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AMOXICILLIN 125MG/5ML ORAL SUSPENSION

Active substance: AMOXICILLIN TRIHYDRATE

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Each 5 ml contains 125 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 60 ml
of water and shake until all of the powder
is dispersed.
Store in a cool, dry place.
KEEP OUT OF THE REACH AND
SIGHT OF CHILDREN
Product Licence holder:
Crescent Pharma Ltd,
Overton, Hants RG25 3ED
POM

AMOXICILLIN
125mg/5ml
ORAL SUSPENSION
Powder for
oral suspension

100ml

M0170TB

PL20416/0010

If you take more medicine 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 a dose of 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 TWO DOSES
AT THE SAME TIME.

4. POSSIBLE SIDE EFFECTS

Some people may have side effects when taking this medicine. If you have
any unwanted side-effects you should seek advice from your doctor,
pharmacist or healthcare professional. Also you can help
to make sure medicines remain as safe as possible by
reporting any unwanted side-effects via the internet at
www.mhra.gov.uk/yellowcard; alternatively you can call

Freephone 0808 100 3352 (available between 10 am - 2 pm MondayFriday) or fill in a paper form available from your local pharmacy.
Stop taking the medicine and tell your doctor straightaway if you notice
any of the following ver y rare serious side effects (may occur in less
than 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 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 additionally 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)
● 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.
Tell your doctor or pharmacist if you notice any of the side effects listed in
the following sections:
Less than 1 in 10 people have experienced:
● Diarrhoea, indigestion, feeling sick
● Skin rash.

Less than 1 in 100 people have experienced:
Itching, hives
● Being sick.
Less than 1 in 10,000 people have experienced:
● 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
● 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
● 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.
Other effects:
● Indigestion.



5. HOW TO STORE AMOXICILLIN ORAL SUSPENSION

KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
Store in a cool, dry place. Use within 7 days of preparation. Do not transfer
your medicine to another container.
Do not take the medicine if the expiry date on the label has passed.
If you have any medicines that are out of date, return them to your
pharmacist for safe disposal.

6. FURTHER INFORMATION

Ingredients
Each 5ml of oral suspension contains 125 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 the medicine looks like:
After preparation the medicine is a lime coloured suspension. The bottle
contains 100 ml of medicine.
Who makes this medicine and holds the product licence:
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units,
Polhampton Lane, Overton, Hants, RG25 3ED.
Date leaflet revised: September 2012.
If you would like this leaflet in a different format, please contact the
licence holder at the above address.

Job No.: 300771
Date: 25 October 2012
PL20416/0010
PL 20416/0010

125mg/5ml
ORAL SUSPENSION

100ml

100%

Colour Reference:
EXP:

Powder for
oral suspension

PROOF 2

BN.:

POM

AMOXICILLIN

M0170TB
M0164TB

L
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

Each 5 ml contains 125 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
60 ml of water and shake until all of
the powder is dispersed.
Store in a cool, dry place.
KEEP OUT OF THE REACH
AND SIGHT OF CHILDREN

Label Code M0170TB





Black

192

Base Label:

52 x 125mm

Leaflet Page 1:

52 x 93mm

Left Hand Opening



Overall Leaflet Size:

Text Size
8 pt

52 x 625

Page Widths: 93 90 89 88 88 89 88

PATIENT INFORMATION LEAFLET

Amoxicillin 125mg/5ml Oral Suspension
Please read all of this leaflet carefully before you start taking this
medicine.
Keep the leaflet, you may need to read it again.
If you have any questions or are not sure about anything, ask your
doctor or pharmacist.
This medicine has been prescribed for you. Do 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 gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

IN THIS LEAFLET:

2. BEFORE YOU TAKE AMOXICILLIN ORAL SUSPENSION

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

Do not take this medicine if:
● you know you are allergic to amoxicillin or to any of the other ingredients
which are listed in section 6. (An allergic reaction may be recognised as
shortness of breath, blocked nose, rash, itching, swollen face or lips)
● you have ever had an allergic reaction to another penicillin antibiotic or
any other antibiotic in the past.
Check with your doctor before taking this medicine if:
● you are pregnant or trying to become pregnant
● you are breastfeeding
● you have a history of allergies
● you have glandular fever (a viral infection which causes sore throat,
high temperature, tiredness, muscle pains and headache)
● you are not passing water regularly
● you suffer from any kidney problems.

1. What Amoxicillin Oral Suspension is and what it is used for
2. 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. Further information

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 bacterial infections of the ear,
respiratory tract (e.g. lungs and chest), urinary tract (e.g. kidneys and
bladder), skin, and gastrointestinal tract such as typhoid. It may also be
used for other infections determined by your doctor.

Having urine or blood tests
If you are having tests on your water (urine glucose tests) or blood tests
for liver function, let the doctor or nurse know you are taking this
medicine as it can affect the results of these tests.
Taking other medicines
Amoxicillin Oral Suspension and other medicines you may be taking may
affect how each other work. Make sure your doctor or pharmacist knows
if you are taking any other medicines, especially:
● probenecid (used to treat gout)
● allopurinol (used to treat gout) as it may be more likely that you will
have an allergic skin reaction if taken with amoxicillin
● oral contraceptives (as they may not work properly and you will need to
use other means of contraception e.g. a condom)
● medicines to help stop blood clots e.g. warfarin as extra blood tests
may be needed when taken with amoxicillin

cephalosporin antibiotics (also used to treat infections e.g. cefaclor,
cefalexin).
Other special warnings:
Thrush (a yeast infection of moist areas of the body) may develop if
amoxicillin is used for a long time. If this occurs tell your doctor.
Important information about some of the ingredients:
Each 5 ml dose of the medicine contains 3.05 g 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
your doctor before taking this medicine.
Also contains E219 which may cause allergic reactions (possibly delayed).
Driving and using machiner y:
This medicine should not affect the ability to drive or to operate machinery.
However, if you think you are affected do not drive or operate machinery.


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 follow your
doctor’s instructions. The pharmacist’s label will tell you how much
medicine to take and how often to take it. If you do not understand
anything, ask your doctor or pharmacist.
Dosage:
Adults:
- Infections: The usual dose to treat an infection is 250 mg (two 5 ml
spoonfuls) three times a day. In more severe infections this dose may be
increased to 500 mg (four 5 ml spoonfuls) three times a day.
The following doses may be given for the following conditions:
- Urinary tract infection: Two 3 g doses with 10 to 12 hours between each
dose.

- Severe recurrent chest infections: Maximum 6 g daily in divided doses.
- Gonorrhoea: A single 3 g dose.
- Prevention of infection during dental procedures: If a local or no anaesthetic
is used, 3 g one hour before surgery. If a general anaesthetic is used, 3 g four
hours before surgery and 3 g after surgery.
Children:
- Children weighing more than 40 kg should be given the usual adult dose.
- Children under 40 kg will be given a dose dependent on their weight and the
type of infection being treated. The doctor will advise on the correct 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. Keep taking this medicine
until your doctor tells you to stop. Do not stop taking it just because you feel
better. If you stop taking the medicine, your condition may reoccur or get
worse.

Each 5 ml contains 125 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 60 ml
of water and shake until all of the powder
is dispersed.
Store in a cool, dry place.
KEEP OUT OF THE REACH AND
SIGHT OF CHILDREN
Product Licence holder:
Crescent Pharma Ltd,
Overton, Hants RG25 3ED
POM

AMOXICILLIN
125mg/5ml
ORAL SUSPENSION
Powder for
oral suspension

100ml

M0170TB

PL20416/0010

If you take more medicine 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 a dose of 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 TWO DOSES
AT THE SAME TIME.

4. POSSIBLE SIDE EFFECTS

Some people may have side effects when taking this medicine. If you have
any unwanted side-effects you should seek advice from your doctor,
pharmacist or healthcare professional. Also you can help
to make sure medicines remain as safe as possible by
reporting any unwanted side-effects via the internet at
www.mhra.gov.uk/yellowcard; alternatively you can call

Freephone 0808 100 3352 (available between 10 am - 2 pm MondayFriday) or fill in a paper form available from your local pharmacy.
Stop taking the medicine and tell your doctor straightaway if you notice
any of the following ver y rare serious side effects (may occur in less
than 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 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 additionally 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)
● 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.
Tell your doctor or pharmacist if you notice any of the side effects listed in
the following sections:
Less than 1 in 10 people have experienced:
● Diarrhoea, indigestion, feeling sick
● Skin rash.

Less than 1 in 100 people have experienced:
Itching, hives
● Being sick.
Less than 1 in 10,000 people have experienced:
● 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
● 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
● 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.
Other effects:
● Indigestion.



5. HOW TO STORE AMOXICILLIN ORAL SUSPENSION

KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
Store in a cool, dry place. Use within 7 days of preparation. Do not transfer
your medicine to another container.
Do not take the medicine if the expiry date on the label has passed.
If you have any medicines that are out of date, return them to your
pharmacist for safe disposal.

6. FURTHER INFORMATION

Ingredients
Each 5ml of oral suspension contains 125 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 the medicine looks like:
After preparation the medicine is a lime coloured suspension. The bottle
contains 100 ml of medicine.
Who makes this medicine and holds the product licence:
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units,
Polhampton Lane, Overton, Hants, RG25 3ED.
Date leaflet revised: September 2012.
If you would like this leaflet in a different format, please contact the
licence holder at the above address.

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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