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Augmentine 625mg Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER AUGMENTINE® 625 mg TABLETS / CO-AMOXICLAV 500/125mg TABLETS

(amoxicillin and clavulanic acid)

This product is available as any of the above but will be referred to as Augmentine throughout the remainder of this leaflet. 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 doctor or pharmacist.

•    This medicine has been prescribed for you (or for your child). Do not pass it on to others. It may harm them, even if their signs 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.

What is in this leaflet:

1.    What Augmentine is and what it is used for

2.    What you need to know before you take Augmentine

3.    How to take Augmentine

4.    Possible side effects

5.    How to store Augmentine

6.    Contents of the pack and other information

|1. WHAT AUGMENTINE IS AND WHAT IT IS USED FOI

Augmentine 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.

Augmentine 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 YOU TAKE AUGMENTINEl

Do not take Augmentine:

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

Warnings and Precautions

Talk to your doctor or pharmacist before taking Augmentine 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 Augmentine.

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 Augmentine or a different medicine.

Conditions you need to look out for

Augmentine 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 Augmentine, 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 Augmentine. This is because Augmentine can affect the results of these type of tests.

Other medicines and Augmentine

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) with Augmentine, 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 Augmentine.

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

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

•    Augmentine may 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 or pharmacist for advice before taking this medicine.

Driving and using machines

Augmentine can have side effects and the symptoms may make you unfit to drive.

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

|3. HOW TO TAKE AUGMENTINEl

Always take Augmentin exactly as your doctor or pharmacist has told you. 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 Augmentine oral suspension or sachets.

Ask your doctor or pharmacist for advice when giving Augmentine tablets to children weighing less than 40 kg. The tablets are not suitable for children weighing less than 25 kg.

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 see how your liver is working.

How to take Augmentine

•    Swallow the tablets whole with a glass of water at the start of a meal or slightly before. Tablets can be broken along the score line to make them easier to swallow. You must take both pieces of the tablet at the same time.

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

•    Do not take Augmentine for more than 2 weeks.

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

If you take more Augmentine than you should

If you have too much Augmentine, 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 or bottle to show the doctor.

If you forget to take Augmentine

•    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 Augmentine

Keep taking Augmentine 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.

. POSSIBLE SIDE EFFECTSl

Like all medicines, this medicine 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.

^ Contact a doctor immediately if you get any of these symptoms. Stop taking Augmentine.

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.

Very common side effects

These may affect more than 1 in 10 people

•    diarrhoea (in adults).

Common side effects

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 Augmentine before food

•    vomiting

•    diarrhoea (in children).

Uncommon side effects

These may affect up to 1 in 100 people

•    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

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.

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

•    hyperactivity

•    convulsions (in people taking high doses of Augmentine or who have kidney problems)

•    black tongue which looks hairy.

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, pharmacist or nurse. 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 AUGMENTINE!

•    Keep out of the sight and reach of children.

•    Should be stored in a dry place, below 25°C. Keep the tablets in their original packaging.

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

•    If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

•    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. CONTENTS OF THE PACK AND OTHER INFORMATION!

Your medicine is called Augmentine. Each tablet contains the active ingredients Amoxycillin 500mg (as trihydrate) and Clavulanic acid 125mg (as potassium clavulanate). Each tablet is white, coated and oval and marked 'A' breakline 'C' on one side and plain on the reverse.

Augmentine also contain the following: sodium starch glycollate, magnesium stearate, colloidal silicon dioxide, microcrystalline cellulose, titanium dioxide (E171), ethyl cellulose, diethyl phthalate, hydroxypropyl methylcellulose and dimethicone.

Augmentine are available as blister packs of 12 tablets.

PL No: 15814/0083    Augmentine® 625 Mg Tablets / Co-Amoxiclav 500/125mg Tablets    |POM|

This product is manufactured by Glaxo Wellcome Production, Z.I. de la Peyenniere, 53101 Mayenne, France and is procured from within the EU and repackaged by the Product Licence holder who is: OPD Laboratories Ltd, Unit 6 Colonial Way, Watford, Herts WD24 4PR.

Augmentine is a registered trademark of the GlaxoSmithKline group of companies.

Leaflet revision and issue date (Ref.) 05.11.2015.

To request a copy of this in Braille, large print or audio please call 01923 332 796.

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 for you 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.