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«1 What Augmentin is and what it is used for 2 What you need to know before you have Augmentin 3 How Augmentin is given 4 Possible side effects 5 How ...»

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Package leaflet: Information for the user

AUGMENTIN® Intravenous

co-amoxiclav (amoxicillin and clavulanic acid)

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 further questions, ask your doctor, pharmacist or nurse.

 If you get any side effects, talk to your doctor or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet 1 What Augmentin is and what it is used for 2 What you need to know before you have Augmentin 3 How Augmentin is given 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 and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called “penicillins” that can sometimes be stopped from working (made inactive). The other active component (clavulanic acid) stops 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  intra-abdominal infections  genital organ infections in women.

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

2 What you need to know before you have Augmentin

You should not have 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 ever had a severe allergic reaction to any other antibiotic. This can include a skin rash or swelling of the face or throat.

 if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Biopharma site used for supply of Augmentin 1000 mg/200 mg powder for solution for injection or infusion only  Do not take Augmentin if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before having Augmentin.

Warnings and Precautions

Talk to your doctor or pharmacist or nurse before having Augmentin if you:

 have glandular fever  are being treated for liver or kidney problems  are not passing water regularly.

If you are not sure if any of the above apply to you, talk to your doctor, pharmacist or nurse before taking Augmentin.

In some cases, your doctor may investigate the type of bacteria that is causing your infection. Depending on the results, you may be given a different strength of Augmentin or a different medicine.

Conditions you need to look out for Augmentin can make some existing conditions worse, or cause serious side effects.

These include allergic reactions, convulsions (fits) and inflammation of the large intestine. You must look out for certain symptoms while you are taking Augmentin, to reduce the risk of any problems. See ‘Conditions you need to look out for’ in section 4.

Blood and urine tests If you are having blood tests (such as red blood cell status tests or liver function tests) or urine tests (for glucose), let the doctor or nurse know 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, pharmacist or nurse if you are using, have recently used or might use any other medicines.

 If you are taking allopurinol (used for gout) with Augmentin, it may be more likely that you will have an allergic skin reaction.

 If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Augmentin.

 If medicines to help stop blood clots (such as warfarin) are taken with Augmentin then extra blood tests may be needed.

 Augmentin can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.

 Augmentin can affect how mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organs) works.

Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.

Driving and using machines Biopharma site used for supply of Augmentin 1000 mg/200 mg powder for solution for injection or infusion only Augmentin can have side effects and the symptoms may make you unfit to drive.

Do not drive or operate machinery unless you are feeling well.

Augmentin contains sodium and potassium:

 Augmentin 500 mg/100 mg contains approximately 31.4 mg (1.4 mmol) of sodium.

This should be considered if you are on a controlled sodium diet.

 Augmentin 500 mg/100 mg contains approximately 19.6 mg (0.5 mmol) of potassium.

This should be considered by patients with kidney problems or patients on a controlled potassium diet.

 Augmentin 1000 mg/200 mg contains approximately 62.9 mg (2.7 mmol) of sodium.





This should be considered if you are on a controlled sodium diet.

 Augmentin 1000 mg/200 mg contains approximately 39.3 mg (1.0 mmol) of potassium. This should be considered by patients with kidney problems or patients on a controlled potassium diet.

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

The recommended doses are:

Adults, and children weighing 40 kg and over

–  –  –

Patients with kidney and liver problems  If you have kidney problems you may be given a different dose. A different strength or a different medicine may be chosen by your doctor.

 If you have liver problems your doctor will keep a close check on you and you may have more regular liver function tests.

Biopharma site used for supply of Augmentin 1000 mg/200 mg powder for solution for injection or infusion only How Augmentin will be given to you  Augmentin will be given as an injection into a vein or by intravenous infusion.

 Make sure you drink plenty of fluids while having Augmentin.

 You will not normally be given Augmentin for longer than 2 weeks without the doctor reviewing your treatment.

If more Augmentin is given to you than recommended It is unlikely you will be given too much, but if you think you have been given too much Augmentin, tell your doctor, pharmacist or nurse immediately. Signs may be an upset stomach (feeling sick, being sick or diarrhoea) or convulsions.

If you have any further questions about how this medicine is given, ask your doctor, pharmacist or nurse.

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

Conditions you need to look out for

Allergic reactions:

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

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

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

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

Common side effects These may affect up to 1 in 10 people  thrush (candida - a yeast infection of the vagina, mouth or skin folds)  diarrhoea Uncommon side effects These may affect up to 1 in 100 people  skin rash, itching  raised itchy rash (hives)  feeling sick (nausea), especially when taking high doses  vomiting  indigestion Biopharma site used for supply of Augmentin 1000 mg/200 mg powder for solution for injection or infusion only  dizziness  headache.

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

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

Rare side effects These may affect up to 1 in 1,000 people  skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge - erythema multiforme)  if you notice any of these symptoms contact a doctor urgently.

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

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

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

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

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

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

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

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

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

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

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

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

Reporting of side effects Biopharma site used for supply of Augmentin 1000 mg/200 mg powder for solution for injection or infusion only If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the

Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine 5 How to store Augmentin Augmentin Intravenous is for use in hospital only and the expiry date and storage instructions stated on the label are for the doctor, nurse or pharmacist’s information. The doctor, pharmacist or nurse will make up your medicine. It should be used within 20 minutes of reconstitution.

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

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

Do not store above 25°C.

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

6 Contents of the pack and other information

What Augmentin contains:

500 mg/100 mg powder for injection or infusion  The active substances are amoxicillin and clavulanic acid. Each vial or bottle contains sodium amoxicillin equivalent to 500 mg amoxicillin and potassium clavulanate equivalent to 100 mg of clavulanic acid.

1000 mg/200 mg powder for injection or infusion  The active substances are amoxicillin and clavulanic acid. Each vial or bottle contains sodium amoxicillin equivalent to 1000 mg amoxicillin and potassium clavulanate equivalent to 200 mg of clavulanic acid.

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

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

What Augmentin looks like and contents of the pack Augmentin IV 500 mg/100 mg powder for solution for injection or infusion is supplied as clear glass vials of sterile powder for making up as an injection or infusion. The vials are supplied in packs of 1, 5 or 10.

Augmentin IV 1000 mg/200 mg powder for solution for injection is supplied as clear glass vials or bottles of sterile powder for making up as an injection or infusion. The vials are supplied in packs of 1, 5, 10, 25 or 100. The bottles are supplied in packs of 5.

Biopharma site used for supply of Augmentin 1000 mg/200 mg powder for solution for injection or infusion only Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Beecham Group Ltd, Stockley Park West, Uxbridge, Middlesex UB11 1BT

Manufacturer:

SmithKline Beecham, Worthing, West Sussex BN14 8QH or Biopharma S.r.l., Via delle Gerbere 22/30, 00134 Santa Palomba, Roma - Italy Other formats To listen or to request a copy of this leaflet in Braille, large print or audio please call, free

of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

–  –  –

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

This leaflet was last revised in October 2015.

Augmentin is a registered trade mark of the GSK group of companies.

© 2015 GSK group of companies. All rights reserved.



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