AUGMENTIN INTRAVENOUS 600 MG AND AUGMENTIN INTRAVENOUS 1.2 G - patient leaflet, side effects, dosage

Information for the Healthcare Professional

AUGMENT1N Intravenous co-amoxidav (amoxicillin and clavulanic acid)

Children weighing less than 40 kg

All doses are worked out depending on the child's bodyweight in kilograms.

Please refer to the Summary of Product Characteristics for further information

Administration

Augmentin may be administered either by slow intravenous injection over a period of 3 to 4 min directly into a vein or via a drip tube or by infusion over 30 to 40 min. Augmentin is not suitable for intramuscular administration.

Reconstitution

For single use only. Discard any unused solution.

The reconstitution/di­lution is to be made under aseptic conditions. The solution is to be inspected visually for particulate matter and discolouration prior to administration. The solution should only be used if the solution is clear and free from particles.

Augmentin vials or bottles are not suitable for multi-dose use.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Preparation of solutions for intravenous injection

500 mg/100 mg powder for solution for injection/infusion

Water for Injections Ph.Eur. is the normal solvent. Augmentin IV 500 mg/100 mg should be dissolved in 10 ml of solvent. This yields approximately 10.5 ml of solution for single-dose use.

A transient pink colouration may or may not develop during reconstitution. Reconstituted solutions are normally colourless to yellow in colour.

Augmentin IV for bolus injection should be administered within 20 min of reconstitution.

1000 mg/200 mg powder for solution for injection/infusion

Water for Injections Ph.Eur. is the normal solvent. Augmentin IV 1000 mg/200 mg should be dissolved in 20 ml of solvent. This yields approximately 20.9 ml of solution for single-dose use.

A transient pink colouration may or may not develop during reconstitution. Reconstituted solutions are normally colourless to yellow in colour.

Augmentin IV for bolus injection should be administered within 20 min of reconstitution.

Preparation of solutions for intravenous infusion

500 mg/100 mg powder for solution for injection/infusion

Augmentin IV must be reconstituted as described above for injection.

Without delay the reconstituted solution should be added to 50 ml of infusion fluid using a minibag or in-line burette.

1000 mg/200 mg powder for solution for injection/infusion

Augmentin IV must be reconstituted as described above for injection.

Without delay the reconstituted solution should be added to 100 ml of infusion fluid using a minibag or in-line burette.

Stability of prepared solutions

Reconstituted vials or bottles (for intravenous injection or before dilution for infusion)

500 mg/100 mg powder for solution for injection/infusion

The reconstituted solution (1 vial with 10 ml of Water for Injections Ph.Eur.) should be used or diluted immediately, within 20 minutes.

1000 mg/200 mg powder for solution for injection/infusion

The reconstituted solution (1 vial or bottle with 20 ml of Water for Injections Ph.Eur.) should be used or diluted immediately, within 20 minutes.

Diluted for intravenous infusion

500 mg/100 mg powder for solution for injection/infusion

Chemical and physical in-use stability has been demonstrated for 2–3 hours at 25°C, or 8 hours at 5°C. From a microbiological point of view, the reconstituted and diluted solution (1 reconstituted vial in a minimum volume of 50 ml of infusion fluid) should be used immediately.

1000 mg/200 mg powder for solution for injection/infusion

Chemical and physical in-use stability has been demonstrated for 2–3 hours at 25°C, or 8 hours at 5°C. From a microbiological point of view, the reconstituted and diluted solution (1 reconstituted vial or bottle in a minimum volume of 100 ml of infusion fluid) should be used immediately.

Intravenous infusions of amoxicillin/cla­vulanic acid may be given in a range of different intravenous fluids. Satisfactory antibiotic concentrations are retained at 5 °C and at room temperature (25°C) in the recommended volumes of the following infusion fluids. If reconstituted and maintained at room temperature (25°C), infusions should be completed within the times stated in the following table:

For storage at 5°C, reconstituted solutions of Augmentin IV may be added to pre-refrigerated infusion bags containing either Water for Injections Ph. Eur. or sodium chloride BP (0.9% w/v), which may be stored for up to 8 hours. Thereafter, the infusion should be administered immediately after reaching room temperature.

The stability of Augmentin IV solutions is concentration dependent. In the event that the use of more concentrated solutions is required, the stability period should be adjusted accordingly.

Augmentin IV is less stable in infusions containing glucose, dextran or bicarbonate. Reconstituted solutions of amoxicillin/cla­vulanic acid may be injected into the drip tubing over a period of 3 to 4 min.

Any residual antibiotic solution should be discarded.

This leaflet was last revised in February 2020.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects below may happen with this medicine.

Conditions you need to look out for

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis) which may be visible as red or purple raised spots on the skin, but can affect other parts of the body
• fever, joint pain, swollen glands in the neck, armpit or groin
• swelling, sometimes of the face or throat (angioedema), causing difficulty in breathing
• collapse.

Contact a doctor immediately if you get any of these symptoms. Stop taking Augmentin.

Inflammation of large intestine

Inflammation of the large intestine, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever.

Contact your doctor as soon as possible for advice if you get these symptoms.

Common side effects

These may affect up to 1 in 10 people

• thrush (candida – a yeast infection of the vagina, mouth or skin folds)
• diarrhoea

Uncommon side effects

These may affect up to 1 in 100 people

• skin rash, itching
• raised itchy rash (hives)
• feeling sick (nausea), especially when taking high doses
• vomiting
• indigestion
• dizziness
• headache.

Uncommon side effects that may show up in your blood tests:

• increase in some substances (enzymes) produced by the liver.

Rare side effects

These may affect up to 1 in 1,000 people

• skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge – erythema multiforme)

• – » if you notice any of these symptoms contact a doctor urgently.

• swelling and redness along a vein which is extremely tender when touched

Rare side effects that may show up in your blood tests:

• low number of cells involved in blood clotting
• low number of white blood cells.

Frequency not known

Frequency cannot be estimated from the available data.

• Allergic reactions (see above)
• Inflammation of the large intestine (see above)
• Inflammation of the protective membrane surrounding the brain (aseptic meningitis)
• Serious skin reactions:

• – a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form, causing extensive peeling of the skin (more than 30% of the body surface – toxic epidermal necrolysis)

• – widespread red skin rash with small pus-containing blisters (bullous exfoliative dermatitis)

• – a red, scaly rash with bumps under the skin and blisters (exanthemouspus­tulosis).

• – flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).

Contact a doctor immediately if you get any of these symptoms.

• inflammation of the liver (hepatitis)
• jaundice, caused by increases in the blood of bilirubin (a substance produced in the liver) which may make your skin and whites of the eyes appear yellow
• inflammation of tubes in the kidney
• blood takes longer to clot
• convulsions (in people taking high doses of Augmentin or who have kidney problems).

Side effects that may show up in your blood or urine tests:

• severe reduction in the number of white blood cells
• low number of red blood cells (haemolytic anaemia)
• crystals in urine.

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: or by searching for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

Augmentin Intravenous is for use in hospital only and the expiry date and storage instructions stated on the label are for the doctor, nurse or pharmacist's in­formation. The doctor, pharmacist or nurse will make up your medicine. It should be used within 20 minutes of reconstitution.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date (EXP) shown on the carton. The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Augmentin contains:

500 mg/100 mg powder for injection/infusion

• The active substances are amoxicillin and clavulanic acid. Each vial contains sodium amoxicillin equivalent to 500 mg amoxicillin and potassium clavulanate equivalent to 100 mg of clavulanic acid.

1000 mg/200 mg powder for injection/infusion

• The active substances are amoxicillin and clavulanic acid. Each vial or bottle contains sodium amoxicillin equivalent to 1000 mg amoxicillin and potassium clavulanate equivalent to 200 mg of clavulanic acid.

There are no other ingredients. However, see section 2 for further important information about sodium and potassium in Augmentin.

The doctor, nurse or pharmacist will make up the injection before use using an appropriate fluid (such as Water for Injections or an injection/infusion fluid).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Beecham Group Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS

Manufacturer:

Biopharma S.r.L, Via del Ie Gerbere 22/30, 00134 Santa Palomba, Roma – Italy

Other formats

To listen or to 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 Augmentin Intravenous

Reference number 00038/0320

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in February 2020.

Trade marks are owned by or licensed to the GSK group of companies.

© 2020 GSK group of companies or its licensor.

s

NJ

Package leaflet: Information for the user

AUGMENTIN Intravenous co-amoxiclav (amoxicillin/cla­vulanic acid)

1000000 gt

0149840

Information for the Healthcare Professional

AUGMENTIN Intravenous

co-amoxiclav (amoxicillin and clavulanic acid)

Children weighing less than 40 kg

All doses are worked out depending on the child's bodyweight in kilograms.

|Please refer to the Summary of Product Characteristics for further information|

Administration

Augmentin may be administered either by slow intravenous injection over a period of 3 to 4 min directly into a vein or via a drip tube or by infusion over 30 to 40 min.

Augmentin is not suitable for intramuscular administration.

Reconstitution

For single use only. Discard any unused solution.

The reconstitution/di­lution is to be made under aseptic conditions. The solution is to be inspected visually for particulate matter and discolouration prior to administration.

The solution should only be used if the solution is clear and free from particles.

Augmentin vials or bottles are not suitable for multi-dose use.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Preparation of solutions for intravenous injection

500 mq/100 mg powder for solution for injection/infusion

Water for Injections Ph.Eur. is the normal solvent. Augmentin IV 500 mg/100 mg should be dissolved in 10 ml of solvent. This yields approximately 10.5 ml of solution for single-dose use. A transient pink colouration may or may not develop during reconstitution. Reconstituted solutions are normally colourless to yellow in colour.

Augmentin IV for bolus injection should be administered within 20 min of reconstitution.

1000 mg/200 mg powder for solution for injection/infusion

Water for Injections Ph.Eur. is the normal solvent. Augmentin IV 1000 mg/200 mg should be dissolved in 20 ml of solvent. This yields approximately 20.9 ml of solution for single-dose use. A transient pink colouration may or may not develop during reconstitution. Reconstituted solutions are normally colourless to yellow in colour.

Augmentin IV for bolus injection should be administered within 20 min of reconstitution.

Preparation of solutions for intravenous infusion

500 mq/100 mg powder for solution for injection/infusion

Augmentin IV must be reconstituted as described above for injection. Without delay the reconstituted solution should be added to 50 ml of infusion fluid using a minibag or in-line burette.

1000 mg/200 mg powder for solution for injection/infusion

Augmentin IV must be reconstituted as described above for injection. Without delay the reconstituted solution should be added to 100 ml of infusion fluid using a minibag or in-line burette.

Stability of prepared solutions

Reconstituted vials or bottles (for intravenous injection or before dilution for infusion)

500 mq/100 mg powder for solution for injection/infusion

The reconstituted solution (1 vial with 10 ml of Water for Injections Ph.Eur.) should be used or diluted immediately, within 20 minutes.

1000 mg/200 mg powder for solution for injection/infusion

The reconstituted solution (1 vial or bottle with 20 ml of Water for Injections Ph.Eur.) should be used or diluted immediately, within 20 minutes.

Diluted for intravenous infusion

500 mg/100 mg powder for solution for injection/infusion

Chemical and physical in-use stability has been demonstrated for 2–3 hours at 25°C, or 8 hours at 5°C. From a microbiological point of view, the reconstituted and diluted solution (1 reconstituted vial in a minimum volume of 50 ml of infusion fluid) should be used immediately.

1000 mg/200 mg powder for solution for injection/infusion

Chemical and physical in-use stability has been demonstrated for 2–3 hours at 25°C, or 8 hours at 5°C. From a microbiological point of view, the reconstituted and diluted solution (1 reconstituted vial or bottle in a minimum volume of 100 ml of infusion fluid) should be used immediately.

Intravenous infusions of amoxicillin/cla­vulanic acid may be given in a range of different intravenous fluids. Satisfactory antibiotic concentrations are retained at 5°C and at room temperature (25°C) in the recommended volumes of the following infusion fluids. If reconstituted and maintained at room temperature (25°C), infusions should be completed within the times stated in the following table:

For storage at 5°C, reconstituted solutions of Augmentin IV may be added to pre-refrigerated infusion bags containing either Water for Injections Ph.Eur. or sodium chloride BP (0.9% w/v), which may be stored for up to 8 hours. Thereafter, the infusion should be administered immediately after reaching room temperature.

The stability of Augmentin IV solutions is concentration dependent. In the event that the use of more concentrated solutions is required, the stability period should be adjusted accordingly.

Augmentin IV is less stable in infusions containing glucose, dextran or bicarbonate. Reconstituted solutions of amoxicillin/cla­vulanic acid may be injected into the drip tubing over a period of 3 to 4 min.

Any residual antibiotic solution should be discarded.

This leaflet was last revised in February 2020.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects below may happen with this medicine.

Conditions you need to look out for

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis') which may be visible as red or purple raised spots on the skin, but can affect other parts of the body
• fever, joint pain, swollen glands in the neck, armpit or groin
• swelling, sometimes of the face or throat (angioedema), causing difficulty in breathing
• collapse.

• -» Contact a doctor immediately if you get any of these symptoms. Stop taking Augmentin.

Inflammation of large intestine

Inflammation of the large intestine, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever.

• → Contact your doctor as soon as possible for advice if you get these symptoms.

Common side effects

These may affect up to 1 in 10 people

• thrush (candida – a yeast infection of the vagina, mouth or skin folds)
• diarrhoea

Uncommon side effects

These may affect up to 1 in 100 people

• skin rash, itching
• raised itchy rash (hives)
• feeling sick (nausea), especially when taking high doses
• vomiting
• indigestion
• dizziness
• headache.

Uncommon side effects that may show up in your blood tests:

• increase in some substances (enzymes) produced by the liver.

Rare side effects

These may affect upto 1 in 1,000 people

• skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge – erythema multiforme)

• – » if you notice any of these symptoms contact a doctor urgently.

• swelling and redness along a vein which is extremely tender when touched

Rare side effects that may show up in your blood tests:

• low number of cells involved in blood clotting
• low number of white blood cells.

Frequency not known

Frequency cannot be estimated from the available data.

• Allergic reactions (see above)
• Inflammation of the large intestine (see above)
• Inflammation of the protective membrane surrounding the brain (aseptic meningitis)
• Serious skin reactions:

– a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form, causing extensive peeling of the skin (more than 30% of the body surface – toxic epidermal necrolysis)

• – widespread red skin rash with small pus-containing blisters (bullous exfoliative dermatitis)

• – a red, scaly rash with bumps under the skin and blisters (exanthemous pustulosis).

• – flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).

-» Contact a doctor immediately if you get any of these symptoms.

• inflammation of the liver (hepatitis)
• jaundice, caused by increases in the blood of bilirubin (a substance produced in the liver) which may make your skin and whites of the eyes appear yellow
• inflammation of tubes in the kidney
• blood takes longer to clot
• convulsions (in people taking high doses of Augmentin or who have kidney problems).

Side effects that may show up in your blood or urine tests:

• severe reduction in the number of white blood cells
• low number of red blood cells (haemolytic anaemia)
• crystals in urine.

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: or by searching for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

Augmentin Intravenous is for use in hospital only and the expiry date and storage instructions stated on the label are for the doctor, nurse or pharmacist's in­formation. The doctor, pharmacist or nurse will make up your medicine. It should be used within 20 minutes of reconstitution.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date (EXP) shown on the carton. The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Augmentin contains: 500 mq/100 mg powder for injection/infusion

• The active substances are amoxicillin and clavulanic acid. Each vial contains sodium amoxicillin equivalent to 500 mg amoxicillin and potassium clavulanate equivalent to 100 mg of clavulanic acid.

1000 mq/200 mg powder for injection/infusion

• The active substances are amoxicillin and clavulanic acid. Each vial or bottle contains sodium amoxicillin equivalent to 1000 mg EAjflE

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Beecham Group Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS

Manufacturer:

Biopharma S.r.L, Via del Ie Gerbere 22/30, 00134 Santa Palomba, Roma – Italy

Other formats

To listen or to 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 Augmentin Intravenous

Reference number 00038/0320

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in February 2020.

Trade marks are owned by or licensed to the GSK group of companies.

© 2020 GSK group of companies or its licensor.

s

NJ

Package leaflet: Information for the user

AUGMENTIN Intravenous co-amoxiclav (amoxicillin/cla­vulanic acid)

1000000 gt

0149840

Information for the Healthcare Professional

AUGMENTIN Intravenous

co-amoxiclav (amoxicillin and clavulanic acid)

Children weighing less than 40 kg

All doses are worked out depending on the child's bodyweight in kilograms.

|Please refer to the Summary of Product Characteristics for further information|

Administration

Augmentin may be administered either by slow intravenous injection over a period of 3 to 4 min directly into a vein or via a drip tube or by infusion over 30 to 40 min.

Augmentin is not suitable for intramuscular administration.

Reconstitution

For single use only. Discard any unused solution.

The reconstitution/di­lution is to be made under aseptic conditions. The solution is to be inspected visually for particulate matter and discolouration prior to administration.

The solution should only be used if the solution is clear and free from particles.

Augmentin vials or bottles are not suitable for multi-dose use.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Preparation of solutions for intravenous injection

500 mq/100 mg powder for solution for injection/infusion

Water for Injections Ph.Eur. is the normal solvent. Augmentin IV 500 mg/100 mg should be dissolved in 10 ml of solvent. This yields approximately 10.5 ml of solution for single-dose use. A transient pink colouration may or may not develop during reconstitution. Reconstituted solutions are normally colourless to yellow in colour.

Augmentin IV for bolus injection should be administered within 20 min of reconstitution.

1000 mg/200 mg powder for solution for injection/infusion

Water for Injections Ph.Eur. is the normal solvent. Augmentin IV 1000 mg/200 mg should be dissolved in 20 ml of solvent. This yields approximately 20.9 ml of solution for single-dose use. A transient pink colouration may or may not develop during reconstitution. Reconstituted solutions are normally colourless to yellow in colour.

Augmentin IV for bolus injection should be administered within 20 min of reconstitution.

Preparation of solutions for intravenous infusion

500 mq/100 mg powder for solution for injection/infusion

Augmentin IV must be reconstituted as described above for injection. Without delay the reconstituted solution should be added to 50 ml of infusion fluid using a minibag or in-line burette.

1000 mg/200 mg powder for solution for injection/infusion

Augmentin IV must be reconstituted as described above for injection. Without delay the reconstituted solution should be added to 100 ml of infusion fluid using a minibag or in-line burette.

Stability of prepared solutions

Reconstituted vials or bottles (for intravenous injection or before dilution for infusion)

500 mq/100 mg powder for solution for injection/infusion

The reconstituted solution (1 vial with 10 ml of Water for Injections Ph.Eur.) should be used or diluted immediately, within 20 minutes.

1000 mg/200 mg powder for solution for injection/infusion

The reconstituted solution (1 vial or bottle with 20 ml of Water for Injections Ph.Eur.) should be used or diluted immediately, within 20 minutes.

Diluted for intravenous infusion

500 mg/100 mg powder for solution for injection/infusion

Chemical and physical in-use stability has been demonstrated for 2–3 hours at 25°C, or 8 hours at 5°C. From a microbiological point of view, the reconstituted and diluted solution (1 reconstituted vial in a minimum volume of 50 ml of infusion fluid) should be used immediately.

1000 mg/200 mg powder for solution for injection/infusion

Chemical and physical in-use stability has been demonstrated for 2–3 hours at 25°C, or 8 hours at 5°C. From a microbiological point of view, the reconstituted and diluted solution (1 reconstituted vial or bottle in a minimum volume of 100 ml of infusion fluid) should be used immediately.

Intravenous infusions of amoxicillin/cla­vulanic acid may be given in a range of different intravenous fluids. Satisfactory antibiotic concentrations are retained at 5°C and at room temperature (25°C) in the recommended volumes of the following infusion fluids. If reconstituted and maintained at room temperature (25°C), infusions should be completed within the times stated in the following table:

[ 4 Possible side effects

For storage at 5°C, reconstituted solutions of Augmentin IV may be added to pre-refrigerated infusion bags containing either Water for Injections Ph.Eur. or sodium chloride BP (0.9% w/v), which may be stored for up to 8 hours. Thereafter, the infusion should be administered immediately after reaching room temperature.

The stability of Augmentin IV solutions is concentration dependent. In the event that the use of more concentrated solutions is required, the stability period should be adjusted accordingly.

Augmentin IV is less stable in infusions containing glucose, dextran or bicarbonate. Reconstituted solutions of amoxicillin/cla­vulanic acid may be injected into the drip tubing over a period of 3 to 4 min.

Any residual antibiotic solution should be discarded.

This leaflet was last revised in February 2020.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects below may happen with this medicine.

Conditions you need to look out for

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis') which may be visible as red or purple raised spots on the skin, but can affect other parts of the body
• fever, joint pain, swollen glands in the neck, armpit or groin
• swelling, sometimes of the face or throat (angioedema), causing difficulty in breathing
• collapse.

• -» Contact a doctor immediately if you get any of these symptoms. Stop taking Augmentin.

Inflammation of large intestine

Inflammation of the large intestine, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever.

• → Contact your doctor as soon as possible for advice if you get these symptoms.

Common side effects

These may affect up to 1 in 10 people

• thrush (candida – a yeast infection of the vagina, mouth or skin folds)
• diarrhoea

Uncommon side effects

These may affect up to 1 in 100 people

• skin rash, itching
• raised itchy rash (hives)
• feeling sick (nausea), especially when taking high doses
• vomiting
• indigestion
• dizziness
• headache.

Uncommon side effects that may show up in your blood tests:

• increase in some substances (enzymes) produced by the liver.

Rare side effects

These may affect upto 1 in 1,000 people

• skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge – erythema multiforme)

• – » if you notice any of these symptoms contact a doctor urgently.

• swelling and redness along a vein which is extremely tender when touched

Rare side effects that may show up in your blood tests:

• low number of cells involved in blood clotting
• low number of white blood cells.

Frequency not known

Frequency cannot be estimated from the available data.

• Allergic reactions (see above)
• Inflammation of the large intestine (see above)
• Inflammation of the protective membrane surrounding the brain (aseptic meningitis)
• Serious skin reactions:

– a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form, causing extensive peeling of the skin (more than 30% of the body surface – toxic epidermal necrolysis)

• – widespread red skin rash with small pus-containing blisters (bullous exfoliative dermatitis)

• – a red, scaly rash with bumps under the skin and blisters (exanthemous pustulosis).

• – flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).

-» Contact a doctor immediately if you get any of these symptoms.

• inflammation of the liver (hepatitis)
• jaundice, caused by increases in the blood of bilirubin (a substance produced in the liver) which may make your skin and whites of the eyes appear yellow
• inflammation of tubes in the kidney
• blood takes longer to clot
• convulsions (in people taking high doses of Augmentin or who have kidney problems).

Side effects that may show up in your blood or urine tests:

• severe reduction in the number of white blood cells
• low number of red blood cells (haemolytic anaemia)
• crystals in urine.

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: or by searching for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

2 5 How to store Augmentin

Augmentin Intravenous is for use in hospital only and the expiry date and storage instructions stated on the label are for the doctor, nurse or pharmacist's in­formation. The doctor, pharmacist or nurse will make up your medicine. It should be used within 20 minutes of reconstitution.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date (EXP) shown on the carton. The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

r6 Contents of the pack. and other information.

What Augmentin contains: 500 mq/100 mg powder for injection/infusion

• The active substances are amoxicillin and clavulanic acid. Each vial contains sodium amoxicillin equivalent to 500 mg amoxicillin and potassium clavulanate equivalent to 100 mg of clavulanic acid.

1000 mq/200 mg powder for injection/infusion

• The active substances are amoxicillin and clavulanic acid. Each vial or bottle contains sodium amoxicillin equivalent to 1000 mg EAjflE

Product name Augmentin Intravenous

Reference number 00038/0320

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This leaflet was last revised in February 2020.

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© 2020 GSK group of companies or its licensor.

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