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Patient Information for the user

Co-amoxiclav 250mg/125mg Film-coated Tablets

(amoxicillin and clavulanic acid)

Read all of this leaflet carefully before you start taking 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 doctororyour pharmacist.

•    This medicine has been prescribed for you (or for your child) only. Do not pass it on to others. It may harm them, even if theirsigns of illness are the same as yours.

•    If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Other medicines and Co-amoxiclav film-coated tablets

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines taken without a prescription.

If you are taking allopurinol (used for gout) with Co-amoxiclav film-coated tablets, 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 film-coated tablets.

What is in this leaflet

1.    What Co-amoxiclav film-coated tablets are and what are they used for

2.    What you need to know before you take Co-amoxiclavfilm-coated tablets

3.    How to take Co-amoxiclav film-coated tablets

4.    Possible side effects

5.    How to store Co-amoxiclav film-coated tablets

6.    Contents of the pack and other information

1. What Co-amoxiclav film-coated tablets are and what are they 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-amoxiclavfilm-coated tablets are used in adults and children to treat the following infections:

•    sinus infections

•    urinary tract infections

•    skin infections

•    dental infections

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

Co-amoxiclav film-coated tablets can affect how methotrexate (a medicine used to treat canceror rheumatic diseases) works.

Co-amoxiclav film-coated tablets may affect how mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organs) works.

Pregnancy and breast-feeding

If you are pregnant, think you might be pregnant, orare planning to havea baby, or if you are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.

Ask you doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Co-amoxiclav film-coated tablets can have side effects and the symptoms may make you unfit to drive. Don't drive or operate machinery unless you are feeling well.

3. How to take Co-amoxiclav film-coated tablets

2. What you need to know before you take Co-amoxiclav film-coated tablets

Do not take Co-amoxiclav film-coated tablets

•    if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of Co-amoxiclav film-coated tablets (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 film-coated tablets if any of the above apply to you. If

you are not sure, talk to your doctor or pharmacist before taking Co-amoxiclav film-coated tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if you:

•    haveglandularfever

•    are being treated for liver or kidney problems

•    are not passing water regularly

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Co-amoxiclavfilm-coated tablets.

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 film-coated tablets or a different medicine.

Conditions you need to look out for

Co-amoxiclav film-coated tablets 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 film-coated tablets, to reduce the riskof any problems. See Section 4.

Blood and urine tests

If you are having blood tests (such as red blood cell status tests orliverfunction tests) or urine tests (for glucose), let the doctor or nurse know that you are taking Co-amoxiclav film-coated tablets. This is because Co-amoxiclav film-coated tablets can affect the results of these types of tests.

Always take this medicine exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure.

Adults and children weighing 40 kg and over

The usual dose is

•    1 tablet three times a day

Children weighing less than 40 kg

Children aged 6 years or less should preferably be treated with amoxicillin/clavulanic acid oral suspension or sachets. Co-amoxiclav film-coated tablets are not recommended.

Patients with kidney and liver problems

•    If you have kidney problems the dose might be changed. Adifferent strength or a different medicine may be chosen by your doctor.

•    If you have liver problems you may have more frequent blood tests to check how yourliveris working.

How to take Co-amoxiclav film-coated tablets

•    Swallow the tablets whole with a glass of wateratthe start of a meal orslightly before.

•    Space the doses evenly during the day, at least 4 hours apart. Do not take 2 doses in 1 hour.

•    Do not take Co-amoxiclav film-coated tablets for more than two weeks. If you still feel unwell you should go back to see your doctor.

If you take more Co-amoxiclav film-coated tablets than you should,

If you take too much Co-amoxiclav film-coated tablets, signs might include an upset stomach (feeling sick, being sick or diarrhoea) or convulsions. Talk to your doctor as soon as possible. Take the medicine carton to show the doctor.

If you forget to take Co-amoxiclav film-coated tablets

If you forget to take a dose, take it as soon as you remember. You should not take the next dose too soon, but wait about 4 hours before taking the next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Co-amoxiclav film-coated tablets

Keep taking Co-amoxiclav film-coated tablets until the treatment is finished, even if you feel better. You need every dose to help fight the infection. If some bacteria survive they can cause the infection to come back.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

5. How to store Co-amoxiclav film coated tablets

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

Serious side effects

If any of these serious side effects happen, stop taking the medicine and tell your doctor immediately or go to the emergency room at yournearest hospital.

Allergic reactions:

•    inflammation of blood vessels {vasculitis) which may be visible as red or purple raised spots on the skin, but can affect otherpartsofthe body

•    fever, joint pain, swollen glands in the neck, armpit orgroin

•    swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing

•    collapse

•    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)

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

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

•    a red, scaly rash with bumps under the skin and blisters {exanthemouspustulosis)

The following serious side effects have also been reported:

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

•    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 appearyellow

•    convulsions (in people taking high doses of Co-amoxiclav film-coated tablets or who have kidney problems)

•    blood takes longer to clot

Other side effects

If you get any of these side effects, talk to yourdoctoras soon as possible.

Very common: may affect more than 1 in 10 people

•    diarrhoea (in adults)

Common: may affect up to 1 in 10 people

•    thrush {Candida - a yeast infection of the vagina, mouth orskin folds)

•    feeling sick (nausea), especially when taking high doses

^ if affected take Co-amoxiclav film-coated tablets before food

•    vomiting

•    diarrhoea (in children)

Uncommon: may affect up to 1 in 100 people

•    skin rash, itching

•    raised itchy rash (hives)

•    indigestion

•    dizziness

•    headache

Side effects that may show up in your blood tests:

•    increase in some substances {enzymes) produced by the liver

Rare: may affect up to 1 in 1,000 people

Side effects that may show up in your blood tests:

•    low number of cells involved in blood clotting

•    low number of white blood cells

Not known: frequency cannot be estimated from the available data

•    inflammation of tubes in the kidney

•    hyperactivity

•    blacktongue which looks hairy

•    inflammation of the protective membrane surrounding the brain {asepticmeningitis)

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

•    severe reduction in the number of white blood cells

•    low number of red blood cells {haemolytic anaemia)

•    crystals in urine

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

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

Do not use this medicine after the expiry date which is stated on the carton and foil after 'EXP'. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

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 Co-amoxiclav film-coated tablets contain

The active ingredients are amoxicillin and clavulanic acid. Each film-coated tablet contains 297.956 mg amoxicillin trihydrate equivalent to 250 mg amoxicillin and 162.498 mg potassium clavulanate equivalent to 125 mg clavulanic acid.

The other ingredients: Microcrystalline cellulose, colloidal anhydrous silica, crosc-armellose sodium, butylhydroxytoluene (E321), talc, magnesium stearate, hypro-mellose, titanium dioxide (E171), macrogol 400. The printing ink contains: iron oxide black (E172), shellac glaze, ammonium hydroxide and propylene glycol.

Packs containing 21, 30 or 100 film-coated tablets/carton. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ranbaxy (UK) Limited,

Building 4, Chiswick Park,

566 Chiswick High Road,

London, W4 5YE United Kingdom

Manufacturer

Ranbaxy Ireland Limited,

Cashel, Co. Tipperary,

Republic of Ireland.

This leaflet was last revised in February 2015.

Advice/medical education

Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused by viruses.

Sometimes an infection caused by bacteria does not respond to a course of an antibiotic. One of the commonest reasons for this to occur is because the bacteria causing the infection are resistant to the antibiotic that is being taken. This means that they can survive and even multiply despite the antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully can help to reduce the chance of bacteria becoming resistant to them.

When your doctor prescribes a course of an antibiotic it is intended to treat only your current illness. Paying attention to the following advice will help prevent the emergence of resistant bacteria that could stop the antibiotic working.

1.    It is very important that you take the antibiotic at the right dose, at the right times and for the right number of days. Read the instructions on the label and if you do not understand anything ask your doctor or pharmacist to explain.

2.    You should not take an antibiotic unless it has been prescribed specifically for you and you should use it only to treat the infection for which it was prescribed.

3.    You should not take antibiotics that have been prescribed for other people even if they had an infection that was similar to yours.

4.    You should not give antibiotics that were prescribed foryou to other people.

5.    If you have any antibiotic left over when you have taken the course as directed by your doctor you should take the remainder to a pharmacy for appropriate disposal.

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