Augmentin 625mg Tablets
S0131-RM-PIL-05.01.2016
PATIENT INFORMATION LEAFLET
Augmentin® 625 mg Tablets
co-amoxiclav (amoxicillin and clavulanic acid)
The name of your medicine is Augmentin 625 mg Tablets but will be referred to as Augmentin throughout the remainder of this leaflet.
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 (or for your child). 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.
In this leaflet:
1. What Augmentin is and what it is used for
2. Before you take Augmentin
3. How to take Augmentin
4. Possible side effects
5. How to store Augmentin
6. Further information
1. WHAT AUGMENTIN IS AND WHAT IT IS USED FOR What Augmentin is
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:
• 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 AUGMENTIN Do not take Augmentin:
• If you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of Augmentin (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 Augmentin if any of the above apply to you. If you are
not sure, talk to your doctor or pharmacist before taking Augmentin.
Take special care with Augmentin
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 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 type of tests.
Using other medicines
Please tell your doctor or pharmacist 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 Augmentin, 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 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 may affect how mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organs) 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
Augmentin 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 AUGMENTIN
Always take Augmentin exactly as your doctor has told you. You should 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 Augmentin oral suspension or sachets.
Ask your doctor or pharmacist for advice when giving Augmentin tablets to children weighing less than 40 kg. The tablets are not suitable for children weighing less than 25kg.
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 Augmentin
• 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 Augmentin for more than 2 weeks. If you still feel unwell you should go back to see the doctor.
If you take more Augmentin than you should
If you have too much Augmentin, 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 Augmentin
• 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.
If you stop taking Augmentin
Keep taking Augmentin 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
Like all medicines, Augmentin 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.
POM
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.
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 Augmentin 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.
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)
• 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 Augmentin 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.
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.
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 AUGMENTIN
• Keep out of the sight and reach of children.
• Do not use Augmentin after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
• Store in the original package to protect from moisture. Do not store above 25°C. Use tablets within 30 days of opening aluminium wrapper.
• Do not use Augmentin if the tablets are chipped or there are other visible signs of deterioration.
• 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 Augmentin contains
• Each tablet contains amoxicillin trihydrate equivalent to 500 mg amoxicillin with potassium clavulanate equivalent to 125 mg clavulanic acid.
• The other ingredients are magnesium stearate, sodium starch glycollate, colloidal anhydrous silica, microcrystalline cellulose, titanium dioxide (E171), hypromellose 5 cps, hypromellose 15 cps, macrogol 4000, macrogol 6000 and dimethicone 500.
• See section 2 for further important information about one of the ingredients of Augmentin.
What Augmentin looks like and contents of the pack
Augmentin tablets are white to off-white, oval-shaped, film-coated tablets debossed with ‘AC' and a score line on one side and plain on the other side. They are packaged in blister packs, enclosed in a carton. Each pack contains either 14 or 21 tablets.
Manufactured by: Glaxo Wellcome Production, Z.I. de la Payenniere, 53100 Mayenne cedex, France.
Procured from within the EU and repackaged by:
Amimed Direct Ltd, Hendon, London, nW9 6AQ.
Product Licence holder: Sam Pharma Ltd, Unit 20 Garrick Industrial Estate, Irving Way, Hendon, London, NW9 6AQ.
PL 33902/0131
Leaflet revision date: 05/01/2016
Augmentin® is a registered trademark of the GlaxoSmithKline group of companies
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.
S0131-RM-PIL-05.01.2016