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AMOXICILLIN 250MG/5ML ORAL SUSPENSION

Active substance(s): AMOXICILLIN TRIHYDRATE / AMOXICILLIN TRIHYDRATE / AMOXICILLIN TRIHYDRATE

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AMOXICILLIN
250mg/5ml
ORAL SUSPENSION
Powder for
oral suspension

100ml

93mm

Each 5 ml contains 250 mg Amoxicillin (as
trihydrate). Also contains sucrose and
E219. See leaflet for further information.
To the patient: For oral use as instructed
by a doctor.
Please read the leaflet provided. Shake
well before each use. Use within 7 days of
preparation. Complete the prescribed
course of treatment.
To the pharmacist: To prepare, add 57 ml
of water and shake until all of the powder
is dispersed.
Store in a cool, dry place.
KEEP OUT OF THE SIGHT AND
REACH OF CHILDREN
Product Licence holder:
Crescent Pharma Ltd,
Overton, Hants, RG25 3ED, UK POM
M0230TB

If you have any further questions on the use of this medicine, ask your
doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop taking the medicine and tell your doctor straightaway if you notice
any of the following very rare serious side effects (may affect up to 1 in
10,000 people):
Swelling of the face, lips or throat, difficulty in breathing or dizziness.
These may be signs of a severe allergic reaction
Rash or pinpoint flat red round spots under the skin
surface or bruising of the skin due to inflammation of
blood vessel walls caused by an allergic reaction
A delayed allergic reaction may occur 7 to 12 days

PL20416/0011

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muscle pain and skin rash
Yellowing of the skin or whites of the eyes, pale stools and dark urine,
loss of appetite, stomach discomfort caused by liver or blood problems.

after taking the medicine. Symptoms may include rash, fever, joint
pains and swollen lymph nodes. These symptoms may also be due to
a severe allergic reaction called DRESS syndrome with additional
changes in the blood and liver or kidney function
Blistering of the skin, mouth, eyes and genitals, other serious skin
reactions including itchy reddish purple patches on the skin, hives,
pustules, swelling, peeling, redness, pain, itching and scaling. These
may be associated with fever, tiredness, headache and aching body
Blood disorders including severe reduction in the number of white or
red blood cells which may cause pale yellow skin, weakness,
breathlessness, increased risk of bruising or bleeding, and make
infections more likely
Diarrhoea sometimes containing blood, pain and fever caused by
inflammation of the large bowel (colon)
the Jarisch-Herxheimer reaction which occurs during treatment with
Amoxicillin for Lyme disease and causes fever, chills, headache,

Tell your doctor or pharmacist if you notice any of the side effects listed in
the following sections:
Common: may affect up to 1 in 10 people
Diarrhoea, feeling sick
Skin rash.
Uncommon: may affect up to 1 in 100 people
Itching, hives
Being sick.
Very rare: may affect up to 1 in 10,000 people
Tiredness, headache, shortness of breath, dizziness, looking pale and
yellowing of the skin and the whites of the eyes. These may be
symptoms of a type of anaemia

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Thrush (a yeast infection of the vagina, mouth or skin folds)
Increased or decreased urine output, fever, rash, swelling of any area of
the body or weight gain caused by kidney problems
Fits (convulsions) which may be seen in patients taking high doses or
with kidney problems, hyperactivity, dizziness
Crystals in the urine which may cause cloudy urine or difficulty or
discomfort when passing urine (make sure you drink plenty of fluids
to reduce the chance of these symptoms)
An increase in the length of time it takes to stop bleeding if you cut
yourself or have a nosebleed
Black hairy tongue
Tooth discolouration in children which usually returns to normal with
brushing.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.

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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 AMOXICILLIN ORAL SUSPENSION

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 pack.
The expiry date refers to the last day of that month.
Dry powder: Store in a cool, dry place.
Oral suspension: Store in a cool, dry place. Once made up the suspension
should be used within 7 days.
Do not transfer your medicine to another container.
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.

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These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Amoxicillin Oral Suspension contains
Each 5ml of oral suspension contains 250 mg of the active ingredient,
amoxicillin (as trihydrate). The other ingredients are sucrose, carmellose
sodium, sodium citrate, colloidal anhydrous silica, quinoline yellow
(E104), sodium methyl parahydroxybenzoate (E219), lemon and apricot
flavourings (containing maltodextrin, citric acid, gum arabic, natural
lemon oil flavour and nature identical flavouring ingredients).
What Amoxicillin Oral Suspension looks like and contents of the pack
After preparation the medicine is a lime coloured suspension. The bottle
contains 100 ml of medicine.

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Marketing Authorisation Holder and Manufacturer
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units,
Polhampton Lane, Overton, Hampshire, RG25 3ED, UK.
This leaflet was last revised in January 2017.
If you would like this leaflet in a different format, please contact the
licence holder at the above address.

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Amoxicillin 250mg/5ml Oral Suspension
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, pharmacist or nurse.
· This medicine has been 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.
· If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
See section 4.

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What is in this leaflet:

1. What Amoxicillin Oral Suspension is and what it is used for
2. What you need to know before you take Amoxicillin Oral Suspension
3. How to take Amoxicillin Oral Suspension
4. Possible side effects
5. How to store Amoxicillin Oral Suspension
6. Contents of the pack and other information

1. WHAT AMOXICILLIN ORAL SUSPENSION IS AND
WHAT IT IS USED FOR

This medicine contains the active ingredient, amoxicillin (as trihydrate).
Amoxicillin is one of a group of antibiotics called penicillins. It is used to
kill bacteria which cause infections in your body.
Amoxicillin Oral Suspension is used to treat infections caused by bacteria in
different parts of the body. It may also be used in combination with other
medicines to treat stomach ulcers.

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2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
AMOXICILLIN ORAL SUSPENSION

Do not take Amoxicillin Oral Suspension if:
you know you are allergic to amoxicillin or any of the other ingredients
of this medicine (listed in section 6). (An allergic reaction may be
recognised as shortness of breath, blocked nose, rash, itching, swollen
throat, face or lips)
you have ever had an allergic reaction to another penicillin antibiotic or
any other antibiotic in the past.

Warnings and precautions

Talk to your doctor before taking Amoxicillin Oral Suspension if:
you have glandular fever (a viral infection which causes sore throat,
high temperature, tiredness, muscle pains and headache)
you are not passing water (urine) regularly
you suffer from any kidney problems.

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Urine, blood or other tests
If you are having tests on your water (urine glucose tests), blood tests
for liver function or Oestriol test (used during pregnancy to check the baby
is developing normally) let the doctor or nurse know you are taking this
medicine as it can affect the results of these tests.
If you take this medicine for a long time, your doctor may perform additional
tests to check your kidneys, liver and blood are working normally.
Other medicines and Amoxicillin Oral Suspension
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines, especially:
probenecid (used to treat gout), as your doctor may decide to adjust your
dose of amoxicillin
allopurinol (used to treat gout), as it may be more likely that you will
have an allergic skin reaction if taken with amoxicillin
medicines to help stop blood clots e.g. warfarin as extra blood tests
may be needed when taken with amoxicillin

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other antibiotics (such as tetracycline), as amoxicillin may be less
effective
methotrexate (used for the treatment of cancer and severe psoriasis), as
amoxicillin may cause an increase in side effects.
Pregnancy, breast-feeding and fertility
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 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.
Amoxicillin Oral Suspension contains sucrose & E219
Each 5 ml dose of the medicine contains 3.13g of sucrose. This should be
taken into account in patients with diabetes mellitus. Also, if you have been
told by your doctor that you have an intolerance to some sugars, contact

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your doctor before taking this medicine.
Also contains sodium methyl parahydroxybenzoate (E219) which may cause
allergic reactions (possibly delayed).

3. HOW TO TAKE AMOXICILLIN ORAL SUSPENSION

Shake the bottle well before use. Do not further dilute the prepared product.
The dose will be different for different medical conditions and patients. Your
doctor has decided the dose which is best for you. Always take this medicine
exactly as your doctor has told you. The pharmacist’s label will tell you how
much medicine to take and how often to take it. Check with your doctor or
pharmacist if you are not sure.
Dosage:
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 you should give to
your baby or child.

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- 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
This suspension is not usually prescribed for adults and children weighing
more than 40kg. Ask your doctor or pharmacist for advice.
Kidney problems
If you have kidney problems the dose might be lower than the usual dose.
It is important that you take your medicine at the right times of day. Space the
doses out as evenly as possible throughout the day.

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If you take more Amoxicillin Oral Suspension than you should
If you think you have taken too much medicine, contact your doctor
straightaway or go to the nearest hospital casualty department. Take the
bottle with you so that the medicine can be identified.
If you forget to take Amoxicillin Oral Suspension
If you forget to take a dose of this medicine, take it as soon as you
remember. However if it is almost time for the next dose, skip the missed
dose and take the next dose at the usual time. Do not take a double dose
to make up for a forgotten dose.
If you stop taking Amoxicillin Oral Suspension
• Keep taking this medicine 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. Sometimes an infection caused by bacteria does not respond to
a course of amoxicillin.

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Date 08/03/2017
PL 20416/0011

250mg/5ml
ORAL SUSPENSION

100ml

Proof 9

Base Label Size

52 x 125mm

Overall Leaflet Size

52 x 713mm

Page Widths:

93 90 89 88
88 89 88 88

Market Trade Name

Amoxicillin 250mg Leaflet Label

Leaflet Page 1

52 x 93mm

Item Number

M0230T

Left Hand Opening

Yes

Body Text Size

8 pt

Printed Colours
EXP:

Powder for
oral suspension

BN.:

POM

AMOXICILLIN

M0230TB

Peel here to open but do not remove

PL Holder:
Crescent Pharma Limited
Units 3 & 4, Quidhampton Business Units,
Polhampton Lane, Overton, Hampshire, RG25 3ED, UK

Each 5 ml contains 250mg
Amoxicillin (as trihydrate).
Also contains sucrose and E219.
See leaflet for further information.
To the patient: For oral use as
instructed by a doctor.
Please read the leaflet provided.
Shake well before each use. Use
within 7 days of preparation.
Complete the prescribed course of
treatment.
To the pharmacist: To prepare, add
57 ml of water and shake until all of
the powder is dispersed.
Store in a cool, dry place.
KEEP OUT OF THE SIGHT
AND REACH OF CHILDREN

Black

P2746

Expand Transcript

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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