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AMOCLAN 125 MG/31.25 MG/5 ML POWDER FOR ORAL SUSPENSION
Active substance(s): AMOXICILLIN TRIHYDRATE / CLAVULANIC ACID / AMOXICILLIN TRIHYDRATE / CLAVULANIC ACID / AMOXICILLIN TRIHYDRATE / CLAVULANIC ACID
powder for sugar free oral suspension
Amoxicillin / Clavulanic acid
Read all of this leaflet carefully before you start giving your child this
• 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
• 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. See section 4.
In this leaflet:
1. What Amoclan 125 mg/31.25 mg/5 ml powder for oral suspension is and
what it is used for
2. What you need to know before you take Amoclan
3. How to give this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
1. WHAT AMOCLAN 125MG/ 31.25 MG/5 ML POWDER FOR
ORAL SUSPENSION IS AND WHAT IT IS USED FOR
Amoclan 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.
Amoclan 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMOCLAN
Do not give your child this medicine:
• if they are allergic (hypersensitive) to amoxicillin, clavulanic acid or any of the
other ingredients of this medicine (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.
gDo not give this medicine 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 this
Take special care with this medicine:
Check with their doctor or pharmacist before giving your child this medicine if
• 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 this medicine.
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 this medicine or a different medicine.
Conditions you need to look out for
This medicine 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 this medicine, to reduce the risk of any problems. See ‘Conditions you
need to look out for’ in Section 4.
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
this medicine. This is because this medicine 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 this medicine, 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 this medicine.
• If medicines to help stop blood clots (such as warfarin) are taken with this
medicine then extra blood tests may be needed.
This medicine 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 in this medicine
Each 5 ml of suspension contains Potassium and Sodium. Therefore,
this medicine may not be suitable for your child if he/she is on a controlled
potassium diet, controlled sodium diet or if he/she has reduced kidney function.
Check with your doctor if you are unsure about this.
This medicine also contains small amounts of ethanol (alcohol), less than 100
mg per 5 ml.
3. HOW TO GIVE THIS MEDICINE
Always give this medicine 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 Amoclan you should give to your baby
• 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 this medicine
• 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 this medicine for more than 2 weeks. If your child still
feels unwell they should go back to see the doctor.
If you give more of this medicine than you should
If you give your child too much of this medicine, 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 this medicine
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 this medicine
Keep giving your child this medicine 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.
Section 3 continued
If you have any further questions on the use of this product, ask your doctor
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
gContact a doctor immediately if your child gets any of these
symptoms. Stop taking this medicine.
• Inflammation of large intestine
Inflammation of the large intestine, causing watery diarrhoea usually with
blood and mucus, stomach pain and/or fever.
• 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
- a red, scaly rash with bumps under the skin and blisters (exanthemous
gContact 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
• 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
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
gif affected take this medicine before food
• diarrhoea (in children)
Uncommon side effects
These may affect up to 1 in 100 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 – erythema
gif 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.
• blood takes longer to clot
• convulsions (in people taking high doses of this medicine or who have
• 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
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more information on the safety of this
5. HOW TO STORE THIS MEDICINE
Store the reconstituted suspension at 2°C-8°C. Do not freeze.
Discard any unused suspension after 7 days.
Store in the original container. Keep the container tightly closed.
Keep out of the reach and sight of children.
Do not use this medicine 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What this medicine contains
• The active substances are: amoxicillin (as trihydrate) 125 mg; clavulanic
acid (as potassium clavulanate) 31.25 mg.
• The other ingredients are xantham gum, succinic acid, colloidal silicon
dioxide, sodium saccharin, hydroxypropyl methyl cellulose, strawberry
powder flavour (containing benzyl alcohol and ethanol), orange powder
flavour, lemon powder flavour, silicon dioxide.
What this medicine looks like and contents of the pack
When prepared as directed this medicine is an off-white suspension with a
fruity flavour. It comes in a 125 ml amber glass bottle with a white aluminium
Marketing Authorisation Holder & Manufacturer
Hikma Farmaceutica (Portugal) S.A., Estrada do Rio da Mo, Nº8, 8A e 8B,
Fervença, 2705-906 Terrugem SNT, Portugal.
This leaflet was last approved in 06/2015
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
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
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
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
Instructions for reconstitution
Check cap seal is intact before using. Shake bottle to loosen powder. Add
volume of water (as indicated below) invert and shake well.
125 mg/31.25 mg/5 ml
Volume of water to be
added At reconstitution
At reconstitution (ml)
Shake the bottle well before each dose.
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.