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CO-AMOXICLAV 250 MG/125 MG FILM-COATED TABLETS

Active substance(s): AMOXICILLIN / AMOXICILLIN TRIHYDRATE / CLAVULANIC ACID / POTASSIUM CLAVULANATE / POTASSIUM CLAVULANATE MICROCRYSTALLINE CELLULOSE BLEND

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Package leaflet: Information for the patient
Co-amoxiclav 250 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 (or for your child). Do not pass it on to others. It may harm
them, even if their symptoms 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 tablets 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 full name of your medicine is Co-amoxiclav 250 mg/125 mg film-coated tablets. In this leaflet the
shorter name Co-amoxiclav tablets is used. Co-amoxiclav tablets 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 tablets is used in adults and children to treat the following infections:





2.

Sinus infections
Urinary tract infections
Skin infections
Dental infections.

What you need to know before you take Co-amoxiclav tablets:

Do not take Co-amoxiclav tablets :
 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 (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 tablets if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before taking Co-amoxiclav tablets

1

Warnings and precautions
Talk to your doctor or pharmacist before taking Co-amoxiclav tablets 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 Coamoxiclav tablets .
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 tablets or a different medicine.
Conditions you need to look out for
Amoxicillin/clavulanic acid 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 amoxicillin/clavulanic acid, to reduce the risk of any problems. See
‘Conditions you need to look 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 tablets. This is because
amoxicillin/clavulanic acid can affect the results of these types of tests.
Other medicines and Co-amoxiclav tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take 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 tablets , it may be more likely that you’ll
have an allergic skin reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Co-amoxiclav
tablets .
If medicines to help stop blood clots (such as warfarin) are taken with Co-amoxiclav tablets then extra blood
tests may be needed.
Co-amoxiclav tablets can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases)
works.
Co-amoxiclav tablets may affect how mycophenolate mofetil (a medicine used to prevent the rejection of
transplanted organs) works.
Pregnancy, breast-feeding and fertility
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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Co-amoxiclav tablets can have side effects and the symptoms may make you unfit to drive. Do not drive or
operate machinery unless you are feeling well.
3.

How to take Co-amoxiclav tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you
are not sure.
2

Adults and children weighing 40 kg and over


The usual dose 1 tablet three times a day

Children weighing less than 40 kg
Co-amoxiclav tablets are not recommended.
Children aged 6 years or less should preferably be treated with amoxicillin/clavulanic acid oral suspension
or sachets.
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 tablets
 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 tablets for more than two weeks. If you still feel unwell you should go back
to see the doctor.
If you take more Co-amoxiclav tablets than you should
If you take too much Co-amoxiclav tablets , 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.
If you forget to take Co-amoxiclav tablets
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.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Co-amoxiclav tablets
Keep taking Co-amoxiclav tablets 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 you 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.
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Stop taking Co-amoxiclav tablets.
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)
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 affected take Co-amoxiclav tablets 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)
 Inflammation of the protective membrane surrounding the brain (aseptic meningitis)
 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)
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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 Co-amoxiclav tablets or who have kidney problems)
Black tongue which looks hairy

Side effects that may show up in your blood or urine tests:
 Severe reduction in the number of white blood cells
 Low 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.
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 the Yellow Card Scheme at
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 tablets
Do not store this medicine above 25°C. Store in the original package in order to protect from 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 or 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 tablets contains:




The active substances are amoxicillin and clavulanic acid
Each tablet contains amoxicillin trihydrate equivalent to 250 mg amoxicillin and potassium clavulanate
equivalent to 125 mg clavulanic acid
The other excipients are:
Tablet core: Microcrystalline cellulose (E460), crospovidone type A (E1202), croscarmellose sodium
(E468), colloidal anhydrous silica (E551), magnesium stearate (E470b).
Film-coating: Basic butylated methacrylate copolymer, titanium dioxide (E171), talc (E553b), macrogol
6000.

What Co-amoxiclav tablets looks like and contents of the pack
White to off white oblong film-coated tablet with a score line on one side. The score line is only to facilitate
breaking for ease of swallowing and not to divide into equal doses.

5

OPA/Al/PVC-Al blisters: 4/5/6/10/12/14/16/18/20/21/24/30/36/42/48/54/60/66/72/78/84/90/96/100/500
film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorization Holder
Rivopharm UK Ltd.
30th Floor
40 Bank Street
Canary Wharf
London E14 5NR
United Kingdom
Manufacturer
PenCef Pharma GmbH
Breitenbachstrasse 13
13409 Berlin, Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom: Co-amoxiclav 250 mg/125 mg film-coated tablets
Malta: Co-amoxiclav 250 mg/125 mg film-coated tablets

This leaflet was last revised in July 2016

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 to 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.

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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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