• Inflammation of the large bowel (colon) with diarrhoea sometimes containing blood (which may be
associated with pseudomembraneous colitis and haemorrhagic colitis), pain and fever
• a yeast infection of the nails, skin, mouth, vagina, stomach, urinary tract and other mucocutaneous
parts of the body (mucocutaneous candidiasis)
• kidney problems (interstitial nephritis)
• fits (convulsions), seen in patients on high doses or with kidney problems
• dizziness
• hyperactivity (hyperkinesias)
• crystals in the urine (crystalluria), which may be seen as cloudy urine, or difficulty or discomfort in
passing urine. Make sure your child drinks plenty of fluids to reduce the chance of these symptoms
• teeth may appear stained, usually returning to normal with brushing (this has been reported in
children)
• the tongue may change to yellow, brown or black and it may have a hairy appearance
• an excessive breakdown of red blood cells causing a form of anaemia. Signs include: tiredness,
headaches, shortness of breath, dizziness, looking pale and yellowing of the skin and the whites of the
eyes (jaundice)
• itchy skin (erythema multiforme, Steven-Johnson syndrome, toxic epidermal necrolysis)
• skin blisters (bullous dermatitis)
• scaling of the skin (exfoliative dermatitis)
• skin rash (acute generalised exanthematous pustulosis)
• the blood may take longer to clot than it normally would. You may notice this if your child has a
nosebleed or cuts them self.
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 HPRA Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.
By reporting side effects you can help provide more information on the safety of this medicine.”
5 How to store Amoxil
• Keep this medicine out of the sight and reach of children.
• Do not use after the expiry date which is stated on the carton and label after ‘EXP’. The expiry date
refers to the last day of that month.
• The expiry date which is stated on the carton and label is for the pharmacist’s use. The pharmacist will
have made up your medicine. Any medicine remaining after 14 days must not be used and should be
returned to your pharmacist.
• Do not use this medicine if its appearance, smell or texture changes over time.
• Do not store above 25°C.
• Keep the bottle tightly closed in order to protect from moisture.
• Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines
you no longer use. These measures will help protect the environment.
6 Contents of the pack and other information
What Amoxil contains
• Each 1.25 ml of Amoxil contains 125 mg amoxicillin as amoxicillin trihydrate.
• The other ingredients are sodium benzoate (E211), sodium carboxymethyl cellulose (E466),
crospovidone, xanthan gum, silica hydrophobic colloidal, magnesium stearate, lemon-peach-strawberry
flavour (containing sulphur dioxide (E220)), aspartame (E951) and maltodextrin (contains glucose).
The pharmacist will add water. Amoxil is citrus flavoured.
• See also Important information about some of the ingredients in Amoxil in section 2.
What Amoxil looks like and contents of the pack
Your child’s Amoxil Paediatric 125mg / 1.25ml Powder for Oral Suspension is a white powder with
yellowish grains which comes in a bottle. When made up by your pharmacist, the bottle contains 20 ml of
a citrus flavoured colourless liquid mixture, called a suspension. It also contains a syringe for giving this
medicine to your child.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: GlaxoSmithKline (Ireland) Limited, Stonemasons Way, Rathfarnham,
Dublin 16.
Manufacturer: Glaxo Wellcome Production, Z.I. de la Peyenniere, 53100 Mayenne, France.
This leaflet was last revised in October 2014.
Amoxil is a registered trade mark of the GSK group of companies
© 2014 GSK group of companies
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5126882021
Package Leaflet: Information for the Parent or Carers of Children
Amoxil® Paediatric 125mg / 1.25ml Powder for Oral Suspension
(amoxicillin)
Read all of this leaflet carefully before you start giving your child 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.
• The medicine is usually 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 your child gets any side-effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet:
1 What Amoxil is and what it is used for
2 What you need to know before you give Amoxil
3 How to give Amoxil
4 Possible side effects
5 How to store Amoxil
6 Contents of the pack and other information
1 What Amoxil is and what it is used for
What Amoxil is
Amoxil Paediatric 125mg / 1.25ml Powder for Oral Suspension (called Amoxil in this leaflet) is an antibiotic.
It contains a medicine called amoxicillin. This belongs to a group of medicines called ‘penicillins’.
Amoxil is used for
Amoxil is used to treat infections in different parts of the body caused by bacteria such as gonorrhoea
(a sexually transmitted infection), tonsillitis, ear infections, infections caused by bites from ticks (Lyme
Disease), infections of the tooth (dental abscess), severe or recurrent chest infections & urinary (water)
tract infections. It is also used to stop infections when you have a tooth removed or other surgery.
• You must talk to a doctor if you do not feel better or if you feel worse after a few days.
2 What you need to know before you give Amoxil
Do not give your child Amoxil if they:
• are allergic (hypersensitive) to amoxicillin, penicillin, cephalosporins or any of the ingredients of
Amoxil (listed in section 6).
• have ever had an allergic (hypersensitive) reaction to any antibiotic. This can include shortness of
breath, a skin rash or swelling of the face or neck.
Do not give Amoxil to your child if any of the above apply. If you are not sure, talk to their doctor or
pharmacist before giving Amoxil.
Warnings and precautions
Talk to their doctor or pharmacist before giving your child Amoxil if they:
• have glandular fever
• are being treated for kidney problems
• are being treated for blood clotting problems
• are not passing water regularly
Prolonged use of Amoxil may occasionally result in an increase in the number of non-susceptible organisms.
If your child is less than one month old or is a premature baby, they should have their kidney,
liver & blood checked while taking Amoxil.
If you are not sure if any of the above apply to your child, talk to their doctor or pharmacist before giving
Amoxil.
Having urine or blood tests
If your child is having tests on their water (urine glucose tests) or blood tests for liver function, let the
doctor or nurse know that they are on Amoxil. This is because Amoxil can affect the results of these tests.
Taking other medicines
Please tell your doctor or pharmacist if your child is taking, has recently taken or might take any other
medicines. This includes medicines that can be bought without a prescription and herbal medicines. This is
because Amoxil can affect the way some other medicines work. Also some other medicines can affect the
way Amoxil works.
Amoxil should not be given to your child if they take:
• any medicine to stop blood clots, such as warfarin or acenocoumarol, as Amoxil may interact with
these medicines to alter blood clotting
• allopurinol, as it may interact with Amoxil and cause allergic skin reactions
• probenecid a medicine used for gout, as the concentration of Amoxil may be increased
• combined oral contraceptives, as their effectiveness may be reduced by Amoxil.
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Pregnancy and breast-feeding
If your daughter is pregnant or breast-feeding, think she may be pregnant or is planning to have a baby,
ask your doctor or pharmacist for advice before giving her this medicine.
Driving and using machines
Amoxil is not likely to affect you being able to drive or use any tools or machines.
Important information about some of the ingredients of Amoxil
• Amoxil contains sodium (0.85 mg/1.25 ml dose). This should be considered if your child is on a
controlled sodium diet.
• Amoxil contains sodium benzoate (E211) which is a mild irritant to the skin, eyes and mucous
membrane. It may increase the risk of jaundice in newborn babies.
• The lemon-peach-strawberry flavour contains sulphur dioxide (E220) which may rarely cause severe
allergic reaction (called hypersensitivity reaction) and tightness in your chest (called ‘bronchospasm’).
• Amoxil contains aspartame (E951). This contains a source of phenylalanine & may be harmful for
people with phenylketonuria.
• Amoxil contains maltodextrin (contains glucose). If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor before taking this medicinal product.
3 How to give Amoxil
Always give Amoxil exactly as your doctor has told you. You should check with your doctor or pharmacist
if you are not sure.
When giving Amoxil
• Always shake the bottle well before each dose.
• Use the syringe provided to measure the dose.
• You can give before, with or after food, unless the label specifies particular times.
• Space the doses evenly during the day, at least 4 hours apart.
• Never give 2 doses in 1 hour.
The recommended dose is:
Adults and children weighing over 40kg
• Standard adult dosage: The usual daily dosage is 750mg in divided doses (i.e. 2.5ml three times daily).
In cases of severe infection the dosage may be doubled, or ‘Amoxil’ given by injection.
• High dosage therapy: (maximum recommended oral dosage of 6g daily in divided doses): A dosage
of 3g twice daily is recommended in appropriate cases for the treatment of severe or recurrent chest
infections.
• Short course therapy: Urinary tract infection: two 3g doses with 10-12 hours between the doses.
Gonorrhoea: 3g as a single dose.
Dental Infections: two 3g doses with 8 hours between the doses.
• Children weighing more than 40kg should be given the usual adult dose.
Children weighing under 40kg
• The exact dose will be decided by your child’s doctor depending on your child’s body weight in kilograms.
• The recommended daily dosage for children weighing less than 40kg is 40 - 90 mg for every kilogram
of body weight per day in two or three divided doses (not more than 3 g per day) depending on what
the infection is and how severe it is.
• Tonsillitis: 50 mg for every kilogram of body weight per day in two divided doses.
• Infections of the ear: Your Doctor will decide the appropriate dose.
• Early Lyme disease (infection due to a bite from a tick): 50 mg for every kilogram of body weight per
day in three divided doses, over 14-21days.
• Amoxil Paediatric Suspension is recommended for children under 6 months of age.
Kidney problems
If your child has kidney problems the dose might be lower than the usual dose.
To prevent infection during surgery
• the dose will vary according to the type of surgery. Other medicines may also be given at the same
time.
• People who have, or have had, heart problems may need an antibiotic
when they go to the dentist to prevent them from getting a heart infection
(endocarditis).
• Adults and Children over 40kg who are having dental treatment may need 3 g Amoxil before the
dental treatment. A second 3 g dose may be needed six hours later.
• Children weighing under 40kg: The usual dose is 50 mg for every kilogram of body weight given as a
single dose one hour before surgery.
• Your doctor, pharmacist or nurse can give you more details.
How to give Amoxil
1. Shake the bottle well before each use.
2. Unscrew the cap.
3. Using the syringe provided, draw up the required dose.
4. Put the syringe into your child’s mouth placing the tip of the syringe onto the tongue.
5. Slowly push the plunger in until all the medicine in the syringe has been pushed out, allowing time to
swallow.
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6. For adults and more severe infections you may have to repeat steps 3 to 5 above to get the correct dose.
7. Wash out the syringe with water. Shake to remove any drops of water.
8. Replace the cap on the bottle.
If you give more Amoxil than you should
If your child has too much Amoxil, signs might be an upset stomach (feeling sick, being sick or diarrhoea)
or crystals in the urine, which may be seen as cloudy urine, or problems passing urine. Talk to their doctor
as soon as possible. Take the medicine bottle to show the doctor.
If you forget to give Amoxil
• If you forget to give a dose don’t worry, give it as soon as you remember.
• Don’t give your child the next dose too soon, wait about 4 hours before giving the next dose.
• Do not take a double dose to make up for a forgotton dose.
How long should your child take Amoxil for?
• Keep giving your child Amoxil 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 your child still feels unwell when the treatment is finished they should go back to see the doctor.
Thrush (a yeast infection of moist areas of the body) may develop if Amoxil is used for a long time. If this
occurs tell your doctor.
If you stop giving Amoxil
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, Amoxil can cause side effects, although not everybody gets them. The following side
effects may happen with this medicine:
Stop giving your child Amoxil and see a doctor straight away, if you notice any of the following serious
side effects – they may need urgent medical treatment:
The following are very rare (affects less than 1 in 10,000 people)
• allergic reactions, the signs may include: skin itching or rash, swelling of the face, lips, tongue, body or
breathing difficulties. These can be serious and occasionally deaths have occurred
• rash or pinpoint flat red round spots under the skin surface or bruising of the skin. This is due to
inflammation of blood vessel walls due to an allergic reaction. It can be associated with joint pain
(arthritis) and kidney problems
• a delayed allergic reaction can occur usually 7 to 12 days after having Amoxil, some signs include:
rashes, fever, joint pains and enlargement of the lymph nodes especially under the arms
• a skin reaction known as ‘erythema multiforme’ where your child may develop: itchy reddish purple
patches on the skin especially on the palms of the hands or soles of the feet, ‘hive-like’ raised swollen
areas on the skin, tender areas on the surfaces of the mouth, eyes and private parts. Your child may
have a fever and be very tired
• other severe skin reactions can include: changes in skin colour, bumps under the skin, blistering,
pustules, peeling, redness, pain, itching, scaling. These may be associated with fever, headaches and
body aches
• high temperature (fever), chills, a sore throat or other signs of an infection, or if they bruise easily.
These may be signs of a problem with their blood cells
• inflammation of the large bowel (colon) with diarrhoea sometimes containing blood, pain and fever
• serious liver side effects may occur which are often reversible. They are mainly associated with people
having treatment over a long period, males and the elderly. You must tell your doctor urgently if your
child gets:
- severe diarrhoea with bleeding
- blisters, redness or bruising of the skin
- darker urine or paler stools
- yellowing of the skin or the whites of the eyes (jaundice). See also anaemia below which might
result in jaundice.
These can happen when having the medicine or for up to several weeks after.
If any of the above happen to your child stop giving them the medicine and see your doctor straight away.
The other possible side effects are:
Common (affects less than 1 in 10 people)
• skin rash
• feeling sick (nausea)
• diarrhoea.
Uncommon (affects less than 1 in 100 people)
• being sick (vomiting)
• a type of rash which is made up of wheals (Urticaria)
• itchy skin (Pruritus).
Very rare (affects less than 1 in 10,000 people)
• an abnormally low number of white blood cells in the blood (leucopenia, neutropenia or
agranulocytosis)
• an abnormally low number of platelets in the blood (reversible thrombocytopenia)
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