Active substance: AMOXICILLIN SODIUM

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Amoxicillin 250mg, 500mg or 1g,
Powder for Solution for Injection or Infusion
Amoxicillin as Amoxicillin Sodium
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• 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 get serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or nurse.
In this leaflet:
1. What Amoxicillin Injection is and what it is used for
2. Before you are given Amoxicillin Injection
3. How Amoxicillin Injection is given
4. Possible side effects
5. How to store Amoxicillin Injection
6. Further information
The name of your medicine is “Amoxicillin 250mg,
500mg, 1g Powder for Solution for Injection or
Infusion” (referred to as Amoxicillin Injection
throughout this leaflet).

Your medicine contains the active substance
amoxicillin (as amoxicillin sodium), which is one of a
group of medicines called “penicillins”. These
medicines are also known as “antibiotics” and they
work by killing the bacteria that cause infections.
Amoxicillin injection is used to treat a wide range of
bacterial infections which may include those affecting
• Chest (bronchitis or pneumonia)
• Tonsils (tonsillitis)
• Ears (otitis media)
• Sinuses (sinusitis)
• Kidneys, bladder or the urethra (the tube which
carries urine from the bladder)
• Female reproductive system including infections
caused by difficulties during childbirth (puerperal
sepsis and septic abortion)
• Abdomen (intra-abdominal sepsis and peritonitis)
• Heart (endocarditis)
• Blood (septicaemia)
• Teeth and gums
• Skin (including animal bites)
Amoxicillin injection can also be used to treat
gonorrhoea (a sexually transmitted infection),
infections associated with pregnancy and typhoid and
paratyphoid (fevers caused by a group of bacteria
called Salmonella).


Before you are given Amoxicillin Injection
You must tell the doctor or nurse if any of the following
apply to you:
• You are on a low sodium diet (See “Important
information about some of the ingredients of
Amoxicillin injection”).
• You are being treated for kidney problems
• You have glandular fever
Taking other medicines:
Tell the doctor or nurse if you are taking any of the
following medicines:
• the contraceptive pill (in which case you will need to
take extra contraceptive precautions such as using a
• any medicine to prevent blood clots e.g. warfarin
• allopurinol (used to treat gout)
Please tell your doctor if you are taking or have
recently taken any other medicines including any that
you may have bought without a prescription.
Taking Amoxicillin injection with food and drink
You should drink several more glasses of water than
normal on each day of your treatment unless told
otherwise by your doctor.
Pregnancy and breast-feeding:
If you are pregnant, think you might be pregnant or are
breast feeding, you must tell your doctor or nurse
before you are given this medicine.
Driving and using machines
This medicine has no known effects on the ability to
drive or use machines.
Important information about some of the ingredients
of Amoxicillin injection
The sodium content of each vial is 19 mg (250 mg vial),
38 mg (500 mg vial) and 76 mg (1g vial). This should be
taken into consideration by patients on a controlled
sodium diet. Tell your doctor or nurse if this applies to

You should not be given this medicine if:
• You know that you are allergic to penicillin or any
other antibiotic
• You have ever had a skin rash or swelling of the face
or neck when taking any antibiotic.

-------------------------------------------------------------------------------------INFORMATION FOR THE HEALTHCARE PROFESSIONAL
The following information is intended for medical or healthcare professionals only.
Special precautions for storage
Store below 25°C
From a microbiological point of view, the product
should be used immediately. If not used immediately,
in-use storage times and conditions prior to use are
the responsibility of the user.

Instructions for use and handling
Intravenous Injection:
Dissolve 250mg in 5 ml Water for Injections BP (final
volume 5.2 ml). Dissolve 500mg in 10 ml Water for
Injections BP (final volume 10.4 ml). Dissolve 1g in
20ml Water for Injections BP (final volume 20.8 ml).
Amoxicillin injection, suitably diluted, may be injected
directly into a vein or the infusion line over a period of
three to four minutes.

Your doctor or nurse will prepare your injection in the
form of a liquid. They will inject this into a muscle
(intramuscular) or into a vein (intravenous). Your
doctor will decide how much you need and how often
the injections should be given.
Adults including the elderly:
Treatment of infection:
The usual dose is 500mg given every 8 hours or more
frequently if considered necessary by your doctor.
Prevention of heart infection (endocarditis)
If you have had heart problems, you may need an
antibiotic before you have surgery, dental treatment of
certain medical examinations. This is to prevent you
from getting a heart infection.
The usual dose is 1g given before you are given a
general anaesthetic (if one is to be given).
You may be given another antibiotic (gentamicin) at
the same time.
You may need a second injection of 500mg or 1g to be
given 6 hours later, or when recovering from the
general anaesthetic, if you are unable to take
amoxicillin by mouth.
Children weighing more than 40 kg should be given the
usual adult dosage.
Children weighing < 40 kg
The daily dosage is 40 - 90 mg/kg/day in two to three
divided doses (not exceeding 3 g/day) except in the
following cases, where your doctor may prescribe a
different dose:
Tonsillitis, ear infections, prevention of heart infection
(endocarditis), and early Lyme disease.
Doses may also be reduced or given less frequently in
patients with kidney problems.
If you think you have missed an injection:
Speak to your doctor or nurse.
If you are given more of this medicine than you
This is unlikely to happen but if it does, the doctor will
treat any symptoms that follow.

The following side effects may also occur. Tell your
doctor if any of these become troublesome:
Common side effects (probably affecting more than 1
in 100 people given this injection)
• Feeling sick (nausea)
• Diarrhoea
Uncommon side effects (probably affecting fewer
than 1 in 100 people given this injection)
• Being sick (vomiting)
Very rare side effects (probably affecting fewer than 1
in 10,000 people given this injection)
• Thrush (a yeast infection of the vagina, mouth or skin
folds). You can get treatment from your doctor or
• Crystals forming in your urine (crystalluria) which
may cause difficulty or discomfort in passing urine
• Excessive body movements (hyperkinesia),
• Dizziness
• Convulsions (fits). People who are on high doses of
amoxicillin or whose kidneys do not work properly
may experience convulsions.
• Reduction in blood cell counts which makes
infections more likely
• Anaemia (a reduction in the body’s red blood cells or
haemoglobin which may be characterised by feeling
weak or light-headed)
• A longer time taken for blood to clot. Tell your doctor
that you are taking amoxicillin if you are having blood
If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or nurse.

Keep out of the reach and sight of children.
Store vials below 25°C. Your doctor, pharmacist or
nurse will know how to store Amoxicillin Injection
Do not use after the expiry date which is printed on
the label and carton, or if the powder shows signs of
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.

Like all medicines, Amoxicillin Injection can cause
side effects, although not everybody gets them.
If you get any of the following side effects soon after
receiving this medicine, tell your doctor or nurse
immediately. If you get them, you may have had a
serious allergic reaction or other type of reaction to
this medicine:
• stomach pain or severe diarrhoea (possibly with
• your skin or the whites of your eyes start turning
• any unexplained bleeding, bruising or skin
• skin rash and itching
• blistering of the skin, mouth, eyes, or genitals
• any sudden wheeziness, difficulty in breathing or
• any swelling of the face, neck or tongue
• your urine becomes darker or your faeces becomes
• convulsions (“fits”)

What Amoxicillin injection contains
Each vial contains 250mg, 500mg or 1g of amoxicillin
(as amoxicillin sodium). There are no other
What Amoxicillin injection looks like and contents of
the pack:
Amoxicillin injection is a white or almost white powder
in a glass vial.
Each carton contains 1, 5, 10, 20 or 50 glass vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Ibigen S.r.l.
04011 Aprilia (Lt), Via Fossignano, 2, Italy
Istituto Biochimico Italiano,
04011 Aprilia (Lt), Via Fossignano, 2, Italy

This leaflet was last revised in January 2012

-------------------------------------------------------------------------------------Intravenous Infusion:
Solutions may be prepared as described for
intravenous injections and then added to an
intravenous solution in a minibag or in-line burette and
administered over a period of half to one hour.
Alternatively, using a suitable reconstitution device,
the appropriate volume of intravenous fluid may be
transferred from the infusion bag into the vial and then
drawn back into the bag after dissolution.
Intramuscular injection:
Add 1.5ml (250mg vial) or 2.5 ml (500mg & 1g vials)
Water for Injections BP and shake vigorously. Final
volumes: 1.7ml (250ml), 2.9ml (500mg) and 3.3ml (1g)

Amoxicillin injection may be added to the following
intravenous fluids and used immediately.
• Water for Injections BP
• Sodium Chloride Intravenous Infusion (0.9%)
• Potassium Chloride (0.3%) and Sodium Chloride
(0.9%) Intravenous Infusion
• Glucose Intravenous Infusion
• Sodium Chloride (0.18%) and Glucose (4%)
Intravenous Infusion
• Dextran 40 Intravenous Infusion (10%) in Sodium
Chloride Intravenous Infusion (0.9%)
• Dextran 40 Intravenous Infusion (10%) in Glucose
Intravenous Infusion (5%)
• Sodium Lactate Intravenous Infusion (M/6)
• Compound Sodium Lactate Intravenous Infusions
(Ringer-Lactate: Hartmann’s Solution)

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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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