FISAMOX®
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this
medicine, speak to your doctor or pharmacist.
FISAMOX contains the active ingredient amoxicillin sodium. FISAMOX is used to treat
some infections in different parts of the body caused by bacteria. For more information,
see Section 1. Why am I using FISAMOX? in the full CMI.
Do not use if you have ever had an allergic reaction to FISAMOX or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use FISAMOX? in the full CMI.
Some medicines may interfere with FISAMOX and affect how it works. A list of these
medicines is in Section 3. What if I am taking other medicines? in the full CMI.
FISAMOX must only be given by a doctor or nurse. More instructions can be found in
Section 4. How do I use FISAMOX? in the full CMI.
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Things you should do
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Remind any doctor, dentist or pharmacist who is treating you that you have been given
FISAMOX.
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.
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Things you should not do
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If you experience diarrhoea, do not take any diarrhoea medicine without first checking
with your doctor.
Do not breast-feed while using this medicine.
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Driving or using machines
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Be careful driving or operating machinery until you know how FISAMOX affects you.
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Looking after your medicine
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FISAMOX will be stored in the pharmacy or on the ward.
FISAMOX is kept in a cool dry place, protected from light and moisture, where the
temperature stays below 25°C.
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For more information, see Section 5. What should I know while using FISAMOX? in the full CMI.
Tell your doctor if you notice any of the following and they worry you: oral thrush - white, furry, sore tongue and mouth, vaginal thrush - sore and itchy
vagina and/or discharge, a mild rash or pain or redness at the site of injection.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following: severe rash, wheezing, irregular heartbeat or you are feeling faint.
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, or fever, in combination with one or both of the aforementioned side effects.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following: severe rash, wheezing, irregular heartbeat or you are feeling faint.
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, or fever, in combination with one or both of the aforementioned side effects.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
FISAMOX®
Active ingredient(s):
amoxicillin sodium
Consumer Medicine Information (CMI)
This leaflet provides important information about using FISAMOX. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using FISAMOX.
Where to find information in this leaflet:
FISAMOX contains the active ingredient amoxicillin sodium. 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.
FISAMOX is 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.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
This medicine is available only with a doctor’s prescription.
There is no evidence that FISAMOX is addictive.
Do not use FISAMOX if:
you are allergic to any medicine containing amoxicillin or penicillin, any other similar
antibiotics such as cephalosporins or any of the ingredients listed at the end of
this leaflet. Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Always check the ingredients to make sure you can use this medicine.
Tell your doctor if you have suffered from any allergic conditions due to the use
of penicillin.
you have ever had liver problems as a result of taking penicillins.
If you are not sure whether you should be given this medicine, talk to your doctor.
Check with your doctor if you:
have allergies to any other medicines, foods, preservatives or dyes.
have or have had any of the following medical conditions:
asthma
kidney or liver disease
If you have not told your doctor about any of the above, tell them before you start
using FISAMOX.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Do not breast-feed if you are using this medicine.
The active ingredient in FISAMOX passes into breast milk and there is a possibility
that your baby may be affected.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with FISAMOX. These include:
Probenecid, a medicine used to treat gout
Allopurinol (these are medicines used to treat gout or kidney stones)
Any other antibiotics such as tetracyclines, erythromycin and chloramphenicol
Anticoagulants such as warfarin, which is used to prevent blood clots.
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 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 are given too much FISAMOX
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 ‘
6. Are there any side effects?’ below. Your doctor has information on how to recognise and treat an overdose. Ask
your doctor if you have any concerns.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Things you should do
If the symptoms of your infection do not improve within a few days, or if they become
worse, tell 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 grow 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.
Call your doctor straight away:
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.
If you get severe diarrhoea. Call your doctor immediately 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.
Remind any doctor, dentist or pharmacist you visit that you are using FISAMOX.
Driving or using machines
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.
Looking after your medicine
FISAMOX will be stored in the pharmacy or on the ward. FISAMOX is kept in a cool dry
place, protected from light and moisture, where the temperature stays below 25°C.
FISAMOX is not to be given after the expiry date on the label.
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.
This medicine helps most people with infections, but it may have unwanted side effects
in a few people. All medicines can have side effects. Sometimes they are serious,
most of the time they are not. You may need medical attention if you get some of the
side effects.
Do not be alarmed by the following lists of side effects. You may not experience any
of them.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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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
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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a severe rash
wheezing
irregular heartbeat
feeling faint
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Serious side effects
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Serious side effects
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What to do
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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
FISAMOX can change bacteria (which are normally present in the bowel and normally
harmless) to multiply and therefore cause the above symptoms.
an illness consisting of a rash, swollen glands, joint pains and fever may occur about
a week after treatment.
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Tell your doctor immediately if you notice any of the following rare but serious side
effects, even if they occur up to several weeks after finishing treatment with FISAMOX.
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Do not take any diarrhoea medicine without first checking with your doctor.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
This medicine is only available with a doctor's prescription.
What FISAMOX contains
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Active ingredient
(main ingredient)
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1000 mg of amoxicillin (as amoxicillin sodium)
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Do not take this medicine if you are allergic to this ingredient.
What FISAMOX looks like
FISAMOX is a fine white to off-white homogenous powder which must be dissolved in
water before it is injected.
It is available in packs of 10 vials.
(AUST R 90880).
