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

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

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135 mm

135 mm

Pharma Code

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 at:
www.mhra.gov.uk/yellowcard.

This medicinal product is authorised in the
Member States of the EEA under the following
names:
UK: Co-Amoxiclav 250-62.5mg/5ml Powder for
Oral Suspension
DE: Amoxicillin/Clavulansäure Micro Labs
250 mg /5 ml + 62,5 mg /5 ml Pulver zur
Herstellung einer Suspension zum Einnehmen

By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Co-Amoxiclav

This leaflet was last approved on 04/2017
Keep this medicine out of the sight and reach of
children.

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.

Dry powder
Store in the original package in order to protect from
moisture.
Do not store above 25°C.
Do not use this medicine after the expiry date which is
stated on the carton. The expiry date refers to the last
day of the month.
Liquid suspension
Store in a refrigerator (2°C - 8°C).
Do not freeze.

Bacteria can become resistant to antibiotics for
many reasons. Using antibiotics carefully can help
to reduce the chance of bacteria becoming resistant
to them.

Once made up, the suspension should be used within
7 days.

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 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.

6. Contents of the pack and other information
What Co-Amoxiclav contains
• The active substances are amoxicillin and
clavulanic acid. Each 5 ml of suspension contains
amoxicillin trihydrate equivalent to 250 mg
amoxicillin and potassium clavulanate equivalent
to 62.5 mg of clavulanic acid.
• The other ingredients are Silica, Colloidal
Hydrated, Aspartame (E951), Succinic acid,
Xanthan gum, Hypromellose, Colloidal anhydrous
silica, Strawberry guarana flavour (including
maltodextrin).
• See “Co-Amoxiclav contains aspartame” in
section 2.
What Co-Amoxiclav looks like and contents of the
pack
Co-Amoxiclav 250/62.5 mg/5 ml Oral Suspension is
a White to off-white granular powder supplied in a
translucent HDPE bottle with polypropylene cap.
Once made up, the bottle contains 100 ml of an offwhite liquid mixture called a suspension.

Co-Amoxiclav 250mg / 62.5mg / 5 ml powder for oral suspension
(Amoxicillin / clavulanic acid)
Read all of this leaflet carefully before you start
using 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 is 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.
• If you notice any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.

Do not use Co-Amoxiclav 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 CoAmoxiclav.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using
Co-Amoxiclav if your child:
• has glandular fever
• is being treated for liver or kidney problems
• is 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.

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

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 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, to
reduce the risk of any problems. See 'Conditions you
need to look out for' in section 4.

1. What Co-Amoxiclav is and what it is 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.

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. This is because Co-Amoxiclav can affect
the results of these types of tests.

Co-Amoxiclav 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.

Other medicines and Co-Amoxiclav
Tell your doctor or pharmacist if your child is using,
has recently used or might use any other medicines.
This includes medicines that can be bought without a
prescription and herbal medicines.

2. What you need to know before you use CoAmoxiclav

Marketing Authorisation Holder and
Manufacturer
Brown & Burk UK Ltd
5 Marryat Close,
Hounslow West
Middlesex, TW4 5DQ
United Kingdom
BBUK Code

Pharma Code

250 mm

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.

Package leaflet: Information for the user

Artwork Code

If your child is taking allopurinol (used for gout) with
Co-Amoxiclav, it may be more likely that they will have
an allergic skin reaction.

Do not use Co-Amoxiclav to your child:
• if they are allergic to amoxicillin, clavulanic acid,
penicillins or any of the other ingredients of this
medicine (listed in section 6)
• if they have ever had an allergic 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.

If your child is taking probenecid (used for gout), your
doctor may decide to adjust the 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.

Front Side
Size: 270 x 250 mm

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270 mm

Co-Amoxiclav can affect how methotrexate (a
medicine used to treat cancer or rheumatic diseases)
works.

go back to see the doctor.
If you use more Co-Amoxiclav than you should
If you give your child too much Co-Amoxiclav, 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.

Co-Amoxiclav 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.

If you forget to use Co-Amoxiclav
Do not give a double dose to make up for a forgotten
dose.
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.

Driving and using machines
Co-Amoxiclav can have side effects and the
symptoms may make you unfit to drive.
Do not drive or operate machinery unless you are
feeling well.

If your child stops taking Co-Amoxiclav
Keep giving your child Co-Amoxiclav 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.

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

Instructions for reconstitution
Check cap seal is intact before using.
Shake the bottle to loosen powder then fill the bottle
with water to just below the line on the bottle. Invert
and shake well, then top up with water exactly to the
line. Invert and again shake well.

250 mm

• Maltodextrin is absorbed as glucose. If you have
been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicinal product.
3. How to use Co-Amoxiclav

Shake the bottle well before each dose.

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

The tables below contains dosing information in mL
suspension dependent on the weight of the child (5 ml
= 250 mg Amoxicillin + clavulanic acid 62.5 mg):
Approximate Body Dosage based
age
weight 20 mg / 5 mg / kg /
(Kg) day to
40 mg / 10 mg / kg /
day
1-1.5 years 10-11 1.25 ml 3 times a
day to 2.5 ml 3 times
a day.
2-3 years 12-13 1.5 ml 3 times a
day to 3 ml 3 times
a day.
14-15 1.5 ml 3 times a
day to 4 ml 3 times
a day.
3-5 years 16-17 2 ml 3 times a day
to 4.5 ml 3 times a
day.
18-19 2 ml 3 times a day
to 5 ml 3 times a
day.
5-7 years
20-21 2.5 ml 3 times a
day to 5 ml 3 times
a day.
22-23 2.5 ml 3 times a
day to 6 ml 3 times
a day.
7-9 years
24-25 3 ml 3 times a day
to 6.5 ml 3 times a
day.
26-27 3 ml 3 times a day
to 7 ml 3 times a
day.
28-29 3.5 ml 3 times a
day to 7.5 ml
3 times a day.

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 CoAmoxiclav you should give to your baby or child.
• You may be provided with or without a measuring
syringe. You should use this to give the correct
dose to your baby or child.
• Recommended 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
• 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 for more than
2 weeks. If your child still feels unwell they should

2

Dosage based
60 mg / 15 mg /
kg / day

10-11 years 30-31 4 ml 3 times a day
to 8 ml 3 times a
day.
32-33 4 ml 3 times a day
to 8.5 ml 3 times a
day.
34-35 4.5 ml 3 times a
day to 9 ml 3 times
a day.
11-12 years 36-37 4.5 ml 3 times a
day to 9.5 ml
3 times a day.
38-39 5 ml 3 times a
day to 10 ml
3 times a day.

12-13 ml
3 times a
day
13-14 ml
3 times a
day
14 ml
3 times a
day

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

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).

Like all medicines, this medicine 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.

Inflammation of large intestine

8 ml
3 times a
day
8.5-9 ml
3 times a
day
9.5-10 ml
3 times a
day
10 ml
3 times a
day
11 ml 3 times
a day

Rare side effects that may show up in blood tests:
• low number of cells involved in blood clotting
• low number of white blood cells.

4 Possible side effects

*

7-7.5 ml
3 times a
day

Rare:
May affect up to 1 in 1,000 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.

* No clinical data is available for this dosage for
children less than 2 years.

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

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.

15 ml
3 times a
day

*

5-6 ml
3 times a
day
6-6.5 ml
3 times a
day







12 ml 3 times
a day

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

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:
May affect more than 1 in 10 people
• diarrhoea (in adults).
Common:
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

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.

If affected take Co-Amoxiclav before food
• vomiting
• diarrhoea (in children).
Uncommon:
May affect up to 1 in 100 people

Reporting of side effects
If your child gets any side effects talk to your doctor,

3

Expand Transcript

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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