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CO-AMOXICLAV 125/31.25MG / 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

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 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 125-31.25mg/5ml Powder for
Oral Suspension
DE: Amoxicillin/Clavulansäure Micro Labs
125 mg /5 ml + 31,25 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.

This leaflet was last approved on 04/2017.
5. How to store Co-Amoxiclav

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 that month.

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

Liquid suspension
Store in a refrigerator (2°C - 8°C).
Do not freeze.

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.

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

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 125 mg
amoxicillin and potassium clavulanate equivalent
to 31.25 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 125/31.25/5ml 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.



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.

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 the
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 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.

Blood and 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.
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
Co-Amoxiclav

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

BBUK Code

Artwork Code

Do not use Co-Amoxiclav to your child:
• if they are allergic (hypersensitive) to amoxicillin,
clavulanic acid, penicillins or any of the other
ingredients of Co-Amoxiclav (listed in section 6)
• if they have ever had a severe allergic reaction to
any other antibiotic. This can include a skin rash
or swelling of the face or neck

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.
If your child is taking probenecid (used for gout),
your doctor may decide to adjust the dose of
Co-Amoxiclav.

Front Side
Size: 270 x 250 mm

4

if they have ever had liver problems or jaundice
(yellowing of the skin) when taking an antibiotic.

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.

Pharma Code

250 mm

Co-Amoxiclav 125mg / 31.25mg / 5ml powder for oral suspension
(Amoxicillin / Clavulanic acid)

Advice / medical education

Keep this medicine out of the sight and reach of
children.

Package leaflet: Information for the user

1

270 mm

If medicines to help stop blood clots (such as
warfarin) are taken with Co-Amoxiclav then extra
blood tests may be needed.





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

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.

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 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 contains aspartame (E951) and
maltodextrin
• 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
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.



250 mm

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 go back to see the doctor.

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

Instructions for reconstitution
Check the cap seal is intact before using.
Shake 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.

3. How to use Co-Amoxiclav
Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

Shake the bottle well before each dose.
The tables below contains dosing information in mL
suspension dependent on the weight of the child (5 ml
= 125 mg Amoxicillin + clavulanic acid 31.25 mg):

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.

Approximate Body
age
weight
(Kg)

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.

6-7
6-12
Months

12-18
Months

8-9
10-11

12-13

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.

2-3 years

How to give Co-Amoxiclav
• Always shake the bottle well before each dose

14-15

Dosage based
20 mg / 5 mg /
kg / day to
40 mg / 10 mg /
kg / day

Dosage
based
60 mg /
15 mg / kg /
day

1.5 ml 3 times *
a day to 3.5 ml
3 times a day.
2 ml 3 times a *
day to 4.5 ml
3 times a day.
2.5 ml 3 times *
a day to 5 ml
3 times a day.
3 ml 3 times a
day to 6.5 ml
3 times a day.
3 ml 3 times a
day to 8 ml
3 times a day.

*

11-12 ml
3 times a
day.

16-17
3-5 years

18-19

20-21

5-7 years

22-23

4 ml 3 times
a day to 9 ml
3 times a day.
4.5 ml 3 times
a day to 10 ml
3 times a day.







12-13 ml
3 times a
day.
14-15 ml
3 times a
day.

Uncommon side effects that may show up in blood
tests:
• increase in some substances (enzymes)
produced by the liver.

5 ml 3 times a **
day to 11 ml
3 times a
day. **
5-6 ml 3 times **
a day to 12 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.
** A presentation with higher potency is available for
this dosage.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.

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

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.
Contact a doctor immediately if your child gets any
of these symptoms. Stop taking Co-Amoxiclav.
Inflammation of large intestine
Inflammation of the large intestine, causing watery
diarrhoea usually with blood and mucus, stomach
pain and/or fever.

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.

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

2

skin rash, itching
raised itchy rash (hives)
indigestion
dizziness
headache

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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