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.
1. Why am I using Flagyl S?
Flagyl S contains the active ingredient metronidazole benzoate (liquid). Flagyl S
is used to treat certain infections caused by bacteria and other organisms in different
parts of the body. It is also used to prevent or treat certain infections that may
occur during surgery.
2. What should I know before I use Flagyl S?
Do not use if you have ever had an allergic reaction to Flagyl S 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.
3. What if I am taking other medicines?
Some medicines may interfere with Flagyl S and affect how it works.
4. How do I use Flagyl S?
Follow the instructions provided and use Flagyl S until your doctor tells you to stop.
5. What should I know while using Flagyl S?
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Things you should do
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Tell your doctor straight away if the symptoms of your infection do not improve or
become worse, if you become pregnant or if you are about to start taking any new medicines.
Stop taking this medicine and tell your doctor straight away if you have irrational
thoughts, hallucinations, feeling confused or feeling depressed, including thoughts
of self-harm or suicide.
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Things you should not do
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Do not stop taking Flagyl S if you feel better. If you do not complete the full course
prescribed by your doctor, all of the bacteria/organisms causing your infection may
not be killed.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how Flagyl
S affects you.
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Drinking alcohol
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Do not drink alcohol or consume any medication containing alcohol while using Flagyl
S and for at least 24 hours after stopping treatment.
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Looking after your medicine
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Keep Flagyl S suspension in a cool dry place where the temperature stays below 25°C.
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6. Are there any side effects?
Serious side effects: Allergic reaction: Some symptoms of an allergic reaction include skin rash, itching,
shortness of breath or swelling of the face, lips or tongue, which may cause difficulty
in swallowing or breathing. If you have been on prolonged Flagyl S therapy, you may
experience unusual numbness of the feet or hands.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
For more information, including what to do if you have any side effects, see Section
in the full CMI.
Active ingredients:
Metronidazole benzoate (met-ro(h)-nide-ah-zole benz-o(h)-ate) 200 mg/5 mL oral suspension
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Flagyl S. 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 Flagyl S.
Where to find information in this leaflet:
1. Why am I using Flagyl S?
Flagyl S contains the active ingredient metronidazole benzoate (liquid). Flagyl S is an antibiotic that belongs to a group of medicines called nitroimidazoles.
Flagyl S is used to treat certain infections caused by bacteria and other organisms
in different parts of the body.
It is also used to prevent or treat certain infections that may occur during surgery.
This medicine works by killing or stopping the growth of bacteria and other organisms
causing these infections.
Your doctor may have prescribed Flagyl S for another reason.
Ask your doctor if you have any questions about why Flagyl S has been prescribed for
you.
This medicine is available only with a doctor's prescription.
There is no evidence that this medicine is addictive.
2. What should I know before I use Flagyl S?
Warnings
Do not use Flagyl S if:
you are allergic to metronidazole or any other nitroimidazoles, or any of the ingredients
listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
you have evidence of, or have a history of, a blood disorder.
you have, or have ever had, a disease of the brain, spinal cord or nerves.
the expiry date on the pack has passed. If you use this medicine after the expiry
date has passed it may have no effect at all, or worse, an entirely different effect.
the packaging is torn or shows signs of tampering.
Check with your doctor if you:
have any allergies to any other medicines or any other substances such as foods, preservatives
or dyes.
have or have ever had any health problems/ medical conditions including:
a blood disorder
disease of the brain, spinal cord or nerves
liver or kidney disease
an inflammatory disease of the small intestine (e.g., Crohn's disease)
Cockayne syndrome
drink alcohol. Do not drink alcohol during (and for 24 hours after stopping) treatment
with Flagyl S.
If you have not told your doctor or pharmacist about any of the above, tell them before
you start using Flagyl S.
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.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
3. What if I am taking other medicines?
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 Flagyl S and affect how well it works. These include:
any medication that may cause ECG disturbances (certain anti-arrhythmics (medicines
for heart rhythm disorders), certain antibiotics, psychotropic medicines)
warfarin or other medicines used to prevent blood clots
Antabuse® (disulfiram), a medicine used to treat chronic alcohol dependence
Medications containing alcohol (ethanol), e.g., some cough syrups
some anticancer drugs, such as carmustine, cyclophosphamide monohydrate, 5-fluorouracil
or busulfan
phenytoin, a drug used to treat convulsions
phenobarbital (phenobarbitone), a medicine for convulsions or sedation
cimetidine, a medicine used to treat gastric reflux and ulcers
lithium, a medicine used to treat manic depressive illness and some other types of
depression
cyclosporin, a medicine used to prevent organ transplant rejection or to treat immune
responses
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Flagyl S.
You may need different amounts of your medicine or you may need to take different
medicines. Your doctor will advise you.
Your doctor and pharmacist may have more information on medicines to be careful with
or avoid while taking Flagyl S.
4. How do I use Flagyl S?
Follow all directions given to you by your doctor and pharmacist carefully. They may
differ from the information contained in this CMI.
If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.
How much to use
The dose will vary from patient to patient. Your doctor will decide the right dose
for you.
Follow the instructions provided when Flagyl S was prescribed, including the number
of days it should be taken.
How long to use
For treating infection, Flagyl S suspension is usually taken for 7 days, however,
your doctor may decide to reduce or extend your treatment. Your doctor will tell you
how much Flagyl S to take.
How to take Flagyl S suspension
Flagyl S suspension should be taken at least one hour before a meal or food.
This medicine works better if taken on an empty stomach.
If you forget to use Flagyl S
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to. Otherwise, take it as soon as you remember, then go back
to taking it as you would normally.
Do not take a double dose to make up for the dose you missed.
If you have trouble remembering to take/use Flagyl S, ask your pharmacist for some
hints.
If you use too much Flagyl S
If you think that you have used too much Flagyl S, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
Australia 13 11 26)
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.
If you take too much suspension you may experience vomiting and a feeling of disorientation.
5. What should I know while using Flagyl S?
Things you should do
Call your doctor straight away if:
the symptoms of your infection do not improve or become worse
you become pregnant
you are about to start taking any new medicines
Some people being treated with metronidazole can experience mental health problems
such as irrational thoughts, hallucinations, feeling confused or feeling depressed,
including thoughts of self-harm or suicide.
These symptoms can occur even in people who have never had similar problems before.
If you or others around you notice any of these side effects stop taking this medicine
and seek medical advice straight away.
If you get a sore, white mouth or tongue while taking or soon after stopping Flagyl
S treatment, tell your doctor. Also tell your doctor if you get vaginal itching or
discharge.
This may mean you have a fungal/yeast infection called thrush. Sometimes the use of
Flagyl S allows fungi/yeast to grow and the above symptoms to occur. Flagyl S does
not work against fungi/yeast.
If you are using Flagyl S for 10 days or longer, make sure you have any tests of your
blood and nervous system that your doctor may request.
If you need to have a blood test while using Flagyl S, tell your doctor as Flagyl
S may affect the results of some laboratory tests.
Remind any doctor, dentist or pharmacist you visit that you are using Flagyl S.
Things you should not do
Do not give Flagyl S to anyone else, even if they have the same condition as you.
Do not use Flagyl S to treat any other medical complaints unless your doctor tells
you to.
Do not stop taking your suspension if you feel better.
If you do not complete the full course prescribed by your doctor, all of the bacteria/organisms
causing your infection may not be killed. These bacteria/organisms may continue to
grow and multiply so that your infection may not clear completely or may return.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Flagyl
S affects you.
While using Flagyl S you may feel dizzy or experience vertigo (spinning sensation),
confused, hallucinations (see or hear things that are not there), convulsions (have
fits) or temporary eyesight problems (such as blurred or double vision). If this happens,
do not drive or use any machinery or tools.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may make you feel very sick, vomit, have stomach cramps, headaches and flushing.
Do not drink alcohol during (and for 24 hours after stopping) treatment with Flagyl
S.
Looking after your medicine
Keep Flagyl S suspension in a cool dry place where the temperature stays below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store in a cool dry place away from moisture, heat or sunlight; for example, do not
store it:
in the bathroom or near a sink, or
in the car or on window sills
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
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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General
joint pain
Mouth-related
oral thrush - white, furry, sore or inflamed tongue and mouth
dry mouth
Ear-related
hearing problems
Urinary disorders
unusual urination patterns (e.g., difficulty in passing urine, large amounts of urine,
incontinence, or pus in urine)
Respiratory related
stuffy nose, nasal congestion
Gastrointestinal
nausea, which may be accompanied by headache, loss of appetite, and vomiting
diarrhoea, stomach discomfort, abdominal cramping or constipation, strange taste in
mouth
Central nervous system-related
confusion, irritability, depression, or sleeplessness
convulsions, dizziness, weakness, feeling of incoordination or uncoordinated movements
vertigo (spinning sensation)
Heart-related
Changes in electrical activity of the heart seen on an Electrocardiogram (QT prolongation)
has been observed particularly when metronidazole was administered with drugs with
potential to prolong QT interval.
Skin-related
skin rashes, flushing, itching
Eye-related
eye problems, including blurred or double vision
Liver-related
yellowing of the skin or eyes, which may be jaundice
Gynecological
vaginal thrush - sore and itchy vagina and/or discharge
dryness of the vagina or vulva
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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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Allergic reaction. Some symptoms of an allergic reaction include skin rash, itching,
shortness of breath or swelling of the face, lips or tongue, which may cause difficulty
in swallowing or breathing.
If you have been on prolonged Flagyl S therapy you may experience unusual numbness
of the feet or hands.
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Stop using Flagyl S, and tell your doctor immediately
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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 effect you experience, you can
report side effects as follows:
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.
7. Product details
This medicine is only available with a doctor's prescription.
What Flagyl S contains
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Active ingredient
(main ingredient)
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Flagyl S - 200 mg -metronidazole benzoate/5 mL of liquid
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Other ingredients
(inactive ingredients)
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Flagyl S suspension also contains monobasic sodium phosphate, aluminium magnesium
silicate, sucrose, methyl and propyl hydroxybenzoate, ethanol, natural soluble lemon
flavour 50 06-0404, orange oil terpeneless.
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Do not take this medicine if you are allergic to any of these ingredients.
What Flagyl S looks like
There are three forms of Flagyl: Flagyl tablets, Flagyl S suspension and Flagyl suppositories.
Flagyl tablets and suppositories are covered by a separate CMI.
Flagyl S suspension (Aust R 27501) is a creamy white to yellow liquid with an orange/lemon
odour in a 100 mL bottle.
Who distributes Flagyl S
Flagyl S is supplied in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Australia
Freecall No: 1800 818 806
This leaflet was prepared in March 2022.
flagyl S-ccdsv17-cmiv12-31mar22