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(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 doctor or your 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
their signs of illness are the same as
• 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 Co-amoxiclav film-coated tablets
are and what are they used for
2. What you need to know before you take
Co-amoxiclav film-coated tablets
3. How to take Co-amoxiclav film-coated
4. Possible side effects
5. How to store Co-amoxiclav film-coated
6. Contents of the pack and other
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-amoxiclav film-coated tablets are used
in adults and children to treat the following
• 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 Co-amoxiclav film-coated tablets
Do not take Co-amoxiclav film-coated
• if you are allergic (hypersensitive) to
amoxicillin, clavulanic acid, penicillin or
any of the other ingredients of Coamoxiclav 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:
• have glandular fever
• are being treated for liver or kidney
• 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-amoxiclav
film-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 Coamoxiclav film-coated tablets or a different
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 risk of any problems.
See 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
Co-amoxiclav film-coated tablets. This is
because Co-amoxiclav film-coated tablets
can affect the results of these types of
Other medicines and Co-amoxiclav filmcoated 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
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
cancer or 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 may be
pregnant, or are planning to have a baby,
or if you are breast-feeding, ask your
doctor or pharmacist for advice before
taking this medicine.
Ask your 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
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
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.
Ask your doctor or pharmacist for advice
when giving Co-amoxiclav film-coated
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 check how
your liver is working.
How to take Co-amoxiclav film-coated
• Swallow the tablets whole with a glass of
water at the start of a meal or slightly
• 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 filmcoated tablets than you should,
If you take too much Co-amoxiclav filmcoated 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.

Allergic reactions:
• 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
• 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
• 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
• widespread red skin rash with small puscontaining blisters (bullous exfoliative
• a red, scaly rash with bumps under the
skin and blisters (exanthemous
• flu-like symptoms with a rash, fever,
swollen glands, and abnormal blood test
results (including increased white blood
cells (eosinophilia) and liver enzymes)
(Drug reaction with Eosinophilia and
Systemic Symptoms (DRESS))
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
• 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
• 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
your doctor as soon as possible.
Very common: may affect more than 1 in
10 people
• diarrhoea (in adults)
Common: may affect up to 1 in 10
• 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 filmcoated tablets before food
• vomiting
• diarrhoea (in children)
Uncommon: may affect up to 1 in 100
• 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
• low number of white blood cells
Not known: frequency cannot be
estimated from the available data
• inflammation of tubes in the kidney
• hyperactivity
• black tongue which looks hairy
• inflammation of the protective membrane
surrounding the brain (aseptic

If you forget to take Co-amoxiclav filmcoated 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

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
• crystals in urine

If you stop taking Co-amoxiclav filmcoated 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.

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: By reporting
side effects you can help provide more
information on the safety of this medicine.

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

5. How to store Co-amoxiclav filmcoated tablets

4. Possible side effects

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

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

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 light.
Do not store above 25°C.
The tablets should be used within 30 days
of opening of the pouch.
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
What Co-amoxiclav film-coated tablets
The active substances are amoxicillin and
clavulanic acid. One film-coated tablet
contains 573.96 mg amoxicillin trihydrate
equivalent to 500 mg amoxicillin and
297.81 mg potassium clavulanate
equivalent to 125 mg clavulanic acid.
The other ingredients are Cellulose
microcrystalline, Sodium starch glycolate,
Silica colloidal anhydrous, Povidone,
Eudragit E100, Magnesium stearate,
Hypromellose, Titanium dioxide (E171),
Macrogol 400, Talc.
What Co-amoxiclav film-coated tablets
look like and contents of the pack
Co-amoxiclav are white to off-white filmcoated oval shaped tablets debossed with
RX713 on one side and plain on the other
Pack sizes of 10, 12, 14, 15, 16, 20, 21, 24,
30, 40 or 50 film-coated tablets packed in
PVC/PVdC/Alu blister pack in pouch
(Polyester film/Aluminium foil/Polyester
film/Polyethylene) with 1g sachet
containing desiccant.
Do not eat the desiccant sachet contained
inside the pouch.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ranbaxy (UK) Limited
5th floor, Hyde Park, Hayes 3
11 Millington Road
Hayes, UB3 4AZ
United Kingdom
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Alkaloida Chemical Company Zrt.
Kabay János u. 29.
Tiszavasvári 4440
This leaflet was last revised in
September 2017.
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
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

5178858 - LIT CO-AMOXICLAV TAB 625mg, Market : UK, Size: 140 x 440 MM ( Single Fold ) SPIL-DWS : 29/09/2017VS, 28/09/2017VS/V1/v2, ITF CODE : 05178858, OLD CODE : 5131015

Font Size: 8pt

Co-amoxiclav 500mg/125 mg Film-coated Tablets

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 your nearest hospital.


Patient Information for the user

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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.