CO-AMOXICLAV 250MG/ 62.5MG/ 5ML POWDER FOR ORAL SUSPENSION
Active substance(s): AMOXICILLIN TRIHYDRATE / POTASSIUM CLAVULANATE / AMOXICILLIN TRIHYDRATE / POTASSIUM CLAVULANATE / AMOXICILLIN TRIHYDRATE / POTASSIUM CLAVULANATE
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
- a red, scaly rash with bumps under the skin and blisters (exanthemous
Contact a doctor immediately if your child gets any of these
• inflammation of the liver (hepatitis)
• jaundice, caused by increases in the blood of bilirubin (a substance
produced in the liver) which may make your child’s 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
• black tongue which looks hairy
• stained teeth (in children), usually removed by brushing.
Sideffects 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 anemia)
• 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 250mg/62.5mg/5ml ORAL
Keep out of sight and reach of children.
Do not use Co-Amoxiclav after the expiry date which is stated on the carton.
The expiry date refers to the last day of the month.
Powder for suspension: Do not store above 25°C. Keep the bottle tightly
Reconstituted suspension: Store in refrigerator at 2-8°C. Do not freeze.
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 Oral Suspension contains
• The active substances are amoxicillin 250mg and clavulanic acid 62.5 mg
(present as Potassium Clavunate) in every 5 ml of suspension. Both of
these ingredients are antibiotics and together they are known as
• The other ingredients are: xanthan gum (E415), aspartame (E951),
silicon dioxide (E551), colloidal silica, anhydrous citric acid,
hypromellose, golden syrup, orange and raspberry flavours.
What Co-Amoxiclav Oral Suspension looks like and the contents of
• When the powder has been reconstituted, Co-amoxiclov Oral suspension
contains 250 mg of amoxicillin (as trihydrate) and 62.5 mg clavulanic
acid (as potassium salt), per 5 ml.
• Co-Amoxiclav Oral Suspension comes in a bottle containing 100 ml of an
off-white liquid mixture called a suspension.
Pack size is a bottle containing 100 ml
PL No.: 21880/0010
Co-Amoxiclav 250mg/62.5mg/5ml Powder for Oral Suspension
Amoxicillin and Clavulanic Acid
Read all of this leaflet carefully before giving your child this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask you doctor or pharmacist.
• This medicine has been prescribed for your 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 250mg/62.5mg/5ml Oral Suspension is and
what it is used for
2. Before you give Co-Amoxiclav 250mg/62.5mg/5ml Oral
3. How to give Co-Amoxiclav 250mg/62.5mg/5ml Oral Suspension
4. Possible side effects
5. How to store Co-Amoxiclav 250mg/62.5mg/5ml Oral Suspension
6. Further information
1. WHAT CO-AMOXICLAV 250mg/62.5mg/5ml ORAL SUSPENSION
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
• 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 250mg/62.5mg/5ml ORAL
Do not give your child Co-Amoxiclav 250mg/62.5mg/5ml Oral
• 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 250mg/62.5mg/5ml Oral Suspension 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 250mg/62.5mg/5ml Oral
Check with their doctor or pharmacist before giving your child this medicine
• 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.
Date of leaflet preparation: December 2012
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK
E-mail : firstname.lastname@example.org
PACKAGE LEAFLET - INFORMATION FOR THE USER
Blood or 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.
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 you are pregnant, you think you might be pregnant or if you are
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 250mg/62.5mg/5ml Oral Suspension
• Co-Amoxiclav contains aspartame (E951) which is a source of
phenylalanine. This may be harmful for children born with a condition
3. HOW TO GIVE CO-AMOXICLAV 250mg/62.5mg/5ml ORAL
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 may be provided with a plastic measuring spoon or measuring cup.
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.
Patients with kidney and 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 250mg/62.5mg/5ml Oral Suspension
• 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 250mg/62.5mg/5ml Oral Suspension
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 250mg/62.5mg/5ml Oral
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 250mg/62.5mg/5ml Oral
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
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
Conditions you need to look out for
• 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
Contact a doctor immediately if your child gets any of these symptoms.
Stop taking Co-Amoxiclav 250mg/62.5mg/5ml Oral Suspension.
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
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
• diarrhoea (in children).
Uncommon side effects
These may affect up to 1 in 10 people
• skin rash, itching
• raised itchy rash (hives)
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 –
• 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:
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.