AMOXICILLIN 125MG/5ML SUGAR FREE SUSPENSION

Active substance: AMOXICILLIN TRIHYDRATE

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PL 19348/0067
Date of last revision: November 2010

Pantone
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2728 C

PL 19348/0067

POM

Pantone
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186 C

100ml
Pantone
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1. WHAT AMOXICILLIN SUSPENSION IS AND
WHAT IT IS USED FOR

In this leaflet:
Marketing Authorisation Holder
and Manufacturer:
LPC Medical (UK) Ltd.,
30 Chaul End Lane, Luton, Bedfordshire,
LU4 8EZ, UK.
Tel: 01582 560393 Fax: 01582 569009
e-mail: info@lpcpharma.com
Date of last revision: November 2010

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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Pack size – 100ml.

AMOXICILLIN SUGAR FREE SUSPENSION BP
125MG/5ML(amoxicillin trihydrate)

2. Before you take Amoxicillin
Suspension

6. FURTHER INFORMATION
What Amoxicillin Suspension contains

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.

Read all of this leaflet carefully before you start
taking this medicine.

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.

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3. How to take Amoxicillin Suspension

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Keep out of the reach and sight 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 fee 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.

The active ingredient in Amoxicillin Suspension BP
125mg/5ml is Amoxicillin Trihydrate BP equivalent to
Amoxicillin BP 125mg.




• 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.

2. BEFORE YOU TAKE AMOXICILLIN
SUSPENSION

Very Rare side effects (experienced by fewer that
1 patient in 10,000 patients):

4. Possible side effects

• 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.

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Uncommon (occur in less than 1 in 100 patients, but
by more than 1 patient in 1,000 patients):
• Vomiting

5. HOW TO STORE AMOXICILLIN
SUSPENSION



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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.

• Nausea (feeling of sickness) or diarrhoea
• Skin Rash

• 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.
• 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)
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.

5. How to store Amoxicillin Suspension

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.

4. POSSIBLE SIDE EFFECTS

Common (occur in less than 1 in 100 patients):



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.
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.

3. HOW TO TAKE AMOXICILLIN
SUSPENSION

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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.
Important information about some of the ingredients of Amoxicillin Suspension
This medicinal product contains
• E211 sodium benzoate can 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.

Gonorrhea (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.
For urinary tract infections: – Two 3g doses with 10-12
hours between doses.
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:
Upto a maximum of 6 g daily in divided dose, ie. 3g twice daily.

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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.

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.

Other dosages which may be given are:

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.

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

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.

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.
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:

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

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

Children aged 5 to 10 years (in dental treatment):
One 5ml spoonful to be taken three times a day (every 8
hours).

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.

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.

PIL - Main Heading type style: 13pt Helvetica Bold

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
2. media), nose, GIVE urinary tract, heart, skin and
(otitisBEFORE YOUthroat, PARACETAMOL ELIXIR
teeth and also for prevention of endocarditis (inflammation
of the heart lining, heart muscles and heart valves) during
dental procedures. They are also used to treat typhoid

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

Acute otitis media: In areas with high prevalence of
pneumococci with reduced susceptibility to penicillins, dosage
regimens should be guided by national/local recommendations.

Type: Marburg Medium
Dot diameter: 1.6mm
Character spacing: 6mm
Line spacing: 10mm

Label Size: 60 x 165mm with 12 panel Fix-a-Form

6. Further information

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Children weighing less than 40 kg

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Children:

Tonsillitis: 50 mg/kg/day in two divided doses.

Amoxicillin Sugar Free Suspension 125mg / 5ml (0068) Fix-a-Form

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Dosage may be lower than those listed above in the patients
with kidney problems.

BRAILLE
Blind embossing
DO NOT PRINT

Braille:
Amoxicillin Sugar Free
Suspension 125mg / 5ml

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.

KEEP OUT OF THE
REACH AND SIGHT
OF CHILDREN

COLOUR LIST:

Amoxicillin Sugar Free
Suspension 125mg/5ml
Powder for Amoxicillin Oral Suspension.
Each 5ml spoonful of reconstituted Suspension contains
Amoxicillin Trihydrate BP equivalent to 125mg amoxicillin
Excipients: Sodium Benzoate and Sorbitol
To be swallowed. Do not store above 25ºC.
To the pharmacist: To prepare add 84ml 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.

Marketing Authorisation Holder:
LPC Medical (UK) Ltd.,30 Chaul End Lane, Luton, Bedfordshire, LU4 8EZ, UK.

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

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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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