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CO-AMOXICLAV 125/31.25 MG/5 ML POWDER FOR ORAL SUSPENSION

Active substance(s): AMOXICILLIN TRIHYDRATE / POTASSIUM CLAVULANATE

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CP.CMX.JNT.SuSF.SN.V2P1

Package leaflet: Information for the user

CO-AMOXICLAV 125/31.25mg/5ml AND 250/62.5mg/5ml
POWDER FOR ORAL SUSPENSION
(Amoxicillin and Clavulanic acid)
Read all of this leaflet carefully before you start giving your child 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 is usually prescribed for a baby or child. Do not pass it on to others. It may harm them, even if their symptoms are
the same as your child’s.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Co-amoxiclav Oral Suspension is and what it is used for
2. Before you give Co-amoxiclav Oral Suspension
3. How to give Co-amoxiclav Oral Suspension
4. Possible side effects
5. How to store Co-amoxiclav Oral Suspension
6. Further Information

1.

WHAT CO-AMOXICLAV ORAL SUSPENSION IS AND
WHAT IT IS USED FOR

The name of your child’s medicine is either Co-amoxiclav
125/31.25 mg/5 ml Powder for Oral Suspension or
Co-amoxiclav 250/62.5 mg/5 ml Powder for Oral Suspension. It
will be referred to as Co-amoxiclav Oral Suspension throughout
this leaflet, as you will receive it in the form of an oral
suspension from your doctor or pharmacist (please see section
3 for further information).
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 Oral Suspension is used in babies 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 GIVE CO-AMOXICLAV ORAL
SUSPENSION

Do not give your child Co-amoxiclav Oral Suspension if:
• if they are allergic (hypersensitive) to amoxicillin and
clavulanic acid, or any of the other ingredients of
Co-amoxiclav Oral Suspension (listed in section 6).
• if they 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 they have ever had liver problems or jaundice (yellowing of
the skin) when taking an antibiotic.

can affect the results of these types of tests.
Using other medicines
Please tell your doctor or pharmacist if your child is taking or
has recently taken any other medicines. This includes medicines
that can be bought without a prescription and herbal medicines.
If your child is taking allopurinol (used for gout) with
Co-amoxiclav Oral Suspension, it may be more likely that they
will have an allergic skin reaction.
If your child is taking probenecid (used for gout), your doctor
may decide to adjust the dose of Co-amoxiclav Oral
Suspension.
If medicines to help stop blood clots (such as warfarin) are taken
with Co-amoxiclav Oral Suspension then extra blood tests may
be needed.
Co-amoxiclav Oral Suspension can affect how methotrexate (a
medicine used to treat cancer or rheumatic diseases) works.
Co-amoxiclav Oral Suspension may affect how mycophenolate
mofetil (a medicine used to prevent the rejection of transplanted
organs) works.
Pregnancy and breast-feeding
If your child who is about to take this medicine is pregnant or
breast-feeding, please tell your doctor or pharmacist.
Ask your doctor or pharmacist for advice before taking any
medicine.
Important information about some of the ingredients of
Co-amoxiclav Oral Suspension
Co-amoxiclav Oral Suspension contains aspartame (E951)
which is a source of phenylalanine. This may be harmful for
children born with a condition called ’phenylketonuria’.

3.

HOW TO GIVE CO-AMOXICLAV ORAL SUSPENSION

How to give Co-amoxiclav Oral Suspension
• Always shake the bottle well before each dose
• The measuring spoon provided is marked to show doses of
1.25 ml, 2.5 ml and 5 ml. If you are using the measuring
spoon, take care to ensure it is filled to the correct dosage
marking.
- To measure 1.25 ml of suspension, carefully tilt the spoon
and fill up to the dosing line marked 1.25 ml.
- To measure 2.5 ml of suspension, keep the spoon level and
fill up to the dosing line marked 2.5 ml.
- To measure 5 ml of suspension, keep the spoon level and
fill up to the brim.
Ask your doctor or pharmacist if you are unsure.
• Give 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 give your child Co-amoxiclav Oral Suspension for
more than 2 weeks. If your child still feels unwell they should
go back to see the doctor.
If you give more Co-amoxiclav Oral Suspension than you
should
If you give your child too much Co-amoxiclav Oral Suspension,
signs might include an upset stomach (feeling sick, being sick or
diarrhoea) or convulsions. Talk to their doctor as soon as
possible. Take the medicine bottle to show the doctor.
If you forget to give Co-amoxiclav Oral Suspension
If you forget to give your child a dose, give it as soon as you
remember. You should not give your child the next dose too
soon, but wait about 4 hours before giving the next dose.
If your child stops taking Co-amoxiclav Oral Suspension
Keep giving your child Co-amoxiclav Oral Suspension until the
treatment is finished, even if they feel better. Your child needs
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 Oral Suspension can cause
side effects, although not everybody gets them. The side effects
below may happen with this medicine.
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 your child gets any of these
symptoms. Stop taking Co-amoxiclav Oral Suspension.

Do not give Co-amoxiclav Oral Suspension to your child if
any of the above apply to your child. If you are not sure, talk
to their doctor or pharmacist before giving Co-amoxiclav Oral
Suspension.

This product is supplied to your doctor or pharmacist as a
powder. He/she will use this powder to form an oral suspension
which will be provided to you for use. If you have any questions
please check with your doctor or pharmacist.

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 your
child gets these symptoms.

Take special care with Co-amoxiclav Oral Suspension
Check with their doctor or pharmacist before giving your child
this medicine if they:
• have glandular fever
• are being treated for liver or kidney problems
• are not passing water regularly.

Always give Co-amoxiclav Oral Suspension exactly as your
doctor has told you. You should check with your doctor or
pharmacist if you are not sure.

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

Adults and children weighing 40 kg or over
• This suspension is not usually recommended for adults and
children weighing 40 kg and over.
Ask your doctor or pharmacist for advice.

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 Oral Suspension before food
• vomiting
• diarrhoea (in children).

If you are not sure if any of the above apply to your child, talk to
their doctor or pharmacist before giving Co-amoxiclav Oral
Suspension.
In some cases, your doctor may investigate the type of bacteria
that is causing your child’s infection. Depending on the results,
your child may be given a different strength of Co-amoxiclav or
a different medicine.
Conditions you need to look out for
Co-amoxiclav Oral Suspension 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
your child is taking Co-amoxiclav Oral Suspension, to reduce
the risk of any problems. See ‘Conditions you need to look out
for’ in Section 4.
Blood or urine tests
If your child is 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 they are taking Co-amoxiclav Oral
Suspension. This is because Co-amoxiclav Oral Suspension

Children weighing less than 40 kg
All doses are worked out depending on the child’s bodyweight in
kilograms.
Your doctor will advise you how much Co-amoxiclav Oral
Suspension you should give to your baby or child.
You may be provided with a plastic measuring spoon. You
should use this to give the correct dose to your baby or child
(see ‘How to give Co-amoxiclav Oral Suspension’ for further
information).
Usual dose – 20 mg/5 mg to 60 mg/15 mg for each kilogram
of body weight a day, given in three divided doses.
Patients with kidney and liver problems
If your child has kidney problems the dose might be lowered. A
different strength or a different medicine may be chosen by your
doctor.
If your child has liver problems they may have more frequent
blood tests to see how their liver is working.

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 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 your child gets 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 child’s
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 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 blood or urine tests
• severe reduction in the number of white blood cells
• low number of red blood cells (haemolytic anaemia)
• crystals in urine.

Reporting of side effects
If your child gets any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme
(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 ORAL
SUSPENSION

Keep out of the reach and sight of children.
Store at 2-8°C. Do not freeze. Keep container tightly closed.
Do not use Co-Amoxiclav Oral Suspension after the expiry date
which is stated on the carton. The expiry date refers to the last
day of the month.
After reconstitution to form an oral suspension, this medicine
should only be used for up to 7 days from the dispensing date
stated on the label.
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 Oral Suspension contains:
Co-amoxiclav Oral Suspension is available in two strengths
(125/31.25mg/5ml and 250/62.5mg/5ml).
The active ingredients are amoxicillin 125mg and clavulanic acid
31.25mg per 5ml or amoxicillin 250mg and clavulanic acid
62.5mg per 5ml. This combination of antibiotics is also known as
Co-amoxiclav.
Co-amoxiclav Oral Suspension also contains: anhydrous citric
acid, trisodium citrate, aspartame, talc, guar galactomannan,
colloidal silicon dioxide, flavouring agents (lemon, peach-apricot
and orange containing essence of bergamot).
What Co-amoxiclav Powder for Oral Suspension looks like
and contents of the pack:
Co-amoxiclav Powder for Oral Suspension comes in a bottle
containing 100ml of suspension. Co-amoxiclav Oral Suspension
is off-white in colour with a fruity flavour.
Marketing Authorisation Holder and Manufacturer
Product Licence Holder:
Sandoz Ltd, Frimley Business Park, Frimley, Camberley,
Surrey, GU16 7SR, UK.
Manufacturer:
Sandoz GmbH, A-6250 Kundl, Tyrol, Austria.
Distributed by:
Kent Pharmaceuticals Limited, Repton Road, Measham,
DE12 7DT, U.K.
This leaflet was last revised in 04/2014

CP.CMX.JNT.SuSF.SN.V2P1

Revision:
ARTWORK FOR SUBMISSION
Supersedes: n/a

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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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