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FISAMOX®

Amoxycillin (as amoxycillin sodium) Powder for Injection


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about FISAMOX®.

It does not contain all the available information.

It does not take the place of talking to your doctor and pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you receiving FISAMOX® against the benefits this medicine is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What FISAMOX® is used for

FISAMOX® is an antibiotic used to treat some infections in different parts of the body caused by bacteria.

FISAMOX® will not work against infections caused by viruses, such as colds or the flu.

FISAMOX® is an antibiotic that belongs to a group of medicines called penicillins. These antibiotics work by killing the bacteria that are causing your infection.

Your doctor may have prescribed FISAMOX® for another reason. Ask your doctor why FISAMOX® has been prescribed for you.

This medicine is available only with a doctor’s prescription.

There is no evidence that FISAMOX® is addictive.

Before you are given FISAMOX®

When you must not be given it

Do not use FISAMOX® if:

  • you have an allergy to FISAMOX® or other penicillins.
    Some of the symptoms of an allergic reaction may include skin rash, itching and difficult breathing.
  • you have had an allergic reaction to cephalosporins.
    You may have an increased chance of being allergic to FISAMOX® if you are allergic to cephalosporins.

If you are not sure whether you should start taking FISAMOX®, talk to your doctor.

Before you are given it

Tell your doctor if:

  1. you have an allergy to FISAMOX® or other penicillins.
  2. you have had any type of allergic reaction to cephalosporin medicines.
    You may have an increased chance of being allergic to FISAMOX® if you are allergic to cephalosporins.
  3. you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes. This may include medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.
  4. you have or have ever had any other health problems/medical conditions, including asthma, kidney or liver disease.
  5. you are pregnant or intend to become pregnant.
    Your doctor will discuss the risks and benefits of using FISAMOX® during pregnancy.
  6. you are breast-feeding or plan to breast-feed.
    Your doctor will discuss the risks and benefits of using FISAMOX® when breast-feeding.

If you have not told your doctor about any of the above, tell him/her before you are given FISAMOX®.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may interfere with FISAMOX®. These include:

  • probenecid (Benemid)
  • Allopurinol (these are medicines used to treat gout)
  • Other antibiotics eg. tetracyclines, erythromycin and chloramphenicol

These medicines may be affected by FISAMOX®, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist has more information on medicines to be careful with or avoid whilst receiving FISAMOX®.

Some antibiotics may decrease the effectiveness of some birth control pills. Talk to your doctor about the need for an additional method of contraception whilst receiving FISAMOX®.

How FISAMOX® is given

FISAMOX® may be given in two ways:

  • as a slow injection into a vein
  • as a deep injection into a large muscle

FISAMOX® must only be given by a doctor or nurse.

Your doctor will decide what dose and for how long you receive FISAMOX®. This depends on your infection and other factors, such as your weight. For most infections, FISAMOX® is usually given in divided doses throughout the day. Sometimes only a single dose of FISAMOX® is required for the treatment and prevention of certain infections.

If you have too much (overdose)

This rarely happens as FISAMOX® is administered under the care of a highly trained doctor or nurse. However, if you are given too much FISAMOX®, you may experience some of the effects listed under ‘Side Effects’ below. Your doctor has information on how to recognise and treat an overdose. Ask your doctor if you have any concerns.

After you have been given FISAMOX®

Things you must do

If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.

If you develop itching with swelling or skin rash or difficulty breathing after you have been given FISAMOX®, you may be having an allergic reaction to FISAMOX®. Contact your doctor immediately.

If you get severe diarrhoea tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after FISAMOX® has been stopped. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care.

Do not take any diarrhoea medicine without first checking with your doctor.

If you get a sore white mouth or tongue after you have been given FISAMOX®, tell your doctor. Also tell your doctor if you get a vaginal itching or discharge. This may mean you have a fungal infection called thrush. Sometimes the use of FISAMOX® allows fungi to grown and the above symptoms to occur. FISAMOX® does not work against fungi.

If you become pregnant while you are receiving FISAMOX®, tell your doctor.

If you have to have any urine tests tell your doctor you have been given FISAMOX®. FISAMOX® may affect the results of some tests.

Tell any doctor, dentist or pharmacist who is treating you that you have been given FISAMOX®.

Things to be careful of

Be careful driving or operating machinery until you know how FISAMOX® affects you. FISAMOX® generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, FISAMOX® may cause dizziness, drowsiness or tiredness in some people.

Side Effects

Tell your doctor as soon as possible if you have any problems whilst receiving FISAMOX®, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

Like other medicines, FISAMOX® can cause some side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.

Ask your doctor or pharmacist to answer any questions you may have.

Whilst being given FISAMOX®

Tell your doctor immediately or go to casualty at your nearest hospital if you notice any of the following:

  • a severe rash
  • wheezing
  • irregular heart beat
  • feeling faint

Tell your doctor if you notice any of the following:

  • oral thrush - white, furry, sore tongue and mouth
  • vaginal thrush - sore and itchy vagina and/or discharge
  • a mild rash
  • pain or redness at the site of injection

Other side effects not listed above may also occur in some patients. These include very rare conditions of brain, blood, liver and kidney disorders.

After finishing FISAMOX®

Tell your doctor immediately if you notice any of the following side effects, even if they occur up to several weeks after finishing treatment with FISAMOX®:

  • severe abdominal cramps or stomach cramps
  • watery and severe diarrhoea, which may also be bloody
  • fever, in combination with one or both of the above

These are rare but serious side effects. FISAMOX® can change bacteria (which are normally present in the bowel and normally harmless) to multiply and therefore cause the above symptoms. You may need urgent medical attention.

Do not take any diarrhoea medicine without first checking with your doctor.

An illness consisting of a rash, swollen glands, joint pains and fever may occur about a week after treatment.

Tell your doctor if you notice any side effects.

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known. Ask your doctor or pharmacist if you are concerned.

After receiving FISAMOX®

Storage

FISAMOX® will be stored in the pharmacy or on the ward. FISAMOX® is kept in a cool dry place, protected from light, where the temperature stays below 25°C.

FISAMOX® is not to be given after the expiry date on the label.

FISAMOX® description

What it looks like

FISAMOX® Injection is a white to off-white powder which has to be dissolved in water before it is injected.

Ingredients

Amoxycillin sodium, 500mg or 1g.

FISAMOX® does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

The Australian Registration Number is:
1g AUST R 90880
500mg AUST R 29406

Sponsor

Aspen Pharmacare Australia Pty Limited, ABN 51 096 236 985
34-36 Chandos Street, St Leonards 2065
NSW Australia

Date of revision: February 2016

FISAMOX® is a registered trademark of Aspen Pharmacare Australia Pty Ltd.

Published by MIMS May 2017

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