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CO-AMOXICLAV TABLETS 500/125MG

Active substance(s): AMOXYCILLIN TRIHYDRATE / POTASSIUM CLAVULANATE

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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 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 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
tablets
4. Possible side effects
5. How to store Co-amoxiclav film-coated
tablets
6. Contents of the pack and other information
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
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 Co-amoxiclav film-coated tablets
Do not take Co-amoxiclav film-coated
tablets






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 filmcoated 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 problems
• 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 Co-amoxiclav
film-coated tablets or a different medicine.
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 Coamoxiclav 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 filmcoated tablets. This is because Co-amoxiclav
film-coated tablets can affect the results of
these types of tests.

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 tablets.
If medicines to help stop blood clots (such as
warfarin) are taken with Co-amoxiclav filmcoated 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
tablets
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 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 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
tablets
• 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 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 film-coated
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.
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 dose.
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.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
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.
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 breathing
• collapse
• a widespread rash with blisters and
peeling skin, particularly around the
mouth, nose, eyes and genitals (StevensJohnson syndrome), and a more severe
form, causing extensive peeling of the
skin (more than 30% of the body surface –
toxic epidermal necrolysis)
• 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)
• widespread red skin rash with small puscontaining blisters (bullous exfoliative
dermatitis)
• a red, scaly rash with bumps under the skin
and blisters (exanthemous pustulosis)
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 fever
• 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 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 film-coated
tablets before food
• vomiting
• diarrhoea (in children)
Uncommon: may affect up to 1 in 100
people
• skin rash, itching
• raised itchy rash (hives)
• indigestion
• dizziness
• headache

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
information
What Co-amoxiclav film-coated tablets
contain
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 Coamoxiclav are white to off-white film-coated
oval shaped tablets debossed with RX713 on
one side and plain on the other side.
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
Manufacturer
Sun Pharmaceutical Industries
Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Alkaloida Chemical Company Zrt.
Kabay János u. 29.
Tiszavasvári 4440
Hungary
This leaflet was last revised in July 2016.
Advice/medical education
Antibiotics are used to treat infections caused
by bacteria. They have no effect against
infections caused by viruses.

Rare: may affect up to 1 in 1,000 people

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.

Side effects that may show up in your blood
tests:
• low number of cells involved in blood clotting
• low number of white blood cells

Bacteria can become resistant to antibiotics
for many reasons. Using antibiotics carefully
can help to reduce the chance of bacteria
becoming resistant to them.

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 meningitis)

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.

Side effects that may show up in your blood
tests:
• increase in some substances (enzymes)
produced by the liver

5. How to store Co-amoxiclav film-coated
tablets

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.

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

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
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:
www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more
information on the safety of this medicine.

5131015 - LIT CO-AMOXICLAV TAB (R3) 625mg, Market : UK, Size: 140 x 400 MM ( Single Fold ) SPIL-DWS : 11.07.16VS, ITF CODE : 05131015, OLD CODE : 5115620

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

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

5131015

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.

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