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AMOXIL VIALS FOR INJECTION 500MG

Active substance(s): AMOXICILLIN SODIUM

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Reason for update: Type IAIN National Implementation of Article 30 (non-clinical and clinical only)
Agency Approval Date: 20/08/2015
Text Date: 20/02/2016
Text Issue and Draft No.: issue2draft3
[GlaxoSmithKline Logo]
Package leaflet: Information for the user

Amoxil Vials for Injection
500 mg and 1 g
amoxicillin
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor, pharmacist or nurse.
 If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Amoxil is and what it is used for
2.
What you need to know before you take Amoxil
3.
How to take Amoxil
4.
Possible side effects
5.
How to store Amoxil
6.
Contents of the pack and other information

1 What Amoxil is and what it is used for
What Amoxil is
Amoxil is an antibiotic. The active ingredient is amoxicillin. This belongs to a group of medicines called
‘penicillin’.
What Amoxil is used for
Amoxil is used to treat infections caused by bacteria in different parts of the body.
Amoxil Powder for Solution for Injection or Infusion is usually used for urgent treatment of severe infection
or if patients cannot take Amoxil by mouth.

2 What you need to know before you take Amoxil
Do not take Amoxil:
 if you are allergic to amoxicillin, penicillin or any of the other ingredients of this medicine (listed in
section 6).
 if you have ever had an allergic reaction to any antibiotic. This can include a skin rash or swelling of the
face or throat.
Do not take Amoxil if any of the above apply. If you are not sure, talk to your doctor, pharmacist or nurse
before taking Amoxil.

Reason for update: Type IAIN National Implementation of Article 30 (non-clinical and clinical only)
Agency Approval Date: 20/08/2015
Text Date: 20/02/2016
Text Issue and Draft No.: issue2draft3
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking Amoxil if you:
 have glandular fever (fever, sore throat, swollen glands and extreme tiredness)
 have kidney problems
 are not urinating regularly.
If you are not sure if any of the above apply to you, talk to your doctor, pharmacist or nurse before taking
Amoxil.
Blood and urine tests
If you are having:
 Urine tests (glucose) or blood tests for liver function
 Oestriol tests (used during pregnancy to check the baby is developing normally)
Tell your doctor, pharmacist or nurse that you are taking Amoxil. This is because Amoxil can affect the
results of these tests.
Other medicines and Amoxil
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.






If you are taking allopurinol (used for gout) with Amoxil, it may be more likely that you will have an
allergic skin reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Amoxil.
If you are taking medicines to help stop blood clots (such as warfarin), you may need extra blood tests.
If you are taking other antibiotics (such as tetracycline) Amoxil may be less effective.
If you are taking methotrexate (used for the treatment of cancer and severe psoriasis) Amoxil may cause
an increase in side effects.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor, pharmacist or nurse for advice before taking this medicine.
Driving and using machines
Amoxil can have side effects and the symptoms (such as allergic reactions, dizziness and convulsions) may
make you unfit to drive.
Do not drive or operate machinery unless you are feeling well.
Important information about one of the ingredients of Amoxil
Each vial of Amoxil Vials for Injection 500 mg contains 38 mg of sodium.
Each vial of Amoxil Vials for Injection 1 g contains 76 mg of sodium.
This should be considered if you are on a controlled sodium diet.

3 How Amoxil is given
You will never give yourself this medicine. A qualified person, like a doctor or a nurse, will give you this
medicine.

Reason for update: Type IAIN National Implementation of Article 30 (non-clinical and clinical only)
Agency Approval Date: 20/08/2015
Text Date: 20/02/2016
Text Issue and Draft No.: issue2draft3




Amoxil will be given as an injection or an infusion into a vein (intravenously) or muscle
(intramuscularly).
Your doctor will decide how much you need each day and how often the injections should be given.
Make sure you drink plenty of fluids while having Amoxil.

To treat infections
The usual doses are as follows.
Children up to 40 kg
 Most infections: 20 mg to 200 mg for every kilogram of body weight in divided doses throughout the
day.
 Lyme disease (an infection spread by parasites called ticks): isolated erythema migrans (early stage –
red or pink circular rash) 25 mg to 50 mg for every kilogram of body weight in divided doses throughout
the day; systemic manifestations (late stage – for more serious symptoms or when the disease spreads
around your body) 100 mg for every kilogram of body weight in divided doses throughout the day.
 Maximum single dose: 50 mg for every kilogram of body weight.
 Intramuscular maximum daily dose: 120 mg for every kilogram of body weight as 2 to 6 equally
divided doses.
Adults, elderly patients and children weighing 40 kg or more
 Usual daily dosage: 750 mg to 6 g administered in divided doses.
 Intravenous maximum daily dose: 12 g per day.
 Intravenous maximum single dose: 2 g by infusion or 1 g by bolus injection.
 Intramuscular maximum daily dose: 4 g per day
 Intramuscular maximum single dose: 1 g.
 Lyme disease (an infection spread by parasites called ticks): isolated erythema migrans (early stage –
red or pink circular rash) 4 g per day; systemic manifestations (late stage - for more serious symptoms or
when the disease spreads around your body) 6 g per day.
Kidney problems
If you have kidney problems the dose might be lower than the usual dose.
If more Amoxil is given to you than recommended
It is unlikely you will be given too much, but if you think you have been given too much Amoxil, tell your
doctor, pharmacist or nurse immediately. Signs might be an upset stomach (feeling sick, being sick or
diarrhoea) or crystals in the urine, which may be seen as cloudy urine or problems urinating.
If you think you have missed an injection of Amoxil
Speak to your doctor, pharmacist or nurse.
How long will you need to take Amoxil for?
You will not normally be given Amoxil for more than 2 weeks without the doctor reviewing your
treatment.
Thrush (a yeast infection of moist areas of the body which can cause soreness, itching and white discharge)
may develop if Amoxil is used for a long time. If this occurs, tell your doctor, pharmacist or nurse.

Reason for update: Type IAIN National Implementation of Article 30 (non-clinical and clinical only)
Agency Approval Date: 20/08/2015
Text Date: 20/02/2016
Text Issue and Draft No.: issue2draft3
If you are given Amoxil for a long time, your doctor may perform additional tests to check your kidneys, liver
and blood are working normally.
If you have any further questions about how this product is given, ask your doctor, pharmacist or nurse.

4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Amoxil and see a doctor straight away, if you notice any of the following serious side effects
– you may need urgent medical treatment:
The following are very rare (may affect up to 1 in 10,000 people)


allergic reactions, the signs may include: skin itching or rash, swelling of the face, lips, tongue, body or
breathing difficulties. These can be serious and occasionally deaths have occurred
 rash or pinpoint flat red round spots under the skin surface or bruising of the skin. This is due to
inflammation of blood vessel walls due to an allergic reaction. It can be associated with joint pain
(arthritis) and kidney problems
 a delayed allergic reaction can occur usually 7 to 12 days after having Amoxil, some signs include: rashes,
fever, joint pains and enlargement of the lymph nodes especially under the arms
 a skin reaction known as ‘erythema multiforme’ where you may develop: itchy reddish purple patches on
the skin especially on the palms of the hands or soles of the feet, ‘hive-like’ raised swollen areas on the
skin, tender areas on the surfaces of the mouth, eyes and genitals. You may have a fever and be very tired
 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
 fever, chills, a sore throat or other signs of an infection, or if you bruise easily. These may be signs of a
problem with your blood cells
 the Jarisch-Herxheimer reaction which occurs during treatment with Amoxil for Lyme disease and causes
fever, chills, headache, muscle pain and skin rash.
 inflammation of the large bowel (colon) with diarrhoea (sometimes containing blood), pain and fever
 serious liver side effects may occur. They are mainly associated with people having treatment over a long
period, males and the elderly. You must tell your doctor urgently if you get:
o severe diarrhoea with bleeding
o blisters, redness or bruising of the skin
o darker urine or paler stools
o yellowing of the skin or the whites of the eyes (jaundice). See also anaemia below which might
result in jaundice.
These can happen when having the medicine or for up to several weeks after.
If any of the above occurs talk to your doctor or nurse straight away.
Sometimes you may get less severe skin reactions such as:
 a mildly itchy rash (round, pink-red patches), ‘hive-like’ swollen areas on forearms, legs, palms, hands or
feet. This is uncommon (may affect up to 1 in 100 people).
If you have any of these talk to your doctor or nurse as Amoxil will need to be stopped.

Reason for update: Type IAIN National Implementation of Article 30 (non-clinical and clinical only)
Agency Approval Date: 20/08/2015
Text Date: 20/02/2016
Text Issue and Draft No.: issue2draft3
The other possible side effects are:
Common (may affect up to 1 in 10 people)

skin rash

feeling sick (nausea)

diarrhoea.
Uncommon (may affect up to 1 in 100 people)

being sick (vomiting).
Very rare (may affect up to 1 in 10,000 people)

thrush (a yeast infection of the vagina, mouth or skin folds), you can get treatment for thrush from your
doctor, pharmacist or nurse

kidney problems

fits (convulsions), seen in patients on high doses or with kidney problems

dizziness

hyperactivity

crystals in the urine, which may be seen as cloudy urine, or difficulty or discomfort in passing urine.
Make sure you drink plenty of fluids to reduce the chance of these symptoms

an excessive breakdown of red blood cells causing a type of anaemia. Signs include: tiredness,
headaches, shortness of breath, dizziness, looking pale and yellowing of the skin and the whites of the
eyes

low number of white blood cells

low number of cells involved with blood clotting

the blood may take longer to clot than it normally would. You may notice this if you have a nosebleed
or cut yourself.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Amoxil
Amoxil Vials for Injection are for use in hospital only and the expiry date and storage instructions stated on
the label are for the doctor, pharmacist or nurse’s information. The doctor, pharmacist or nurse will make up
your medicine. When administered directly into a muscle or a vein, it should be used immediately following
reconstitution (usually this process takes about 5 minutes). (If Amoxil is being administered by slow infusion
this takes about half to one hour.)

6 Contents of the pack and other information
What Amoxil contains
 Amoxil Vials for Injection are available in 2 strengths.
Amoxil Vials for Injection 500 mg contains amoxicillin 500 mg.
Amoxil Vials for Injection 1 g each contain amoxicillin 1,000 mg.

Reason for update: Type IAIN National Implementation of Article 30 (non-clinical and clinical only)
Agency Approval Date: 20/08/2015
Text Date: 20/02/2016
Text Issue and Draft No.: issue2draft3


There are no other ingredients. However, for information about sodium in Amoxil, please see section 2
Important information about one of the ingredients of Amoxil.

What Amoxil looks like and contents of the pack
Amoxil is supplied as a clear glass vial of sterile powder for making up as an injection. The vial has a rubber
bung and an aluminium foil overseal. The vials are packed in cartons of 5 or 10.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Beecham Group plc, Stockley Park West, Uxbridge, Middlesex UB11 1BT
Manufacturer: SmithKline Beecham, Worthing, West Sussex BN14 8QH
Other formats
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
Reference number

Amoxil Vials for Injection 500 mg
Amoxil Vials for Injection 1 g
00038/0222

This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in September 2015.
Amoxil is a registered trade mark of the GlaxoSmithKline group of companies.
© [2015] GlaxoSmithKline group of companies. All rights reserved.
[GlaxoSmithKline Logo]

Reason for update: Type IAIN National Implementation of Article 30 (non-clinical and clinical only)
Agency Approval Date: 20/08/2015
Text Date: 20/02/2016
Text Issue and Draft No.: issue2draft3

General advice regarding the use of antibiotics
Antibiotics are used to treat infections caused by bacteria. They have no effect against infections
caused by viruses.
Sometimes an infection caused by bacteria does not respond to a course of an antibiotic. One of the
commonest reasons for this to occur is because the bacteria causing the infection are resistant to the
antibiotic that is being taken. This means that they can survive and even multiply despite the
antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully can help
to reduce the chance of bacteria becoming resistant to them.
When your doctor prescribes a course of an antibiotic it is intended to treat only your current
illness. Paying attention to the following advice will help prevent the emergence of resistant
bacteria that could stop the antibiotic working.
1.

2.
3.
4.
5.

It is very important that you take the antibiotic at the right dose, at the right times and for the
right number of days. Read the instructions on the label and if you do not understand
anything ask your doctor or pharmacist to explain.
You should not take an antibiotic unless it has been prescribed specifically for you and you
should use it only to treat the infection for which it was prescribed.
You should not take antibiotics that have been prescribed for other people even if they had
an infection that was similar to yours.
You should not give antibiotics that were prescribed for you to other people.
If you have any antibiotic left over when you have taken the course as directed by your
doctor you should take the remainder to a pharmacy for appropriate disposal.

Reason for update: Type IAIN National Implementation of Article 30 (non-clinical and clinical only)
Agency Approval Date: 20/08/2015
Text Date: 20/02/2016
Text Issue and Draft No.: issue2draft3
--------------------------------------------------------------------------------------------------------------------------[GlaxoSmithKline Logo]
The following information is intended for healthcare professionals only:

Amoxil Vials for Injection
500 mg and 1 g
amoxicillin
Please refer to the Summary of Product Characteristics for further information
Intravenous administration
Vial
500 mg
1g

Diluent (ml)
10
20

Water for injections is the normal diluent.
A transient pink colouration may or may not develop during reconstitution. Reconstituted solutions are
normally colourless or a pale straw colour. All solutions should be shaken vigorously before injection.
500 mg powder for solution for injection or infusion
Preparation of intravenous infusions and stability: add without delay the reconstituted solution of 500 mg
(as prepared above - these are minimum volumes) to 50 ml of infusion fluid.
1 g powder for solution for injection or infusion
Preparation of intravenous infusions and stability: add without delay the reconstituted solution of 1 g (as
prepared above - these are minimum volumes) to 100 ml infusion fluid (e.g. using a mini bag or in-line
burette).
Intravenous amoxicillin may be given in a range of different intravenous fluids.
Intravenous solution
Water for injection
NaCl
Ringer NaCl
Sodium lactate
Ringer sodium lactate
Dextrose
NaCl - dextrose
Amoxicillin is less stable in infusions containing carbohydrate. Reconstituted solutions of amoxicillin may be
injected into the drip tubing over a period of 0.5 to 1 hour.

Reason for update: Type IAIN National Implementation of Article 30 (non-clinical and clinical only)
Agency Approval Date: 20/08/2015
Text Date: 20/02/2016
Text Issue and Draft No.: issue2draft3
Intramuscular administration
Vial
500 mg
1g

Diluent
2.5 ml water for injections
or 5.1 ml benzyl alcohol solution
2.5 ml lidocaine hydrochloride solution

All solutions should be shaken vigorously before injection and administered within 30 minutes of
reconstitution.
Any residual antibiotic solution should be discarded.
For single use only.

This leaflet was last revised in September 2015.
Amoxil is a registered trade mark of the GlaxoSmithKline group of companies.
© 2015 GlaxoSmithKline group of companies. All rights reserved.

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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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