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CO-AMOXICLAV 875MG/125MG FILM-COATED TABLETS

Active substance(s): AMOXICILLIN TRIHYDRATE / POTASSIUM CLAVULANATE / POTASSIUM CLAVULANATE DILUTED

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135 mm

135 mm

If you are taking allopurinol (used for gout) with Coamoxiclav, it may be more likely that you will have an
allergic skin reaction.

- The active substances are Amoxicillin Trihydrate
and Potassium Clavulanate., Diluted
Each film-coated tablet contains 875mg amoxicillin
as amoxicillin trihydrate and 125mg of clavulanic acid
as potassium clavulanate, diluted.
- The other ingredients are:

Package leaflet: Information for the user

If you are taking probenecid (used for gout), your
doctor may decide to adjust your dose of Coamoxiclav.

Co-amoxiclav 875mg/125mg
film-coated Tablets

If medicines to help stop blood clots (such as
warfarin) are taken with Co-amoxiclav Tablets then
extra blood tests may be needed.

(Amoxicillin/clavulanic acid)

Cellulose, microcrystalline (E460)
Sodium starch glycolate, Type A
Silica, Colloidal anhydrous (E551)
Magnesium Stearate (E470b)

Ÿ
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
Ÿ
if you have ever had liver problems or jaundice
(yellowing of the skin) when taking an antibiotic.

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 pharmacist.
- This medicine has been prescribed for you 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.

Film coat
Titanium dioxide (E171)
Hypromellose (E464)
Macrogol
What Co-amoxiclav looks like and contents of the
pack
White, capsule-shaped film-coated tablet, debossed
with 'I 07' on one side and plain on the other.

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 Tablets.
Warnings and precautions

What is in this leaflet:
1. What Co-amoxiclav Tablet is and what it is used for
2. What you need to know before you take Coamoxiclav Tablets
3. How to take Co-amoxiclav Tablets
4. Possible side effects
5. How to store Co-amoxiclav tablets
6. Contents of the pack and other information

The tablets are packaged in aluminium blister strips
consisting of: 4, 5, 6, 7, 8, 10, 12, 14, 15, 16, 20, 21,
25, 30, 35, 40, 50, 100 & 500 tablets

250 mm

Ÿ
If you have kidney problems the dose might be
changed. A different strength or a different
medicine may be chosen by your doctor.
Ÿ
If you have liver problems you may have more
frequent blood tests to check how your liver is
working.

prescription and herbal medicines.

6. Contents of the pack and other information
What Co-amoxiclav Tablets contains:

Not all pack sizes may be marketed
Marketing Authorisation Holder and
Manufacturer
Brown & Burk UK Ltd
5 Marryat Close
Hounslow West
Middlesex
TW4 5DQ
UK.

Talk to your doctor or pharmacist before taking this
medicine if you:
Ÿ
have glandular fever
Ÿ
are being treated for liver or kidney problems
Ÿ
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 these
tablets.

1. What Co-amoxiclav Tablets is and what it is
used for

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.

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.

This medicinal product is authorised in the
Member States of the EEA under the following
names:
UK & IE: Co-amoxiclav 875mg/125mg Film-coated
Tablets
SE: Amoxicillin/ Clavulanic acid BB 875mg/125mg
filmdragerade tabletter

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.

Co-amoxiclav is used in adults and children to treat
the following infections:
Ÿ
middle ear and sinus infections
Ÿ
respiratory tract infections
Ÿ
urinary tract infections
Ÿ
skin and soft tissue infections including dental
infections
Ÿ
bone and joint infections.

This leaflet was last approved on 07/2014

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.

2. What you need to know before you take Coamoxiclav Tablets
BBUK Code

135 mm

Artwork Code

Do not take Co-amoxiclav:
Ÿ
if you are allergic (hypersensitive) to amoxicillin,
clavulanic acid, penicillins or any of the other
ingredients of Co-amoxiclav tablets (listed in
section 6)

4

Other medicines and Co-amoxiclav Tablets
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

1

How to take Co-amoxiclav Tablets

Ÿ
Swallow the tablets whole with a glass of water at
the start of a meal or slightly before.
Ÿ
Space the doses evenly during the day, at least 4
hours apart. Do not take 2 doses in 1 hour.
Ÿ
Do not take Co-amoxiclav for more than 2 weeks. If
you still feel unwell you should go back to see the
doctor.

Co-amoxiclav can affect how methotrexate (a
medicine used to treat cancer or rheumatic diseases)
works.

If you take more Co-amoxiclav Tablets than you
should

Co-amoxiclav can affect how mycophenolate mofetil
(a medicine used to prevent the rejection of
transplanted organ ) works.

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.

This medicine contains 0.63 mmol (or 24.632 mg)
potassium per tablet. To be taken into consideration
by patients with reduced kidney function or patients
on a controlled potassium diet.

If you forget to take Co-amoxiclav Tablets

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.

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.

Ask your doctor or pharmacist for advice before
taking any medicine.

If you stop taking Co-amoxiclav Tablets
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.

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.

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

3. How to take Co-amoxiclav Tablets

4. Possible side effects

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.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Conditions you need to look out for

Adults and children weighing 40 kg and over

Allergic reactions:

Usual dose - 1 tablet two times a day
Higher dose - 1 tablet three times a day

Ÿ
skin rash
Ÿ
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
Ÿ
fever, joint pain, swollen glands in the neck, armpit
or groin
Ÿ
swelling, sometimes of the face or mouth
(angioedema), causing difficulty in breathing
Ÿ
collapse.

Children weighing less than 40 kg
Children aged 6 years or less should preferably be
treated with Co-Amoxiclav oral suspension or
sachets.

135 mm

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
Ÿ
diarrhoea (in adults).

Contact a doctor immediately if you get any of
these symptoms:
Ÿ
inflammation of the liver (hepatitis)
Ÿ
jaundice, caused by increases in the blood of
bilirubin (a substance produced in the liver) which
may make your skin and whites of eyes appear
yellow
Ÿ
inflammation of tubes in the kidney
Ÿ
blood takes longer to clot
Ÿ
hyperactivity
Ÿ
convulsions (in people taking high doses of Coamoxiclav or who have kidney problems)
Ÿ
black tongue which looks hairy

Common side effects
These may affect up to 1 in 10 people
Ÿ
thrush (candida - a yeast infection of the vagina,
mouth or skin folds)
Ÿ
feeling sick (nausea), especially when taking high
doses
If affected take Co-amoxiclav before food
Ÿ
vomiting.
Ÿ
Diarrhoea (in children)
Uncommon side effects

Side effects that may show up in your blood or urine
tests:
Ÿ
severe reduction in the number of white blood cells
Ÿ
low number of red blood cells (haemolytic
anaemia)
Ÿ
crystals in urine.

These may affect up to 1 in 100 people
Ÿ
skin rash, itching
Ÿ
raised itchy rash (hives)
Ÿ
indigestion
Ÿ
dizziness
Ÿ
headache.

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.

Uncommon side effects that may show up in your
blood tests:
Ÿ
increase in some substances (enzymes) produced
by the liver
Rare side effects
These may affect up to 1 in 1000 people
Ÿ
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)

5. How to store Co-amoxiclav Tablets
Keep this medicine out of the sight and reach of
children.

If you notice any of these symptoms contact a doctor
urgently.

Do not store above 25°C.
Do not take Co-amoxiclav tablets after the expiry date
which is stated on the carton and blister strip after
EXP. The expiry date refers to the last day of that
month.

Rare side effects that may show up in your blood
tests:
Ÿ
low number of cells involved in blood clotting
Ÿ
low number of white blood cells.

Do not take Co-amoxiclav Tablets if you notice any
visible signs of deterioration.

Other side effects

Ask your doctor or pharmacist for advice when giving
Co-amoxiclav tablets to children weighing less than
40 kg. The tablets are not suitable for children
weighing less than 25 kg.

Warning: Allergic reactions can sometimes occur
delayed.

Other side effects have occurred in a very small
number of people but their exact frequency is
unknown.

Patients with kidney and liver problems

Contact a doctor immediately if you get any of

Ÿ
Allergic reactions (see above)

2

Ÿ
Inflammation of the large intestine (see above)
Ÿ
Serious skin reactions:
Ÿ
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)
Ÿ
widespread red skin rash with small puscontaining blisters (bulloous exfoliative
dermatitis)
Ÿ
a red, scaly rash with bumps under the skin and
blisters (exanthemous pustulosis).
Ÿ
Inflammation of the protective membrane
sorrunding the brain (aseptic meningitis)

these symptoms. Stop taking Co-amoxiclav
Tablets.

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.

3

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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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