Augmentin

PACKAGE LEAFLET: INFORMATION FOR THE USER

Augmentin 875 mg/125 mg film-coated tablets

Amoxicillin/clavulanic acid
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you (or your child) only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Augmentin is and what it is used for
2. What you need to know before taking Augmentin
3. How to take Augmentin
4. Possible side effects
5. How to store Augmentin
6. Contents of the pack and other information

1. What Augmentin is and what it is used for

Augmentin is an antibiotic that works by killing bacteria causing infections. It contains two different active ingredients called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins", whose activity can sometimes be blocked (i.e. rendered inactive). The other active component (clavulanic acid) prevents this from happening.
Augmentin is used in adults and children to treat the following infections:

• ear and sinus infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections, including dental infections
• bone and joint infections

2. What you need to know before taking Augmentin

Do not take Augmentin:

• if you are allergic to amoxicillin, clavulanic acid, penicillin, or any of the other ingredients of this medicine (listed in section 6)
• if you have had a severe allergic reaction to any other antibiotic. This may include rash or swelling of the face or throat.
• if you have previously had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

→ Do not take Augmentin if any of these apply to you. If you are unsure, speak with your doctor or
pharmacist before taking Augmentin.
Warnings and precautions
Talk to your doctor or pharmacist before taking Augmentin if you:

• have infectious mononucleosis
• have previously been treated for liver or kidney problems
• do not urinate regularly.

If you are not sure whether any of the conditions listed above apply to you, speak to your doctor or
pharmacist before taking Augmentin.
In some cases, your doctor may carry out tests to identify the type of bacteria causing your infection.
Based on the results, they may prescribe a different dose of Augmentin or a different medicine.
Conditions you should be aware of
Augmentin may worsen certain pre-existing conditions or cause serious side effects.
These may include allergic reactions, seizures, and inflammation of the bowel. You should pay attention to
certain symptoms while taking Augmentin, in order to reduce any risk. See “Conditions you should be aware of” in section 4.
Blood and urine tests
If you are due to have blood tests (for example, checks on red blood cells or liver function tests) or urine tests (for glucose), inform your doctor or nurse that you are taking
Augmentin. This is because Augmentin can affect the results of these types of tests.
Other medicines and Augmentin
Tell your doctor or pharmacist if you are using, have recently used, or might use any other
medicines.
If you are taking allopurinol (used for gout) together with Augmentin, you are very likely to develop a skin allergic reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of
Augmentin.
If you are taking medicines (such as warfarin) that help prevent blood clots together with Augmentin, additional blood tests may be required.
Augmentin can affect how methotrexate (a medicine used to treat cancers or rheumatic diseases) works.
Augmentin can affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Augmentin may cause side effects, and the symptoms may make you unfit to drive.
Do not drive or operate machinery unless you feel well.
Augmentin contains sodium

• This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Augmentin

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults and children weighing 40 kg or more

• Usual dose – 1 tablet twice daily
• Higher dose – 1 tablet three times daily

Children weighing less than 40 kg
Children up to 6 years of age should preferably be treated with Augmentin oral suspension or
sachets.
Ask your doctor or pharmacist for advice on administering Augmentin tablets to
children weighing less than 40 kg. The tablets are not suitable for children weighing less than 25 kg.
Patients with kidney or liver problems

• If you have kidney problems, your dose may need to be adjusted. Your doctor may choose a different dosage or a different medicine.
• If you have liver problems, you may require more frequent blood tests to monitor your liver function.

How to take Augmentin

• Take with meals.
• Swallow the tablet whole with a glass of water. The tablets may be divided along the break line to make swallowing easier. Both parts of the tablet should be taken immediately.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take Augmentin for longer than 2 weeks. If you still do not feel better, you should see your doctor.

If you take more Augmentin than you should
If you take too much Augmentin, symptoms may include stomach disturbances (nausea, vomiting, or
diarrhoea) or seizures. Contact your doctor as soon as possible. Take the medicine pack with you to
show the doctor.
If you forget to take Augmentin
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too early, but wait approximately 4 hours. Do not take a double dose to make up for a forgotten dose.
If you stop taking Augmentin
Continue taking Augmentin for the full duration of treatment, even if you feel better. You need every dose to fight the infection. If some bacteria survive, they may cause the infection to return.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. The side effects listed below may occur with this medicine.
Conditions you should pay attention to
Allergic reactions:

• skin rashes
• inflammation of blood vessels ( vasculitis ), which may appear as red or purple spots on the skin, but may also affect other parts of the body
• fever, joint pain, swelling of the glands in the neck, armpits or groin
• swelling, sometimes of the face or throat ( angioedema ), causing difficulty breathing
• collapse
• chest pain occurring in the context of allergic reactions, which may be a symptom of allergy-triggered heart attack ( Kounis syndrome ). Contact your doctor immediately if you experience any of these symptoms. Stop taking Augmentin.

Intestinal inflammation
Intestinal inflammation, causing watery diarrhoea usually containing blood and mucus, stomach pain
and/or fever.
Drug-induced enterocolitis syndrome (DIES)
DIES has been reported mainly in children treated with amoxicillin/clavulanate. It is a type of allergic reaction whose main symptom is repeated vomiting (1-4 hours after administration of the drug). Additional symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.
Acute inflammation of the pancreas (acute pancreatitis)
If you have severe and persistent pain in the stomach area, this could be a sign of acute pancreatitis.
➔ Contact your doctor as soon as possible for advice if these symptoms occur.
Very common side effects
May affect more than 1 in 10 people

• diarrhoea (in adults).

Common side effects
May affect up to 1 in 10 people

• thrush ( candida – a fungal infection of the vagina, mouth or skin folds)
• nausea, especially when taking high doses ➝ if this occurs, take Augmentin with meals
• vomiting
• diarrhoea (in children).

Uncommon side effects
May affect up to 1 in 100 people

• skin rash, itching
• raised, itchy rash ( urticaria )
• indigestion
• dizziness
• headache.

Uncommon side effects may be detected through blood tests:

• increased levels of certain proteins ( enzymes ) produced by the liver.

Rare side effects
May affect up to 1 in 1,000 people

• skin rashes, which may appear as blisters and resemble small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme ). If you notice any of these symptoms, contact your doctor urgently.

Rare side effects may be detected through blood tests:

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

Frequency not known
Frequency cannot be estimated from the available data.

• Allergic reactions (see above)
• Intestinal inflammation (see above)
• Inflammation of the membranes surrounding the brain and spinal cord ( aseptic meningitis )
• Severe skin reactions:
• widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome ) and a more severe form causing extensive skin detachment (more than 30% of body surface – toxic epidermal necrolysis )
• widespread red rash with small pus-filled blisters ( exfoliative bullous dermatitis )
• red rash with crusts, swellings under the skin and blisters ( pustular exanthema )
• flu-like symptoms with rash, fever, swollen glands and abnormal blood test results (including increased white blood cell count ( eosinophilia ) and elevated liver enzymes) ( Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) )
• a red rash commonly seen on both sides of the buttocks, upper inner thighs, armpits and neck (Drug-related Symmetrical Drug-related Intertriginous Flexural Exanthema (SDRIFE)).

If you experience any of these symptoms, contact your doctor immediately.

• Rash with blistering arranged in a ring-shaped pattern with a central crust or resembling a string of pearls ( linear IgA disease )
• inflammation of the liver ( hepatitis )
• jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and whites of the eyes
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity
• seizures (in people taking high doses of Augmentin or who have kidney problems)
• black hairy tongue

Side effects that may be detected through blood or urine tests:

• severe reduction in white blood cell count
• low red blood cell count ( haemolytic anaemia )
• crystals in the urine leading to acute kidney damage.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Augmentin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the pack. The expiry date refers to the
last day of the month.
Do not store above 25°C.
Tablets stored in foil blister packs with desiccant must be used within 30 days of opening.
Store in the original container to protect from moisture.
Do not use the tablets if chipped or damaged.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Augmentin Contains

• The active substances are amoxicillin and clavulanic acid. Each tablet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
• Other components are: Tablet core – magnesium stearate, sodium carboxymethyl starch A, anhydrous colloidal silica, microcrystalline cellulose. Film coating – titanium dioxide (E171), hypromellose, macrogol (4000, 6000), and silicone oil (dimethicone).

Description of the Appearance of Augmentin and Package Contents
Augmentin 875 mg/125 mg – film-coated tablets – white to off-white, capsule-shaped tablets, marked “AC” on both sides and with a break line on one side.
They are packaged in:

• Blister packs, contained in a cardboard carton. Each pack contains 2, 4, 10, 12, 14, 16, 20, 24, 30, 100 or 500 tablets.
• Blister pack inserted into a bag, contained in a cardboard carton. The bag contains a desiccant sachet. The desiccant must remain inside the bag and must not be ingested. Each pack contains 14 tablets.

Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
GlaxoSmithKline S.p.A. - Viale dell’Agricoltura, 7 - 37135 Verona - Italy
Manufacturer
Glaxo Wellcome Production - Manufacturing site: Mayenne (France)
This medicinal product is authorized in the European Economic Area countries under the following
names:
Austria – Augmentin
Belgium – Augmentin
Bulgaria – Augmentin
Cyprus – Augmentin
Czech Republic – Augmentin
Estonia – Augmentin
Germany – Augmentan
Greece – Augmentin
Hungary – Augmentin Duo
Ireland – Augmentin
Italy – Augmentin-Clavulin
Latvia – Augmentin
Lithuania – Augmentin
Luxembourg – Augmentin
Malta – Augmentin
Netherlands – Augmentin
Poland – Augmentin
Portugal – Augmentin Duo
Romania – Augmentin
Slovakia – Augmentin
Slovenia – Augmentin
Spain – Augmentine, Clavumox
United Kingdom – Augmentin

Behavioural Hygiene
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Sometimes a bacterial infection does not respond to antibiotic therapy. The most common reason for this is that the bacteria causing the infection are resistant to the antibiotic being used.
This means that the bacteria survive and multiply despite the antibiotic.
Bacteria become resistant to antibiotics for various reasons. By using antibiotics appropriately, you can help reduce the development of bacterial resistance.
When your doctor prescribes an antibiotic treatment, it is intended solely for the illness you currently have.
Please follow the advice below to help prevent the emergence of bacterial resistance, which can lead to failure of antibiotic therapy.

1. It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the correct number of days. Read the instructions in the package leaflet carefully and, if anything is unclear, ask your doctor or pharmacist for clarification.
2. Do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed.
3. Do not use antibiotics that have been prescribed for other people, even if you have a similar infection.
4. Do not give your antibiotics to other people, even if they have the same type of infection.
5. If you have leftover antibiotics after completing your treatment, return them to your pharmacist for proper disposal.

Package leaflet: Information for the user

Augmentin 875 mg/125 mg powder for oral suspension in sachets

Amoxicillin/clavulanic acid
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you (or your child) only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Augmentin is and what it is used for
2. What you need to know before taking Augmentin
3. How to take Augmentin
4. Possible side effects
5. How to store Augmentin
6. Contents of the pack and other information

1. What Augmentin is and what it is used for

Augmentin is an antibiotic that works by killing bacteria that cause infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins", whose activity can sometimes be blocked (i.e. rendered inactive). The other active component (clavulanic acid) prevents this from happening.
Augmentin is used in adults and children to treat the following infections:

• middle ear and sinus infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections, including dental infections
• bone and joint infections

2. What you need to know before taking Augmentin

Do not take Augmentin:

• if you are allergic to amoxicillin, clavulanic acid, penicillin, or any of the excipients of this medicine (listed in section 6)
• if you have had a severe allergic reaction to any other antibiotic. This may include rash or swelling of the face or throat.
• if you have had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

→ Do not take Augmentin if any of these apply to you. If in doubt, speak to your doctor or pharmacist before taking Augmentin.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking this medicine if you:

• have infectious mononucleosis
• have previously been treated for liver or kidney problems
• do not urinate regularly.

If you are unsure whether any of the above conditions apply to you, discuss them with your doctor or pharmacist before taking Augmentin.
In some cases, your doctor may carry out tests to identify the type of bacteria causing your infection.
Based on the results, your doctor may prescribe a different dose of Augmentin or a different medicine.
Conditions to which you should pay attention
Augmentin may worsen certain pre-existing conditions or cause serious side effects.
These may include allergic reactions, seizures, and inflammation of the bowel. You should be aware of certain symptoms while taking Augmentin in order to reduce any risk. See “Conditions to which you should pay attention” in Section 4.
Blood and urine tests
If you are about to have blood tests (such as tests for red blood cells or liver function) or urine tests (for glucose), inform your doctor or nurse that you are taking Augmentin.
This is because Augmentin may affect the results of these tests.
Other medicines and Augmentin
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
If you are taking allopurinol (used for gout) together with Augmentin, you are very likely to develop a skin allergic reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Augmentin.
If you are taking medicines such as warfarin (which help prevent blood clots) together with Augmentin, additional blood tests may be required.
Augmentin may affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
Augmentin may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
Augmentin may cause side effects, and the symptoms may make you unfit to drive.
Do not drive or operate machinery unless you feel better.
Augmentin contains aspartame and maltodextrin

• This medicine contains 24 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder that causes phenylalanine to accumulate because the body cannot eliminate it properly.
• Augmentin contains maltodextrin (glucose). If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Augmentin

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults and children weighing 40 kg or more

• Recommended dose – 1 sachet twice a day
• Higher dose – 1 sachet three times a day

Children weighing less than 40 kg
Augmentin 875 mg/125 mg sachets are not recommended.
Patients with kidney or liver problems

• If you have kidney problems, your dose may need to be adjusted. Your doctor may choose a different dosage or a different medicine.
• If you have liver problems, more frequent blood tests may be needed to monitor your liver function.

How to take Augmentin

• Just before taking Augmentin, open the sachet and mix the contents with half a glass of water.
• Take during meals.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take Augmentin for longer than 2 weeks. If you still do not feel better, you should see your doctor again.

If you take more Augmentin than you should
If you take too much Augmentin, symptoms may include stomach disturbances (nausea, vomiting, or
diarrhoea) or seizures. Speak to your doctor as soon as possible. Take the medicine package with you to
show the doctor.
If you forget to take Augmentin
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too early, but wait approximately 4 hours. Do not take a double dose to make up for a forgotten dose.
If you stop taking Augmentin
Continue taking Augmentin for the full duration of the treatment, even if you start to feel better. You need
every dose to fight the infection. If some bacteria survive, they may cause the infection to return.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this one can cause side effects, although not everyone will experience them. The side effects that may occur with this medicine are listed below.

Conditions you should pay attention to

Allergic reactions:

• skin rashes
• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may also affect other parts of the body
• fever, joint pain, swelling of the glands in the neck, armpits, or groin
• swelling, sometimes of the face or throat (angioedema), causing difficulty breathing
• collapse
• chest pain occurring during allergic reactions, which may be a symptom of an allergy-triggered heart attack (Kounis syndrome). Contact your doctor immediately if you experience any of these symptoms. Stop taking Augmentin.

Intestinal inflammation
Intestinal inflammation, causing watery diarrhoea usually containing blood and mucus, stomach pain and/or fever.

Drug-induced enterocolitis syndrome (DIES):
DIES has been mainly reported in children treated with amoxicillin/clavulanate. It is a type of allergic reaction whose main symptom is repeated vomiting (1–4 hours after taking the medicine). Additional symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.

Acute inflammation of the pancreas (acute pancreatitis)
If you have severe and persistent pain in the stomach area, this could be a sign of acute pancreatitis.
➔ Contact your doctor as soon as possible for advice if these symptoms occur.

Very common side effects
May affect more than 1 in 10 people

• diarrhoea (in adults)

Common side effects
May affect up to 1 in 10 people

• thrush (candida – a fungal infection of the vagina, mouth, or skin folds)
• nausea, especially when taking high doses → if affected, take Augmentin with food
• vomiting
• diarrhoea (in children)

Uncommon side effects
May affect up to 1 in 100 people

• skin rashes, itching
• raised, itchy skin rash (urticaria)
• indigestion
• dizziness
• headache

Uncommon side effects may be detected through blood tests:

• increased levels of certain proteins (enzymes) produced by the liver

Rare side effects
May affect up to 1 in 1,000 people

• skin rashes, which may appear as blisters and resemble small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme)
  If you notice any of these symptoms, contact your doctor urgently.

Rare side effects may be detected through 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)
• Intestinal inflammation (see above)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• Severe skin reactions:
  • widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing extensive skin detachment (more than 30% of body surface – toxic epidermal necrolysis)
  • widespread red rash with small blisters containing pus (exfoliative bullous dermatitis)
  • red rash with crusts, swellings under the skin, and blisters (pustular exanthema)
• flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased white blood cell count (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms)
• a red rash commonly seen on both sides of the buttocks, upper inner thighs, armpits, and neck (Symmetrical Drug-Related Intertriginous Flexural Exanthema, SDRIFE)

If you experience any of these symptoms, contact your doctor immediately.

• Rash with blisters arranged in a ring with a central crust or resembling a string of pearls (linear IgA disease)
• inflammation of the liver (hepatitis)
• jaundice, caused by increased bilirubin levels in the blood (a substance produced in the liver), which may cause yellowing of the skin and whites of the eyes
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity
• seizures (in people taking high doses of Augmentin or who have kidney problems)
• black hairy tongue
• tooth staining (in children), usually removable by brushing

Side effects that may be detected through blood or urine tests:

• severe reduction in white blood cell count
• low number of red blood cells (haemolytic anaemia)
• crystals in the urine leading to acute kidney damage

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Augmentin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the pack. The expiry date refers to the last day of the month.
Store below 25°C.
Keep in the original container to protect from moisture.
Do not use this medicine if the sachet is torn or damaged.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Augmentin contains

• The active substances are amoxicillin and clavulanic acid. Each sachet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
• The other excipients are: magnesium stearate, crospovidone, colloidal silicon dioxide, aspartame (E951), peach-lemon-strawberry flavour (containing maltodextrins).
• See section 2 for further information regarding one of the excipients of Augmentin.

Description of the appearance of Augmentin and package contents
Augmentin 875 mg/125 mg - oral suspension powder in sachets contains a whiteish powder for oral suspension.
The sachets are contained in a carton box. Each pack contains 12, 20 or 30 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A. - Viale dell’Agricoltura, 7 - 37135 Verona - Italy
Manufacturer
Glaxo Wellcome Production - Manufacturing site: Mayenne (France)

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Italy – Augmentin, Clavulin
Spain – Augmentine, Clavumox

Behavioural hygiene
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Sometimes, bacterial infections do not respond to antibiotic treatment. The most common reason for this is that the bacteria causing the infection are resistant to the antibiotic being used.
This means that bacteria survive and multiply despite the presence of the antibiotic.
Bacteria become resistant to antibiotics for various reasons. By using antibiotics appropriately, you can help reduce the development of bacterial resistance.
When your doctor prescribes you an antibiotic, it is intended solely for the illness you currently have. Please follow the advice below to help prevent the emergence of bacterial resistance, which can lead to antibiotics becoming ineffective.

1. It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the full duration of treatment. Read the instructions in this leaflet carefully and, if anything is unclear, ask your doctor or pharmacist for clarification.
2. Do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed.
3. Do not use antibiotics that have been prescribed for other people, even if you believe your infection is similar.
4. Do not give your prescribed antibiotics to other people.
5. If you have leftover antibiotics after completing your treatment, return them to your pharmacist for proper disposal.

---

Reconstitution instructions
The contents of the sachets must be dissolved in half a glass of water before administration.

Package leaflet: Information for the user

Augmentin children 400 mg/57 mg powder for oral suspension in sachets

Amoxicillin/clavulanic acid
Please read this leaflet carefully before giving this medicine to your child, as it contains
important information for your child.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for your child only. Do not give it to others, even if their symptoms appear identical to your child’s, as it could be harmful.
• If any side effect occurs, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Augmentin is and what it is used for
2. What you need to know before giving Augmentin
3. How to give Augmentin
4. Possible side effects
5. How to store Augmentin
6. Package contents and other information

1. What Augmentin is and what it is used for

Augmentin is an antibiotic that works by killing bacteria that cause infections. It contains two different active ingredients called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins", whose activity can sometimes be blocked (i.e. rendered inactive). The other active component (clavulanic acid) prevents this from happening.
Augmentin is used in adults and children to treat the following infections:

• middle ear and sinus infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections, including dental infections
• bone and joint infections

2. What you should know before giving Augmentin

Do not give Augmentin to your child:

• if he/she is allergic to amoxicillin, clavulanic acid, penicillin, or to any of the excipients of this medicine (listed in section 6)
• if he/she has had a severe allergic reaction to any other antibiotic. This may include rash or swelling of the face or throat
• if he/she has had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not give Augmentin if any of these cases apply to your child. If you have any doubts, talk to your doctor or pharmacist before giving Augmentin.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before giving Augmentin to your child if:

• he/she has infectious mononucleosis
• he/she has previously been treated for liver or kidney problems
• he/she does not urinate regularly.

If you are unsure whether any of the above conditions apply to your child, consult your doctor or pharmacist before giving Augmentin.
In some cases, the doctor may carry out tests to identify the type of bacteria causing your child's infection.
Based on the results, he/she may prescribe a different dose of Augmentin or a different medicine.
Conditions you should monitor
Augmentin may worsen certain pre-existing conditions or cause serious side effects. These may include allergic reactions, seizures, and inflammation of the intestine. You should watch for certain symptoms while your child is taking Augmentin, in order to minimize any risks. See “Conditions you should monitor” in section 4.
Blood and urine tests
If your child is due to have blood tests (such as red blood cell counts or liver function tests) or urine tests (for glucose), inform the doctor or nurse that he/she is taking Augmentin. This is because Augmentin may affect the results of these tests.
Other medicines and Augmentin
Inform the doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.
If your child is taking allopurinol (used for gout) together with Augmentin, he/she is more likely to develop a skin allergic reaction.
If your child is taking probenecid (used for gout), the doctor may decide to adjust the dose of Augmentin.
If your child is taking medicines (such as warfarin) that help prevent blood clots, additional blood tests may be needed while taking Augmentin.
Augmentin may affect the action of methotrexate (a medicine used to treat tumors or rheumatic diseases).
Augmentin may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy, breastfeeding and fertility
If your daughter who is taking this medicine is pregnant, suspects she may be pregnant, is planning to become pregnant, or is breastfeeding, please consult your doctor or pharmacist before using this medicine.
Driving and using machines
Augmentin may cause side effects, and the symptoms may make your child unfit to drive or operate machinery.
Do not drive or operate machinery unless your child feels well.
Augmentin contains aspartame and maltodextrins

• This medicine contains 11 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare inherited disorder that causes phenylalanine to accumulate in the body because it cannot be properly metabolized.
• Augmentin contains maltodextrins (glucose). If your doctor has diagnosed your child with intolerance to certain sugars, consult him/her before taking this medicine.

3. How to take Augmentin

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults and children weighing 40 kg or more

• The sachets are not recommended for adults and children weighing 40 kg or more. If you have any doubts, consult your doctor or pharmacist.

Children weighing less than 40 kg
All doses are calculated based on the child's body weight expressed in kilograms.

• Your doctor will advise you on the appropriate dose of Augmentin for your child.
• Recommended dose – from 25 mg/3.6 mg up to 45 mg/6.4 mg per kg of body weight per day, given in two divided doses.
• Higher dose – up to 70 mg/10 mg per kg of body weight per day, given in two divided doses.

Patients with kidney or liver problems

• If your child has kidney problems, the dose may need to be reduced. Your doctor may choose a different dosage or a different medicine.
• If your child has liver problems, more frequent blood tests may be needed to monitor liver function.

How to take Augmentin

• Just before administering Augmentin, open the sachet and mix the contents with half a glass of water.
• Give the resulting mixture to your child with meals.
• Space the doses evenly throughout the day, at least 4 hours apart. Do not give two doses within one hour.
• Do not let your child take Augmentin for longer than 2 weeks. If your child does not feel better, you must return to the doctor.

If you give more Augmentin than you should
If your child takes too much Augmentin, symptoms may include stomach disturbances (nausea, vomiting, or diarrhoea) or seizures. Speak to your doctor as soon as possible. Take the medicine pack or bottle with you to show the doctor.

If you forget to give Augmentin
If you forget to give your child a dose, give it as soon as you remember. Do not give the next dose too early; wait approximately 4 hours. Do not give a double dose to make up for a forgotten dose.

If your child stops treatment with Augmentin
Continue giving Augmentin to your child until the treatment is complete, even if your child seems to be feeling better. Your child needs every dose to fight the infection. If some bacteria survive, they may cause the infection to return.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this one can cause side effects, although not everyone experiences them. The side effects that may occur with this medicine are listed below.

Conditions you should pay attention to

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may also affect other parts of the body
• fever, joint pain, swelling of the glands in the neck, armpits, or groin
• swelling, sometimes of the face or throat (angioedema), causing difficulty in breathing
• collapse
• chest pain during allergic reactions, which may be a sign of an allergy-triggered heart attack (Kounis syndrome). Contact your doctor immediately if your child experiences any of these symptoms. Stop taking Augmentin.

Intestinal inflammation
Intestinal inflammation causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.

Drug-induced enterocolitis syndrome (DIES):
DIES has been reported mainly in children treated with amoxicillin/clavulanate. It is a type of allergic reaction whose main symptom is repeated vomiting (1-4 hours after taking the medicine). Additional symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.

Acute inflammation of the pancreas (acute pancreatitis)
If you have severe and persistent pain in the stomach area, this could be a sign of acute pancreatitis.
➔ Contact your doctor as soon as possible for advice if these symptoms occur.

Very common side effects
May affect more than 1 in 10 people

• diarrhoea (in adults)

Common side effects
May affect up to 1 in 10 people

• thrush (candida – a fungal infection of the vagina, mouth, or skin folds)
• nausea, especially when high doses are taken → if this affects you, take Augmentin with food
• vomiting
• diarrhoea (in children)

Uncommon side effects
May affect up to 1 in 100 people

• skin rash, itching
• raised, itchy skin rash (urticaria)
• indigestion
• dizziness
• headache

Uncommon side effects may also be detected through blood tests:

• increased levels of certain proteins (enzymes) produced by the liver

Rare side effects
May affect up to 1 in 1,000 people

• skin rash, which may appear as blisters and look like small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme). If you notice any of these symptoms, contact your doctor urgently.

Rare side effects may also be detected through 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)
• Intestinal inflammation (see above)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• Severe skin reactions:
  • widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form causing extensive skin detachment (more than 30% of body surface – toxic epidermal necrolysis)
  • widespread red rash with small blisters containing pus (exfoliative bullous dermatitis)
  • red rash with crusts, swellings under the skin, and blisters (pustular exanthema)
• flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased number of white blood cells (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms - DRESS)
• a red rash commonly seen on both sides of the buttocks, upper inner thighs, armpits, and neck (Symmetrical Drug-Related Intertriginous and Flexural Erythema – SDRIFE)

If your child experiences any of these symptoms, contact your doctor immediately.

• Rash with blisters arranged in a ring-like pattern with a central crust or resembling a string of pearls (linear IgA disease)
• liver inflammation (hepatitis)
• jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may cause the skin and whites of the eyes to appear yellow
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity
• seizures (in people taking high doses of Augmentin or who have kidney problems)
• black, hairy-looking tongue
• tooth staining (in children), usually removable by brushing

Side effects that may be detected through blood or urine tests:

• severe reduction in the number of white blood cells
• low number of red blood cells (haemolytic anaemia)
• crystals in the urine leading to acute kidney damage

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Augmentin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the
last day of the month.
Store below 25°C.
Keep in the original container to protect from moisture.
Do not use this medicine if the sachet is torn or damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Augmentin contains

• The active substances are amoxicillin and clavulanic acid. Each sachet contains: amoxicillin trihydrate equivalent to 400 mg of amoxicillin and potassium clavulanate equivalent to 57 mg of clavulanic acid.
• The other excipients are: magnesium stearate, crospovidone, colloidal silicon dioxide, aspartame (E951), peach-lemon-strawberry flavour (containing maltodextrins).
• See paragraph 2 for further information on one of the excipients of Augmentin.

Description of the appearance of Augmentin and package contents
Augmentin paediatric 400 mg/57 mg powder for oral suspension in sachets contains a whitish powder for oral suspension.
The sachets are contained in a carton. Each pack contains 12 sachets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A. - Viale dell’Agricoltura, 7 - 37135 Verona - Italy
Manufacturer
Glaxo Wellcome Production - Manufacturing site: Mayenne (France)
This medicinal product is authorised in the European Economic Area countries under the following
names:
400 mg/57 mg powder for oral suspension in sachets
Italy – Augmentin, Clavulin
Behavioural hygiene

Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Sometimes a bacterial infection does not respond to antibiotic therapy. The most common reason for this is that the bacteria causing the infection are resistant to the antibiotic being used.
This means that bacteria survive and multiply despite the antibiotic treatment.
Bacteria become resistant to antibiotics for various reasons. By using antibiotics appropriately, you can help reduce the development of bacterial resistance.
When your doctor prescribes you an antibiotic, it is intended solely for the illness you currently have.
Please follow the advice below to help prevent the emergence of bacterial resistance, which can lead to antibiotics becoming ineffective.

1. It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the full prescribed duration. Read the instructions in the package leaflet carefully and, if anything is unclear, ask your doctor or pharmacist for clarification.
2. Do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed.
3. Do not use antibiotics that have been prescribed for other people, even if you have a similar infection.
4. Do not give your antibiotics to other people, even if they appear to have the same condition as you.
5. If you have any antibiotic left over after completing your course of treatment, return it to your pharmacist for proper disposal.

---

Instructions for reconstitution
The contents of the sachets must be dissolved in half a glass of water before administration.

Package leaflet: Information for the user

Augmentin Children 400 mg/57 mg/5 ml powder for oral suspension (mixed fruits flavour)

amoxicillin/clavulanic acid
Please read this leaflet carefully before giving this medicine to your child, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for children. Never give it to anyone else. It could be harmful to others, even if their symptoms are the same as your child's.
• If your child experiences any side effect, contact your doctor, pharmacist, or nurse. This includes any possible side effect not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Augmentin is and what it is used for
2. What you need to know before using Augmentin
3. How to use Augmentin
4. Possible side effects
5. How to store Augmentin
6. Contents of the pack and other information

1. What Augmentin is and what it is used for

Augmentin is an antibiotic that works by killing bacteria that cause infections. It contains two different active ingredients called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins", whose activity can sometimes be blocked (i.e. rendered inactive). The other active component (clavulanic acid) prevents this from happening.
Augmentin is used in adults and children to treat the following infections:

• middle ear and sinus infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections, including dental infections
• bone and joint infections

2. What you should know before giving Augmentin to your child

Do not give Augmentin to your child:

• if he/she is allergic to amoxicillin, clavulanic acid, penicillin, or to any of the excipients in this medicine (listed in section 6)
• if he/she has had an allergic reaction to any other antibiotic. This may include rash or swelling of the face or throat
• if he/she has had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not give Augmentin to your child if any of these cases apply to him/her. If you have any doubts,
speak with your doctor or pharmacist before giving Augmentin.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before giving Augmentin to your child if:

• he/she has infectious mononucleosis
• he/she has been treated for liver or kidney problems
• he/she does not urinate regularly.

If you are unsure whether any of the above conditions apply to your child, discuss this with your doctor or pharmacist before
giving Augmentin.
In some cases, the doctor may perform tests to identify the type of bacteria causing your child’s infection.
Based on the results, he/she may prescribe a different dose of Augmentin or a different medicine.
Conditions you should watch for
Augmentin may worsen certain pre-existing conditions or cause serious side effects.
These may include allergic reactions, seizures, and inflammation of the intestine. You should watch for certain symptoms while your child is taking Augmentin, in order to reduce any risk. See “Conditions you should watch for” in Section 4.
Blood and urine tests
If your child is about to have blood tests (such as checks for red blood cells or liver function tests) or urine tests (for glucose), inform the doctor or nurse that he/she is taking Augmentin. This is because Augmentin may affect the results of these tests.
Other medicines and Augmentin
Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.
If your child is taking allopurinol (used for gout) together with Augmentin, he/she is more likely to develop a skin allergic reaction.
If your child is taking probenecid (used for gout), the doctor may decide to adjust the dose of Augmentin.
If your child is taking medicines (such as warfarin) that help prevent blood clots together with Augmentin, additional blood tests may be needed.
Augmentin may affect how methotrexate (a medicine used to treat tumours or rheumatic diseases) works.
Augmentin may affect how mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs) works.
Pregnancy, breastfeeding and fertility
If your daughter is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, consult your doctor or pharmacist before giving this medicine.
Driving and using machines
Augmentin may cause side effects, and the symptoms may impair the ability to drive.
Do not drive or operate machinery until you feel well.
Augmentin contains aspartame, benzyl alcohol and maltodextrins.

• This medicine contains 2.5 mg of aspartame per ml. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine to accumulate because the body cannot properly eliminate it.
• Augmentin contains traces of benzyl alcohol. Benzyl alcohol may cause allergic reactions.
• Augmentin contains maltodextrins (glucose). If you know your child has an intolerance to certain sugars, consult your doctor before giving this medicine.

3. How to use Augmentin

Always use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

Adults and children weighing 40 kg or more

• This suspension is not recommended for adults and children weighing 40 kg or more. If you have any doubts, consult your doctor or pharmacist.

Children weighing less than 40 kg
All doses are calculated based on the child's body weight in kilograms. Your doctor will advise you on the correct dose of Augmentin for your child.

• You must use a plastic dosing spoon or an oral dosing syringe. Instructions on how to use the dosing syringe are provided at the end of this leaflet. Use them to give your child the correct dose.
• Recommended dose – from 25 mg/3.6 mg/kg/day (0.4 ml of suspension/kg/day) up to 45 mg/6.4 mg/kg/day (0.6 ml of suspension/kg/day), given in two divided doses.
• Higher dose – up to 70 mg/10 mg/kg/day (1.0 ml of suspension/kg/day), given in two divided doses.

Patients with kidney or liver problems

• If your child has kidney problems, the dose may need to be reduced. Your doctor may choose a different dosage or an alternative medicine.
• If your child has liver problems, more frequent blood tests may be needed to monitor liver function.

How to use Augmentin

• Always shake the bottle well before measuring each dose.
• Administer the dose at the beginning of a meal or just before a meal.
• Space the doses evenly throughout the day, at least 4 hours apart. Do not give two doses within one hour.
• Do not let your child take Augmentin for longer than 2 weeks. If your child does not feel better, you should return to the doctor.

If you give more Augmentin than you should
If your child takes too much Augmentin, symptoms may include stomach problems (nausea, vomiting, or diarrhoea) or seizures. Speak to your doctor as soon as possible. Take the medicine pack or bottle with you to show the doctor.

If you forget to give Augmentin
If you forget to give a dose to your child, give it as soon as you remember. Do not give the next dose too early; wait approximately 4 hours.

If your child stops treatment with Augmentin
Continue giving Augmentin to your child until the full course is completed, even if your child seems to be feeling better. Your child needs every dose to fully eliminate the infection. If some bacteria survive, the infection may return.

If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Conditions requiring your attention
Allergic reactions:

• skin rash
• inflammation of blood vessels ( vasculitis ), which may appear as red or purple spots on the skin, but may also affect other parts of the body
• fever, joint pain, swelling of the glands in the neck, armpits or groin
• swelling, sometimes of the face or throat (angioedema), causing difficulty in breathing
• collapse
• chest pain occurring during allergic reactions, which may be a symptom of an allergy-triggered heart attack ( Kounis syndrome ). Contact your doctor immediately if your child experiences any of these symptoms. Stop giving Augmentin to your child.

Intestinal inflammation
Intestinal inflammation, causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.

Drug-induced enterocolitis syndrome (DIES):
DIES has been mainly reported in children treated with amoxicillin/clavulanic acid. It is a type of allergic reaction whose main symptom is repeated vomiting (1-4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.

Acute inflammation of the pancreas (acute pancreatitis)
If you have severe and persistent pain in the stomach area, this could be a sign of acute pancreatitis.
➔ Contact your doctor as soon as possible for advice if these symptoms occur.

Common side effects
May affect up to 1 in 10 people

• thrush ( candida – a fungal infection of the vagina, mouth or skin folds)
• nausea, especially when taking high doses → if affected, take Augmentin before meals
• vomiting
• diarrhoea (in children)

Uncommon side effects
May affect up to 1 in 100 people

• skin rashes, itching
• raised, itchy rash ( urticaria )
• indigestion
• dizziness
• headache

Uncommon side effects that may be detected in blood tests:

• increased levels of certain proteins ( enzymes ) produced by the liver

Rare side effects
May affect up to 1 in 1,000 people

• skin rashes, which may appear as blisters and resemble small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme ). If you notice any of these symptoms, contact your doctor urgently.

Rare side effects that may be detected in blood tests:

• low number of cells involved in blood clotting
• low white blood cell count

Frequency not known
Frequency cannot be estimated from the available data.

• Allergic reactions (see above)
• Intestinal inflammation (see above)
• Inflammation of the membranes surrounding the brain and spinal cord ( aseptic meningitis )
• Severe skin reactions:
• widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome ), and a more severe form causing extensive skin detachment (more than 30% of body surface – toxic epidermal necrolysis )
• widespread red rash with small pus-filled blisters ( exfoliative bullous dermatitis )
• red rash with crusts, swellings under the skin and blisters ( pustular exanthema )
• flu-like symptoms with rash, fever, swollen glands and abnormal blood test results (including increased white blood cell count ( eosinophilia ) and elevated liver enzymes) ( Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) )
• a red rash commonly seen on both sides of the buttocks, upper inner thighs, armpits and neck (Symmetrical Drug-Related Intertriginous and Flexural Erythema (SDRIFE)).

If your child experiences any of these symptoms, contact your doctor immediately.

• rash with ring-shaped blisters with a central crust or resembling a string of pearls ( linear IgA disease )
• inflammation of the liver ( hepatitis )
• jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and whites of the eyes
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity
• seizures (in people taking high doses of Augmentin or who have kidney problems)
• black hairy tongue
• tooth staining (in children), usually removable by brushing

Side effects that may be detected in blood or urine tests:

• severe reduction in white blood cell count
• low red blood cell count ( haemolytic anaemia )
• crystals in urine leading to acute kidney injury

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Augmentin

Keep this medicine out of the sight and reach of children.
Dry powder
Store in the original container to protect from moisture.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date (EXP) stated on the pack. The expiry date refers to the last day of the month.
Reconstituted suspension
Store in the refrigerator (2°C – 8°C).
Do not freeze.
The reconstituted suspension must be used within 7 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Augmentin contains

• The active substances are amoxicillin and clavulanic acid. Each ml of suspension contains amoxicillin trihydrate equivalent to 80 mg of amoxicillin and potassium clavulanate equivalent to 11.4 mg of clavulanic acid.

The other ingredients are aspartame (E951), xanthan gum, silicon dioxide, anhydrous colloidal silica, succinic acid, hypromellose, orange flavour 1* (contains benzyl alcohol), orange flavour 2*, raspberry flavour*, and Golden syrup flavour* (* also containing maltodextrins).

• See also section 2 for important information on aspartame, benzyl alcohol and maltodextrins in Augmentin.

Description of the appearance of Augmentin and contents of the pack
Augmentin bambini 400 mg/57 mg/5 ml powder for oral suspension (mixed fruit flavour) is a whitish powder in a clear glass bottle.
Once reconstituted, the bottle contains 35, 70 or 140 ml of a suspension ranging in colour from white to light brown.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A. – Viale dell’Agricoltura, 7 – Verona
Manufacturer
Glaxo Wellcome Production
ZI de la Peyenniere
53100 Mayenne Cedex
France

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria – Augmentin 400 mg/57 mg/5 ml Pulver zur Herstellung einer Suspension zum Einnehmen Multifruchtgeschmack
Bulgaria – Аугментин 400 mg/57 mg/5 ml прах за перорална суспензия
Croatia – Augmentin 400 mg + 57 mg/5 ml prašak za oralnu suspenziju s okusom voća
Cyprus – Augmentin Mixed Fruit
Czech Republic – Augmentin
Estonia – Augmentin Fruit
France – Augmentin 80 mg – 11,4 mg par ml Poudre pour suspension buvable
Germany – Augmentan Kindersaft
Greece - Augmentin MF
Hungary – Augmentin DUO
Ireland – Augmentin Duo Mixed Fruit
Italy – Augmentin - Clavulin
Latvia – Augmentin Fruit 400 mg/57 mg/5 ml pulveris iekšķīgi lietojamas suspensijas pagatavošanai
Lithuania – Augmentin
Malta – Augmentin Duo Mixed Fruit
Norway – Augmentin
Poland – Augmentin MFF
Portugal – Augmentin Duo
Romania – Augmentin FP
Slovakia – Augmentin DUO s príchuťou miešaného ovocia
United Kingdom (Northern Ireland) – Augmentin Duo

Behavioural hygiene
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Sometimes, bacterial infections do not respond to antibiotic treatment. The most common reason for this is that the bacteria causing the infection are resistant to the antibiotic being used.
This means that bacteria survive and multiply despite the presence of the antibiotic.
Bacteria become resistant to antibiotics for various reasons. By using antibiotics appropriately, you can help reduce the development of bacterial resistance.
When your doctor prescribes you an antibiotic, it is intended only for the specific illness you have.
Please follow the advice below to help prevent the emergence of bacterial resistance, which can lead to failure of antibiotic therapy.

1. It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the full prescribed duration. Read the instructions in this leaflet carefully, and if anything is unclear, ask your doctor or pharmacist for clarification.
2. Do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed.
3. Do not use antibiotics prescribed for other people, even if you think you have a similar infection.
4. Do not give your prescribed antibiotics to other people.
5. If you have any antibiotic left over after completing your treatment, return it to your pharmacist for proper disposal.

---

Instructions for reconstitution
Remove the cap. Before use, check that the protective seal on the bottle is intact.
Close the bottle with the cap.

1. Shake the bottle to loosen the powder.

2. Remove the cap from the bottle.

3. Remove the protective film.

4. Add the volume of water (as indicated below). Close the bottle, invert it, and shake well.

Additional text for markets with a level line on the bottle or label
Alternatively, fill the bottle with water just below the level indicated on the bottle label.
Close the bottle with the cap, invert and shake well, then fill with water exactly to the level.
Close the bottle with the cap, invert and shake well again.

5. Store in a refrigerator and always shake well before use. The reconstituted oral suspension must be used within 7 days.

Text to be included for packages with syringe
Instructions for use of the syringe
An oral syringe is provided for administering Augmentin
The syringe must be used only for the administration of Augmentin and must not be used to administer other medicines, as the markings are specific to this product. The syringe is supplied with an adapter that allows attachment to the bottle.
The dose on the oral dosing syringe is indicated in millilitres (ml). The dose to be given to your child must be the one recommended by your doctor.
Check the cleanliness of the syringe and adapter before use; rinse with clean water if required.

1. Shake the suspension in the bottle well before each administration.

2. Remove the adapter from the syringe. Hold the bottle firmly and insert the adapter into the neck of the bottle (the adapter should remain securely in place). Insert the syringe into the adapter, ensuring it is properly seated.

3. Insert the syringe into the adapter, ensuring it is properly seated.

4. Invert the bottle, keeping the syringe in position, and withdraw the required dose as prescribed by the doctor.

5. Return the bottle to an upright position and remove the syringe.

6. To administer the dose, carefully insert the tip of the syringe into the mouth and slowly push the plunger of the syringe down (repeat steps 3, 4, 5 and 6 if more than one syringe is required to administer the full dose).

7. Rinse the syringe thoroughly with clean water. Allow the syringe to dry completely before next use.

8. Close the bottle with the cap.

9. Store in a refrigerator and always shake well before use. The suspension, once reconstituted, must be used within 7 days.

Package leaflet: Information for the user

Augmentin Children 400 mg/57 mg/5 ml powder for oral suspension (strawberry flavor)

Amoxicillin/clavulanic acid
Please read this leaflet carefully before giving this medicine to your child because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for infants or children. Never give it to others. It could be harmful to other individuals, even if their symptoms are the same as your child's.
• If your child experiences any side effect, contact your doctor, pharmacist, or nurse. This includes any possible side effect not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Augmentin is and what it is used for
2. What you need to know before using Augmentin
3. How to use Augmentin
4. Possible side effects
5. How to store Augmentin
6. Package contents and other information

1. What Augmentin is and what it is used for

Augmentin is an antibiotic that works by killing bacteria that cause infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins", whose activity can sometimes be blocked (i.e. rendered inactive). The other active component (clavulanic acid) prevents this from happening.
Augmentin is used in infants and children to treat the following infections:

• middle ear and sinus infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections, including dental infections
• bone and joint infections

2. What you should know before using Augmentin

Do not give Augmentin to your child:

• if he/she is allergic to amoxicillin, clavulanic acid, penicillin, or to any of the excipients of this medicine (listed in section 6)
• if he/she has had an allergic reaction to any other antibiotic. This may include skin rash or swelling of the face or throat
• if he/she has had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not give Augmentin to your child if any of these cases apply to him/her. If you have any doubts,
talk to your doctor or pharmacist before giving Augmentin.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before giving Augmentin to your child if:

• he/she has infectious mononucleosis
• he/she has been treated for liver or kidney problems
• he/she does not urinate regularly.

If you are unsure whether any of the above conditions apply to your child, consult your doctor or pharmacist before
giving Augmentin.
In some cases, the doctor may carry out tests to identify the type of bacteria causing your child's infection.
Based on the results, he/she may prescribe a different dose of Augmentin or a different medicine.
Conditions you should watch for
Augmentin may worsen certain pre-existing conditions or cause serious side effects.
These may include allergic reactions, seizures, and inflammation of the intestine. You should watch for certain symptoms during treatment with Augmentin in order to reduce any risk. See “Conditions you should watch for” in section 4.
Blood and urine tests
If your child is due to have blood tests (for example, checks on red blood cells or liver function tests) or urine tests (for glucose), inform the doctor or nurse that he/she is taking Augmentin. This is because Augmentin may affect the results of these tests.
Other medicines and Augmentin
Inform the doctor or pharmacist if your child is taking, has recently taken, or might take any other medicine.
If your child is taking allopurinol (used for gout) together with Augmentin, he/she is very likely to develop a skin allergic reaction.
If your child is taking probenecid (used for gout), the doctor may decide to adjust the dose of Augmentin.
If your child is taking medicines together with Augmentin (such as warfarin) that help prevent blood clots, additional blood tests may be required.
Augmentin may affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
Augmentin may affect how mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs) works.
Pregnancy, breastfeeding and fertility
If your daughter is pregnant, breastfeeding, suspects she may be pregnant, or is planning a pregnancy, inform the doctor or pharmacist and seek advice before giving any medicine.
Driving and using machines
Augmentin may cause side effects, and symptoms may impair the ability to drive.
Do not drive or operate machinery until you feel well again.
Augmentin contains aspartame, sodium benzoate and maltodextrin
Augmentin contains 3.32 mg of aspartame (E951) per ml. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot eliminate it properly.
This medicine contains 1.77 mg of sodium benzoate (E211) per ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.
Augmentin contains maltodextrin (glucose). If you are aware of your child's intolerance to certain sugars, consult your doctor before giving this medicine.

3. How to use Augmentin

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults and children weighing 40 kg or more

• This suspension is not recommended for adults and children weighing 40 kg or more. If you have any doubts, consult your doctor or pharmacist.

Children weighing less than 40 kg
All doses are calculated based on the child's body weight in kilograms. Your doctor will advise you on the appropriate dose of Augmentin to give your infant or child.

• You must use a plastic dosing spoon, dosing cup, or oral syringe to administer the correct dose to your infant or child. Instructions on how to use the oral syringe can be found at the end of this leaflet.
• Recommended dose – from 25 mg/3.6 mg up to 45 mg/6.4 mg per kg of body weight per day, given in two divided doses.
• Higher dose – up to 70 mg/10 mg per kg of body weight per day, given in two divided doses.

Patients with kidney or liver problems

• If your child has kidney problems, the dose may need to be reduced. Your doctor may choose a different dosage or an alternative medicine.
• If your child has liver problems, more frequent blood tests may be required to monitor liver function.

How to take Augmentin

• Always shake the bottle well before measuring each dose.
• Administer the dose at the beginning of a meal or just before eating.
• Space the doses evenly throughout the day, at least 4 hours apart. Do not give two doses within one hour.
• Do not let your child take Augmentin for longer than 2 weeks. If your child does not feel better, you should return to the doctor.

If you give more Augmentin than you should
If your child takes too much Augmentin, symptoms may include stomach problems (nausea, vomiting, or diarrhoea) or seizures. Speak to your doctor as soon as possible. Take the medicine pack or bottle with you so you can show it to the doctor.

If you forget to give a dose
If you forget to give a dose to your child, give it as soon as you remember. Do not give the next dose too early; wait approximately 4 hours. Do not give a double dose to make up for a missed dose.

If your child stops treatment with Augmentin
Continue giving Augmentin to your child until the full course of treatment is completed, even if your child seems to be feeling better. Your child needs every dose to fully treat the infection. If some bacteria survive, they may cause the infection to return.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Conditions you should pay attention to

Allergic reactions:

• skin rash
• inflammation of blood vessels ( vasculitis ), which may appear as red or purple spots on the skin, but may also affect other parts of the body
• fever, joint pain, swelling of the glands in the neck, armpits or groin
• swelling, sometimes of the face or throat ( angioedema ), causing difficulty in breathing
• collapse
• chest pain occurring as part of an allergic reaction, which may be a symptom of an allergy-triggered heart attack ( Kounis syndrome ). Contact your doctor immediately if your child experiences any of these symptoms. Stop giving Augmentin.

Intestinal inflammation
Intestinal inflammation, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever.

Drug-induced enterocolitis syndrome (DIES):
DIES has been reported mainly in children treated with amoxicillin/clavulanate. It is a type of allergic reaction whose main symptom is repeated vomiting (1-4 hours after taking the medicine). Additional symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.

Acute inflammation of the pancreas (acute pancreatitis)
If you have severe and persistent pain in the stomach area, this could be a sign of acute pancreatitis.
Contact your doctor as soon as possible for advice if these symptoms occur.

Very common side effects
May affect more than 1 in 10 people

• diarrhoea (in adults)

Common side effects
May affect up to 1 in 10 people

• thrush ( candida – a fungal infection of the vagina, mouth or skin folds)
• nausea, especially when high doses are taken → if this affects you, take Augmentin with meals
• vomiting
• diarrhoea (in children)

Uncommon side effects
May affect up to 1 in 100 people

• skin rashes, itching
• raised, itchy rash ( urticaria )
• indigestion
• dizziness
• headache

Uncommon side effects may be detected through blood tests:

• increase in certain proteins ( enzymes ) produced by the liver

Rare side effects
May affect up to 1 in 1,000 people

• skin rashes, which may appear as blisters and look like small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme ). If you notice any of these symptoms, contact your doctor urgently.

Rare side effects may be detected through 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)
• Intestinal inflammation (see above)
• Inflammation of the membranes surrounding the brain and spinal cord ( aseptic meningitis )
• Severe skin reactions:
• 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 skin detachment (more than 30% of body surface – toxic epidermal necrolysis )
• widespread red rash with small blisters containing pus ( exfoliative bullous dermatitis )
• red rash with crusts, swellings under the skin and blisters ( pustular exanthema )
• flu-like symptoms with rash, fever, swollen glands and abnormal blood test results (including increased number of white blood cells ( eosinophilia ) and elevated liver enzymes) ( Drug Reaction with Eosinophilia and Systemic Symptoms )
• a red rash commonly seen on both sides of the buttocks, upper inner thighs, armpits, and neck (Symmetrical Drug-Related Intertriginous Flexural Exanthema (SDRIFE)).

If your child experiences any of these symptoms, contact your doctor immediately.

• Rash with blistering arranged in a ring-shaped pattern with a central crust or resembling a string of pearls ( linear IgA disease )
• inflammation of the liver ( hepatitis )
• jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and whites of the eyes
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity
• seizures (in people taking high doses of Augmentin or who have kidney problems)
• black hairy tongue, appearing covered with hair-like projections
• tooth staining (in children), usually removable by brushing

Side effects that may be detected through blood or urine tests:

• severe reduction in the number of white blood cells
• low number of red blood cells ( haemolytic anaemia )
• crystals in the urine leading to kidney damage

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Augmentin

Keep this medicine out of the sight and reach of children.
Dry powder
Store in the original container to protect from moisture.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the month.
Suspension
Store in the refrigerator (2°C – 8°C).
Do not freeze.
Once reconstituted, the suspension must be used within 7 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Augmentin contains

• The active substances are amoxicillin and clavulanic acid. Each ml of suspension contains amoxicillin trihydrate equivalent to 80 mg of amoxicillin and potassium clavulanate equivalent to 11.4 mg of clavulanic acid.
• The other components are magnesium stearate, aspartame (E951), crospovidone, xanthan gum, hydrated colloidal silica, anhydrous colloidal silica, sodium benzoate, sodium carmellose, strawberry flavour (containing maltodextrins).
• See also Important information about other components in section 2.

Description of the appearance of Augmentin and contents of the pack
Augmentin Paediatric 400 mg/57 mg/5 ml (strawberry flavour) powder for oral suspension is a whitish powder
in a clear glass bottle of 107, 147, 190 or 200 ml with an aluminium roll-on pilfer-proof (ROPP) cap with an internal seal of Polyvinyl Chloride (PVC) or Polyolefin.
When reconstituted, the bottle contains 35, 70 or 140 ml of a whitish liquid called suspension.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A. - Viale dell’Agricoltura, 7 - 37135 Verona - Italy
Manufacturer
Glaxo Wellcome Production - Manufacturing site Mayenne (France).

This medicinal product is authorised in European Economic Area Member States under the following
names:
Cyprus – Augmentin,
Czech Republic – Augmentin Duo,
Estonia – Augmentin,
Finland – Augmentin,
Greece – Augmentin,
Hungary – Augmentin Duo,
Iceland – Augmentin,
Ireland – Augmentin Duo,
Italy – Augmentin, Clavulin,
Latvia – Augmentin 400mg/57mg/5ml pulveris iekšķīgi lietojamas suspensijas pagatavošanai,
Malta – Augmentin,
Portugal – Augmentin Duo,
Romania – Augmentin BIS,
Slovakia – Augmentin DUO,
Slovenia – Augmentin,
United Kingdom – Augmentin

Behavioural hygiene
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Sometimes, bacterial infections do not respond to antibiotic treatment. The most common reason for this is that the bacteria causing the infection are resistant to the antibiotic being used.
This means that bacteria survive and multiply despite the antibiotic.
Bacteria become resistant to antibiotics for various reasons. By using antibiotics appropriately, you can help reduce the development of bacterial resistance.
When your doctor prescribes you an antibiotic, it is intended only for the illness you currently have.
Please follow the advice below to help prevent the emergence of bacterial resistance, which can lead to failure of antibiotic therapy.

6. It is very important that you take the antibiotic at the correct dose, at the correct times, and for the correct number of days. Read the instructions in this leaflet carefully and, if anything is unclear, ask your doctor or pharmacist for clarification.
7. Do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed.
8. Do not use antibiotics that have been prescribed for someone else, even if you have a similar infection.
9. Do not give your antibiotics, which have been specifically prescribed for you, to anyone else.
10. If you have any antibiotic left over after completing your course, return it to your pharmacist for proper disposal.

---

Reconstitution instructions
Before use, check that the seal on the cap is intact. Shake the bottle to loosen the powder.
Add the volume of water (as indicated below), invert and shake well.

Dosage | Volume of water to add for reconstitution (ml) | Final volume of reconstituted oral suspension (ml)
--- | --- | ---
400 mg/57 mg/5 ml | 32 | 35
400 mg/57 mg/5 ml | 64 | 70
400 mg/57 mg/5 ml | 127 | 140

Alternatively, shake the bottle to loosen the powder, then fill the bottle with water just below the level indicated on the bottle label, invert and shake well. Then fill with water exactly to the level, invert and shake well again.

Instructions for using the oral syringe
An oral syringe is provided for administering Augmentin
The syringe must be used only for administering Augmentin and must not be used for other medicines, as the markings are specific to this product. The syringe is supplied with an adapter that allows attachment to the bottle.
The dose on the oral syringe is indicated in millilitres (ml). The dose to be given to your child must be the one recommended by your doctor.
Check that the syringe and adapter are clean before use; rinse with clean water if necessary.

5. Shake the bottle well before each administration.

Remove the cap.
Fill the bottle with water just below the level indicated on the bottle label. Close, invert and shake well. Then fill with water exactly to the level, invert and shake well again.

6. Open the bottle.

7. Remove the adapter from the syringe. Hold the bottle firmly and insert the adapter into the neck of the bottle (the adapter should remain securely in place). Insert the syringe into the adapter, ensuring it is properly seated.

8. Invert the bottle, keeping the syringe in place, and draw up the required dose as prescribed by the doctor.

7. Return the bottle to an upright position and remove the syringe.
8. To administer the dose, carefully insert the tip of the syringe into the mouth and slowly push down the plunger (repeat steps 4, 5 and 6 if more than one syringe is needed to administer the full dose).

8. Rinse the syringe thoroughly with clean water. Allow the syringe to dry completely before next use.

10. Close the bottle with the cap.

Store in the refrigerator and always shake well before use.
Once reconstituted, the suspension must be used within 7 days.

Package leaflet: Information for the user

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

Amoxicillin/clavulanic acid
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any 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.

Contents of this leaflet

1. What Augmentin is and what it is used for
2. What you need to know before taking Augmentin
3. How to take Augmentin
4. Possible side effects
5. How to store Augmentin
6. Contents of the pack and other information

1. What Augmentin is and what it is used for

Augmentin is an antibiotic that works by killing bacteria that cause infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins", whose activity can sometimes be blocked (rendered inactive). The other active component (clavulanic acid) prevents this from happening.
Augmentin is used in adults and children to treat the following infections:

• severe ear, nose and throat infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections, including dental infections
• bone and joint infections
• abdominal infections
• female genital tract infections.

Augmentin is also used in adults and children to prevent infections associated with major surgical procedures.

2. What you need to know before taking Augmentin

Do not take Augmentin:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin, or to any of the other ingredients of this medicine (listed in section 6).
• if you have had a severe allergic reaction to any other antibiotic. This may include a rash or swelling of the face or throat.
• if you have had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not take Augmentin if any of these cases apply to you. If you have any doubts, speak with your doctor,
pharmacist, or nurse before taking Augmentin.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse about Augmentin if you:

• have infectious mononucleosis
• have previously been treated for liver or kidney problems
• do not urinate regularly. If you are unsure whether any of the above conditions apply to you, consult your doctor, pharmacist, or nurse before taking Augmentin.

In some cases, your doctor may carry out tests to identify the type of bacteria causing your infection.
Based on the results, they may prescribe a different dose of Augmentin or a different medicine.
Conditions you should be aware of
Augmentin may worsen certain pre-existing conditions or cause serious side effects.
These may include allergic reactions, seizures, and inflammation of the bowel. You should pay attention to
certain symptoms while taking Augmentin in order to reduce any risks. See “Conditions you should be aware of” in Section 4.
Blood and urine tests
If you are scheduled for blood tests (such as tests for red blood cells or liver function) or urine tests (for glucose), inform your doctor or nurse that you are taking Augmentin.
This is because Augmentin may affect the results of these types of tests.
Other medicines and Augmentin
Inform your doctor, pharmacist, or nurse if you are currently using, have recently used, or might use any other medicines.
If you are taking allopurinol (used for gout) together with Augmentin, you are very likely to develop a skin allergic reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Augmentin.
If you are taking medications (such as warfarin) that help prevent blood clots along with Augmentin, additional blood tests may be required.
Augmentin may affect how methotrexate (a medicine used to treat cancers or rheumatic diseases) works.
Augmentin may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Augmentin may cause side effects, and symptoms may make driving unsafe.
Do not drive or operate machinery unless you feel well.
Augmentin contains sodium and potassium:

• Augmentin contains approximately 62.9 mg (2.7 mmol) of sodium. This should be taken into account in patients following a low-sodium diet.
• Augmentin contains approximately 39.3 mg (1.0 mmol) of potassium. This should be taken into account in patients with reduced kidney function or those following a low-potassium diet.

3. How to take Augmentin

Never take this medicine on your own initiative. This medicine will be administered to you by a qualified person, such as a doctor or nurse.
The recommended doses are:
Adults and children weighing equal to or more than 40 kg

Children weighing less than 40 kg

• All doses are calculated based on the child's body weight expressed in kilograms.

Patients with kidney and liver problems

• If you have kidney problems, your dose may need to be adjusted. Your doctor may choose a different dosage or a different medicine.
• If you have liver problems, more frequent blood tests may be required to monitor how well your liver is functioning.

How Augmentin will be administered to you

• Augmentin will be administered to you by intravenous injection or intravenous infusion.
• Make sure you drink an adequate amount of fluids while receiving Augmentin.
• Do not take Augmentin for longer than 2 weeks. If you do not feel well, you should return to your doctor.

If you receive more Augmentin than you should
It is very unlikely that this will occur, but if you think it has happened, contact your doctor, pharmacist, or nurse immediately. Symptoms may include gastrointestinal disturbances (nausea, vomiting, or diarrhoea) or seizures.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Conditions you should pay attention to

Allergic reactions:

• skin rashes
• inflammation of blood vessels ( vasculitis ), which may appear as red or purple spots on the skin, but may also affect other parts of the body
• fever, joint pain, swelling of the glands in the neck, armpits or groin
• swelling, sometimes of the face or throat ( angioedema ), causing difficulty in breathing
• collapse.

Contact your doctor immediately if you experience any of these symptoms. Stop taking Augmentin.

Intestinal inflammation
Intestinal inflammation, causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.
If you experience these symptoms, contact your doctor as soon as possible for advice.

Common side effects
May affect up to 1 in 10 people

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

Uncommon side effects
May affect up to 1 in 100 people

• skin rashes, itching
• raised, itchy skin rash ( urticaria )
• nausea, especially when high doses are taken
• if affected, take Augmentin before food
• vomiting
• indigestion
• dizziness
• headache.

Uncommon side effects may be detected in blood tests:

• increased levels of certain proteins ( enzymes ) produced by the liver.

Rare side effects
May affect up to 1 in 1,000 people

• skin rashes, which may appear as blisters and resemble small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme ). If you notice any of these symptoms, contact your doctor urgently.
• swelling and redness along the vein, with increased pain on touching.

Rare side effects may be detected in 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)
• Intestinal inflammation (see above)
• Inflammation of the protective membrane surrounding the brain (aseptic meningitis)
• Severe skin reactions:
  • widespread rash with blisters and peeling of the 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 body surface – toxic epidermal necrolysis )
  • widespread red rash with small pustule-filled blisters ( exfoliative bullous dermatitis )
  • a red rash with crusts, swellings under the skin and blisters ( pustular exanthema )
• flu-like symptoms with skin rash, fever, swollen glands and abnormal blood test results (including increased number of white blood cells (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms – DRESS)

If you experience any of these symptoms, contact your doctor immediately.

• inflammation of the liver ( hepatitis )
• jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and whites of the eyes
• inflammation of the kidney tubules
• blood takes longer to clot
• seizures (in people taking high doses of Augmentin or who have kidney problems)

Side effects that may be detected in blood or urine tests:

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Augmentin

The expiry date and storage conditions indicated on the labels are intended for the doctor, nurse,
or pharmacist. The doctor, pharmacist, or nurse will prepare your medicine for you. It must be
used within 20 minutes of reconstitution.
Keep this medicine out of the sight and reach of children.
Do not use Augmentin after the expiry date (EXP) stated on the packaging. The expiry date refers to the last
day of that month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Augmentin contains
The active substances are amoxicillin and clavulanic acid. Each vial contains sodium amoxicillin equivalent to 1000 mg of amoxicillin and potassium clavulanate equivalent to 200 mg of clavulanic acid.
There are no other components. However, see section 2 for further information regarding sodium and potassium in Augmentin.
The doctor, nurse, or pharmacist will prepare the injection before use with the appropriate infusion liquid (such as Water for Injections or injection/infusion fluid).

Description of the appearance of Augmentin and contents of the pack
Augmentin e.v. 1000 mg/200 mg powder for injection or infusion solution is supplied as a glass vial or bottle containing sterile powder for the preparation of an injection or infusion.
Vials are available in packs of 1, 5, 10, 25 or 100.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 - Verona
Manufacturer
Biopharma S.r.l. – Via delle Gerbere, 20/22 - Santa Palomba, Roma (Italy)
or
SmithKline Beecham Pharmaceuticals – Clarendon Road – Worthing, West Sussex (United Kingdom)

This medicinal product is authorised in the European Economic Area countries under the following names:
1000 mg/200 mg powder for solution for injection or infusion
Belgium – Augmentin
Cyprus – Augmentin
Czech Republic – Augmentin
Estonia – Augmentin
France – Augmentin IV
Germany – Augmentan IV
Greece – Augmentin
Hungary – Augmentin
Iceland – Augmentin IV
Ireland – Augmentin Intravenous
Italy – Augmentin
Latvia – Augmentin
Luxembourg – Augmentin
Malta – Augmentin Intravenous
Netherlands – Augmentin
Poland – Augmentin
Romania – Augmentin Intravenos
Slovenia – Augmentin
Spain – Augmentine Intravenoso
United Kingdom – Augmentin Intravenous

This Patient Information Leaflet was last revised on:

The following information is intended for healthcare professionals only:

Refer to the Summary of Product Characteristics for further information
Administration
Augmentin may be administered either by intravenous route (slow 3–4 minute infusion) or directly into a vein via intravenous line or by 30 to 40 minute infusion. Augmentin is not suitable for intramuscular administration.
Reconstitution
For single use only. Unused solution must be discarded.
Reconstitution/dilution must be carried out under aseptic conditions. Prior to administration, the solution should be visually inspected for particulate matter and discoloration. Solutions should only be used if clear and free from particles.
AUGMENTIN vials are not suitable for multiple-dose use.
Any unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.
Preparation of solutions for intravenous injection
Water for injections Ph. Eur. is the standard solvent used.
A transient pink coloration may develop during reconstitution.
The color of reconstituted solutions normally ranges from colorless to yellow.
Augmentin e.v. for intravenous injection must be administered within 20 minutes of reconstitution.
1000 mg/200 mg powder for injection or infusion
Augmentin e.v. 1000 mg/200 mg must be dissolved in 20 ml of solvent. This will result in approximately 20.9 ml of solution for single-dose use.
Preparation of solutions for intravenous infusion
Augmentin e.v. must be reconstituted as described above for injections. The reconstituted solution must be added immediately to 100 ml of infusion fluid using a bag or cannula.
Stability of prepared solution
Reconstituted vial (for intravenous injection or prior to dilution for infusion)
The reconstituted solution (1 vial with 20 ml of Water for injections) must be used or diluted immediately, within 20 minutes.
Dilution for intravenous infusion
Chemical and physical in-use stability has been demonstrated for 2–3 hours at 25°C, or for 8 hours at 5°C.
From a microbiological standpoint, the reconstituted and diluted solution (1 reconstituted vial in a minimum volume of 100 ml of infusion fluid) should be used immediately.
Intravenous infusion of amoxicillin-clavulanate may be administered with various infusion fluids.
Satisfactory antibiotic concentrations are maintained at 5°C and at room temperature (25°C) in the recommended volumes of the following infusion fluids. If reconstituted and stored at room temperature (25°C), the infusion must be completed within the time limits specified in the table below.

For storage at 5°C, reconstituted solutions of Augmentin e.v. may be added to infusion bags containing Water for Injections Ph. Eur. or sodium chloride BP (0.9% w/v), which can be stored for up to 8 hours. After the storage period, infusions must be used immediately after reaching room temperature.
The stability of Augmentin e.v. solutions depends on the concentration. When multiple concentrated solutions are required, the stability period must be appropriately adjusted.
Augmentin e.v. is less stable in infusions containing glucose, dextran, or bicarbonate. Reconstituted Augmentin solutions may be administered by slow infusion over 3–4 minutes. Any residual antibiotic solutions should be discarded.

Package leaflet: Information for the user

Augmentin 2000 mg/200 mg powder for solution for infusion

Amoxicillin/clavulanic acid
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Augmentin is and what it is used for
2. What you need to know before taking Augmentin
3. How to take Augmentin
4. Possible side effects
5. How to store Augmentin
6. Contents of the pack and other information

4. What Augmentin is and what it is used for

Augmentin is an antibiotic that works by killing bacteria that cause infections. It contains two different active ingredients called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins", whose activity can sometimes be blocked (rendered inactive). The other active component (clavulanic acid) prevents this from happening.

Augmentin is used in adults and children to treat the following infections:

• severe ear, nose, and throat infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections, including dental infections
• bone and joint infections
• abdominal infections
• genital infections in women.

Augmentin is used in adults and children to prevent infections associated with major surgical procedures.

5. What you need to know before taking Augmentin

Do not take Augmentin:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin, or to any of the excipients in this medicine (listed in section 6)
• if you have had a severe allergic reaction to any other antibiotic. This may include a skin rash or swelling of the face or throat.
• if you have had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not take Augmentin if any of these apply to you. If you have any doubts, speak with your doctor,
pharmacist, or nurse before taking Augmentin.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse about Augmentin if you:

• have infectious mononucleosis
• have previously been treated for liver or kidney problems
• do not urinate regularly. If you are unsure whether any of the above conditions apply to you, discuss this with your doctor, pharmacist, or nurse before taking Augmentin.

In some cases, your doctor may perform tests to identify the type of bacteria causing your infection.
Based on the results, they may prescribe a different dose of Augmentin or a different medicine.
Conditions to which you should pay attention
Augmentin may worsen certain pre-existing conditions or cause serious side effects.
These may include allergic reactions, seizures, and inflammation of the bowel. You should be aware of
certain symptoms while taking Augmentin, in order to reduce any risk. See “Conditions to which you should pay attention” in Section 4.
Blood and urine tests
If you are due to have blood tests (such as tests for red blood cells or liver function) or urine tests (for glucose), inform your doctor or nurse that you are taking
Augmentin. This is because Augmentin may affect the results of these types of tests.
Other medicines and Augmentin
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) together with Augmentin, you are very likely to develop a
skin allergic reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of
Augmentin.
If you are taking medicines together with Augmentin (such as warfarin) that help prevent blood
clots, additional blood tests may be needed.
Augmentin may affect the action of methotrexate (a medicine used to treat cancers or rheumatic diseases).
Augmentin may affect the function of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, please seek advice from your doctor or pharmacist before using this medicine.
Driving and using machines
Augmentin may cause side effects, and symptoms may make driving unsafe.
Do not drive or operate machinery unless you feel well.
Augmentin contains sodium and potassium

• Augmentin contains approximately 125.9 mg (5.5 mmol) of sodium. This should be taken into consideration in patients following a low-sodium diet.
• Augmentin contains approximately 39.3 mg (1.0 mmol) of potassium. This should be taken into consideration in patients with impaired kidney function or those following a low-potassium diet.

6. How to take Augmentin

Never take this medicine on your own initiative. This medicine will be administered to you by a qualified person, such as a doctor or nurse.
The recommended doses are:
2000 mg/200 mg powder for infusion
Adults and children weighing equal to or more than 40 kg

Children weighing less than 40 kg

• All doses are calculated based on the child's body weight expressed in kilograms.

Patients with kidney and liver problems

• If you have kidney problems, your dose may need to be adjusted. Your doctor may choose a different dosage or a different medicine.
• If you have liver problems, more frequent blood tests may be required to monitor your liver function.

How Augmentin will be administered to you

• Augmentin will be administered to you by intravenous injection or intravenous infusion.
• Make sure you drink an adequate amount of fluids while receiving Augmentin.
• Do not take Augmentin for longer than 2 weeks. If you do not feel well, you should return to your doctor.

If you take more Augmentin than you should
It is very unlikely that this will happen, but if you think it has occurred, contact your doctor, pharmacist, or nurse immediately. Symptoms may include gastrointestinal disturbances (nausea, vomiting, or diarrhoea) or seizures.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Augmentin can cause side effects, although not everybody gets them.

Conditions you should pay attention to

Allergic reactions:

• skin rashes
• inflammation of blood vessels ( vasculitis ), which may appear as red or purple spots on the skin, but may also affect other parts of the body
• fever, joint pain, swelling of the glands in the neck, armpits or groin
• swelling, sometimes of the face or throat ( angioedema ), causing difficulty in breathing
• collapse. Contact your doctor immediately if you experience any of these symptoms. Stop taking Augmentin.

Intestinal inflammation
Intestinal inflammation, causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.
If you experience these symptoms, contact your doctor as soon as possible for advice.

Common side effects
May affect up to 1 in 10 people

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

Uncommon side effects
May affect up to 1 in 100 people

• skin rashes, itching
• raised itchy rash ( urticaria )
• nausea, especially when taking high doses
• if this affects you, take Augmentin before food
• vomiting
• indigestion
• dizziness
• headache

Uncommon side effects may be detected in blood tests:

• increased levels of certain proteins ( enzymes ) produced by the liver

Rare side effects
May affect up to 1 in 1,000 people

• skin rashes, which may appear as blisters and resemble small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme ); if you notice any of these symptoms, contact your doctor urgently
• swelling and redness along a vein, with increased pain on touch

Rare side effects may be detected in 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)
• Intestinal inflammation (see above)
• Inflammation of the protective membrane surrounding the brain (aseptic meningitis)
• Severe skin reactions:
• widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome ), and a more severe form causing extensive skin detachment (more than 30% of body surface – toxic epidermal necrolysis )
• widespread red rash with small pus-filled blisters ( exfoliative bullous dermatitis )
• a rash that is red, crusted, with swellings under the skin and blisters ( pustular eruption )
• flu-like symptoms with rash, fever, swollen glands and abnormal blood test results (including increased number of white blood cells (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms)

If you experience any of these symptoms, contact your doctor immediately.

• inflammation of the liver ( hepatitis )
• jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and whites of the eyes
• inflammation of the kidney tubules
• blood takes longer to clot
• seizures (in people taking high doses of Augmentin or who have kidney problems)

Side effects that may be detected in blood or urine tests:

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Augmentin

The expiry date, storage conditions and instructions on the labels are intended for the doctor,
nurse or pharmacist. Your medicine will be prepared for you by the doctor, pharmacist or nurse.
It must be used within 20 minutes of reconstitution.
Keep out of the sight and reach of children.
Do not use Augmentin after the expiry date (EXP) stated on the packaging. The expiry date refers to the last
day of the month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Augmentin contains

• The active substances are amoxicillin and clavulanic acid. Each vial contains sodium amoxicillin equivalent to 2000 mg of amoxicillin and potassium clavulanate equivalent to 200 mg of clavulanic acid.

There are no other excipients. However, see section 2 for further information regarding sodium and potassium in Augmentin.
The doctor, nurse, or pharmacist will prepare the injection before use with the appropriate infusion fluid (such as Water for Injections or injection/infusion liquid).
Description of the appearance of Augmentin and contents of the pack
Augmentin e.v. 2000 mg/200 mg powder for infusion is supplied as a glass vial containing sterile powder for preparing an infusion. Vials are supplied in packs of 10. Bottles are supplied in packs of 1, 5 or 50.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 - Verona
Manufacturer
Biopharma S.r.l. – Via delle Gerbere, 20/22 - Santa Palomba, Roma (Italy)
or
SmithKline Beecham Pharmaceuticals – Clarendon Road – Worthing, West Sussex, (United Kingdom)
or
GlaxoSmithKline Pharmaceuticals S.A. – Poznan (Poland)
This medicinal product is authorised in the European Economic Area Member States under the following
names:
2000 mg/200 mg powder for solution for infusion
Austria – Augmentin intravenös, Clavamox intravenös
Belgium – Augmentin
France – Augmentin IV
Germany – Augmentan IV
Italy – Augmentin
Luxembourg – Augmentin
Netherlands – Augmentin
Poland – Augmentin
Romania – Augmentin Intravenos
Spain – Augmentine Intravenoso
This patient information leaflet has been last reviewed on:

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The following information is intended for the physician and healthcare professionals:
Refer to the Summary of Product Characteristics for further information
Administration
Augmentin may be administered either by intravenous route (slow 3–4 minute injection) or directly into a vein via drip or by 30 to 40 minute infusion. Augmentin is not administered by intramuscular route.
Reconstitution
For single use only. Discard any unused solution.
The reconstitution/dilution procedure must be carried out under aseptic conditions. Prior to administration, the solution should be visually inspected for particulate matter and discoloration. Solutions should only be used if clear and free from particles.
AUGMENTIN e.v. vials are not suitable for multi-dose use.
Unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.
Preparation of intravenous injection solutions
Water for Injections Ph. Eur. is the usual solvent used.
During reconstitution, a transient pink discoloration may occur. Reconstituted solutions are normally yellowish in colour.
Augmentin e.v. 2000 mg/200 mg is not suitable for direct intravenous injection. Administration must be performed by intravenous infusion.
Preparation of intravenous infusion solutions
Augmentin e.v. 2000 mg/200 mg must be reconstituted with 20 ml of Water for Injections Ph. Eur. (this is the minimum volume). The reconstituted solution must be added immediately to 100 ml of infusion fluid using a bag or syringe.
Stability of the prepared solution
Reconstituted vial (for intravenous injection or prior to dilution for infusion)
The reconstituted solution (1 vial with 20 ml of Water for Injections) must be used or diluted immediately, within 20 minutes.
Dilution for infusion
Chemical and physical stability in use has been demonstrated for 1–2 hours at 25°C.
From a microbiological standpoint, the reconstituted and diluted solution (1 reconstituted vial in a minimum volume of 100 ml of infusion fluid) should be used immediately.
Intravenous infusion of amoxicillin-clavulanate can be administered with various infusion fluids.
Satisfactory antibiotic concentrations are maintained at room temperature (25°C) in the recommended volumes of the following infusion fluids. If reconstituted and stored at room temperature (25°C), the infusion must be completed within the time limits specified in the table below.

The stability of Augmentin i.v. solutions depends on the concentration. When more concentrated solutions are used, the stability period must be appropriately adjusted.
Augmentin i.v. is less stable in infusions containing glucose, dextrose or bicarbonate. Reconstituted Augmentin solutions may be administered by slow infusion over 3 – 4 minutes. Any residual antibiotic solutions should be discarded.