drug-medicine : amoxil syrups sucrose-free

PATIENT INFORMATION LEAFLET

Amoxil® Syrups Sucrose-Free/Dye-Free

125 mg/5 ml and 250 mg/5 ml

amoxicillin

PLEASE READ THIS LEAFLET BEFORE TAKING THIS MEDICINE OR GIVING YOUR CHILD THIS MEDICINE

Always follow your doctor’s advice. If there is anything you do not understand, or if you have any questions, please ask your doctor or pharmacist (chemist).

Amoxil Syrups are mainly prescribed for children but may also be prescribed for adults. The leaflet is just as important for adults taking this medicine.

Information for patients and carers of children

Your Amoxil comes in a bottle containing 100 ml of an off-white liquid mixture, called a syrup.

Amoxil Syrups Sucrose-Free/Dye-Free contain the active ingredient amoxicillin. The syrups come in two strengths containing either 125 mg or 250 mg of amoxicillin in each 5 mls. The other ingredients in the syrups are: disodium edetate, sodium benzoate, saccharin sodium, silica (E551), xanthan gum (E415), peach, strawberry and lemon dry flavours and sorbitol (E420). Each 5 ml dose of the 125 mg syrup contains 1.3 mg of sodium and 752 mg of sorbitol. Each 5 ml dose of the 250 mg syrup contains 4.2 mg of sodium and 576 mg of sorbitol.

What is Amoxil ?

Amoxil is an antibiotic for treating infections. It belongs to a group of antibiotics called “penicillins”. Amoxil works by killing the bacteria that can cause infections.

Why has your doctor prescribed your child Amoxil ?

Amoxil can treat a wide range of infections including those of the chest (bronchitis or pneumonia), tonsils (tonsillitis), ears (otitis media), sinuses (sinusitis), the bladder or the urethra (the tube which carries urine from the bladder), kidneys, the female reproductive system including infections caused by difficulties during childbirth (puerperal sepsis and septic abortion), abdomen (intra-abdominal sepsis and peritonitis), heart (endocarditis), blood (septicaemia), skin, bone, teeth and gums (abscesses). Amoxil can also be used to treat gonorrhoea (a sexually transmitted infection), infections associated with pregnancy and typhoid and paratyphoid (fevers caused by a group of bacteria called Salmonella).

Amoxil Syrups can be used as part of treatment to prevent heart infections (endocarditis).

Before giving or taking this medicine

Let your doctor know if any of the following apply to your child:

Your child has ever had a skin rash or swelling of the face or neck when taking any antibiotic
You know that your child is allergic to penicillin (or any other antibiotic)
Your child has, or you think they may have, glandular fever
Your child has hereditary fructose intolerance (as the syrup contains sorbitol)
Your child has been treated for kidney problems
Your child is being treated with any medicine (such as warfarin) to prevent blood clots
Your child is taking allopurinol for conditions such as gout which can be caused by uric acid build-up.

If you are an adult taking this medicine you must also tell your doctor if:

You are taking a contraceptive pill (in which case you will need to take extra contraceptive precautions such as using a condom)
You are breast-feeding.

If any of the above apply to you or your child, your doctor may decide that you or your child need a different dose of Amoxil or a different medicine instead of Amoxil.

This medicine contains sodium benzoate. Sodium benzoate is a derivative of benzoic acid which may irritate the skin, eyes and mucous membranes.

Sorbitol can cause stomach upset and diarrhoea.

How to take or give Amoxil Syrups to your child

Amoxil Syrup is usually given to children, although it can be given to adults who have difficulty swallowing tablets. The dose that your doctor tells you to give will depend on the type of infection your child has. Your doctor’s instructions should be on the bottle. Read them carefully. If you have any questions talk to your doctor or pharmacist.

Usual Dosages for children:

The usual dose for children up to 10 years is 5 ml of Amoxil Syrup Sucrose-Free/Dye-Free 125 mg/5 ml to be given three times a day. This can be increased to 5 ml of Amoxil Syrup Sucrose-Free/Dye-Free 250 mg/5 ml if the infection is more severe.

In severe or frequent ear infections (otitis media), a dose of 750 mg (15 ml of the 250 mg Syrup) may be given twice a day for two days in children aged three to 10 years.

Your chemist will give you a spoon to give your child the right dose. Or the chemist may give you a syringe. In both cases shake the bottle well before removing the cap. If the chemist has given you a syringe follow these simple rules.

1. After shaking the bottle, remove the cap and replace with the syringe.
2. Use the syringe to measure out the right dose.
3. Put the syringe tip into your child’s mouth and drip the medicine in gently. Don’t hurry your child, allow time for him or her to swallow the medicine slowly.
4. After each dose, wash the syringe well. When you have finished, put the bottle and syringe somewhere safe, out of the reach of children.

Usual Dosages for Adults:

If you are taking Amoxil Syrups, for most infections you have to take 250 mg three times a day. This can be increased to 500 mg three times a day if the infection is severe.

For severe or frequent chest infections your doctor may recommend taking 3 g two times a day. Infections of the bladder or urethra (water infections) can be treated with two 3 g doses taken within 10-12 hours of each other. Teeth and gum infections (abscesses) can be treated with two 3 g doses taken within eight hours between each other. Gonorrhoea (a sexually transmitted infection) can be treated with a single 3 g dose.

Usual Dosage for preventing Endocarditis:

People who have had heart problems may need an antibiotic when they go to the dentist or if they have to go into hospital for surgery to prevent them from getting a heart infection (endocarditis). People who are having dental treatment without a general anaesthetic may need 3 g Amoxil before the dental treatment.

A second 3 g dose may be needed six hours later. People who are having dental treatment with a general anaesthetic may need a 3 g dose four hours before anaesthesia followed by another 3 g dose straight after the dental treatment has finished. People who are having surgery in hospital will usually be given Amoxil by injection before their treatment and will be given a 500 mg dose six hours later by mouth or by injection. Children under 10 usually take half these adult doses. Children under five take a quarter of the adult doses.

Further information for all patients:

The maximum dose needed for most infections is 6 g daily given in divided doses.

Doses may be lower than those listed above in patients with kidney problems.

During treatment with Amoxil:

you should make sure your child has several more drinks of water each day

or

if you are taking Amoxil, you should drink several more glasses of water each day unless told otherwise by your doctor.

When should I give my child Amoxil Syrups ?

Try to give or take this medicine as part of the daily routine - for example at mealtimes. You may give or take Amoxil before, with or after food, unless the label advises a specific time.

It is not normally necessary to arrange to have a dose in the middle of the night - unless your doctor has told you to do so. But remember, space the doses as evenly as possible throughout the day.

Try not to give your child more than one dose every four hours and never give two doses within an hour or so.

Keep giving the medicine until it is finished, even if you or your child seem to be better.

Your child needs every dose to help fight off the infection. If you stop this medicine before the end of the course, some bacteria may survive and cause the infection to come back.

If you or your child are still unwell after taking all the medicine, go and see your doctor.

Never give or take more than the recommended dose each day.

What if I forget a dose ?

If you forget a dose don’t worry – just give it or take it as soon as you remember. But don’t give or take the next dose too soon. Try to wait about four hours before the next dose. Always try to keep the doses evenly spaced.

What if too much medicine has been taken ?

If you or your child has taken too much medicine, contact your doctor or local hospital casualty department at once. Show the doctor the bottle of syrup.

Information on possible side effects

As with all medicines, some people may experience side effects with Amoxil.

The more common side effects of Amoxil that have been reported in more than 1 in 100 people taking it include:

Nausea (feeling of sickness) or diarrhoea
Skin rash.

Uncommon side effects that have been reported in between 1 in 100 and 1 in 1,000 people taking Amoxil include:

Vomiting
Allergic skin reactions with itching e.g. 'hives' or 'nettle' rash. If you or your child start to itch or get a rash, STOP taking Amoxil and tell your doctor at once.

Rare side effects that have been reported in between 1 in 1,000 and 1 in 10,000 people. There are no rare side effects documented for Amoxil.

Very rare side effects that have been reported in less than 1 in 10,000 people taking Amoxil include:

Hypersensitivity or severe allergic reaction including swollen face or breathing problems. Tell your doctor straight away if you notice any of these symptoms and STOP taking Amoxil
Thrush (a yeast infection of the vagina, mouth or skin folds). You can get treatment for thrush from your doctor or pharmacist
Tooth discolouration. The colour usually returns to normal with brushing
Inflammation of the kidney. Tell your doctor that you or your child are taking Amoxil if you or your child are having urine tests because Amoxil may affect the results
Excessive body movements (hyperkinesia), dizziness or convulsions. People who are on high doses of Amoxil or whose kidneys do not work properly may experience convulsions
Reduction (reversible) in blood cell counts including anaemia (a reduction in the body's red blood cells or haemoglobin which may be characterised by feeling weak or light-headed) or a longer time taken for blood to clot. Tell your doctor that you or your child are taking Amoxil if you or your child are having blood tests
Crystalluria, forming of crystals in the urine.

See your doctor straight away if you or your child experience any of the following very rare side effects:

Severe diarrhoea with bleeding
Notice your urine becoming darker or your faeces (otherwise known as poo) becoming paler
Notice your skin or the white of your eyes turning yellow
Convulsions
Difficulty or discomfort in passing urine or have cloudy urine.

If you or your child gets any other problems while having this medicine tell your doctor or pharmacist.

Storing Amoxil Syrups Sucrose-Free/Dye-Free 125 mg/5 ml and 250 mg/5 ml

Don’t use this medicine if the expiry date printed on the bottle has passed.

Keep the medicine in its original bottle. This medicine should not be used beyond 14 days from when it was dispensed. Keep all medicines well out of the reach of children – it’s best to lock them in a cupboard or medicine cabinet.

If your doctor tells you to stop using this medicine, or if for any other reason you have some medicine left over, please return it to the pharmacist.

Remember, this medicine is just for you or your child. Do not give it to anyone else. It may not be suitable for them, even if their symptoms seem to be the same.

Medicine: amoxil syrups sucrose-free