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AMOXICILLIN 250MG/5ML POWDER FOR ORAL SUSPENSION

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

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Dosage may be lower than those listed above in the
patients with kidney problems.
Children:
Children weighing less than 40 kg.
The daily dosage for children is 40 - 90 mg/kg/day
in two to three divided doses (not exceeding 3
g/day) depending on the indication, severity of the
disease and the susceptibility of the pathogen.
Dosing three times daily is associated with
enhanced efficacy, thus twice daily dosing is only

recommended when the dose is in the upper range.
Children weighing more than 40 kg should be given
the usual adult dosage.
Other dosages which may be given are:
Tonsillitis: 50 mg/kg/day in two divided doses.
Acute otitis media: In areas with high prevalence of
pneumococci with reduced susceptibility to
penicillins, dosage regimens should be guided by
national/local recommendations.
Early Lyme disease (isolated erythema migrans):
50 mg/kg/day in three divided doses, over
14-21days.
Prophylaxis for endocarditis: 50 mg amoxicillin/kg
body weight given as a single dose one hour
preceding the surgical procedure.

PACKAGE LEAFLET: INFORMATION FOR
THE USER
AMOXICILLIN SUGAR FREE SUSPENSION BP
250MG/5ML (Amoxicillin Trihydrate)
Read all of this leaflet carefully before you
start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, 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.

Impaired renal function: The dose should be
reduced. In patients with a creatinine clearance of
less than 30 ml/min an increase in the dosage
interval and a reduction in the total daily dose is
recommended
Children (up to 10 years of age): Half 5ml
spoonful to be taken three times a day (every 8
hours). This may be doubled in more severe
infections.
Children aged 5 to 10 years (in dental
treatment): Half 5ml spoonful to be taken three
times a day (every 8 hours).
Children under 5 years: Quarter 5ml spoonful
(1.25ml) three times a day (every 8 hour).
If you take more Amoxicillin Suspension than

In this leaflet:

In this leaflet:
1. What Amoxicillin Suspension is and
what it is used for
2. Before you take
Amoxicillin Suspension
3. How to take Amoxicillin Suspension
4. Possible side effects
5. How to store Amoxicillin Suspension
6. Further information

you should
If you take more Amoxicillin Suspension than you
should, contact your doctor or nearest hospital
emergency department immediately. Show the
doctor the medicine bottle.
If you forget to take Amoxicillin Suspension
If you forget to take a dose, take it 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 Suspension
Do not stop taking Amoxicillin Suspension without
talking to your doctor, even if you feel better. If you
stop your medicine before the end of the course,
some bacteria may survive and cause the infection
to come back.

IS AND
1. WHAT AMOXICILLIN SUSPENSION
IS AND WHAT IT IS USED FOR
The name of your medicine is Amoxicillin Suspension
BP 250mg/5ml. It contains the active ingredient
called amoxicillin trihydrate.
Amoxicillin Suspension is an antibiotic for treating
infections. They belong to a group of antibiotics
called “Penicillins” and work by killing the bacteria
that can cause infections.
Amoxicillin Suspension can treat a wide range of
infections including those of the chest (bronchitis or
pneumonia), ears (otitis media), nose, throat, urinary
tract, heart, skin and teeth and also for prevention of
endocarditis (inflammation of the heart lining, heart
muscles and heart valves) during dental procedures.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Amoxicillin Suspension can cause
some side effects, although not everybody gets them.
Very serious side effects - If any of the following
happens, stop taking Amoxicillin Suspension and tell
your doctor immediately or go to the nearest
hospital emergency department:
• Rare allergic (Hypersensitive) reactions such as
difficulty of breathing, swelling of your face, throat
or tongue, skin rash, itching and hives.
Common (occur in less than 1 in 100 patients):
• Nausea (feeling of sickness) or diarrhoea
• Skin Rash
Uncommon (occur in less than 1 in 100 patients, but
by more than 1 patient in 1,000 patients):
• Vomiting

They are also used to treat typhoid fever,
gonorrhoea (a sexually transmitted infection) & other
gynaecological infections, infections caused by a
group of bacteria called Salmonella, inflammation of
abdominal linings (peritonitis), inflammation of the
bone and bone marrow (osteomyelitis), and
inflammation of the membranes that cover the brain
and spinal cord (meningitis).
In children with urinary tract infections, the need for
further clinical investigation should be considered.

2. BEFORE YOU TAKE AMOXICILLIN
SUSPENSION
Do not take Amoxicillin Suspension if you are
allergic (hypersensitive) to amoxicillin trihydrate,

Very Rare side effects (experienced by fewer than
1 patient in 10,000 patients):
• Reduction (reversible) in blood cell counts
including anaemia (a reduction in the body’s red
blood cells or haemoglobin which may be
characterised by feeling weak or light-headed) or
a longer time taken for blood to clot. Tell your
doctor if you are taking Amoxicillin Suspension if
you are having blood tests.
• Excessive body movement (hyperkinesias),
dizziness or convulsions. People who are on high
doses of Amoxicillin Suspension or whose kidneys
do not work properly experience convulsions.
• Thrush (a yeast infection of the vagina, mouth or
skin folds). You can get treatment for thrush from
your doctor or pharmacist.

penicillin (or cephalosporins or any other antibiotics)
or any of the other ingredients in this medicinal
product. See section 6.
Take special care with Amoxicillin Suspension
Seek advice from your doctor before treatment if you
• have been taking Amoxicillin for a long time
• have, or think you have glandular fever
• suffer from kidney problems or have decreased
urinary output
• are to have surgery involving general anaesthesia
• have heart problems
In premature children and during the neonatal
period: renal, hepatic and haematological functions
should be monitored.
Other precautions you should take:
Amoxicillin may cause a reduction in the efficacy of

• Tooth discolouration. The colour usually returns to
normal with brushing.
• Inflammation of the liver and jaundice (yellowing of
the skin and whites of your eyes)
• Inflammation of the kidney
• Forming of crystals in the urine
• Colitis (Inflammation in the bowel, causing
abdominal pain, diarrhoea, fever, sometimes with
bleeding)
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.

oral contraceptives. Extra precaution should be taken
during antibiotic treatment such as using a condom.
Taking other medicines
You should tell your doctor if you are taking or have
taken any of the following medicines as they may
interact with your Amoxicillin Suspension. Examples
of medicines that can affect Amoxicillin Suspension
are:
• Contraceptive pill (in which case you will need to
take extra contraceptive precautions such as
using a condom)
• Warfarin, used to prevent blood clots
• Methotrexate, used to treat arthritis, psoriasis and
certain types of cancer
• Allopurinol, Sulfinpyrazone & Probenecid used in
treating gout or excess uric acid in the blood.

Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date printed
on the pack.
Keep the suspension tightly closed.
The expiry date refers to the last day of that month.
The reconstituted sugar free Suspension should be
used within 7 days of preparation.
Return any sugar free Suspension not used by this
time to the pharmacist. 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.

Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without prescription.
Pregnancy and Breast-feeding
Before you start to take Amoxicillin Suspension,
please tell your doctor or pharmacist if you are
pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking
Amoxicillin Suspension, please consult your doctor
immediately. Ask your doctor or pharmacist for
advice before taking any medicine.
Effects on laboratory tests
Keep all appointments with your doctor and the
laboratory. Your doctor may order certain lab tests to
check your body's response to Amoxicillin. If you are
being checked for the presence of glucose or sugar

KEEP OUT OF
THE SIGHT
AND REACH
OF CHILDREN

A0203/O/LL/A1

5. HOW TO STORE AMOXICILLIN
SUSPENSION

PL No: 28444/0203

Amoxicillin Sugar Free
Suspension 250mg/5ml

6. FURTHER INFORMATION

What Amoxicillin Suspension contains
The active ingredient in Amoxicillin Suspension BP
250mg/5ml is Amoxicillin Trihydrate BP equivalent to
Amoxicillin BP 250mg.
The other ingredients are Sodium Benzoate E211,
Disodium Edetate, Sodium Citrate, Citric Acid, Colloidal
Anhydrous Silica, Sorbitol E420, Saccharin Sodium,
Banana Flavour, Quinoline Yellow E104, Xanthan Gum.
Pack size – 100ml.
MA Holder: Activase Pharmaceuticals Limited,
11 Boumpoulinas, Nicosia 1060, Cyprus
Manufacturer: Ascenders Consulting Services Limited,
110 Butterfield, Great Marlings, Luton, Bedfordshire, LU2 8DL
PL No: 28444/0203 Date leaflet last revised: 04/2017

A0203/O/PIL/A1
A0203/O/LL/A1

Prevention of endocarditis- inflammation of the
heart lining, heart muscles and heart valves
(during dental procedures):
3g orally given one hour before treatment followed
by second dose six hours later, if necessary.

250
mg

5ml

MA Holder: Activase Pharmaceuticals Ltd., 11 Boumpoulinas, Nicosia 1060, Cyprus

Please read the Package Leaflet before use on the reverse of this label.

in urine, please tell your doctor you are taking
Amoxicillin Suspension.

should check with your doctor or pharmacist if you
are not sure. Keep the suspension tightly closed.

Important information about some of the
ingredients of Amoxicillin Suspension
This medicinal product contains
• Sodium Benzoate E211. May increase the risk of
jaundice in newborn babies.
• Sorbitol E420 (This medicinal product contains 16g
Sorbitol. When taken as recommended, each dose
supplies upto 0.8g Sorbitol); can have a mild laxative
effect. Calorific value 2.6 kcal/g Sorbitol.

METHOD AND ROUTE OF ADMINISTRATION
Shake the bottle well before taking each dose. Take
Amoxicillin Suspension with or after food unless the
label advises a specific time.

3. HOW TO TAKE AMOXICILLIN
SUSPENSION
Always take Amoxicillin Suspension (reconstituted
suspension) exactly as your doctor has told you. You

Powder for Amoxicillin Oral Suspension.
Each 5ml spoonful of reconstituted Suspension contains
Amoxicillin Trihydrate BP equivalent to 250mg amoxicillin.
Excipients: Sodium Benzoate and Sorbitol.
To be swallowed. Do not store above 25ºC.
To the pharmacist: To prepare add 82ml of potable
water and shake until all powder is dispersed.
This product may be diluted with either
Sorbitol Solution BP or potable water.
To the patient: Use as directed by the doctor.
Keep tightly closed. Shake well before each use.
Reconstituted Suspension when refrigerated to be
consumed in 7 days. Dispose of any unused Suspension.

Drink several glasses of water each day of your
treatment, unless told otherwise by your doctor.
Keep taking Amoxicillin Suspension until your
prescribed course is finished. Do not stop just
because you feel better. If you stop too soon, the
infection may return.

DOSAGE
Adults (including elderly):
One 5ml spoonful three times a day (every 8 hours).
May be doubled in severe infections
Other dosages which may be given are:
For severe or recurrent respiratory tract
infections: Up to a maximum of 6g daily in divided
dose, ie. 3g twice daily.
For urinary tract infections: Two 3g doses with
10-12 hours between doses.
Gonorrhoea (a sexually transmitted infection):
A single 3g dose (combined with 1g of Probenecid).

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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