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CO-AMOXICLAV 875/125MG FILM-COATED TABLETS

Active substance(s): AMOXICILLIN TRIHYDRATE / POTASSIUM CLAVULANATE

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Package leaflet: Information for the patient
Co-amoxiclav 875/125mg, 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). 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. 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 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 this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Co-amoxiclav. This is especially important if you:

have glandular fever
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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 this
medicine.
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 this medicine, 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.
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.
Co-amoxiclav can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) and
mycophenolate mofetil (a medicine used after organ transplants) work.
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.
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 this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you
are not sure.
Adults and children weighing 40 kg and over
• Usual dose - 1 tablet twice a day
• Higher dose - 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
(in bottle or sachets).
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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.

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

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Conditions you need to look out for
Allergic reactions:
• 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
• fever, joint pain, swollen glands in the neck, armpit or groin
• Swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
• Collapse.
Contact a doctor immediately if you get any of these symptoms. Stop taking Co-amoxiclav.
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

diarrhoea (in adults).
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Common side effects
These 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 this applies to you, take /…/ before food

vomiting

diarrhoea (in children)
Uncommon side effects
These may affect up to 1 in 100 people

skin rash, itching

raised itchy rash (hives)

indigestion

dizziness

headache
Uncommon side effects that may show up in your blood tests:

increase in some substances (enzymes) produced by the liver.
Rare side effects
These may affect up to 1 in 1000 people

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
If you notice any of these symptoms contact a doctor urgently.
Rare side effects that may show up in your blood tests:

low number of cells involved in blood clotting

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

Allergic reactions (see above)

Inflammation of the large intestine (see above)

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)
- Widespread red skin rash with small pus-containing blisters (buloous exfoliative dermatitis)
- a red, scaly rash with bumps under the skin and blisters (exanthemous pustulosis).
Contact a doctor immediately if you get any of these symptoms.












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
inflammation of tubes in the kidney
blood takes longer to clot
hyperactivity
seizures/convulsions (in people taking high doses of amoxicillin/clavulanic acid or who have kidney
problems)
black tongue which looks hairy
stained teeth (in children), usually removed by brushing
inflammation of the brain membranes (aseptic meningitis)
inflammation of the bile duct (cholangitis).
pain in the chest.
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Side effects that may show up in your blood or urine tests:

severe reduction in the number of white blood cells

lower 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 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.

5. How to store Co-amoxiclav
This medicinal product does not require any special temperature storage conditions. Store in the original
package in order to protect from light and moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister 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 and potassium clavulanate. Each film-coated tablet
contains amoxicillin trihydrate corresponding to 875mg amoxicillin and potassium clavulanate
corresponding to 125mg clavulanic acid.

The other ingredients are:
Core:
Microcrystalline cellulose (E460), colloidal silicon dioxide, magnesium stearate (E470b), sodium
starch glycolate (Type A)
Film coating:
Hypromellose (E464), macrogol 400, titanium dioxide (E171).
What Co-amoxiclav looks like and contents of the pack
Film-coated tablets.
Co-amoxiclav 875/125mg tablets are white, capsule shaped, film-coated tablets inscribed with ‘A’ on one
side and ‘6’ and ‘5’ on the other side with a score line in between.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Co-amoxiclav
875/125mg
are
available
in
blister
4/5/6/7/8/10/12/14/15/16/20/21/25/30/35/40/50/100/500 film-coated tablets.
Not all listed pack sizes will be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC ehf.
5

packs

with

Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Milpharm Limited
Ares, Odyssey Business Park,
West End Road
South Ruislip
HA4 6QD
United Kingdom

This leaflet was last revised in september 2013

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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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