Metronidazole

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Metronidazole
CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common questions about Metronidazole Intravenous Infusion. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking Metronidazole Intravenous Infusion against the benefits this medicine is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet.
You may need to read it again.

What METRONIDAZOLE INTRAVENOUS INFUSION is used for

This medicine is used to treat
serious infections caused by bacteria and other organisms when metronidazole cannot be given orally
prevent certain infections that may occur during surgery
This medicine is an antibiotic.
This medicine works by killing or stopping the growth of bacteria and other organisms causing these infections.
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 not addictive.
This medicine is available only with a doctor's prescription.

Before you are given METRONIDAZOLE INTRAVENOUS INFUSION

When you must not be given it

Do not use Metronidazole Intravenous Infusion if:
you have an allergy to any medicine containing metronidazole, any other medicines used to treat infections or any of the ingredients listed at the end of this leaflet
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.
you have or have had a blood disorder
you have a disease or disorder involving the brain, spinal cord or nerves
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:
blood disease or history of blood disease
disease or disorder involving the brain, spinal cord or nerves
liver disease or any liver problems
heart disease or any heart problems
any kidney problems
Crohn's disease, an inflammatory disease of the intestines
Cockayne syndrome
Tell your doctor if you drink alcohol.
Do not drink alcohol during (and for one day after stopping) treatment with metronidazole.
Tell your doctor if you are on a low sodium diet.
Tell your doctor if you are pregnant or intend to become pregnant.
Metronidazole may affect your developing baby if you use it during pregnancy. Your doctor will discuss the risks and benefits of using metronidazole during pregnancy.
Tell your doctor if you are breast-feeding or intend to breast-feed.
Metronidazole passes into breast milk and may affect your baby. The use of metronidazole is not recommended while breast- feeding. Your doctor will discuss the risks and benefits of using it when breast-feeding.
If you have not told your doctor about any of the above, tell your doctor before you are given Metronidazole Intravenous Infusion.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Metronidazole Intravenous Infusion may interfere with each other. These include:
disulfiram, a medicine used to treat chronic alcohol dependence
some anticancer drugs such as carmustine, cyclophosphamide fluorouracil, 5-fluorouracil and busulfan
warfarin or other medicines used to prevent blood clots
phenytoin, a medicine used to treat convulsions
phenobarbitone, a medicine to treat convulsions or for sedation
cimetidine, a medicine used to treat ulcers
corticosteroids such as prednisone or cortisone
lithium, a medicine used to treat some types of depression
azathioprine, a medicine used to suppress the immune system
cyclosporin, a medicine used to prevent organ transplant rejection or to treat immune responses
These medicines may be affected by Metronidazole Intravenous Infusion or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Do not drink alcohol while you are being given Metronidazole Intravenous Infusion.
Metronidazole and alcohol together can cause abdominal cramps, nausea, vomiting, headaches and flushing.
Talk to your doctor about the need for an additional method of contraception while you are being given metronidazole.
Some antibiotics may decrease the effectiveness of some birth control pills, although this has not been shown with metronidazole.
Your doctor or pharmacist may have more information on medicines to be careful with or avoid while taking metronidazole.

How METRONIDAZOLE INTRAVENOUS INFUSION is given

Metronidazole Intravenous Infusion is given by injection into a vein. Metronidazole Intravenous Infusion must only be given by a doctor or nurse.
Your doctor will decide what dose and how long you will receive Metronidazole Intravenous Infusion. This will depend on your age, weight, type of infection and how well your kidneys and liver are working. However, the usual adult dose of Metronidazole Intravenous Infusion is 500mg every eight hours for the course of treatment, as decided by your doctor.

If you are given too much (overdose)

As Metronidazole Intravenous Infusion is usually given to you in hospital or clinic, it is very unlikely that you will receive an overdose. However, if you are given too much metronidazole, you may experience some of the effects listed under "Side Effects" below.
Contact Poisons Information Centre (telephone 13 11 26) for advice or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have been given too much Metronidazole Intravenous Infusion.

While you are given METRONIDAZOLE INTRAVENOUS INFUSION

Things you must do

If the symptoms of your infection do not improve or if they become worse, tell your doctor.
If you get severe diarrhoea tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after Metronidazole Intravenous Infusion 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 while using or soon after stopping Metronidazole Intravenous Infusion, tell your doctor. Also tell your doctor if you get vaginal itching or discharge.
This may mean you have a fungal infection called thrush. Sometimes the use of Metronidazole Intravenous Infusion allows fungi to grow and the above symptoms to occur. Metronidazole Intravenous Infusion does not work against fungi.
If you become pregnant while you are being treated with Metronidazole Intravenous Infusion tell your doctor immediately.
If you are using Metronidazole Intravenous Infusion for 10 days or longer, make sure you have any tests of your blood and nervous system that your doctor may request.
If you are about to start using any new medicine, tell your doctor and pharmacist that you are being treated with Metronidazole Intravenous Infusion.
If you need to have any blood tests tell your doctor you are being given Metronidazole Intravenous Infusion.
Metronidazole Intravenous Infusion may affect the results of some blood tests.
Tell all the doctors, dentists and pharmacists that you are being treated with Metronidazole Intravenous Infusion.

Things you must not do

Do not drink any alcohol or any alcoholic drinks while being treated with (and for at least one day after stopping) Metronidazole Intravenous Infusion.
The use of alcohol with Metronidazole Intravenous Infusion may make you feel sick, vomit or have stomach cramps, headaches or flushing.

Things to be careful of

Be careful driving or operating machinery until you know how Metronidazole Intravenous Infusion affects you.
This medicine may cause dizziness, confusion, hallucination (hearing or seeing strange or unusual things), convulsions (“fits”) or affect how you see things.

Side effects

Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while you are using metronidazole.
Like other medicines, metronidazole can cause some side effects. If they occur, most are likely to be minor or temporary. However, some may be serious and need medical attention.
Ask your doctor or pharmacist to answer any questions that you may have.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Tell your doctor if you notice any of the following and they worry you:
nausea, vomiting, loss of appetite
constipation/diarrhoea
abdominal pain, indigestion or discomfort
metallic or unpleasant taste in the mouth
swollen red or sore tongue
sore, red mouth
ulcers or cold sores
oral thrush - white, furry, sore tongue and/or mouth
vaginal thrush - sore and itchy vagina and/or discharge
dryness of the mouth, vagina or genitals
loss of sex drive or painful sex
joint pains
nasal congestion
Tell your doctor or nurse as soon as possible if you notice any of the following:
confusion, irritability, depression, disorientation
clumsiness, lack of co-ordination, problems with moving or balancing
difficulty in speaking
headache, stiff neck and extreme sensitivity to bright light
problems with sleeping
fits or seizures
dizziness or spinning sensation
ringing/ persistent noise in the ears (tinnitus) or other hearing problems
blurred/ double vision or other eye problems
yellowing of the eyes/skin or flushing
swelling or redness along the vein which is extremely tender when touched
pain when passing urine or passing more urine than normal
blood or pus in the urine, darker urine
loss of control of your bladder or bowels
feeling of pressure around the pelvis
sore back passage, sometimes with bleeding or discharge
These may be serious side effects. You may need medical attention.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
rash, itchiness, hives
swelling of the face, lips, mouth, throat or neck which may cause difficulty swallowing or breathing
tingling or numbness of the hands or feet, pins and needles or muscle weakness
severe blisters and bleeding in the lips, eyes, mouth, nose and genitals
signs of frequent infections such as fever, severe chills, sore throat or mouth ulcers
severe abdominal cramps or stomach cramps
watery and severe diarrhoea, which may also be bloody
These are very serious side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some patients.
Some of these side effects (changes in the liver, levels of blood cells or changes in heart rhythm) can only be found when your doctor does tests from time to time to check your progress.

Storage

Metronidazole Intravenous Infusion will be stored in the pharmacy or on the ward. The infusion is kept in a cool dry place, protected from light, where the temperature stays below 25°C.

Product Description

What it looks like

Metronidazole Intravenous Infusion is a clear, almost colourless to pale yellow solution in a glass vial.

Ingredients

Metronidazole Intravenous Infusion contains 500 mg of metronidazole as the active ingredient.
The intravenous infusion also contains:
citric acid
dibasic sodium phosphate
sodium chloride
water for Injections
It does not contain preservatives.

Supplier

Metronidazole intravenous infusion is supplied in Australia by:
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizer.com.au

Australian Registration Numbers

Metronidazole intravenous infusion 500 mg in 100 mL (sterile) glass vial, available as 10 vials per pack.
AUST R 12728

Date of Preparation

This leaflet was prepared in
February 2020.
© Pfizer Australia Pty Ltd