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CO-AMOXICLAV 250MG / 125MG FILM-COATED TABLETS

Active substance(s): AMOXICILLIN / CLAVULANIC ACID

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Co-Amoxiclav 250mg/125mg film-coated tablets
amoxicillin/clavulanic acid
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. See section 4.
In this leaflet:
1. What Co-Amoxiclav 250mg/125mg film-coated tablets are and what
they are used for
2. What you need to know before you take Co-Amoxiclav 250
mg/125 mg film-coated tablets
3. How to take your medicine
4. Possible side effects
5. How to store your medicine
6. Contents of the pack and other information
1. WHAT CO-AMOXICLAV 250 MG/125 MG FILM-COATED TABLETS
ARE AND WHAT THEY ARE USED FOR
Co-Amoxiclav 250mg/125mg film-coated tablets are an antibiotic and
work 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 250mg/125mg film-coated tablets are used in adults and
children to treat the following infections:
· sinus infections
· urinary tract infections
· skin infections
· dental infections.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-AMOXICLAV
250 MG/125 MG FILM-COATED TABLETS
Do not take your medicine:
· if you are allergic (hypersensitive) to amoxicillin, clavulanic acid,
penicillin or any of the other ingredients of your 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 your medicine if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist before taking your
medicine.
Take special care with your medicine
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 your medicine.
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.
Important information about some of the ingredients in your
medicine
This medicine contains 0.63mmol (24.5mg) potassium per tablet,
therefore, it may not be suitable if you are on a controlled potassium diet
or you have reduced kidney function. Check with your doctor if you are
unsure about this.
Conditions you need to look out for
Your medicine 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 your medicine, 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 your medicine. This is because your medicine can
affect the results of these types 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 your medicine, 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 your medicine.
If medicines to help stop blood clots (such as warfarin) are taken with
your medicine then extra blood tests may be needed.
Your medicine can affect how methotrexate (a medicine used to treat
cancer or rheumatic diseases) 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
Your medicine 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 YOUR MEDICINE
Always take your medicine 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
Co-Amoxiclav oral suspension.
Co-Amoxiclav tablets are not recommended.
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.
How to take your medicine
· 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 your medicine for more than 2 weeks. If you still feel
unwell you should go back to see the doctor.
If you take more of your medicine than you should
If you take too much of your medicine, 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 your medicine
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 your medicine
Keep taking your medicine 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.
2INAMX375U-E-10/2015

4. POSSIBLE SIDE EFFECTS
Like all medicines, your 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 your medicine.
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 your medicine 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 edgeerythema 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)
· Serious skin reaction:
- 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 this medicine 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
· 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. Website: 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 YOUR MEDICINE
Do not store above 25° C. Keep the tablets in the original packaging.
Keep out of the reach and sight of children.
Do not use your medicine 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What your medicine contains
· The active substances are: amoxicillin (as trihydrate) 250 mg; clavulanic acid (as potassium clavulanate) 125 mg.
· The other ingredients are microcrystalline cellulose (E460), sodium
starch glycollate, magnesium stearate (E572), colloidal silica anhydrous.
· The film-coating contains: hypromellose (E464), titanium dioxide
(E171), propylene glycol, ethylcellulose.
What your medicine looks like and contents of the pack
Co-Amoxiclav 250mg/125mg film-coated tablets are white capsule
shaped film-coated tablets.
Your medicine comes either in a blister pack of 21 tablets or as a white
plastic bottle with a white pilfer proof polypropylene screw cap with a
desiccant capsule, containing 21 tablets.
Marketing Authorisation Holder and manufacturer
Hikma Farmaceutica (Portugal) S.A., Estrada do Rio da Mo, Nº8, 8A e 8B,
Fervenca, 2705-906 Terrugem SNT, Portugal.
Manufacturer
Infosaúde – Instituto de Formação e Inovação em Saúde Unipessoal, Lda.
Rua das Ferrarias Del Rei, n.°6, Urbanização da Fãbrica da Pólvora,
Barcarena, 2730-269, Portugal
Distributed by:
Consilient Health (UK) Ltd., No.1 Church Road, Richmond upon Thames,
Surrey. TW9 2QE.
This leaflet was last revised in 10/2015
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
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.
P0380
2INAMX375U-E-10/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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