NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
FISAMOX
amoxicillin sodium
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 or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you receiving FISAMOX against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet in a safe place.
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.
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.
Before you are given FISAMOX
When you must not be given it
You must not be given FISAMOX if you have an allergy to:
any medicine containing amoxicillin
any medicine containing penicillin or any other similar antibiotics such as cephalosporins
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
Tell your doctor if you have suffered from any allergic conditions due to the use of penicillin.
Do not use this medicine if you have had ever had liver problems as a result of taking penicillins.
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.
If you are not sure whether you should be given this medicine, talk to your doctor.
Before you are given it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you 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 taking FISAMOX.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you get 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
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 (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.
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.
Ask your doctor to answer any questions you may have.
Whilst being given FISAMOX
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
pain or redness at the site of injection
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
a severe rash
wheezing
irregular heartbeat
feeling faint
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 anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
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 and moisture, 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 is a fine white to off-white powder which has to be dissolved in water before it is injected. It is available in packs of 10 vials.
Ingredients
FISAMOX contains 1000 mg (1 g) of amoxicillin as the active ingredient.
FISAMOX does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.
Distributor
FISAMOX is distributed in Australia by:
Alphapharm Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au
This leaflet was prepared in November 2020.
AUST R 90880
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