drug-medicine : amoxil

Patient Information Leaflet on Amoxil® Vials for Injection

250 mg, 500 mg and 1 g

amoxicillin

This leaflet tells you about Amoxil Vials for Injection. Please read it carefully. If there is anything you do not understand, or if you want to know more about your treatment, ask your doctor, nurse or pharmacist (chemist).

Please keep this leaflet. You may want to read it again.

What is Amoxil Vials for Injection ?

The active ingredient in this medicine is amoxicillin. This is the new name for amoxycillin. The ingredient itself has not changed.

Amoxil Vials for Injection contains the active ingredient amoxicillin.

It is available in three strengths. Your doctor will decide which strength you need.

Amoxil Vials for Injection 250 mg : each contain 250 mg amoxicillin.
Amoxil Vials for Injection 500 mg : each contain 500 mg amoxicillin.
Amoxil Vials for Injection 1 g vials : each contain 1000 mg amoxicillin.

The vials for injection contain no other ingredients.

Sodium content:

Amoxil Vials for Injection 250 mg - 19 mg per vial
Amoxil Vials for Injection 500 mg - 38 mg per vial
Amoxil Vials for Injection 1 g - 76 mg per vial

Amoxil Vials for Injection 250 mg, 500 mg and 1 g vials are supplied to your doctor in packs of 10

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 is your doctor giving you 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, 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).

Before having this medicine

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

You have ever had a skin rash or swelling of the face or neck when taking any antibiotic
You know you are allergic to penicillin (or any other antibiotic)
You are taking a contraceptive pill (in which case you will need to take extra contraceptive precautions such as using a condom)
You have, or you think you have, glandular fever
You are breast feeding
You have been treated for kidney problems
You are taking any medicine (such as warfarin) to prevent blood clots
You are taking allopurinol for conditions such as gout which can be caused by uric acid build-up.

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

Having this medicine

Your medicine will be given to you by injection into a vein (intravenous) or into a muscle (intramuscular). Your doctor will decide how much you need each day and how often the injections should be given.

You should drink several more glasses of water each day of your treatment, unless told otherwise by your doctor.

The usual dose for treating infection is:

Adults and children over 10 years: 500 mg every eight hours into muscle for most infections. Such a dose may be given more frequently if considered necessary by your doctor. Your doctor may give the required dose into a vein if this is more convenient.

Children up to 10 years of age: 50-100 mg for each kilogram of body weight in divided doses throughout the day.

These doses may be reduced in patients with kidney problems.

Speak to your doctor or nurse if :

you think you have missed an injection

or

you think you have been given too much medicine.

Prevention of heart infection (endocarditis)

Dental treatment

If you have had heart problems you may need an antibiotic when you go to the dentist to prevent you from getting a heart infection (endocarditis).

Adults and children over 10 years: If you are having dental treatment with a general anaesthetic you may need a 1 g injection given into a vein or a muscle, if it is not possible to take Amoxil by mouth, before the anaesthetic is given. If you are recovering from a general anaesthetic you may also need a 1 g injection if you are unable to take Amoxil by mouth.

Children under 10 years are usually given half the adult dose.

Children under five years are usually given one-quarter the adult dose.

Dental treatment where referral to hospital is recommended

If you have been referred to hospital for dental treatment for any of the following reasons:

you need a general anaesthetic and have had a penicillin in the last month
you need a general anaesthetic and have an artificial heart valve
you have had one or more attacks of a heart infection called endocarditis.

Adults and children over 10 years: You may need a 1 g injection given into a vein or a muscle before you are given a general anaesthetic, if one is to be given, or 15 minutes before dental treatment. 120 mg of another antibiotic, called gentamicin, may be needed at the same time. Six hours later you may need 500 mg of Amoxil to be given by mouth.

Children under 10 years: May need half the adult dose of Amoxil and a dose of gentamicin of 2 mg per kg body weight may be needed.

Children under five years: May need one-quarter the adult dose of Amoxil and a dose of gentamicin of 2 mg per kg body weight may be needed.

Surgery and procedures involving medical instruments

If:

you are having surgery or an examination of your bladder, urethra (the tube that carries urine from your bladder) or genitals which requires you to have a general anaesthetic and you have no infection of your urethra or bladder
you are female and having surgery or an examination of your reproductive organs and have an artificial heart valve
you are having surgery or an examination of your intestines or stomach and have an artificial heart valve.

Adults and children over 10 years: You may need a 1 g injection given into a vein or a muscle just before you are given a general anaesthetic. 120 mg of another antibiotic, called gentamicin, may be needed at the same time given into a vein or muscle. Six hours later you may need 500 mg of Amoxil to be taken by mouth.

Children under 10 years: May need half the adult dose of Amoxil and a dose of gentamicin of 2 mg per kg body weight may be needed.

Children under five years: May need one-quarter the adult dose of Amoxil and a dose of gentamicin of 2 mg per kg body weight may be needed.

If you are having surgery or an examination of your mouth, nose or throat.

Adults and children over 10 years: You may need a 1 g injection given into a vein or muscle just before you are given a general anaesthetic. Six hours later you may need a 500 mg injection. If you have an artificial heart valve you may also need 120 mg of gentamicin given into a vein or muscle at the same time as you receive your first injection of Amoxil.

Children under 10 years: May need half the adult dose of Amoxil. If your child has an artificial heart valve a dose of gentamicin of 2 mg per kg body weight may also be needed.

Children under five years: May need quarter the adult dose of Amoxil. If your child has an artificial heart valve a dose of gentamicin of 2 mg per kg body weight may also be needed.

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 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
Inflammation of the kidney. Tell your doctor that you are taking Amoxil if you 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 are taking Amoxil if you are having blood tests
Crystalluria, forming of crystals in the urine.

See your doctor straight away if you 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 get any other problems while taking this medicine tell your doctor, nurse or pharmacist.

Storing Amoxil Vials for Injection

Amoxil Vials for Injection should be kept in a cool dry place until given to you
The vials contain sterile powder. The powder is made up into a liquid for injection before it is given to you.

There is an expiry date on the label, the doctor or nurse will check that this date has not passed.