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AMOXICILLIN SUGAR FREE SUSPENSION BP 125MGL5ML
Active substance(s): AMOXICILLIN TRIHYDRATE / AMOXICILLIN TRIHYDRATE / AMOXICILLIN TRIHYDRATE
longer time taken for blood to clot. Tellyour 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
Tooth discolouration. The colour usually returns to normal with
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)
The tongue may change to yellow, brown or black and it may
have a hairy appearance
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:
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 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
Medicines should not be disposed of via waste water 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 125 mg/5 ml and
250 mg/5ml is Amoxicillin Trihydrate EP equivalent to Amoxicillin
EP 250 mg.
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 - 100 ml
Amoxicillin Suspension 125 mg/5 ml - PL 21880/0123
Amoxicillin Suspension 250 mg/5 ml - PL 21880/0124
Date of prepration: January 2015
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMOXICILLIN SUGAR FREE SUSPENSION
125 MG / 5 ML & 250 MG / 5 ML
Read all of this leaflet carefully before you start taking this
• 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
• 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
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
1. WHAT AMOXICILLIN SUSPENSION IS AND WHAT IT
IS USED FOR
The name of your medicine is Amoxicillin Suspension 125 mg/5ml
& 250mg/5ml. It contains the active ingredient called amoxicillin
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, kidneys, heart, skin and soft
tissues 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
gynaecological infections, infections caused by a group of bacteria
called Salmonella, inflammation of abdominal linings (peritonitis),
inflammation of the bone and bone marrow (osteomyelitis), blood
poisoning (septicaemia) 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.
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
• amoxicillin is for a newly born or prematurely born baby
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
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• Contraceptive pill (in which case you will need to take extra
contraceptive precautions such as using a condom)
• Medicines used to prevent blood clots such as Warfarin
• Medicines like Methotrexate, used to treat arthritis, psoriasis
and certain types of cancer
• Medicines like 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
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
Children weighing more than 40 kg should be given the usual adult
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
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 14-21 days.
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
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
This medicinal product contains
• Sodium Benzoate (E21); May increase the risk of jaundice in
new born babies.
• Sorbitol (E420) (This medicinal product contains 16 g sorbitol.
When taken as recommended, each dose supplies upto 0.8 g
sorbitol); can have a mild laxative effect. Calorific value 2.6
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
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 other wise 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
start up again.
Adults (including elderly):
One 5 ml teaspoonful 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. 3 g twice daily.
For urinary tract infections: - Two 3 g doses with 10-12hours
Gonorrhea (a sexually transmitted infection): - A single 3 g dose
(combined with 1 g of Probenecid).
Prevention of endocarditis- inflammation of the heartlining,
heart muscles and heart valves (during dental procedures): 3 g
orally given one hour before treatment followed by second dose six
hours later, if necessary. In some cases different doses may be given
depending on other medical conditions.
Dental abscess: Two 3 g doses with 8 hours between the doses.
Dosage may be lower than those listed above in the patients with
Children (up to 10 years of age):
Half 5 ml teaspoonful 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 5 ml teaspoonful (1.25ml) three times a day (every 8 hour).
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Amoxicillin Suspension can cause some side
effects, although not every body 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 that 1 patient in
• 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
This section is continued overleaf
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.