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AMOXICILLIN 250MG/5ML POWDER FOR ORAL SUSPENSION SUGAR FREE

Active substance(s): AMOXICILLIN TRIHYDRATE

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Dosing three times daily is associated with enhanced
efficacy, thus twice daily dosing is only recommended
when the dose is in the upper range.

Early Lyme disease (isolated erythema migrans):
50 mg/kg/day in three divided doses, over 14-21days.

Children under 5 years: Quarter 5ml spoonful (1.25ml)
three times a day (every 8 hour).

Prophylaxis for endocarditis: 50 mg amoxicillin/kg body
weight given as a single dose one hour preceding the
surgical procedure.

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.

Children weighing more than 40 kg should be given the
usual adult dosage.

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

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.

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).

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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Amoxicillin Suspension can cause
some side effects, although not everybody gets them.

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.

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.

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

Common (occur in less than 1 in 100 patients):
• Nausea (feeling of sickness) or diarrhoea
• Skin Rash

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

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.

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
Amoxicillin Suspension or whose kidneys do not work
properly experience convulsions.

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.

• 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)
• Other severe skin reactions can include: changes in
skin colour, bumps under the skin, blistering, pustules,
peeling, redness, pain, itching, scaling. These may be
associated with fever, headaches and body aches
• Flu-like symptoms with a rash, fever, swollen glands,
and abnormal blood test results (including increased

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.

white blood cells (eosinophilia) and liver enzymes) (Drug
Reaction with Eosinophilia and Systemic Symptoms
(DRESS)).
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
SUSPENSION
Keep out of the sight and reach of children.
Do not store above 25°C.

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.

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.

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 breast-feeding. If you become
pregnant while taking Amoxicillin Suspension, please
consult your doctor immediately. Ask your doctor or
pharmacist for advice before taking any medicine.

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: 09/2017

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.

Important information about some of the ingredients
of Amoxicillin Suspension

METHOD AND ROUTE OF ADMINISTRATION Shake
the bottle well before taking each dose. Take Amoxicillin

PL No: 28444/0203

Amoxicillin Sugar Free
Suspension 250mg/5ml

The other ingredients are Sodium Benzoate E211,

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.

KEEP OUT OF
THE SIGHT
AND REACH
OF CHILDREN

A0203/O/LL/A1

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.

250
mg

A0203/O/LL/A2

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.

5ml

A0202/O/LL/A2

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.

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

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

Suspension with or after food unless the label advises a
specific time.

For urinary tract infections: Two 3g doses with 10-12
hours between doses.

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.

Gonorrhoea (a sexually transmitted infection):
A single 3g dose (combined with 1g of Probenecid).

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.

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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