Very rare (may affect up to 1 in 10,000 people)

•    thrush (a yeast infection of the vagina, mouth or skin folds), you can get treatment for thrush from your doctor or pharmacist

•    kidney problems

•    fits (convulsions), seen in patients on high doses or with kidney problems

•    dizziness

•    hyperactivity

•    crystals in the urine, 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

•    the blood may take longer to clot than it normally would. You may notice this if your child has a nosebleed or cuts themself.

If your child gets any side effects, talk to your

doctor, or pharmacist or nurse. This includes any

possible side effects not listed in this leaflet.

5 How to store Amoxil

•    Keep this medicine out of the sight and reach of children.

•    The expiry date which is stated on the label is for the pharmacist's use. The pharmacist will have made up your medicine. It should be used within 14 days.

•    Do not store above 2 5°C.

•    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.

6 Contents of the pack and other information

What Amoxil contains

•    Each 1.25 ml contains 125 mg of the active substance amoxicillin.

•    The other ingredients are crospovidone, xanthan gum (E415), sodium benzoate (E211), sodium carboxymethylcellulose (E466), silica hydrophobic colloidal, magnesium stearate (E572), lemon-peach-strawberry flavour and aspartame (E951). The pharmacist will add water or syrup. Amoxil is citrus flavoured.

•    See also Important information about some of the ingredients of Amoxil in section 2.

What Amoxil looks like and contents of the pack

Your child's Amoxil comes in a bottle containing 20 ml of an off-white liguid 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 UK,

Stockley Park West, Uxbridge, Middlesex UB11 1BT Manufacturer:

Glaxo Wellcome Production,

Z.l. de la Peyenniere, 53100 Mayenne, France

Other formats

To listen to or reguest a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information: Product name Amoxil Paediatric Suspension

Reference number 00038/0107

This is a service provided by the Royal National

Institute of Blind People.

Leaflet date: October 2012

Amoxil is a registered trademark of the GlaxoSmithKline group of companies

© 2012 GlaxoSmithKline group of companies

GlaxoSmithKline

Package Leaflet: Information for the Parent or Carers of Children

Amoxil® Paediatric Suspension 125 mg per 1.25 ml

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 or nurse.

•    The medicine is usually prescribed for a child under 10 years. 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 or nurse. This includes any possible side effects not listed in this leaflet.

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 Suspension (called Amoxil in this leaflet) is an antibiotic. It contains a medicine called amoxicillin. This belongs to a group of medicines called 'penicillins'.

What Amoxil is used for

Amoxil is used to treat infections in different parts of the body caused by bacteria. It is also used to stop infections when you have a tooth removed or other surgery.

2 What you need to know before you give Amoxil

Do not give your child Amoxil if they:

•    are allergic (hypersensitive) to amoxicillin, penicillin or any of the other ingredients of Amoxil (listed in section 6)

•    have ever had an allergic (hypersensitive) reaction to any antibiotic. This can include 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

Check with their doctor, or pharmacist or nurse before giving your child this medicine if they:

•    have glandular fever (a viral infection which causes a sore throat, high temperature (above 39°C (102.2°F)), tiredness, muscle pains and headache

•    are being treated for 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 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.

Other medicines and Amoxil

Please tell your doctor, or pharmacist or nurse if your child is taking, using or has recently taken or might take/use any other medicines.

This is because Amoxil can affect the way some other medicines work. Also some other medicines can affect the way Amoxil works.

•    If your child is taking allopurinol (used for gout) with Amoxil, 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 their dose of Amoxil.

•    If medicines to help stop blood clots (such as warfarin) are taken with Amoxil then extra blood tests may be needed.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice if your

daughter who is about to take this medicine

is taking the contraceptive pill, pregnant or

breast-feeding.

Amoxil contains:

•    Aspartame (E951) which is a source of phenylalanine. This may be harmful for children born with a condition called 'phenylketonuria'.

•    Sodium (0.85 mg/1.25 ml dose). This should be considered if your child is on a controlled sodium diet.

•    Sodium benzoate (E211). Sodium benzoate may irritate the skin, eyes and mucous membranes.

3 How to give Amoxil

Always give this medicine exactly as your doctor or pharmacist has told you. 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.

•    Give at the start of a meal or slightly before 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.

•    Do not give doses of Amoxil at night.

The recommended dose is:

Children weighing less than 40 kg

All doses are worked out depending on the child's

body weight in kilograms.

•    Your doctor will advise you how much Amoxil you should give to your baby or child.

•    Usual dose - 40 mg to 90 mg for each kilogram of body weight a day, given in two or three divided doses.

To stop infection during surgery

•    If your child is having Amoxil to stop infections, the dose will be 50 mg for each kilogram body weight in a single dose, given one hour before the surgery. Other medicines may also be given at the same time.

•    Your doctor, pharmacist or nurse can give you more details.

Adults and children weighing more than 40 kg

This suspension is not usually prescribed for adults and children weighing more than 40 kg. Ask your doctor or pharmacist for advice.

Kidney problems

If your child has kidney problems the dose might be lower than the usual dose.

How to give Amoxil

1    Shake the bottle well before each use

2    Unscrew the cap

3    Using the provided syringe draw up the reguired dose

4    Put the medicine onto your child's tongue using the syringe until all the medicine in the syringe has been pushed out

5    Wash out the syringe with water.

Shake to remove any drops of water.

If you give too much Amoxil

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.

How long should your child take Amoxil for?

•    Keep giving your child Amoxil until the treatment is finished, even if theyfeel better. Your child needs every dose to help fight the infection. If some bacteria survive they can cause the infection to come back. Treatment should be continued for 2 to 3 days after the symptoms have gone.

• Your child should not need to take Amoxil for more than 2 weeks. If your child still feels unwell 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 and your child has been taking Amoxil for longer than recommended, tell your doctor.

If you have any further guestions on the use of this medicine, ask your doctor, or pharmacist or nurse.

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 (may affect up to 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.

Sometimes your child may get less severe skin reactions such as:

•    a mildly itchy rash (round, pink-red patches), 'hive-like' swollen areas on their forearms, legs, palms, hands or feet. This is uncommon (may affect up to 1 in 100 people).

If your child has any of these talk to their doctor as Amoxil will need to be stopped.

The other possible side effects are:

Common (may affect up to 1 in 10 people)

•    skin rash

•    feeling sick (nausea)

•    diarrhoea.

Uncommon (may affect up to 1 in 100 people)

•    being sick (vomiting).

Side 3