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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

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.
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
Do not give Co-amoxiclav to your child if:

• 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
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 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).
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.

Pregnancy and breast-feeding

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

Co-amoxiclav contains aspartame (E951)

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

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

Use in 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 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

• Always shake the bottle well before each dose
• Use the measuring spoon provided to give the
suspension, preferably just before 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.

If your child stops taking Co-amoxiclav

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 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)
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)
• a widespread rash with blisters and peeling skin
or bleeding, 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)
• 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)
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 (overgrowth of non-susceptible organisms).
• crystals in urine (seen as cloudy urine or in a
urine test).

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

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, Herts, EN6 1TL.

Manufacturer:

Generics [UK] Limited, Potters Bar, Herts, EN6 1TL,
United Kingdom.

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.
This leaflet was last revised in
January 2015.

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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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