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

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Pharma: TBC

Dimensions: 140 x 315 mm

Proof # & Date: 14 07.12.11
PL: 04569/0460 & 0461

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(amoxicillin/clavulanic acid)

Read all of this leaflet carefully before you start
giving your child this medicine.
• 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 symptoms are the same as your child's.
• If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
1. What Co-Amoxiclav is and what it is used for.
2. Before you give Co-Amoxiclav.
3. How to give Co-Amoxiclav.
4. Possible side effects.
5. How to store Co-Amoxiclav.
6. Further 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 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.
2. BEFORE YOU GIVE CO-AMOXICLAV
Do not give your child Co-Amoxiclav:
• if they are allergic (hypersensitive) to amoxicillin,
clavulanic acid or any of the other ingredients of
Co-Amoxiclav (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
Do not give 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 Co-Amoxiclav.
Take special care with Co-Amoxiclav
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
If you are not sure if any of the above apply to your
child, talk to their doctor or pharmacist before giving
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.
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.
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 Co-Amoxiclav. This is because Co-Amoxiclav
can affect the results of these types of tests.
Using other medicines
Please 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.

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Customer

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(if applicable)

Change/Creation Reason: PUT & Article 30 amendments

CO-AMOXICLAV POWDER
FOR ORAL SUSPENSION
125/31.25 mg/5 ml and
250/62.5 mg/5 ml

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Quality
Assurance
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(if applicable)

Packed @: Sandoz

PACKAGE LEAFLET: INFORMATION FOR THE USER

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Technical
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PRO
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Braille

Supersedes: 301935

Proof Revision Reason: RTQ amendments

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Registration Officer
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Reg. Officer: Dmitry Obolskiy

Colours PMS:

Product: Co-Amoxiclav Suspension 250/62.5 & 125/31.25 mg
Code: 10001847

Marketing
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date

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Designer: Vikki Lusby

Customer: Mylan

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Batch/exp

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ARTWORK FOR SUBMISSION

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.
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.
Pregnancy and breast-feeding
If your child who is about to take this medicine is pregnant
or breast-feeding, please tell your doctor or pharmacist.
Ask your doctor or pharmacist for advice before taking
any medicine.
Important information about some of the
ingredients of Co-Amoxiclav
• Co-Amoxiclav contains aspartame (E951) which is a
source of phenylalanine. This may be harmful for
children born with a condition called 'phenylketonuria'.
3. HOW TO GIVE CO-AMOXICLAV
Always give Co-Amoxiclav exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
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 Co-Amoxiclav
you should give to your baby or child.
• You will be provided with a plastic measuring spoon.
You should use this to give the correct dose to your
baby or child.
• Usual dose-20 mg/5 mg to 60 mg/15 mg for
each kilogram of body weight a day, given in three
divided doses.
Your pharmacist will have prepared the suspension for
you.
Patients 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.
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 go
back to see the doctor.
If you give 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.
If you forget to give Co-Amoxiclav
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.
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.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

Mylan Design Department,
Albany Gate, Darkes Lane,
Potters Bar, Herts, EN6 1AG

4. POSSIBLE SIDE EFFECTS
Like all medicines, Co-Amoxiclav 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 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):
• 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 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.
Uncommon side effects that may show up in blood
tests:
• 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 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.
Rare side effects that may show up in blood tests:
• low number of cells involved in blood clotting
• low number of white blood cells.
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)
• 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).
Contact a doctor immediately if you get 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 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 or who have kidney problems)
• black tongue which looks hairy
• stained teeth (in children), usually removed by
brushing.

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 your child gets side effects
Tell your doctor or pharmacist if any of the side
effects become severe or troublesome, or if you notice
any side effects not listed in this leaflet.
5. HOW TO STORE CO-AMOXICLAV
Keep out of the reach and sight of children.
The medicine should only be used for up to 7 days
from the dispensing date stated on the label.
Do not use Co-Amoxiclav after the expiry date that is
stated on the carton after 'EXP'. The expiry date refers
to the last day of that month. Store in a refrigerator
(2-8°C). Do not freeze. Keep container tightly closed.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.
6. FURTHER INFORMATION
What Co-Amoxiclav contains
Co-Amoxiclav Powder for Oral Suspension is available
in two strengths (125/31.25 mg/5 ml and
250/62.5 mg/5 ml). The active ingredients 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,
trisodium citrate, aspartame, talc, guar galactomannan,
colloidal silicon dioxide, flavouring agents (lemon, peachapricot and orange containing essence of bergamot).
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.
Marketing Authorisation Holder and Manufacturer:
Mylan, Potters Bar, Herts, EN6 1TL, United Kingdom.
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 approved in: MM/YYYY

10001847

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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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