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CO-AMOXICLAV 200 MG/28.5 MG/5 ML SUGAR FREE POWDER FOR ORAL SUSPENSION

Active substance(s): AMOXICILLIN TRIHYDRATE / POTASSIUM CLAVULANATE / AMOXICILLIN TRIHYDRATE / POTASSIUM CLAVULANATE

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270 mm
135 mm

By reporting side effects you can help provide more
information on the safety of this medicine.

What Co-amoxiclav Sugar Free Suspension
looks like and contents of the pack
Co-amoxiclav Sugar Free powder for Oral
Suspension is a white to off-white dry powder,
which when reconstituted as directed, yields a white
to off-white suspension with a mixed fruit flavour.

5. HOW TO STORE CO-AMOXICLAV SUGAR
FREE SUSPENSION
Dry powder: This medicinal product does not
require any special temperature storage conditions.
Store in the original package in order to protect
from moisture.

This product is available in plastic bottles with a
CRC cap as follows:
• 60ml bottle containing 30ml of reconstituted
suspension.
• 115ml bottle containing 60ml of reconstituted
suspension.
• 115ml bottle containing 70ml of reconstituted
suspension.
• 150ml bottle containing 100ml of reconstituted
suspension.

After reconstitution: Store in a refrigerator
between 2°C to 8°C in the container supplied and
use within 7 days
Shake well before use.
Keep this medicine out of the sight and reach of
children.

Each pack may be supplied with or without a 5 ml
oral syringe made from polystyrene.
Not all pack sizes may be marketed.

Do not use this medicine after the expiry date which
is stated on the carton. The expiry date refers to the
last day of that month.

Marketing Authorisation Holder and
Manufacturer
Brown & Burk UK Limited
5 Marryat Close
Hounslow West
Middlesex
TW4 5DQ
UK

Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you no
longer use. These measures will help to protect the
environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION

This medicinal product is authorized in the
Member States of the EEA under the following
names:
PT : Amoxicilina + Ácido Clavulânico Brown
200 mg/5 ml + 28,5 mg/5ml Pó para
suspensão oral
Amoxicilina + Ácido Clavulânico Brown
400 mg/5 ml + 57 mg/5 ml Pó para
suspensão oral
UK : Co-amoxidav 200 mg/28.5 mg/5 ml Sugar
Free Powder for oral suspension
Co-amoxidav 400 mg/57 mg /5 ml Sugar
Free Powder for oral suspension
IE : Co-amoxidav Sugar Free 200 mg/28.5 mg/
5 ml Powder for oral suspension
Co-amoxidav Sugar Free 400 mg/57 mg /
5 ml Powder for oral suspension

What Co-amoxiclav Sugar Free Suspension
contains
• Co-amoxiclav 200mg/28.5mg/5ml Sugar Free
Powder for Oral Suspension contains 200mg of
amoxicillin (as amoxicillin trihydrate) and 28.5mg
of Clavulanic acid (as potassium clavulanate) in
every 5 ml of reconstituted product.
• Co-amoxiclav 400mg/57mg/5ml Sugar Free
Powder for Oral Suspension contains 400mg of
amoxicillin (as amoxicillin trihydrate) and 57mg
of Clavulanic acid (as potassium clavulanate) in
every 5 ml of reconstituted product.
The active substances are amoxicillin trihydrate and
potassium clavulanate
The other ingredients are:.
- Silicon dioxide (E551)
- Aspartame (E951)
- Succinic acid (E363)
- Xanthan gum (E415)
- Hypromellose (E464)
- Colloidal anhydrous silica (E551)
- Raspberry Flavour [Acacia gum (E414), Nature
identical flavouring substance, Propylene glycol
(E1520), Artificial flavouring substance and
Flavouring preparation]
- Orange Flavour [Acacia gum (E414), Flavouring
preparation and Butylated
hydroxyanisole (E320)]
- Golden Caramel [Maltodextrin,
Triethyl Citrate (E1505), Artificial
Flavours and Acetic acid (E260)]

This leaflet was last approved in 12 /2016

Pharma code

PACKAGE LEAFLET: INFORMATION FOR THE USER

Co-amoxiclav 200mg/28.5mg/5ml Sugar Free
Powder for Oral Suspension
Co-amoxiclav 400mg/57mg/5ml Sugar Free
Powder for Oral Suspension
Amoxicillin/clavulanic acid
Read all of this leaflet carefully before you start
giving your child this medicine because it
contains important information for them.
- Keep this leaflet. You may need to read it
again.
- If you have any further questions, ask your
doctor, pharmacist or nurse.
- This medicine usually prescribed for a baby or
child. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as your child's .
- If your child gets any of the side effects, talk to
your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet.
See section 4.

2. WHAT YOU NEED TO KNOW BEFORE YOU
GIVE CO-AMOXICLAV SUGAR FREE
SUSPENSION
Do not give your child Co-amoxiclav Sugar Free
Suspension:
• if they are allergic (hypersensitive) to amoxicillin,
clavulanic acid or any of the other ingredients of
this medicine (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.

What is in this leaflet:
1. What Co-amoxiclav Sugar Free Suspension is
and what it is used for
2. What you need to know before you give Coamoxiclav Sugar Free Suspension
3. How to give Co-amoxiclav Sugar Free
Suspension
4. Possible side effects
5. How to store Co-amoxiclav Sugar Free
Suspension
6. Contents of the pack and other information

Do not give Co-amoxiclav Sugar Free
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 Sugar Free
Suspension.
Take special care with Co-amoxiclav Sugar Free
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.

1. WHAT CO-AMOXICLAV SUGAR FREE
SUSPENSION IS AND WHAT IT IS USED FOR
Co-amoxiclav Sugar Free Suspension 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.

If you are not sure if any of the above apply to your
child, talk to their doctor or pharmacist before giving
Co-amoxiclav Sugar Free 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 Sugar Free
Suspension or a different medicine.

Co-amoxiclav Sugar Free 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.

Pharma code

250 mm

135 mm

4

BBUK Code

Artwork Code

Conditions you need to look out for
Co-amoxiclav Sugar Free 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 Sugar Free
Suspension, to reduce the risk of any problems.
See 'Conditions you need to look out for' in
Section 4.

You must talk to a doctor if your child does not feel
better or if your child feels worse.

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adults and children weighing 40 kg and over.
Ask your doctor or pharmacist for advice.

250 mm

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,
let the doctor or nurse know that they are taking Coamoxiclav Sugar Free Suspension. This is because
Co-amoxiclav Sugar Free Suspension can affect
the results of these types of tests.
Other medicines and Co-Amoxiclav Sugar Free
Suspension
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 Sugar Free 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 Sugar Free Suspension.
• If medicines to help stop blood clots (such as
warfarin) are taken with Co-amoxiclav Sugar
Free Suspension then extra blood tests may be
needed.
• Co-amoxiclav Sugar Free Suspension can affect
how methotrexate (a medicine used to treat
cancer or rheumatic diseases) works.
• Co-amoxiclav Sugar Free Suspension can affect
how mycophenolate mofetil (a medicine used to
prevent the rejection of transplanted organs)
works.

Like all medicines, this medicine can cause side
effects, although not everybody gets them. The side
effects below may happen with this medicine.

• Your doctor will advise you how much Coamoxiclav Sugar Free Suspension you should
give to your baby or child.
• You may be provided with a plastic measuring
spoon or plastic measuring cup or dosing
syringe. You should use this to give the correct
dose to your baby or child.
• Recommended dose – 25 mg/3.6 mg to
45 mg/6.4 mg for each kilogram of body weight
a day, given in two divided doses.
• Higher dose – up to 70 mg/10 mg for each
kilogram of body weight a day, given in two
divided doses.

Conditions you need to look out for

How to give Co-amoxiclav Sugar Free
Suspension
• Always shake the bottle well before each dose
• 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 Sugar Free
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 Sugar Free
Suspension than you should
If you give your child too much Co-amoxiclav Sugar
Free 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.

Driving and using machines
Co-amoxiclav Sugar Free Suspension can have
side effects and the symptoms may make you unfit
to drive. Do not drive or operate machinery unless
you are feeling well.
Ask your doctor or pharmacist for advice before
taking any medicine.

If you forget to give Co-amoxiclav Sugar Free
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.

Co-amoxiclav Sugar Free Suspension contains
aspartame:
• Co-amoxiclav Sugar Free Suspension contains
aspartame (E951) which is a source of
phenylalanine. This may be harmful for children
born with a condition called 'phenylketonuria'.

If your child stops taking Co-amoxiclav Sugar
Free Suspension
Keep giving your child Co-amoxiclav Sugar Free
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.

3. HOW TO GIVE CO-AMOXICLAV SUGAR
FREE SUSPENSION
Always give this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose is:
Adults and children weighing 40 kg or over
• This suspension is not usually recommended for

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

targets (central dark spots surrounded by a paler
area, with a dark ring around the edge –
erythema multiforme)

4. POSSIBLE SIDE EFFECTS

Children weighing less than 40 kg
All doses are worked out depending on the child's
bodyweight in kilograms.

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.

Pregnancy and breast-feeding
If your child who is about to take this medicine is
pregnant or breast-feeding, thinks they may be
pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine

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If you notice any of these symptoms contact a
doctor urgently.
Rare side effects that may show up in blood tests:
• low number of cells involved in blood clotting
• low number of white blood cells

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.

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 puscontaining 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.

Contact a doctor immediately if your child gets
any of these symptoms.
Stop taking Co-amoxiclav Sugar Free
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

• 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
Sugar Free Suspension or who have kidney
problems)
• black tongue which looks hairy
• stained teeth (in children), usually removed by
brushing.

• 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 Sugar Free
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.

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.

Uncommon side effects that may show up in blood
tests:

Reporting of side effects
If your child gets 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

• 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

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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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