Flagyl(R)
Metronidazole 200 & 400 mg tablets
Metronizadole benzoate 200 mg/5 mL oral suspension
Metronidazole 500 mg suppositories
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Flagyl.
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 taking or using Flagyl against the expected benefits they will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Flagyl is used for
Flagyl 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.
Flagyl is an antibiotic which belongs to a group of medicines called nitroimidazoles.
This medicine works by killing or stopping the growth of bacteria and other organisms causing these infections.
Your doctor may have prescribed Flagyl for another reason.
Ask your doctor if you have any questions about why Flagyl has been prescribed for you.
This medicine is available only with a doctor`s prescription.
Before you take or use Flagyl
When you must not take/use it
Do not take or use Flagyl if you have ever had an allergic reaction to:
Flagyl or any other nitroimidazoles
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of allergic reaction may include wheezing, difficulty in breathing, itching, runny nose, skin rash.
Do not take or use Flagyl if
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 take 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.
If you are not sure whether to start taking or using Flagyl, talk to your doctor.
Before you start to take it or use it
You must tell your doctor if you have any allergies to any other medicines or any other substances such as foods, preservatives or dyes.
Tell your doctor if you 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).
you drink alcohol.
Do not drink alcohol during (and for 24 hours after stopping) treatment with Flagyl.
you plan to become pregnant or breastfeed
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking/using Flagyl.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines you buy without prescription from a pharmacy, supermarket or health food shop.
Some medicines may interfere with Flagyl. These include:
warfarin, a medicine used to prevent blood clots
Antabuse(R), a medicine used to treat chronic alcohol dependence
some anticancer drugs, such as BCNU or cyclophosphamide or 5-fluorouracil
phenytoin, a drug used to treat convulsions
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
alcohol.
These medicines may be affected by Flagyl 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 will advise you.
Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking Flagyl.
How to take or use Flagyl
Follow all directions given to you by your doctor and pharmacist carefully
They may differ from the information contained in this leaflet.
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.
How to take Flagyl tablets
Swallow Flagyl 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.
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.
How to use FLAGYL suppositories
Your doctor will tell you how many suppositories you need to use each day.
If possible, go to the toilet and empty your bowels before using your suppository.
Suppositories work best if your bowels are empty.
Follow these steps to use Flagyl suppositories:
1.Wash your hands thoroughly with soap and water.
2.Feel the suppository while it is still in the foil.
3.If it feels soft, keep it in the foil/plastic, chill it in the fridge or by holding it under cold water for a few minutes. Do not remove the foil/plastic wrapper while you are chilling it.
4.Put on a disposable glove, if desired (available from a pharmacy).
5.Remove all of the foil/plastic wrapper from the suppository.
6.Moisten the suppository by dipping it briefly in cool water.
7.Lie on your side and raise your knee to your chest.
8.Push the suppository (blunt end first) gently into your rectum (back passage).
9.Remain lying down for a few minutes so that the suppository dissolves.
10.Throw away used materials and wash your hands thoroughly.
Try not go to the toilet and open your bowels for at least an hour after inserting the suppository.
The suppository takes about one hour to be completely absorbed and do its work.
If you are not sure how to use a suppository, ask your doctor or pharmacist.
How long to take or use it
For treating infection Flagyl tablets and suspension are usually taken for 7 days, however, your doctor may decide to reduce or extend your treatment. Your doctor will tell you how much Flagyl to take.
Flagyl suppositories are usually used for a short time after surgery. Your doctor may replace your suppositories with oral tablets or suspension as soon as possible.
Do not stop taking your tablets or suspension or using your suppositories 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.
If you forget to take or use it
If you are taking more than a single dose of Flagyl, and 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 Flagyl, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 131126) or go to casualty at your nearest hospital if you think that you, or anyone else, has taken too much Flagyl, even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep these telephone numbers handy.
If you take too many tablets or too much suspension you may experience vomiting and a feeling of disorientation.
While you are taking or using Flagyl
Things you must do
Tell your doctor immediately if:
the symptoms of your infection do not improve or become worse
you become pregnant
you are about to start taking any new medicines.
If you get a sore, white mouth or tongue while taking or soon after stopping Flagyl 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 allows fungi/yeast to grow and the above symptoms to occur. Flagyl does not work against fungi/yeast.
If you are taking Flagyl 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 taking Flagyl, tell your doctor as Flagyl may affect the results of some laboratory tests.
Tell all doctors, dentists and pharmacists who are treating you that you are taking Flagyl.
Things you must not do
Do not drink alcohol or any alcoholic drinks while taking Flagyl and for at least one day after finishing treatment.
The use of alcohol may make you feel very sick, vomit, have stomach cramps, headaches and flushing.
Do not stop taking or using your medicine because you are feeling better, unless advised by your doctor.
If you do not take all of the medicine 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.
Do not give Flagyl to anyone else, even if they have the same condition as you.
Do not use Flagyl to treat any other medical complaints unless your doctor tells you to.
Things to be careful of
Be careful driving or operating machinery until you know how Flagyl affects you.
Side Effects
Tell your doctor as soon as possible if you have any problems while taking or using Flagyl, even if you do not think the problem is connected with the medicine or is not listed in this leaflet.
As with most medications, Flagyl can sometimes cause unwanted 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.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
oral thrush - white, furry, sore or inflamed tongue and mouth
vaginal thrush - sore and itchy vagina and/or discharge
nausea, which may be accompanied by headache, loss of appetite, and vomiting
diarrhoea, stomach discomfort, abdominal cramping or constipation, strange taste in mouth
convulsions, dizziness, weakness, feeling of incoordination or uncoordinated movements
confusion, irritability, depression or sleeplessness
skin rashes, flushing, itching
stuffy nose, dry mouth, nasal congestion, dryness of the mouth (or vagina or vulva)
unusual urination patterns (e.g. difficulty in passing urine, large amounts of urine, incontinence, or pus in urine)
joint pain
If you have been on prolonged Flagyl therapy, and experience any unusual numbness of the feet or hands, stop taking or using Flagyl, and tell your doctor immediately.
Other side effects not listed above may also occur in some patients.
Tell your doctor as soon as possible if you notice any other effects.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
After using Flagyl
Storage
Keep Flagyl tablets/suppositories in the blister pack until it is time to take them.
If you take the tablets/suppositories out of the blister pack, they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 30 degrees C.
Keep your suspension in a cool dry place where the temperature stays below 25 degrees C
Keep your suppositories in the fridge between 2 degrees C and 8 degrees C. Do not freeze.
Do not store them or any other medicine in the bathroom or near a sink.
Do not leave them in the car or on windowsills.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metre above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking Flagyl, or the medicines have passed their expiry date, ask your pharmacist what to do with any medicine that is left over.
Product Description
What it looks like
There are three forms of Flagyl: Flagyl tablets, Flagyl S supension and Flagyl suppositories.
Flagyl tablets come in two strengths.
Flagyl 200 mg - round, white, with a break bar, marked FLAGYL on one side. A box contains 21 tablets.
Flagyl 400 mg - round, white, with a break bar, marked FLAGYL 400 on one side. A box contains 21 tablets
Flagyl S suspension is a creamy white to yellow liquid with an orange/lemon odour in a 100 mL bottle.
Flagyl suppositories are smooth cream coloured and torpedo-shaped. They are packed in a blister and a carton pack contains 10 suppositories.
Ingredients
Active Ingredient
Flagyl 200 - 200 mg metronidazole/tablet
Flagyl 400 - 400 mg of metronidazole/tablet
Flagyl S - 200 mg of metronidazole benzoate/5 mL of liquid
Flagyl suppositories - 500 mg of metronidazole/suppository.
Inactive Ingredients
Flagyl 200 mg tablets also contain calcium carbonate, starch-wheat, microcrystalline cellulose, magnesium stearate, methyl hydroxybenzoate, sodium lauryl sulfate.
Flagyl 400 mg tablets also contain calcium carbonate, starch-maize, microcrystalline cellulose, sodium hydroxide, methyl hydroxybenzoate, potassium phosphate (monobasic), stearic acid powder, sodium lauryl sulfate.
Flagyl S suspension also contains sodium phosphate - dibasic dihydrate, aluminium magnesium silicate, sucrose, methyl and propyl hydroxybenzoate, ethanol, lemon no. 1 NA, oil orange terpeneless, water -purified.
Flagyl suppositories also contain suppository base E75 and W35.
Flagyl is supplied in Australia by:
Aventis Pharma Pty Ltd
27 Sirius Rd
Lane Cove NSW 2066
Australia
This leaflet was prepared in February 2004
Australian Registration Number:
Flagyl 200mg tablet: AUST R 27497
Flagyl 400mg tablet: AUST R 47090
Flagyl S suspension: AUST R 27501
Flagyl suppositories: AUST R 27499
