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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.

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 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).

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.

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.

X

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

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.

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")

K........................................

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.

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.

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:

Bowmed Limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, UK

Manufacturer:

Istituto Biochimico Italiano, 04011 Aprilia (Lt), Via di Fossignano, 2, Italy

This leaflet was last revised in November 2010

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)

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 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).

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.

X

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

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.

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")

K.............................................

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.

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.

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:

Bowmed Limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, UK

Manufacturer:

Istituto Biochimico Italiano, 04011 Aprilia (Lt), Via di Fossignano, 2, Italy

This leaflet was last revised in November 2010

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)