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CO-AMOXICLAV 500/125MG TABLETS

Active substance(s): AMOXICILLIN TRIHYDRATE / AMOXYCILLIN / CLAVULANIC ACID / POTASSIUM CLAVULANATE

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CP.CMX.500-125T.SN.V3P2

• Do not take Co-amoxiclav for more than 2 weeks. If you
still feel unwell you should go back to see the doctor.

Package leaflet: Information for the user

CO-AMOXICLAV 500/125mg TABLETS
(Amoxicillin and 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. What Co-amoxiclav is and what it is used for
2. Before you take Co-amoxiclav
3. How to take Co-amoxiclav
4. Possible side effects
5. How to store Co-amoxiclav
6. Further information

1.

WHAT CO-AMOXICLAV IS AND WHAT IT IS 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 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 CO-AMOXICLAV

Do NOT take Co-amoxiclav:
- if you are allergic (hypersensitive) to amoxicillin,
clavulanic acid, penicillin or any of the other ingredients
of Co-amoxiclav (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 if any of the above apply to
you. If you are not sure, talk to your doctor or pharmacist
before taking Co-amoxiclav.
Take special care with Co-amoxiclav
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 Co-amoxiclav.
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.
Conditions you need to look out for
Co-amoxiclav 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, 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 Co-amoxiclav.
This is because Co-amoxiclav 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
Co-amoxiclav, 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.
• If medicines to help stop blood clots (such as warfarin)
are taken with Co-amoxiclav then extra blood tests may
be needed.
• Co-amoxiclav can affect how methotrexate (a medicine
used to treat cancer or rheumatic diseases) works.
• Co-amoxiclav 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
Co-amoxiclav 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

Always take Co-amoxiclav Tablets 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.
Ask your doctor or pharmacist for advice when giving
Co-amoxiclav tablets to children weighing less than 40 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
• 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.

Dimensions: 175mm x 315mm

Supersedes: n/a

Pantone Blue
280 C

• Indigestion.
• Dizziness.
• Headache.

If you take more Co-amoxiclav than you should
If you take too much Co-amoxiclav, 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.

Uncommon side effects that may show up in your
blood tests (may affect up to 1 in 100 people)
• Increase in some substances (enzymes) produced by the
liver.

If you forget to take Co-amoxiclav
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.

Rare side effects that may show up in your blood tests
(may affect up to 1 in 1,000 people)
• Low number of cells involved in blood clotting.
• Low number of white blood cells.

If you stop taking Co-amoxiclav
Keep taking Co-amoxiclav 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.

Not known (frequency cannot be estimated from the
available data)
• Hyperactivity.
• Black tongue which looks hairy.
• Stained teeth (in children), usually removed by brushing.

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

Not known side effects that may show up in your blood
or urine tests (frequency cannot be estimated from the
available data)
• Severe reduction in the number of white blood cells.
• Low number of red blood cells (haemolytic anaemia).
• Crystals in urine.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Co-amoxiclav can cause side effects,
although not everybody gets them.
If any of the following side effects occur, stop taking
Co-amoxiclav and go to the hospital at once
• Allergic reactions such as
- Fever, joint pain, swollen glands in the neck, armpit or
groin.
- Swelling, sometimes of the face or mouth (angioedema),
causing difficulty in breathing.
- Collapse.
- 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.
• 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).
- A 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).
- A 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)
• Inflammation of the protective membrane surrounding the
brain (aseptic meningitis)
• Convulsions (in people taking high doses of Co-Amoxiclav
or who have kidney problems).
If any of the following side effects occur, tell your
doctor straight away
• Inflammation of the large intestine, causing watery
diarrhoea usually with blood and mucus, stomach pain
and/or fever.
• Inflammation of the liver (hepatitis), causing tiredness,
fever and yellowing of the skin and whites of the eyes.
• 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, causing fever,
change in the amount of urine produced, blood in your
urine, nausea (feeling sick), vomiting (being sick) and
confusion.
• Blood takes longer to clot.
Other side effects include:
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).
• Nausea (feeling sick), especially when taking high doses.
If affected, it may help to take Co-amoxiclav before food.
• Vomiting (being sick).
• Diarrhoea (in children).
Uncommon (may affect up to 1 in 100 people)
• Itching.
• Raised itchy rash (hives).

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 CO-AMOXICLAV

Do not store above 25°C.
Store in the original package.
Keep out of reach and sight of children.
Do not use Co-amoxiclav after the expiry date which is
stated on the carton. The expiry date refers to the last day
of the 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.

FURTHER INFORMATION

What Co-amoxiclav contains:
The active ingredients of Co-amoxiclav Tablets are
amoxicillin 500mg as amoxicillin trihydrate and clavulanic
acid 125mg. This combination of antibiotics is also known
as Co-amoxiclav.
Co-amoxiclav Tablets also contain:
magnesium stearate (E572), talc, povidone, microcrystalline
cellulose, croscarmellose sodium, triethyl citrate, ethyl
cellulose, sodium lauryl sulphate, cetyl alcohol,
hypromellose, and titanium dioxide (E171).
What Co-amoxiclav looks like and contents of the pack:
Co-amoxiclav Tablets are oval, convex, film-coated and
off-white in colour. The tablets are scored on both sides.
Co-amoxiclav Tablets come in packs of 21.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Limited,
Frimley Business Park,
Frimley, Camberley,
Surrey, GU16 7SR.
United Kingdom
Manufacturer:
Sandoz GmbH,
A-6250 Kundl,
Tyrol, Austria.
Distributed by:
Kent Pharmaceuticals Limited,
Repton Road,
Measham, DE12 7DT.
United Kingdom
This leaflet was last revised in 06/2014.
CP.CMX.500-125T.SN.V3P2

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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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