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 METROGYL?
METROGYL contains the active ingredient metronidazole. METROGYL is used to 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 METROGYL?
Do not use if you have ever had an allergic reaction to METROGYL 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 METROGYL and affect how it works.
4. How do I use METROGYL?
Follow the instructions provided and use METROGYL until your doctor tells you to stop.
5. What should I know while using METROGYL?
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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 METROGYL 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 METROGYL
affects you.
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Drinking alcohol
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Do not drink alcohol or consume any medication containing alcohol while using METROGYL
and for at least 24 hours after stopping treatment.
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Looking after your medicine
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Keep METROGYL in a cool dry place where the temperature stays below 30°C. Protect
from light.
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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 METROGYL
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.
Active ingredient(s):
metronidazole
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using METROGYL. 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 METROGYL.
Where to find information in this leaflet:
1. Why am I using METROGYL?
METROGYL contains the active ingredient metronidazole. METROGYL is an antibiotic that belongs to a group of medicines called nitroimidazoles.
METROGYL 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 METROGYL for another reason.
Ask your doctor if you have any questions about why METROGYL 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 METROGYL?
Warnings
Do not use METROGYL if:
you are allergic to metronidazole, 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 METROGYL.
If you have not told your doctor or pharmacist about any of the above, tell them before
you start using METROGYL.
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 METROGYL and affect how 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 METROGYL.
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 METROGYL.
4. How do I use METROGYL?
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 take
The dose will vary from patient to patient. Your doctor will decide the right dose
for you.
Follow the instructions provided when METROGYL was prescribed, including the number
of days it should be taken.
How long to use
For treating infection, METROGYL tablets are usually taken for 7 days, however, your
doctor may decide to reduce or extend your treatment. Your doctor will tell you how
much METROGYL to take.
How to take METROGYL
Swallow METROGYL tablets whole with a glass of water, preferably during or after a
meal.
Do not chew the tablets.
This may help reduce the possibility of stomach upset.
If you forget to take METROGYL
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 METROGYL, ask your pharmacist for some hints.
If you use too much METROGYL
If you think that you have used too much METROGYL, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(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.
If you take too many tablets you may experience vomiting and a feeling of disorientation.
5. What should I know while using METROGYL?
Things you should do
Call your doctor straight away if you:
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 METROGYL
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
METROGYL allows fungi/yeast to grow and the above symptoms to occur. METROGYL does
not work against fungi/yeast.
If you are using METROGYL 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 METROGYL, tell your doctor as METROGYL
may affect the results of some laboratory tests.
Remind any doctor, dentist or pharmacist you visit that you are using METROGYL.
Things you should not do
Do not give METROGYL to anyone else, even if they have the same condition as you.
Do not use METROGYL to treat any other medical complaints unless your doctor tells
you to.
Do not stop taking your tablets 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 METROGYL
affects you.
While using METROGYL 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 METROGYL.
Looking after your medicine
Keep METROGYL tablets in the bottle until it is time to use them. If you take tablets
out of the bottle, they may not keep well.
Keep METROGYL tablets in a cool dry place where the temperature stays below 30°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it 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
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.
7. Product details
This medicine is only available with a doctor's prescription.
What METROGYL contains
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Active ingredient
(main ingredient)
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Metronidazole 200 mg or 400 mg
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Other ingredients
(inactive ingredients)
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lactose monohydrate
disodium edetate
ethylcellulose
sodium starch glycollate
colloidal anhydrous silica
guar gum
magnesium stearate
quinoline yellow aluminium lake (METROGYL 400 only)
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Potential allergens
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galactose
sulfites
sugars as lactose
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Do not take this medicine if you are allergic to any of these ingredients.
What METROGYL looks like
METROGYL 200 (AUST R 17654) is a 11 mm, normal convex, white tablet debossed “MZ/200”
on one side and “G” on the other side. Available in pack sizes of 21 tablets or 250
tablets (hospital use only)
METROGYL 400 (AUST R 17655) is a 12.5 mm, normal convex, pale yellow tablet debossed
“MZ/400” on one side and “G” on the other side. Available in pack size of 21 tablets.
Who distributes METROGYL
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in March 2023.
METROGYL® is a Viatris company trade mark
METROGYL_cmi\Mar23/00