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AMOXICILLIN 125MG/5ML POWDER FOR ORAL SUSPENSION SUGAR FREE

Active substance(s): AMOXICILLIN TRIHYDRATE / AMOXICILLIN TRIHYDRATE

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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.
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):
One 5ml spoonful to be taken three times a day
(every 8 hours). This may be doubled in more
severe infections.

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXICILLIN SUGAR FREE SUSPENSION
BP 125MG/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.

Braille reads:

amoxicillin
sugar free
suspension
#125 mg /
#5 ml

amoxicillin
sugar free
suspension
#125 mg w/
#5 ml

Children aged 5 to 10 years (in dental treatment):
One 5ml spoonful to be taken three times a day
(every 8 hours).
Children under 5 years: Half 5ml spoonful three
times a day (every 8 hour).
If you take more Amoxicillin Suspension than 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.

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

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.

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.

IS AND
1. WHAT AMOXICILLIN SUSPENSION
IS AND WHAT IT IS USED FOR
The name of your medicine is Amoxicillin Suspension
BP 125mg/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.

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
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

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, penicillin (or
cephalosporins or any other antibiotics) or any of the
other ingredients in this medicinal product. See section 6.

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.
• 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

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
oral contraceptives. Extra precaution should be taken
during antibiotic treatment such as using a condom.

KEEP OUT OF
THE SIGHT
AND REACH
OF CHILDREN

A0202/O/LL/A1

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
SUSPENSION
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.

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.
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without prescription.

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.

6. FURTHER INFORMATION
What Amoxicillin Suspension contains
The active ingredient in Amoxicillin Suspension
BP 125mg/5ml is Amoxicillin Trihydrate BP
equivalent to Amoxicillin BP 125mg.

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

DO NOT USE THIS PRODUCT
AFTER ITS EXP DATE

PL No: 28444/0202

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: 28444/0202
Date leaflet last revised: 04/2017

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.

3. HOW TO TAKE AMOXICILLIN
SUSPENSION
Always take Amoxicillin Suspension (reconstituted
suspension) exactly as your doctor has told you. You
should check with your doctor or pharmacist if you
are not sure. Keep the suspension tightly closed.

SPACE FOR 2D BARCODE

A0202/O/PIL/A1
A0202/O/LL/A1

Amoxicillin Sugar Free
Suspension 125mg/5ml

Powder for Amoxicillin Oral Suspension.
Each 5ml spoonful of reconstituted Suspension contains
Amoxicillin Trihydrate BP equivalent to125mg amoxicillin.
Excipients: Sodium Benzoate and Sorbitol.
125
To be swallowed. Do not store above 25ºC.
mg
To the pharmacist: To prepare add 84ml of potable
water and shake until all powder is dispersed.
5ml
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.
MA Holder: Activase Pharmaceuticals Ltd., 11 Boumpoulinas, Nicosia 1060, Cyprus

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

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.
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):
Two 5ml spoonfuls 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).
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.
Dosage may be lower than those listed above in the
patients with kidney problems.
Children:
Children weighing less than 40 kg.

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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