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AMOXICILLIN 125MG/5ML ORAL SUSPENSION BP SUGAR FREE

Active substance(s): AMOXICILLIN

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Transcript
05/02/15

Read the leaflet carefully and keep it in case you want to
read it again. Do not share medicines with other people.
If any of the side effects get serious, or if you have any
other questions, speak to your doctor or pharmacist.
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Some side effects can be serious.
Stop taking the medicine and tell your doctor
straightaway if you notice the following very rare
effects (may occur in less than 1 in 10,000 people):

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 OralSuspension
6. Further information

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

125mg or 250mg of the active ingredient, amoxicillin (as
trihydrate). Amoxicillin is one of a group of antibiotics
called penicillins. lt is used to kill bacteria which cause
infections in your body.

2. Before you take Amoxicillin Oral
Suspension

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 (e.g. stomach and intestines) such
as typhoid. It may also be used for other infections
determined by your doctor.

Do not take this medicine if:

This oral suspension is available in two different

strengths. Each 5ml of oral suspension contains either
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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.

Some people must

not take this medicine.

• You know you are allergic to amoxicillin, penicillin or
to any of the other ingredients (these are listed in
section 6)
• You have ever had an allergic reaction (e.g. rash,
itching, shortness of breath) to another antibiotic in
the past such as cephalosporins e.g. cefaclor.

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The following side effects have also been reported:
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)

You must be especially careful if:
• You have glandular fever or lymphocytic leukaemia
• You are pregnant or trying to become pregnant
• You are breastfeeding
• You are not passing water regularly
• You suffer from any kidney problems.
If any of the conditions above apply to you, please
discuss your treatment with your doctor before taking
this medicine.
Taking other medicines
Amoxicillin Oral Suspension and other medicines you
may be taking may affect how each other work. Make
sure your doctor knows if you are taking any of the
following:
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• 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.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. 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

closed to protect from light and moisture.
Do not transfer your medicine to another container.
Do not use your medicine after the expiry date shown on
the label.
If your doctor tells you to stop taking the medicine, please
take any unused medicine back to your pharmacist to be
destroyed.

6. Further Information

Keep out of the sight and reach of children.
Store this medicine in a refrigerator (2-8°C).
Do not freeze. Store in the original bottle and keep tightly

Ingredients
Each 5ml of medicine contains either 125 mg or 250 mg of
the active ingredient, amoxicillin (as trihydrate). The other

• Anticoagulants (to prevent blood clotting) e.g. warfarin
or phenindione
• Probenecid or allopurinol (used to treat gout)
• Oral contraceptives (as it may not work properly and
you will need to use other means of contraception e.g.
a condom)
• Methotrexate (a cancer drug which can also be used to
treat psoriasis)
• Dietary fibre supplements.
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 amoxicillin because amoxicillin can
affect the results of these tests.

Always tell your doctor or pharmacist about all the
medicines you are taking. This means medicines you
have bought yourself as well as those you have on
prescription from your doctor.
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.
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicine as it contains sorbitol
(E420).

Driving and using machinery
Amoxicillin Oral Suspension may very rarely cause
dizziness and convulsions. Do not drive or operate
machinery if it has this effect on you.

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3. How to take Amoxicillin Oral
Suspension
Shake the bottle well before use. Do not further dilute
the prepared product.
For treating some infections the dose may be different
to the usual dose given below. For example if your
infection is more serious, the dose might be doubled.

ingredients are Sodium Benzoate (E211), Disodium
Edetate, Sodium Citrate, Citric Acid, Colloidal Anhydrous
Silica, Sorbitol (E420), Saccharin Sodium, Banana
Flavour (containing Gum Arabic, Amyl Acetate, Amyl and
Ethyl Butyrates, Euginol, Acetaldehyde, Citral, Ethyl and
Allyl Heptanoates, Amyl Valerianate and Orange Oil),
Quinoline Yellow E104 and Xanthan Gum.
What the medicine looks like
The medicine is a yellow coloured suspension. This bottle
contains 100ml of medicine.
Product licence holder and manufacturer
The product licence holder is Special Concept Development

The doctor will decide what dose you need to take.
Always take the medicine exactly as the doctor has told
you. The dose will be on the pharmacist‘s label. If you are
not sure, ask your doctor or pharmacist.
Carry on taking the medicine for as long as you have been
told unless you have any problems. In that case, check
with your doctor.
The usual doses are as follows:
Adults: To treat an infection, you should usually take
250 mg of your medicine three times a day. This is two 5ml
spoonfuls of Amoxicillin Oral Suspension 125 mg or one
5ml spoonful of Amoxicillin Oral Suspension 250 mg
three times a day.
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(UK) Ltd., Units 1-7 Colonial Way, Watford, Hertfordshire,
WD24 4YR
Manufactured by RX Farma Ltd., Unit 3, Colonial Way,
Watford, Hertfordshire, WD24 4YR.
Product Licence Numbers:
PL 36722/0003
PL 36722/0004
Date of revision: September 2014
If you would like this leaflet in a different format, please
contact the licence holder at the above address.

Children: The doctor will advise you of the 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
You should contact your doctor or go to your nearest hospital
casualty department immediately. Take the bottle with you so
that the doctor knows what you have taken.
UKL-XXX

This medicine will be called Amoxicillin Oral Suspension
in this leaflet.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

UKL-XXXX

Amoxicillin 125mg/5ml Oral Suspension
BP Sugar Free
Amoxicillin 250mgl5ml Oral Suspension
BP Sugar Free

4. Possible side effects

• 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 enlargement of the lymph nodes
especially under the arms
• Blistering of the skin, mouth, eyes and genitals, other
serious skin reactions including itchy reddish purple
patches on the skin, hives, pustules, swelling, peeling,

UKL-XXXX

Patient Information Leaflet

If you forget to take a dose of Amoxicillin Oral
Suspension
Take it as soon as you remember. Then carry on as
before, but do not take two doses within one hour of
each other.

UKL-XXXX

Each 5 ml contains 125 mg
Amoxicillin (as trihydrate) as the
active ingredient.
Also includes Sorbitol E420 (see
leaflet for further information).
TO THE PATIENT
For oral use, use as instructed by a
physician.
Please read the leaflet enclosed.
Store in a refrigerator. Do not freeze.
Keep tightly closed.
Shake well before each use.
Use within 7 days of preparation.
Complete the prescribed course
of treatment.
KEEP OUT OF THE SIGHT AND
REACH OF CHlLDREN

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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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