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

Active substance: POTASSIUM CLAVULANATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Co-amoxiclav 500 mg/125 mg film-coated tablets
Co-amoxiclav 875 mg/125 mg film-coated tablets
(Amoxicillin/Clavulanic acid)
Read this entire 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. 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 gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
1.
2.
3.
4.
5.
6.
1.

WHAT IS CO-AMOXICLAV AND WHAT IS IT USED FOR
BEFORE YOU TAKE CO-AMOXICLAV
HOW TO USE CO-AMOXICLAV
POSSIBLE SIDE EFFECTS
HOW TO STORE CO-AMOXICLAV
FURTHER INFORMATION
WHAT IS CO-AMOXICLAVAND WHAT IS IT 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, penicillins 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 Coamoxiclav can affect the results of these types of tests.
Taking other medicines
Please tell your doctor or your pharmacist if you are taking or have recently taken 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 will
have an allergic skin reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Coamoxiclav.
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.
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 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
500 mg/125 mg film-coated tablets
The usual dose is:
1 tablet three times a day
875 mg/125 mg film-coated tablets
The usual dose is:
Usual dose – 1 tablet two times 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 Co-amoxiclav oral suspension
or sachets.
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 (feeling sick, being
sick or diarrhoea) or convulsions. Talk to your doctor as soon as possible. Take this 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 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 product, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS
Like all medicines, Co-amoxiclav 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 Coamoxiclav.
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 [affects more than 1 user in 10]
diarrhoea (in adults).
Common side effects [affects 1 to 10 users in 100]
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 affected take Co-amoxiclav before food
vomiting
diarrhoea (in children)
Uncommon side effects [affects 1 to 10 users in 1,000]
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 [affects 1 to 10 users in 10,000]
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 [frequency cannot be estimated from the available data]
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 (bullous 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
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.
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.
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.
5.

HOW TO STORE CO-AMOXICLAV
Keep out of the reach and sight of children.
Do not use Co-amoxiclav after the expiry date printed on the box after ‘EXP’. The expiry
date refers to the last day of that month.
Store in the original package in order to protect from light and moisture.
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 substances are amoxicillin trihydrate and potassium clavulanate.
Each film-coated tablet contains amoxicillin trihydrate equivalent to 500mg amoxicillin with
potassium clavulanate equivalent to 125mg clavulanic acid.
Each film-coated tablet contains amoxicillin trihydrate equivalent to 875mg amoxicillin with
potassium clavulanate equivalent to 125mg clavulanic acid.

The other ingredients are:
Core:
Microcrystalline cellulose (E460), colloidal anhydrous silica, 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 500/125 mg tablets are white, oval, film-coated tablets inscribed with ‘A’ on
one side and ‘64’ on the other side.
Co-amoxiclav 875/125 mg tablets are white, capsule shaped, film-coated tablets inscribed with
‘A’ on one side and with a score line in between ‘6’ and ‘5’ on the other side.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal
doses.
Co-amoxiclav tablets are available in Alu/Alu (polyamide/aluminium/PVC - aluminium foil)
blister packs with 4, 5, 6, 7, 8, 10, 12, 14, 15, 16, 20, 21, 25, 30, 35, 40, 50, 100 and 500 filmcoated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland
Manufacturer

Pfizer Service Company BVBA
Hoge Wei 10
1930, Zaventem
Belgium
Or

Pfizer PGM, Zone industrielle,
29, route des Industries,
37530 Pocé-Sur-Cisse,
France
This leaflet was last approved in 07/2013

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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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