Co-amoxiclav 500 mg/100 mg or 1000 mg/200 mg powder for solution for injection or infusion

(AmoxidNin/davulanic acid)

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor, pharmacist or nurse.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse.

Co-amoxiclav 500 mg/100 mg powder for solution for injection or infusion and Co-amoxiclav 1000 mg/200 mg powder for solution for injection or infusion will both be referred to as Co-amoxiclav in the rest of this leaflet.

IN THIS LEAFLET:

1.    What Co-amoxiclav is and what it is used for

2.    Before you take Co-amoxiclav

3.    How to take Co-amoxiclav

4.    Possible side effects

5.    How to store Co-amoxiclav

6.    Further information

[1 WHAT CO-AMOXICLAV IS AND WHAT IT IS USED FOR

Co-amoxiclav 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.

Co-amoxiclav 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.

Co-amoxiclav is used in adults and children to prevent infections associated with major surgical procedures.

BEFORE YOU TAKE CO-AMOXICLAV

You should not have Co-amoxiclav:

•    if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of Co-amoxiclav (listed in section 6)

•    if you have ever had a severe allergic (hypersensitive) reaction to any other antibiotic. This can include a skin rash or swelling of the face or neck

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

Do not take Co-amoxiclav if any of the above apply to you.

If you are not sure, talk to your doctor, pharmacist or nurse before having Co-amoxiclav.

Take special care with Co-amoxiclav

Talk to your doctor, pharmacist or nurse before taking this medicine 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 Co-amoxiclav.

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 Co-amoxiclav or a different medicine.

Conditions you need to look out for

Co-amoxiclav 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 Co-amoxiclav, 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 Co-amoxiclav. This is because Co-amoxiclav can affect the results of these types of tests.

Using other medicines

Please tell your doctor, pharmacist or nurse if you are using or have recently used any other medicines. This includes medicines that can be bought without a prescription and herbal medicines.

If you are taking allopurinol (used for gout) with Co-amoxiclav, it may be more likely that you'll have an allergic skin reaction.

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

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

Co-amoxiclav can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.

Pregnancy and breast-feeding

Ask your doctor, pharmacist or nurse for advice if you are pregnant or breast-feeding.

Important information about some of the

ingredients of Co-amoxiclav

500 mg/100 mg powder for injection or infusion

•    contains approximately 31.4 mg (1.4 mmol) of sodium. This should be considered if you are on a controlled sodium diet.

•    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.

1000 mg/200 mg powder for injection or infusion

•    contains approximately 62.9 mg (2.7 mmol) of sodium. This should be considered if you are on a controlled sodium diet.

•    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.

^ HOW TO TAKE CO-AMOXICLAV

You will never give yourself this medicine. A qualified person, like a doctor or a nurse, will give you this medicine.

The usual doses are:

Adults and children weighing 40 kg and over

Children weighing less than 40 kg

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

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.

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The following information is intended for medical or healthcare professionals only:

Please refer to the Summary of Product Characteristics for further information

Administration

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

Reconstitution

Preparation of solutions for intravenous injection

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

Water for Injection Ph.Eur. is the normal solvent.

Co-amoxiclav 500/100 mg should be dissolved in 10 ml of solvent. This yields approximately 10.5 ml of solution for single-dose use. A transient pink colouration may or may not develop during reconstitution. Reconstituted solutions are normally colourless or a pale straw colour.

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

Water for Injection Ph.Eur. is the normal solvent.

Co-amoxiclav 1000 mg/200 mg should be dissolved in 20 ml of solvent. This yields approximately 20.9 ml of solution for single-dose use. A transient pink colouration may or may not develop during reconstitution. Reconstituted solutions are normally colourless or a pale straw colour.

Co-amoxiclav should be administered within 20 min of reconstitution.

Preparation of solutions for intravenous infusion

Co-amoxiclav vials are not suitable for multi-dose use.

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

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

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

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

Stability of prepared solutions

From a microbiological point of view, the product should be used immediately after reconstitution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Solutions for injection, prepared as indicated in Section 6.6, should be administered within 20 minutes of reconstitution.

Solutions for infusion should be completed within the times stated in section 6.6 (see individual infusion fluids in section 6.6).

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

How Co-amoxiclav will be given to you

•    Co-amoxiclav will be given as an injection into a vein or by intravenous infusion.

•    Make sure you drink plenty of fluids while having Co-amoxiclav.

•    You will not normally be given Co-amoxiclav for longer than 2 weeks without the doctor reviewing your treatment.

If more Co-amoxiclav 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 Co-amoxiclav, 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 product is given, ask your doctor, pharmacist or nurse.

4 POSSIBLE SIDE EFFECTS

Like all medicines, Co-amoxiclav 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 mouth (angioedema), causing difficulty in breathing

•    collapse.

Contact a doctor immediately if you get any of these symptoms. Stop taking Co-amoxiclav.

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

• if affected take Co-amoxiclav before food

•    vomiting

•    indigestion

•    dizziness

•    headache.

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

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

Rare side effects

These may affect up to 1 in 1000 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.

Other side effects

Other side effects have occurred in a very small number of people but their exact frequency is unknown.

•    Allergic reactions (see above)

•    Inflammation of the large intestine (see above)

•    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 Co-amoxiclav 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.

If you get side effects

Tell your doctor or pharmacist if any of the side effects become severe or troublesome, or if you notice any side effects not listed in this leaflet.

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HOW TO STORE CO-AMOXICLAV

You will not be asked to store your medicine. It will be brought to you ready to be administered straight away. It will be stored below 30°C and kept in the outer carton.

Keep out of the reach and sight of children

Do not use Co-amoxiclav after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

FURTHER information

What Co-amoxiclav contains

•    The active substances are amoxicillin 500 mg or 1000 mg (as sodium) and clavulanic acid 100 mg or 200 mg (as potassium).

•    There are no other ingredients.

What Co-amoxiclav looks like and contents of the pack

Co-amoxiclav comes in clear glass vials. Available in packs of 10 vials.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

TEVA UK Limited, Eastbourne, BN22 9AG.

Manufacturer:

Reig Jofre S.A., C/Gran Capitan, 10, 08970-Sant Joan Despi, Barcelona, Spain.

The leaflet was last revised in February 2011.

PL 00289/1571-2 21050-B