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

Active substance: POTASSIUM CLAVULANATE DILUTED

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or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

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Pharma code

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Co-amoxiclav contains:
PACKAGE LEAFLET: INFORMATION FOR THE USER
- The active substances are Amoxicillin Trihydrate
and Potassium Clavulanate, Diluted

Co-amoxiclav 875mg/125mg
Film-Coated Tablets

Each film-coated tablet contains 875mg amoxicillin as
amoxicillin trihydrate and 125mg of clavulanic acid as
potassium clavulanate, diluted.

Amoxicillin/clavulanic acid

Film coat
Titanium dioxide (E171)
Hypromellose (E464)
Macrogol

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 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.

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(hypersensitive) reaction to any other
antibiotic. This can include a skin rash or
swelling of the face or neck
Ÿ have ever had liver problems or
if you
jaundice (yellowing of the skin) when
taking an antibiotic.

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 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.

- The other ingredients are:
Cellulose, microcrystalline (E460)
Sodium starch glycolate, Type A
Silica, Colloidal anhydrous (E551)
Magnesium Stearate (E470b)

In this leaflet:
1. What Co-amoxiclav Tablet is and what it is used for
2. What you need to know before you take
Co-amoxiclav 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
1. WHAT CO-AMOXICLAV TABLETS IS AND
WHAT IT IS USED FOR

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
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 glandular fever
have
Ÿ being treated for liver or kidney
are
problems
Ÿ not passing water regularly.
are
If you are not sure if any of the above apply to you, talk
to your doctor or pharmacist before taking these
tablets.

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

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.

Co-amoxiclav is used in adults and children to treat
the following infections:

Ÿ ear and sinus infections
middle
Ÿ
respiratory tract infections
Ÿ tract infections
urinary
Ÿ and soft tissue infections including
skin
dental infections
Ÿ and joint infections.
bone

This leaflet was last approved on 05/2013

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 CO-AMOXICLAV TABLETS

Pharma code

4

Do not take Co-amoxiclav:
Ÿyou are allergic (hypersensitive) to
if
amoxicillin, clavulanic acid, penicillin or
any of the other ingredients of
Co-amoxiclav (listed in section 6)
Ÿ have ever had a severe allergic
if you

Other medicines and Co-amoxiclav Tablets
Please tell your doctor or pharmacist if you are using
or have recently used any other medicines. This

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includes medicines that can be bought without a
prescription and herbal medicines.

Co-amoxiclav tablets to children weighing less than
40 kg.

If you are taking allopurinol (used for gout) with
Co-amoxiclav, it may be more likely that you'll have an
allergic skin reaction.

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 are taking probenecid (used for gout), your
doctor may decide to adjust your dose of
Co-amoxiclav.

If you have liver problems you may have more
frequent blood tests to check how your liver is
working.

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

Ÿ
swelling, sometimes of the face or mouth
(angioedema), causing difficulty in
breathing
Ÿ
collapse.

Ÿ reactions (see above)
Allergic
Ÿ
Inflammation of the large intestine (see above)
Ÿ skin reactions:
Serious
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)
widespread red skin rash with small puscontaining blisters (bullous exfoliative
dermatitis)
a red, scaly rash with bumps under the
skin and blisters (exanthemous
pustulosis).

Warning: Allergic reactions can sometimes occur
delayed.
Contact a doctor immediately if you get any of
these symptoms. Stop taking Co-amoxiclav
Tablets.
Inflammation of large intestine

How to take Co-amoxiclav Tablets
Swallow the tablets whole with a glass of water at the
start of a meal or slightly before.

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

Inflammation of the large intestine, causing watery
diarrhoea usually with blood and mucus, stomach
pain and/or fever.

Antibiotics, such as Co-amoxiclav, may affect how
oestrogen (the active ingredient in the contraceptive
pill) is absorbed into your body. This could make the
contraceptive pill less effective. As a precaution, it is
advisable to use an additional form of contraception,
such as a condom. You should use the additional
contraceptive whilst you are taking Co-amoxiclav
tablets, and for one week after you stop.

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

Space the doses evenly during the day, at least 4
hours apart. Do not take 2 doses in 1 hour.

Contact your doctor as soon as possible for
advice if you get these symptoms.

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

Very common side effects
These may affect more than 1 in 10 people
Ÿ
diarrhoea (in adults).

If you take more Co-amoxiclav than you should

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 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.

Common side effects
These may affect up to 1 in 10 people
Ÿ (candida - a yeast infection of the
thrush
vagina, mouth or skin folds)
Ÿ
feeling sick (nausea), especially when
taking high doses

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 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.

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

If you stop taking Co-amoxiclav

Driving and using machines

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.

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
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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Co-amoxiclav can cause side
effects, although not everybody gets them.

Adults and children weighing 40 kg and over

Conditions you need to look out for

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

Allergic reactions:

Children weighing less than 40 kg

Ÿ rash
skin
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 joint pain, swollen glands in the
fever,
neck, armpit or groin

Children aged 6 years or less should preferably be
treated with Co-Amoxiclav oral suspension or
sachets.
Ask your doctor or pharmacist for advice when giving

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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 takes longer to clot
blood
Ÿ
hyperactivity
Ÿ
convulsions (in people taking high doses of
Co-amoxiclav or who have kidney problems)
Ÿ tongue which looks hairy
black
Ÿ teeth (in children), usually removed by
stained
brushing.

If affected take Co-amoxiclav before food
Ÿ
vomiting.
Ÿ
Diarrhoea (in children)
Uncommon side effects

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

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

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

If you get side effects
Tell your doctor or pharmacist if any of the side
effects become severe or troublesome, or if you
notice any side effects not listed in this leaflet.

Rare side effects
These may affect up to 1 in 1000 people
Ÿrash, which may blister, and looks like small
skin
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 out of the sight and reach of children.
Do not store above 25°C.

If you notice any of these symptoms contact a doctor
urgently

Do not take Co-amoxiclav 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

Medicines should not be disposed of via wastewater

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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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