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PACKAGE LEAFLET: INFORMATION FOR THE USER

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|    Co-amoxiclav 500 mg/125 mg

film-coated tablets Co-amoxiclav 875 mg/125 mg film-coated tablets

¹    (Amoxicillin/Clavulanic acid)

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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 or pharmacist.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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

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

2.    BEFORE YOU TAKE CO-AMOXICLAV

3.    HOW TO USE CO-AMOXICLAV

4.    POSSIBLE SIDE EFFECTS

5.    HOW TO STORE CO-AMOXICLAV

6.    FURTHER INFORMATION

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

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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.

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.

Co-amoxiclav can affect how mycophenolate mofetil (a medicine used to prevent the rejection of new organs following a transplant operation) works.

Pregnancy and breast-feeding

If you are pregnant, you think you might be pregnant or if you are breast-feeding, please tell your doctor or pharmacist.

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

Driving and using machines

Co-amoxiclav 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

Always take Co-amoxiclav exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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Adults and children weighing 40 kg and over

500 mg/125 mg film-coated tablets The usual dose is:

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•    1 tablet three times a day

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875 mg/125 mg film-coated tablets The usual dose is:

•    Usual dose - 1 tablet two times a day

•    Higher dose - 1 tablet three times a day

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Children weighing less than 40 kg

Children aged 6 years or less should preferably be treated with co-amoxiclav oral suspension or sachets.

Co-amoxiclav 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. BEFORE YOU TAKE CO-AMOXICLAV

Do not take Co-amoxiclav

•    if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins 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 or pharmacist before taking Co-amoxiclav.

Take special care with Co-amoxiclav

Talk to your doctor or pharmacist 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 or pharmacist 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.

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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.

Taking other medicines

Please tell your doctor or your pharmacist if you are taking or have recently taken 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 will have an allergic skin reaction.

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

Ask your doctor or pharmacist for advice when giving Co-amoxiclav tablets to children weighing less than 40 kg.

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Patients with kidney and liver problems

•    If you have kidney problems the dose might be changed. A different 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 your liver is working.

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How to take Co-amoxiclav

•    Swallow the tablets whole with a glass of water at the start of a meal or slightly 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 for more than 2 weeks.

If you still feel unwell you should go back to see the doctor.

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If you take more Co-amoxiclav than you should

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

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If you forget to take Co-amoxiclav

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.

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If you stop taking Co-amoxiclav

Keep taking Co-amoxiclav 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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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Like all medicines, Co-amoxiclav can cause side effects, although not everybody gets them.

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

•    allergic acute cardiac syndrome (kounis syndrome). ^ 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.

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

Very common side effects [affects more than 1 user in 10]

•    diarrhoea (in adults).

Common side effects [affects 1 to 10 users in 100] These may affect up to 1 in 10 people

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

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

^ if affected take Co-amoxiclav before food

•    vomiting

•    diarrhoea (in children)

Uncommon side effects [affects 1 to 10 users in 1,000]

•    skin rash, itching

•    raised itchy rash (hives)

•    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 [affects 1 to 10 users in 10,000]

•    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.

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 [frequency cannot be estimated from the available data]

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)

•    Inflammation of the layers lining the brain and spinal cord called meninges (aseptic meningitis)

•    Inflammation of the bile tube (cholangitis)

•    allergic acute cardiac syndrome (kounis syndrome)

•    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

•    hyperactivity

•    convulsions (in people taking high doses of amoxicillin/clavulanic acid or who have kidney problems)

•    black tongue which looks hairy

•    stained teeth (in children), usually removed by brushing.

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

•    severe reduction in the number of white blood cells

•    lower 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.

5. HOW TO STORE CO-AMOXICLAV

Keep out of the reach and sight of children.

Do not use Co-amoxiclav after the expiry date printed on the box after 'EXP'. The expiry date refers to the last day of that month.

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

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.

6. FURTHER INFORMATION

What Co-amoxiclav contains

•    The active substances are amoxicillin trihydrate and potassium clavulanate.

Each film-coated tablet contains amoxicillin trihydrate equivalent to 500mg amoxicillin with potassium clavulanate equivalent to 125mg clavulanic acid.

Each film-coated tablet contains amoxicillin trihydrate equivalent to 875mg amoxicillin with potassium clavulanate equivalent to 125mg clavulanic acid.

•    The other ingredients are:

Core:

Microcrystalline cellulose (E460), colloidal anhydrous silica, magnesium stearate (E470b), sodium starch glycolate (Type A).

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Film coating:

Hypromellose (E464), macrogol 400, titanium dioxide (E171).

What Co-amoxiclav looks like and contents of the pack

Film-coated tablets.

Co-amoxiclav 500/125 mg tablets are white, oval, film-coated tablets inscribed with 'A' on one side and '64' on the other side.

Co-amoxiclav 875/125 mg tablets are white, capsule shaped, film-coated tablets inscribed with 'A' on one side and with a score line in between '6' and '5' on the other side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Co-amoxiclav tablets are available in Alu/Alu (polyamide/aluminium/PVC - aluminium foil) blister packs with 4, 5, 6, 7, 8, 10, 12, 14, 15, 16, 20, 21,25, 30, 35, 40, 50, 100 and 500 film-coated tablets. Not all pack sizes may be marketed.

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Marketing Authorisation Holder

Amneal Pharma Europe Limited 70 Sir John Rogerson's Quay Dublin 2 Ireland

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Manufacturer

APL Swift Services (Malta) Limited.,

HF26, Hal Far Industrial Estate,

Hal Far, Birzebbugia, BBG 3000 Malta

This leaflet was last revised in 08/2016