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AMOXICILLIN 500MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): AMOXICILLIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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).
1.

WHAT AMOXICILLIN INJECTION IS AND WHAT IT IS USED FOR

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 the:
• 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).
2.

BEFORE YOU ARE GIVEN AMOXICILLIN INJECTION

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.
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 condom)
• 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.

3.

HOW AMOXICILLIN INJECTION IS GIVEN

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
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 should
This is unlikely to happen but if it does, the doctor will treat any symptoms that follow.
4.

POSSIBLE SIDE EFFECTS

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 bleeding)
your skin or the whites of your eyes start turning yellow
any unexplained bleeding, bruising or skin discolouration
skin rash and itching
blistering of the skin, mouth, eyes, or genitals
any sudden wheeziness, difficulty in breathing or dizziness
any swelling of the face, neck or tongue
your urine becomes darker or your faeces becomes paler
convulsions (“fits”)

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 pharmacist.
• 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 tests.
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.
5.

HOW TO AMOXICILLIN INJECTION

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
properly.

Do not use after the expiry date which is printed on the label and carton, or if the powder shows
signs of discoloration.
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.
6.

FURTHER INFORMATION

What Amoxicillin injection contains
Each vial contains 250mg, 500mg or 1g of amoxicillin (as amoxicillin sodium). There are no other
ingredients.
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:
Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland
Manufacturer:
Istituto Biochimico Italiano, 04011 Aprilia (Lt), Via di Fossignano, 2, Italy
This leaflet was last revised in July 2014

------------------------------------------------------------------------------------------------------------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.
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) respectively.
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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