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CO-AMOXICLAV 500MG/100MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): AMOXICILLIN / AMOXICILLIN SODIUM / CLAVULANATE POTASSIUM / CLAVULANIC ACID / POTASSIUM CLAVULANATE

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620 mm
120 mm

Pharma Code (top to bottom

on the front face when reading the
text design right way up):

UNKNOWN

3rd Party Code: UNKNOWN

Co-amoxiclav 500 mg/100 mg
or 1000 mg/200 mg powder for solution
for injection or infusion
(Amoxicillin/clavulanic acid)
PACKAGE LEAFLET: INFORMATION FOR THE USER

4. Possible side effects
5. How to store Co-amoxiclav
6. Further information

1

WHAT CO-AMOXICLAV IS AND WHAT IT
IS USED FOR

Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor, pharmacist or nurse.
• If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor, pharmacist or nurse.

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 500 mg/100 mg powder for solution
for injection or infusion and Co-amoxiclav
1000 mg/200 mg powder for solution for injection
or infusion will both be referred to as Co-amoxiclav
in the rest of this leaflet.

Co-amoxiclav is used in adults and children to treat
the following infections:
• severe ear, nose and throat infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections including dental
infections
• bone and joint infections
• intra-abdominal infections
• genital organ infections in women.

IN THIS LEAFLET:
1. What Co-amoxiclav is and what it is used for
2. Before you take Co-amoxiclav
3. How to take Co-amoxiclav

Co-amoxiclav should be administered within 20 min of
reconstitution.
Preparation of solutions for intravenous infusion
Co-amoxiclav vials are not suitable for multi-dose use.
500 mg/100 mg powder for solution for injection or
infusion
Co-amoxiclav should be reconstituted as described above for
injection. Without delay the reconstituted solution should be
added to 50 ml of infusion fluid using a minibag or in-line
burette.
1000 mg/200 mg powder for solution for injection or
infusion
Co-amoxiclav should be reconstituted as described above for
injection. Without delay the reconstituted solution should be
added to 100 ml of infusion fluid using a minibag or in-line
burette.
Stability of prepared solutions
From a microbiological point of view, the product should be
used immediately after reconstitution. If not used
immediately, in-use storage times and conditions prior to use
are the responsibility of the user.
Solutions for injection, prepared as indicated in Section 6.6,
should be administered within 20 minutes of reconstitution.
Solutions for infusion should be completed within the times
stated in section 6.6 (see individual infusion fluids in
section 6.6).

• If you have liver problems your doctor will keep a
close check on you and you may have more
regular liver function tests.
How Co-amoxiclav will be given to you
• Co-amoxiclav will be given as an injection into a
vein or by intravenous infusion.
• Make sure you drink plenty of fluids while having
Co-amoxiclav.
• You will not normally be given Co-amoxiclav for
longer than 2 weeks without the doctor
reviewing your treatment.
If more Co-amoxiclav is given to you than
recommended
It is unlikely you will be given too much, but if you
think you have been given too much Co-amoxiclav,
tell your doctor, pharmacist or nurse immediately.
Signs may be an upset stomach (feeling sick, being
sick or diarrhoea) or convulsions.
If you have any further questions about how this
product is given, ask your doctor, pharmacist or
nurse.

Co-amoxiclav is used in adults and children to
prevent infections associated with major surgical
procedures.

2

BEFORE YOU TAKE CO-AMOXICLAV

You should not have Co-amoxiclav:
• if you are allergic (hypersensitive) to amoxicillin,
clavulanic acid, penicillin or any of the other
ingredients of Co-amoxiclav (listed in section 6)
• if you 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 you have ever had liver problems or jaundice
(yellowing of the skin) when taking an antibiotic.
Do not take Co-amoxiclav if any of the above
apply to you.
If you are not sure, talk to your doctor, pharmacist
or nurse before having Co-amoxiclav.
Take special care with Co-amoxiclav
Talk to your doctor, pharmacist or nurse before
taking this medicine if you:
• have glandular fever

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.

• 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 you,
talk to your doctor, pharmacist or nurse before
taking Co-amoxiclav.
In some cases, your doctor may investigate the type
of bacteria that is causing your infection.
Depending on the results, you 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 you are 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 you are 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 you are
taking Co-amoxiclav. This is because Co-amoxiclav
can affect the results of these types of tests.

Contact your doctor as soon as possible for
advice if you get these symptoms.
Common side effects
These may affect up to 1 in 10 people
• thrush (candida - a yeast infection of the vagina,
mouth or skin folds)
• diarrhoea

Contact a doctor immediately if you get any of
these symptoms. Stop taking Co-amoxiclav.

Uncommon side effects
These may affect up to 1 in 100 people
• skin rash, itching
• raised itchy rash (hives)
• feeling sick (nausea), especially when taking high
doses
• if affected take Co-amoxiclav before food
• vomiting
• indigestion
• dizziness
• headache.

Inflammation of large intestine
Inflammation of the large intestine, causing watery
diarrhoea usually with blood and mucus, stomach
pain and/or fever.

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

Using other medicines
Please tell your doctor, pharmacist or nurse if you
are using or have recently used any other
medicines. This includes medicines that can be
bought without a prescription and herbal
medicines.
If you are taking allopurinol (used for gout) with
Co-amoxiclav, it may be more likely that you’ll have
an allergic skin reaction.
If you are taking probenecid (used for gout), your
doctor may decide to adjust your 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
Ask your doctor, pharmacist or nurse for advice if
you are pregnant or breast-feeding.

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.
• swelling and redness along a vein which is
extremely tender when touched.
Rare side effects that may show up in your 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

Important information about some of the
ingredients of Co-amoxiclav
500 mg/100 mg powder for injection or infusion
• contains approximately 31.4 mg (1.4 mmol) of
sodium. This should be considered if you are on a
controlled sodium diet.
• contains approximately 19.6 mg (0.5 mmol) of
potassium. This should be considered by patients
with kidney problems or patients on a controlled
potassium diet.
1000 mg/200 mg powder for injection or infusion
• contains approximately 62.9 mg (2.7 mmol) of
sodium. This should be considered if you are on a
controlled sodium diet.
• contains approximately 39.3 mg (1.0 mmol) of
potassium. This should be considered by patients
with kidney problems or patients on a controlled
potassium diet.

3 HOW TO TAKE CO-AMOXICLAV
You will never give yourself this medicine. A
qualified person, like a doctor or a nurse, will give
you this medicine.
The usual doses are:
Adults and children weighing 40 kg and over

Standard dose

1000 mg/200 mg every 8 hours.

To stop
infections
during and
after surgery

1000 mg/200 mg before the
surgery when you are given your
anaesthetic.

Children weighing less than 40 kg
• All doses are worked out depending on the
child’s bodyweight in kilograms.
Children aged
3 months and
over:

• 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
• convulsions (in people taking high doses of
Co-amoxiclav or who have kidney problems).
Side effects that may show up in your blood or
urine tests:
• severe reduction in the number of white blood cells

25 mg/5 mg for each
kilogram of bodyweight
every 8 hours.

Children aged less than
25 mg/5 mg for each
3 months or weighing less kilogram of bodyweight
than 4 kg
every 12 hours.
Patients with kidney and liver problems
• If you have kidney problems you may be given a
different dose. A different strength or a different
medicine may be chosen by your doctor.

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.

The dose can differ depending on
the type of operation you are
having. Your doctor may repeat
the dose if your surgery takes
longer than 1 hour.

• low number of red blood cells (haemolytic
anaemia)
• crystals in urine.
If you get 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

The following information is intended for medical or
healthcare professionals only:
Please refer to the Summary of Product Characteristics
for further information

Administration
Co-amoxiclav may be administered either by slow
intravenous injection over a period of 3 to 4 min directly into
a vein or via a drip tube or by infusion over 30 to 40 min.
Co-amoxiclav is not suitable for intramuscular administration.

Reconstitution
Preparation of solutions for intravenous injection
500 mg/100 mg powder for solution for injection or
infusion
Water for Injection Ph.Eur. is the normal solvent.
Co-amoxiclav 500/100 mg should be dissolved in 10 ml of
solvent. This yields approximately 10.5 ml of solution for
single-dose use. A transient pink colouration may or may not
develop during reconstitution. Reconstituted solutions are
normally colourless or a pale straw colour.
1000 mg/200 mg powder for solution for injection or
infusion
Water for Injection Ph.Eur. is the normal solvent.
Co-amoxiclav 1000 mg/200 mg should be dissolved in 20 ml
of solvent. This yields approximately 20.9 ml of solution for
single-dose use. A transient pink colouration may or may not
develop during reconstitution. Reconstituted solutions are
normally colourless or a pale straw colour.

6

FURTHER INFORMATION

What Co-amoxiclav contains
• The active substances are amoxicillin 500 mg or
1000 mg (as sodium) and clavulanic acid 100 mg
or 200 mg (as potassium).
• There are no other ingredients.
What Co-amoxiclav looks like and contents of
the pack
Co-amoxiclav comes in clear glass vials. Available in
packs of 10 vials.

You will not be asked to store your medicine. It will
be brought to you ready to be administered straight
away. It will be stored below 30°C and kept in the
outer carton.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
TEVA UK Limited, Eastbourne, BN22 9AG.

Keep out of the reach and sight of children

Manufacturer:
Reig Jofre S.A., C/Gran Capitan, 10, 08970-Sant Joan
Despi, Barcelona, Spain.

Do not use Co-amoxiclav after the expiry date
which is stated on the carton. The expiry date refers
to the last day of that month.
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.

The leaflet was last revised in February 2011.
PL 00289/1571-2
21050-B

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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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