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CO-AMOXICLAV 500/125 MG FILM-COATED TABLETS

Active substance(s): AMOXYCILLIN TRIHYDRATE / POTASSIUM CLAVULANATE

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Package leaflet: Information for the patient

Co-amoxiclav 500 mg/125 mg
film-coated tablets
amoxicillin/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
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.
What is in this leaflet:
1. What Co-amoxiclav is and what it is used for
2. What you need to know before you take Co-amoxiclav
3. How to take Co-amoxiclav
4. Possible side effects
5. How to store Co-amoxiclav
6. Contents of the pack and other 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).
Clavulanic acid stops this from happening.
Co-amoxiclav is used in adults and children to treat the
following infections:
• respiratory infections
• middle ear and sinus infections
• urinary tract and kidney infections
• skin and soft tissue infections including animal bites
and dental infections
• bone and joint infections
You must talk to a doctor if you do not feel better or if you
feel worse after 14 days.

2. What you need to know before you take
Co-amoxiclav
Do not take Co-amoxiclav:
• if you are allergic to amoxicillin, clavulanic acid,
penicillin or any of the other ingredients of this
medicine (listed in section 6).
• if you have ever had a severe allergic reaction to any
other antibiotic. This can include a skin rash or swelling
of the face, lips, tongue, throat or neck.
• if you have ever had liver problems or jaundice
(yellowing of the skin) when taking an antibiotic.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Co-amoxiclav if you:
• have glandular fever
• have 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 must look out for while taking
Co-amoxiclav
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. If you experience an allergic
reaction, you must stop taking Co-amoxiclav and your
doctor will change your medicine. 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. This is because Co-amoxiclav can affect the
results of these types of tests.

Description Co-amoxiclav_500 mg_125 mg_21
Component Type Leaflet
Affiliate Item Code 1303134
Superceded Affiliate Item Code 428803
TrackWise PR No. 1303134
MA No. PL 04569/0459
Packing Site/Printer

Sandoz GmbH
(Kundl - AT)

Supplier Code TBC

Other medicines and Co-amoxiclav
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines:
• If you are taking allopurinol (used for gout) with
Co-amoxiclav, it may be more likely that you will 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.
• If you are taking methotrexate (a medicine used to treat
cancer or rheumatic diseases), Co-amoxiclav can affect
how it works and may cause side effects.
• Co-amoxiclav can affect how mycophenolate mofetil
(a medicine used after an organ transplant) works.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
You should only use Co-amoxiclav whilst pregnant if
your doctor tells you to. This medicine may be harmful to
the baby.
Amoxicillin and clavulanic acid can pass into breast milk.
If you breast-feed while taking this medicine, your baby
may be more likely to get diarrhoea or an infection. You
should only use Co-amoxiclav whilst breast-feeding if your
doctor tells you to.
Driving and using machines
Co-amoxiclav can have side effects such as allergic reactions,
dizziness or fits that may make you unfit to drive.
Do not drive or use machinery unless you are feeling well.

3. How to take Co-amoxiclav
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Use in adults and children weighing 40 kg and over
The recommended dose is 1 tablet three times a day.
Use in children weighing less than 40 kg
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.
Other forms of this medicine may be more suitable for
children under 25 kg; ask your doctor or pharmacist.
Patients with kidney or 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.
Do not take Co-Amoxiclav for more than 2 weeks. If you
still feel unwell you should go back to see the doctor.
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 (fits). Talk to your doctor as soon as possible.
Take the medicine carton to show the doctor.
If you forget to take Co-amoxiclav
If you forget to take a dose, take it as soon as you
remember. You should then wait 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
Keep taking your medicine 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.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Date: 04 Oct 17

Pharma Code TBC

No. of colours

SAP No. N/A

Colours

Vendor Job No. 498385
Trackwise Proof No. 3
Client Market United Kingdom

1

Time: 08:19
Page Count

1/2

Black

Non-Print
Colours

Keyline/Drawing No N/A

Equate CMYK
with

Barcode Info. N/A

Main Font

3D Render ID N/A

Dimensions

Myriad Pro
175 x 315mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v3/Jul 2017

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Stop taking Co-amoxiclav, contact a doctor
immediately or go directly to your nearest hospital
emergency department if you get any of the following:
Rare (may affect up to 1 in 1,000 people):
• frequent infections causing fever, severe chills, sore
throat or mouth ulcers (these may be signs of a low
number of white blood cells).
Frequency not known (cannot be estimated from the
available data):
• signs of a serious allergic reaction which can include:
* sudden itching, red skin rash or swelling of the face,
lips, tongue, throat or neck, difficulty breathing or
swallowing.
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.
• tiredness, headaches, shortness of breath when
exercising, dizziness, pale or yellowing of the skin
or eyes (these may be signs of a low number of red
blood cells).
• sensitivity to light, stiff neck, body aches, sore throat,
severe headache, flu-like symptoms (these may indicate
you have a type of meningitis that cannot be passed on
to others).
• diarrhoea, possibly with blood or mucus, stomach pain
or fever.
• yellowing of the skin or whites of the eyes, dark
urine, pale stools, tiredness, fever, nausea, weakness,
drowsiness and abdominal pain, with blood test results
showing abnormal liver function (These may be signs of
serious problems with your liver).
• serious skin reactions:
* a widespread rash with blisters, bleeding and peeling
skin, particularly around the mouth, nose, eyes or
genitals (Steven’s-Johnson syndrome) or 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 pus-containing
blisters (bullous exfoliative dermatitis).
* a red, scaly rash with bumps under the skin and
blisters (exanthemous pustulosis).
* 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))
• pain passing urine, lower back pain or fever. These may be
signs of a serious kidney problem (interstitial nephritis).
• fits (especially if you take high doses of Co-amoxiclav or
if you have kidney problems).
Other side effects
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 if you take high doses.
If affected take Co-amoxiclav before food.
• being sick (vomiting).
Uncommon (may affect up to 1 in 100 people):
• indigestion.
• dizziness.
• headache.
• increase in some substances (enzymes) produced by the
liver that may show up in blood tests.
Rare (may affect up to 1 in 1,000 people):
• unexplained bruising or bleeding more easily or for
longer than normal. (These may be signs of a low
number of cells involved in blood clotting).
Frequency not known (cannot be estimated from the
available data):
• hyperactivity.
• black tongue which looks hairy.
• other infections that are difficult to treat (over growth
of non-susceptible organisms).
• crystals in urine (seen as cloudy urine or in a urine test).

Reporting 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 or search for MHRA
Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Co-amoxiclav
Keep this medicine out of the sight and reach of children.
Do not store tablets above 25°C. Store in the original
package in order to protect from moisture.
Do not use this medicine after the expiry date which is
stated on the carton after “EXP”. The expiry date refers to
the last day of that month.
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 contains
The active substances are amoxicillin trihydrate
(corresponding to 500 mg amoxicillin) and potassium
clavulanate (corresponding to 125 mg clavulanic acid).
The other ingredients are magnesium stearate (E572),
talc, povidone, microcrystalline cellulose (E460) and
croscarmellose sodium. The tablet coating includes triethyl
citrate, ethylcellulose, sodium laurylsulfate, cetyl alcohol,
hypromellose, talc and titanium dioxide (E171).
What Co-amoxiclav looks like and contents of the pack
Your medicine comes as an off-white, capsule shaped
film-coated tablet with sides that curve out, marked with
‘AXC625’ on one side and ‘GG’ on the other. The tablets are
scored on both sides. Co-amoxiclav is available in blisters of
10, 15, 20, 21, or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan,
Potters Bar, Herts, EN6 1TL, United Kingdom
Manufacturer
Generics [UK] Limited, Station Close,
Potters Bar, Herts, EN6 1TL, United Kingdom
This leaflet was last revised in
September 2017
Other sources of information
Detailed information on this medicine is available on
the website of the Medicines and Healthcare products
Regulatory Agency (MHRA).
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 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.
1303134

Description Co-amoxiclav_500 mg_125 mg_21
Component Type Leaflet
Affiliate Item Code 1303134
Superceded Affiliate Item Code 428803
TrackWise PR No. 1303134
MA No. PL 04569/0459
Packing Site/Printer

Sandoz GmbH
(Kundl - AT)

Supplier Code TBC

Date: 04 Oct 17

Pharma Code TBC

No. of colours

SAP No. N/A

Colours

Vendor Job No. 498385
Trackwise Proof No. 3
Client Market United Kingdom

1

Time: 08:19
Page Count

2/2

Black

Non-Print
Colours

Keyline/Drawing No N/A

Equate CMYK
with

Barcode Info. N/A

Main Font

3D Render ID N/A

Dimensions

Myriad Pro
175 x 315mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v3/Jul 2017

+ Expand Transcript

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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