 x 395mm

Body Text Size 9 pt

Expand view ⇕

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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