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

Active substance(s): AMOXICILLIN TRIHYDRATE / CLAVULANIC ACID / AMOXICILLIN TRIHYDRATE / CLAVULANIC ACID

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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

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Amoxicillin/clavulanic acid

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.

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 has been prescribed for you only. Do not pass
it on to others. It may harm them, even if their signs of illness
are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet
(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.

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 your dose of Co-amoxiclav.

What is in this leaflet:
1. What Co-amoxiclav is and what it is used for
2. What you need to know before you take Co-amoxiclav
3. How to take Co-amoxiclav
4. Possible side effects
5. How to store Co-amoxiclav
6. Contents of the pack and other information

1.

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.

Co-amoxiclav may affect how mycophenolate mofetil (a medicine
used to prevent the rejection of transplanted organs) works.

Pregnancy and breast-feeding:
If your child who is about to take this medicine is pregnant or
breast-feeding, think they may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this
medicine.

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 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.

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.

2.

3.

How to give Co-amoxiclav

Always give this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist, if you are not sure.

What you need to know before you give
Co-amoxiclav

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.

Do not give your child Co-amoxiclav:
• if they are allergic to amoxicillin, clavulanic acid, penicillin or any
of the other ingredients of this medicine (listed in section 6)
• if they have ever had a severe allergic 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.

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.

Warnings and precautions:
Talk to your 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.

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.

Continued on the next page >>

Instructions for reconstitution

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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

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 >>

Artwork Proof Box
draft no.: 982530/4
laetus code: 00
mat.no.: 00000000

Ref: V047: SPC+PIL update in line with reference + Nat Phase
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Date prepared:
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Colours:
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Dimensions: 175 x 315 mm

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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.

• 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

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 medicine, ask
your doctor or pharmacist.

4.

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.

Possible side effects

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
(www.mhra.gov.uk/yellowcard). By reporting side effects you can
help provide more information on the safety of this medicine.

Like all medicines, this medicine 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.

5.

How to store Co-amoxiclav

Keep this medicine out of the sight and reach 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.

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.

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.

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.

Very common side effects (may affect more than 1 in 10 people)
• diarrhoea (in adults).

6.

Common side effects (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).

Contents of the pack and other 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

Uncommon side effects (may affect up to 1 in 100 people)
• skin rash, itching
• raised itchy rash (hives)
• indigestion
• dizziness
• headache.

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).

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

Rare side effects (may affect up to 1 in 1,000 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.

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)

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

Frequency not known (frequency cannot be estimated from the
available data)
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)
• Inflammation of the protective membrane surrounding the brain
(aseptic meningitis)
• 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)

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 was last revised in 02/2015.

Contact a doctor immediately if your child gets any of these
symptoms.

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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.

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.
SZ00000LT000

Artwork Proof Box
draft no.: 982530/4
laetus code: 00
mat.no.: 00000000

Ref: V047: SPC+PIL update in line with reference + Nat Phase
Proof no.
006.1

Date prepared:
19/02/2015

Colours:
Black
Dimensions: 175 x 315 mm

Font size:
7pt
Fonts:
Helvetica

00000000

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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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