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CO-AMOXICLAV 250/62.5 MG/5 ML POWDER FOR ORAL SUSPENSION

Active substance(s): AMOXICILLIN TRIHYDRATE / POTASSIUM CLAVULANATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Co-amoxiclav 125/31.25 mg/5 ml and 250/62.5 mg/5 ml
Powder for Oral Suspension

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(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 gets 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 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.
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.
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.

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.

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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 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

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.
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.
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.

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.

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,

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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.

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.
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 Oral Suspension 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 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

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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)
- 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))
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) 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 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
(125/31.25 mg/5 ml and 250/62.5 mg/5 ml).

The active ingredients are amoxicillin 125 mg and clavulanic acid
31.25 mg per 5 ml or amoxicillin 250 mg and clavulanic acid 62.5 mg
per 5 ml. 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 Oral Suspension looks like and contents of
the pack:
Co-amoxiclav Oral Suspension comes in a bottle containing 100 ml
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.
This leaflet was last revised in 10/2017.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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