In this leaflet:

P0206T
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:
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
• 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).
1. W
hat Amoxicillin Oral Suspension is and
what it is used for
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.
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.
2. B
efore you take Amoxicillin Oral
Suspension
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.
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
Driving and using machinery:
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.
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).
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 or 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.
Measure bar should be 150mm at 100% scale
Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our client’s brief,
the final responsibility must be taken by our client.
If you sign this proof you are signifying
full approval of design and text.
Customer
Crescent Pharma
Colours Used
Description
Amoxicillin 125mg/5ml
Black
Item Code
P0206T
Profile
-
Size
210 x 297mm
Min. Point Size
9.75pt
Market
UK
Language
English
Proof By
Gill Kennedy
Proof No.
Three
Date
15/10/2012
Artwork No.
429039
Keyline(Does Not Print)
Pharma
Code
N/A
-
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.
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 10am-2pm Monday-Friday) 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
very 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 sections below:
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
Store in a cool, dry place. Use within 7 days of
preparation. Do not transfer your medicine to another
container.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT
OF CHILDREN.
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 5 ml 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 prepared: September 2012.
If you would like this leaflet in a different format,
please contact the licence holder at the above
address.
Measure bar should be 150mm at 100% scale
Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our client’s brief,
the final responsibility must be taken by our client.
If you sign this proof you are signifying
full approval of design and text.
Customer
Crescent Pharma
Colours Used
Description
Amoxicillin 125mg/5ml
Black
Item Code
P0206T
Profile
-
Size
210 x 297mm
Min. Point Size
9.75pt
Market
UK
Language
English
Proof By
Gill Kennedy
Proof No.
Three
Date
15/10/2012
Artwork No.
429039
Keyline(Does Not Print)
Pharma
Code
N/A
-