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CO-AMOXICLAV 400/57 MG/5 ML POWDER FOR ORAL SUSPENSION

Active substance(s): AMOXICILLIN TRIHYDRATE / CLAVULANIC ACID

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Co-amoxiclav 400/57 mg/5 ml Powder for Oral Suspension

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Amoxicillin/clavulanic acid

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 or
pharmacist.
• This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.
• 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.

What Co-amoxiclav is and what it is used for

Co-amoxiclav is used in adults 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.

Before you give Co-amoxiclav

Do not give your child Co-amoxiclav:
• if they are allergic (hypersensitive) to amoxicillin, clavulanic acid,
penicillin 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 your 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 childʼs 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
ʻConditions you need to look out forʼ in Section 4.

Instructions for reconstitution

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

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.

2.

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.

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

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.

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.

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At time of dispensing, the dry powder should be reconstituted to form
an oral suspension, as detailed below:
After opening the bottle remove the membrane carefully and
completely and discard before reconstituting the product. Fill the
bottle with water to just below the mark on the label and shake well

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 ʼphenylketonuriaʼ.
Co-amoxiclav contains glucose and sorbitol. If you have been told by
your doctor that you are intolerant to some sugars, contact your
doctor before taking this medicine.

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 and 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 childʼs bodyweight in
kilograms.
• Your doctor will advise you how much Co-amoxiclav you should
give to your baby or child.
• You may be provided with a plastic measuring spoon or syringe
doser. You should use this to give the correct dose to your baby
or child.
• Usual dose – 25 mg/3.6 mg to 45 mg/6.4 mg for each kilogram of
body weight a day, given in two divided doses.
• Higher dose – up to 70 mg/10 mg for each kilogram of body
weight a day, given in two divided doses.

Patients with kidney and liver problems
• If your child has kidney problems the dose might be changed. 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 check 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.
Continued on the next page >>

at once. Then add water exactly to the mark and shake vigorously
again.
Shake the bottle well before every withdrawal.

31.9 ml of water is added in order to get 35 ml prepared oral
suspension.

Continued on the next page >>

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.

4.

Possible side effects

Like all medicines, Co-amoxiclav can cause side effects, although
not everybody gets them.

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 your 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 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 and genitals (Stevens-Johnson
syndrome), and a more severe form, causing extensive peeling

45.5 ml of water is added in order to get 50 ml prepared oral
suspension.
54.6 ml of water is added in order to get 60 ml prepared oral
suspension.
63.7 ml of water is added in order to get 70 ml prepared oral
suspension.

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 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 childʼs 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 of 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 reconstituted suspension should be stored in a refrigerator
(2 - 8°C) and used within 7 days. Keep in the original container.
Keep the container tightly closed.

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

Medicines should be 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
The active substances are amoxicillin and clavulanic acid.
1 ml reconstituted suspension (corresponding to 0.160 g powder)
contains:
Amoxicillin trihydrate corresponding to 80 mg amoxicillin.
Potassium clavulanate corresponding to 11.4 mg clavulanic acid

Other ingredients are: Citric acid, Trisodium citrate, Aspartame
(E951), Talc, Guar galactomannan, Silicon dioxide, Lemon flavouring
(natural flavouring materials, nature-identical flavouring materials,
dextrose, maltodextrin, butylated hydroxyanisole E320, sorbitol syrup
E420, Acacia gum E414); Peach-apricot flavouring, (natural
flavouring materials, nature-identical flavouring materials,
maltodextrin, butylated hydroxyanisole E320, sorbitol syrup E420,
Acacia gum E414); Orange flavouring (nature-identical flavouring
materials, artificial flavouring substances, maltodextrin,
alpha-tocopherol E 307).

What Co-amoxiclav looks like and contents of the pack
The primary packaging materials consists of
Amber glass bottle (type III), 60 ml, 120 ml respectively 150 ml.
Screw closure with sealing membrane
graduated syringe (5 ml) for 60 ml bottles (for pack sizes of 35 ml,
50 ml, 60 ml suspension)
measuring spoon (5 ml) for 120 ml bottles (for pack sizes of 70 ml,
75 ml, 100 ml suspension) and 150 ml bottles (for a pack size of
140 ml suspension)

Original packs for preparing of 35, 50, 60, 70, 75, 100 and 140 ml
suspension. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorization Holder: Sandoz Ltd, Frimley Business
Park, Frimley, Camberley, Surrey, GU16 7SR, UK.
Manufacturer: Sandoz GmbH, Sandoz GmbH, Biochemiestrasse
10, 6250 Kundl, Austria.

This leaflet is last approved in 06/2010 (to be amended upon
approval)
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68.3 ml of water is added in order to get 75 ml prepared oral
suspension.
89.3 ml of water is added in order to get 100 ml prepared oral
suspension.
125.0 ml of water is added in order to get 140 ml prepared oral
suspension.

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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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