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AMOXICILLIN 125MG/5ML SUGAR FREE SUSPENSION
Active substance(s): AMOXICILLIN TRIHYDRATE / AMOXICILLIN TRIHYDRATE / AMOXICILLIN TRIHYDRATE
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.
Children weighing more than 40 kg should be given
the usual adult dosage.
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:
Dosage may be lower than those listed above in the
patients with kidney problems.
Acute otitis media: In areas with high prevalence of
pneumococci with reduced susceptibility to
penicillins, dosage regimens should be guided by
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
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.
Tonsillitis: 50 mg/kg/day in two divided doses.
Children aged 5 to 10 years (in dental
treatment): One 5ml spoonful to be taken three
times a day (every 8 hours).
Early Lyme disease (isolated erythema migrans):
50 mg/kg/day in three divided doses, over 14-21days.
Children under 5 years: Half 5ml spoonful 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
If you take more Amoxicillin Suspension than you
should, contact your doctor or nearest hospital
emergency department immediately. Show the
doctor the medicine bottle.
Impaired renal function: The dose should be reduced.
In patients with a creatinine clearance of less than
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
• 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.
SCD Amoxicillin SF Suspension 125mg/5ml 18pp FaF PIL
58 x 124mm base label + 18pp 58 x 74mm leaflet
COLOURS USED :
5. How to store Amoxicillin Suspension
6. Further information
2. BEFORE YOU TAKE AMOXICILLIN
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.
DO NOT PRINT
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without prescription.
Taking other medicines
You should tell your doctor if you are taking or have
taken any of the following medicines as they may
Pregnancy and Breast-feeding
Before you start to take Amoxicillin Suspension,
please tell your doctor or pharmacist if you are
v3 - 14.05.2015
v4 - 24.07.2015
New PL holder
Special Concept Development (UK)
Limited, Unit 1-7 Colonial Way,
v5 - 28.07.2015
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.
Pack size – 100ml.
MA Holder: Special Concept Development (UK) Limited,
Unit 1-7 Colonial Way, Watford, Hertfordshire, WD24 4YR
Manufacturer: Ascenders Consulting Services Limited,
110 Butterfield, Great Marlings, Luton, Bedfordshire, LU2 8DL, UK.
PL No: 36722/0021
Date leaflet last revised: 05/2015
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
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.
Please note that batch coding area
should be unvarnished.
Amoxicillin Sugar Free
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.
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.
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.
Literature pasting area
SD PharmaBraille UK (complies with Marburg)
Dot Size 1.6mm diameter
#125 mg /
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
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.
v2 - 03.12.2013
5. HOW TO STORE AMOXICILLIN
interact with your Amoxicillin Suspension. Examples
of medicines that can affect Amoxicillin Suspension
• 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.
v1 - 29.11.2013
4. Possible side effects
In children with urinary tract infections, the need for
further clinical investigation should be considered.
By reporting side effects you can help provide more
on the safety of this medicine.
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
• 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.
3. How to take Amoxicillin Suspension
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.
They are also used to treat typhoid fever, gonorrhoea
(a sexually transmitted infection) & other gynaecologi-
cal 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
Batch Print Area
14 x 21 mm
2. Before you take
1. WHAT AMOXICILLIN SUSPENSION
IS AND WHAT IT IS USED FOR
• 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.
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.
1. What Amoxicillin Suspension is and
what it is used for
4. POSSIBLE SIDE EFFECTS
. 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):
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.
In this leaflet:
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.
MA Holder: Special Concept Development (UK) Limited, Unit 1-7 Colonial Way, Watford, Hertfordshire, WD24 4YR
Please read the Package Leaflet before use on the reverse of this label.
• Sorbitol E420 (This medicinal product contains 16g
Sorbitol. When taken as recommended, each dose
supplies up to 0.8g sorbitol); can have a mild
laxative effect. Calorific value 2.6 kcal/g sorbitol.
3. HOW TO TAKE AMOXICILLIN
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.
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).
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.