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CO-AMOXICLAV 250 MG/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 patient

Co-amoxiclav 125 mg/31.25 mg/5 ml
powder for oral suspension
Co-amoxiclav 250 mg/62.5 mg/5 ml
powder for oral suspension
amoxicillin/clavulanic acid

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• 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 signs of illness are the same as your child’s.
• If your child gets any side effects talk to your doctor
or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
If you are an adult who has been given this medicine,
this information applies to you.
What is in this leaflet
1. What Co-amoxiclav is and what it is used for
2. What you need to know before you give
Co-amoxiclav
3. How to give Co-amoxiclav to your child
4. Possible side effects
5. How to store Co-amoxiclav
6. Contents of the pack and other information

Co-amoxiclav is used in adults, babies and children to
treat the following infections:
middle ear and sinus infections
• 
respiratory tract infections
• 
urinary tract and kidney infections
• 
skin and soft tissue infections including animal bites
• 
and dental infections
bone and joint infections.
• 
You must talk to a doctor if your child does not feel
better or if your child feels worse after 14 days.

2. What you need to know before you give
Co-amoxiclav
• your child is allergic to amoxicillin trihydrate,
clavulanic acid or any of the other ingredients of this
medicine listed in section 6.
your child is allergic to penicillin or any other antibiotic
• 
• your child has ever experienced liver problems
(e.g. jaundice) when taking an antibiotic

Warnings and precautions
Talk to your doctor or pharmacist before giving
Co-amoxiclav to your child if:
• your child has kidney or liver problems
• your child has glandular fever
your child is suffering from severe stomach upset
• 
with diarrhoea and vomiting
• your child has a serious blood disorder (lymphatic
leukemia)
• your child is not passing water regularly

Conditions you must look out for while you are
giving Co-amoxiclav
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. If your child experiences an allergic
reaction, your child must stop taking Co-amoxiclav and
your doctor will change the medicine.. See section 4.

Other medicines and Co-amoxiclav
Tell your doctor or pharmacist if your child is taking,
has recently taken or might take any other medicines,
including medicines obtained without a prescription
and herbal medicines, or the following:
• allopurinol (your child may have a higher risk of skin
reactions) or probenecid, to treat gout
• anticoagulants (medicine to help stop blood clots
such as warfarin); the tendency to bleed may
increase. Extra blood tests may be needed.
• other antibiotics e.g. erythromycin, oxytetracycline,
chloramphenicol, co-trimoxazole
• methotrexate (a medicine used to treat cancer or
rheumatic diseases)
• mycophenolate mofetil (a medicine used after an
organ transplant).

Affiliate Item Code 1335929
Superceded Affiliate Item Code 1303125
TrackWise PR No. 1335929
MA No.
Packing Site/Printer

PL04569/0460,
PL 04569/0462
Sandoz Pharmaceuticals
GmbH (Holzkirchen - DE)

Supplier Code TBC

No. of colours

SAP No. N/A

Colours

Vendor Job No. 505118
Trackwise Proof No. 1
Client Market United Kingdom
Keyline/Drawing No pm459e

1

Amoxicillin and clavulanic acid may pass into breast
milk. If you breast-feed while taking this medicine,
the baby may be more likely to get diarrhoea or an
infection. If this happens, you may need to stop breastfeeding. You should only use Co-amoxiclav whilst
breast-feeding if your doctor tells you to.

Co-amoxiclav contains aspartame (E951)

If you have been told by your doctor that your child
has an intolerance to some sugars, contact your doctor
before taking this medicine.

Driving and using machines
Co-amoxiclav can have side effects such as allergic
reactions, dizziness or fits that may make you unfit to
perform activities such as driving, riding bikes or using
machinery.
Do not drive, ride a bike or use machinery unless you are
feeling well.

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

Use in 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:
• The recommended daily dose is one 500 mg/125 mg
dose taken three times daily.
All doses are worked out depending on the child’s
bodyweight in kilograms:
• Your doctor will advise you how much
Co-amoxiclav you should give to your baby or child
and how often.
• You will be provided with a plastic measuring spoon.
You should use this to give the correct dose to your
baby or child.
• The recommended dose is 20 mg/5 mg to
60 mg/15 mg for each kilogram of body weight a day,
given in three divided doses.
Do not give more than the dose your doctor has
recommended.

How to give Co-amoxiclav:

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.

Pharma Code TBC

You should only use Co-amoxiclav whilst pregnant if
your doctor tells you to. This medicine may be harmful
to the baby.

Use in children weighing less than 40 kg

Do not give Co-amoxiclav to your child if:

Component Type Leaflet

This formulation of the medicine is usually given to
children, but 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.

Co-amoxiclav contains dextrose, maltodextrin
(glucose) and sorbitol.

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.

Date: 13 Oct 17

Pregnancy and breast-feeding

Aspartame is a source of phenylalanine. This may
be harmful for children born with a condition called
’phenylketonuria’.

1. What Co-amoxiclav is and what it is used for

Description Co-amoxiclav_250 mg_62.5 mg_125 mg_31.25 mg_100 ml

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 (for glucose), let the doctor or nurse
know that they are taking Co-amoxiclav. This is because
Co-amoxiclav can affect the results of these types
of tests.

• Always shake the bottle well before each dose
• Use the measuring spoon provided to give the
suspension
• Give with a meal
• Space the doses evenly throughout the day, at least
4 hours apart. For example, if you have been told to
give Co-amoxiclav three times a day:
* give the first dose just before breakfast
* give the next dose just before lunch
* give the last dose just before dinner.
• 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.
Your pharmacist will have prepared the suspension for you.

Children with kidney or 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.

If you give more Co-amoxiclav than you should
Contact your doctor or nearest hospital emergency
department immediately. Take the bottle and any
remaining suspension with you. Signs of overdose
might include an upset stomach (feeling sick, being sick
or diarrhoea) or convulsions (fits).

If you forget to give Co-amoxiclav
Give the next dose as soon as you remember unless it is
almost time for your child’s next dose. Do not give your
child a double dose to make up for a forgotten dose,
wait about 4 hours before giving the next dose.

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If your child stops taking Co-amoxiclav

Reporting of side effects

Keep giving your child this medicine until the course is
finished. Do not stop just because he/she feels better. If
you stop too soon the infection may come back again.

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
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.

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

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.

Stop taking Co-amoxiclav and tell your doctor
immediately or go to your nearest hospital
emergency department if you notice any of the
following:
Rare (may affect up to 1 in 1,000 people):
• frequent infections causing fever, severe chills, sore
throat or mouth ulcers (these may be signs of a low
number of white blood cells)
Frequency not known (cannot be estimated from the
available data):
• signs of a serious allergic reaction which can include:
* sudden itching, red skin rash or swelling of
the face, lips, tongue, throat or neck, difficulty
breathing or swallowing.
* 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.
• tiredness, headaches, shortness of breath when
exercising, dizziness, pale or yellowing of the skin or
eyes (haemolytic anaemia)
• sensitivity to light, stiff neck, body aches, sore throat,
severe headache, flu-like symptoms (these may
indicate you have a type of meningitis that can’t be
passed on to others)
• diarrhoea, possibly with blood or mucus, stomach pain
or fever (these may be signs of an inflamed intestine)
• yellowing of the skin or whites of the eyes, dark
urine, pale stools, tiredness, fever, nausea, weakness,
drowsiness and abdominal pain, with blood test
results showing abnormal liver function (these may
be signs of serious problems with your liver)
• 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))
• pain passing urine, lower back pain or fever (these
may be signs of a serious kidney problem (interstitial
nephritis)
• fits (especially if your child takes high doses of
Co-amoxiclav or if your child has kidney problems)

Other side effects:
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 if your child takes
high doses
• being sick (vomiting)
Uncommon (may affect up to 1 in 100 people):
• indigestion
• dizziness
• headache.
• increase in some substances (enzymes) produced by
the liver (detected by a blood test)
Rare (may affect up to 1 in 1,000 people):
• unexplained bruising or bleeding more easily than
normal (these may be signs of a low number of cells
involved in blood clotting)
Frequency not known (cannot be estimated from the
available data):
• hyperactivity
• black tongue which looks hairy
• stained teeth (in children), usually removed by
brushing.
• other infections that are difficult to treat (over-growth
of non-susceptible organisms).
• crystals in urine (seen as cloudy urine or in a urine test).

5. How to store Co-amoxiclav
Keep this medicine out of the sight and reach of children.
The medicine should only be used for up to 7 days from the
dispensing date stated on the label after “Dispensing date”.
Do not use this medicine after the expiry date which is
stated on the carton after “EXP”. The expiry date refers to the
last day of that month.
Store in a refrigerator (2°C to 8°C). Do not freeze. Keep the
bottle tightly closed.
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.

6. Contents of the pack and other information
What Co-amoxiclav contains
Co-amoxiclav is available in two strengths
(125 mg/31.25 mg/ 5 ml and 250 mg/62.5 mg/5 ml). The
active substances are amoxicillin trihydrate (corresponding
to 125 mg or 250 mg amoxicillin) and potassium clavulanate
(corresponding to 31.25 mg or 62.5 mg clavulanic acid).
The other ingredients are anhydrous citric acid, sodium
citrate, aspartame (see section 2 ‘Co-amoxiclav contains
aspartame’), talc, guar galactomannan, colloidal anhydrous
silica, flavouring agents (lemon containing dextrose
and maltodextrin (glucose), peach-apricot containing
maltodextrin (glucose) and sorbitol (E420) and orange
containing essence of bergamot and maltodextrin
(glucose)).

What Co-amoxiclav looks like and contents of
the pack
Co-amoxiclav powder for oral suspension is off-white in
colour with a fruity flavour.
Co-amoxiclav powder for oral suspension comes in a bottle
containing 100 ml of suspension with a child proof screw cap
and a plastic measuring spoon.

Marketing Authorisation Holder
Mylan,
Potters Bar, EN6 1TL,
United Kingdom.

Manufacturers:
Generics [UK] Limited,
Station Close,
Potters Bar,
EN6 1TL,
United Kingdom.
Sandoz GmbH,
Biochemiestrasse 10,
A-6250 Kundl,
Tyrol,
Austria
This leaflet was last revised in
October 2017

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

1335929

Description Co-amoxiclav_250 mg_62.5 mg_125 mg_31.25 mg_100 ml
Component Type Leaflet
Affiliate Item Code 1335929
Superceded Affiliate Item Code 1303125
TrackWise PR No. 1335929
MA No.
Packing Site/Printer

PL04569/0460,
PL 04569/0462
Sandoz Pharmaceuticals
GmbH (Holzkirchen - DE)

Supplier Code TBC

Date: 13 Oct 17

Pharma Code TBC

No. of colours

SAP No. N/A

Colours

Vendor Job No. 505118
Trackwise Proof No. 1
Client Market United Kingdom
Keyline/Drawing No pm459e

1

Time: 11:53
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with

Barcode Info. N/A

Main Font

3D Render ID N/A

Dimensions

Myriad Pro
175 x 400 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v3/Jul 2017

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Further information

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