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 Zidoval?
Zidoval contains the active ingredient metronidazole. Zidoval is used to treat vaginal
infections (bacterial vaginosis) caused by certain bacteria.
2. What should I know before I use Zidoval?
Do not use if you have ever had an allergic reaction to metronidazole 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 Zidoval and affect how it works.
4. How do I use Zidoval?
Use one applicator filled with Zidoval gel. Apply at bedtime
Follow the instructions provided in the package insert on how to apply your dose of
Zidoval.
5. What should I know while using Zidoval?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Zidoval.
Tell your doctor immediately if you become pregnant whilst using Zidoval.
If you are about to have a blood test, tell your doctor you are using Zidoval.
Avoid sexual intercourse while you have a vaginal infection and when using Zidoval.
After completing a course of Zidoval, see your doctor to confirm that the infection
has cleared up.
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Things you should not do
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Zidoval is for vaginal use only. Do not use it any other way.
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Driving or using machines
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Whilst Zidoval is not expected to affect your ability to drive or operate machinery,
be careful with these activities until you know how Zidoval how affects you.
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Drinking alcohol
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Discuss with your doctor whether you may drink alcohol during treatment with Zidoval.
Drinking alcohol when using Zidoval may make you feel dizzy or sick.
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Looking after your medicine
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Store Zidoval in a cool dry place below 25°C.
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6. Are there any side effects?
Common side effects include nausea and vomiting, upset stomach or pain, vaginal discharge,
vaginal or vulval irritation, yeast infection, pelvic discomfort, unpleasant taste
or feeling on the tongue, decreased appetite, dizziness, headache. Serious side effects
include allergic reaction, darkened urine, yellowing of the skin or eyes and seizures.
Active ingredient:
Metronidazole
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Zidoval. 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 Zidoval.
Where to find information in this leaflet:
1. Why am I using Zidoval?
Zidoval contains the active ingredient metronidazole. Zidoval is an antibacterial agent used to kill certain bacteria.
Zidoval is used to treat vaginal infections (bacterial vaginosis) caused by certain
bacteria.
It is not suitable for all types of vaginal infections. By applying Zidoval directly
into the vagina, it can kill the bacteria at the site of the infection.
2. What should I know before I use Zidoval?
Warnings
Do not use Zidoval if:
you are allergic to metronidazole, other nitroimidazole derivatives or any of the
ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine
the packaging is torn or shows signs of tampering.
Check with your doctor if you:
have any allergies to any other medicines, foods, preservatives or dyes
have any other medical conditions including a disease of the blood, liver, kidneys,
or central nervous system
have a condition called Cockayne syndrome, also called Neill-Dingwall syndrome
have, or think you have vaginal thrush (candidiasis). The symptoms of vaginal thrush
may become more noticeable when you use Zidoval, and you may need another treatment
from your doctor for this.
take any medicines for any other condition
are having your period or are about to start your period. Your doctor may wait until
your period is finished before commencing treatment.
have taken disulfiram (Antabuse) in the past 2 weeks. Disulfiram is used to help people
who have a drinking problem. If disulfiram and Zidoval are taken closely together,
serious unwanted effects may occur.
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
Talk with your doctor if you are pregnant or breastfeeding.
Metronidazole crosses the placenta and may harm your unborn baby.
Your doctor can discuss with you benefits and risks of taking Zidoval while you are
pregnant or breastfeeding.
Use in Children
Do not give Zidoval to a child under 12 years of age. Safety and effectiveness of
Zidoval have not been established in this age group.
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 Zidoval and affect how it works including:
medicines to prevent blood clotting (e.g., warfarin)
lithium
cyclosporin
5-fluorouracil
carmustine (BCNU) or cyclophosphamide
disulfiram.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Zidoval.
4. How do I use Zidoval?
How much to use
Each dose consists of one applicator filled with 5 g of Zidoval gel.
Apply Zidoval for 5 days in a row or for as long as your doctor tells you.
To help prevent reinfection, always complete the full course even if your symptoms
start to clear up within a few days.
When to use Zidoval
Use Zidoval at bedtime
Vaginal medicines can leak out of the vagina during treatment. Using Zidoval at bedtime
will help reduce leakage.
Wear a panty liner or sanitary napkin during treatment to help keep Zidoval from getting
onto your clothes. Do not use tampons as they may soak up the medicine and stop you
receiving the full dose.
How to apply Zidoval
Your box of Zidoval contains a tube of vaginal gel and five single use vaginal applicators.
To ensure maximum hygiene always:
wash your hands before opening the tube or touching the applicator
use a new applicator for each dose
dispose of the used applicator in the rubbish bin.
Opening the tube
Before using Zidoval for the first time, puncture the metal seal on the tube. To do
this, unscrew the cap from the tube and pierce the seal using the pointed tip of the
cap.
Filling the applicator
Step 1:
Remove an applicator from its wrapper. Unscrew the cap from the tube and screw the
open end of the applicator onto the tube.
Step 2:
Squeeze the tube slowly from the bottom to fill the applicator with gel. The plunger
will move as the applicator fills and will stop moving when the applicator contains
the correct amount of gel.
Step 3:
Unscrew the applicator and replace the cap on the tube.
Inserting the applicator
Hold the filled applicator by its barrel and gently insert it into your vagina as
far as it will comfortably go.
You may find it easiest to do whilst lying on your back with your knees bent. Otherwise
choose any position you find comfortable.
Applying the gel
Slowly press the plunger to deposit the gel into your vagina. Continue pressing until
the plunger stops. This will ensure you have released the correct amount of gel. Remove
the applicator from the vagina and put it in the rubbish bin.
If you forget to use Zidoval
Zidoval should be used regularly at the same time each day. If you miss your dose
at the usual time, use it as soon as you remember and continue with your treatment
as before.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you use too much Zidoval
If you think that you have used too much Zidoval, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), 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.
5. What should I know while using Zidoval?
Things you should do
Call your doctor straight away if you:
become pregnant while using this medicine.
Remind any doctor, dentist, or pharmacist you visit that you are using Zidoval.
If you going to have surgery, tell the surgeon or anaesthetist that you are using
Zidoval.
If you are about to have a blood test, tell you doctor that you are using Zidoval.
It may interfere with the results of some tests.
Avoid sexual intercourse during the infection and whilst you are using Zidoval.
Zidoval contains ingredients that may cause burning or irritation of the eye. If you
accidentally get Zidoval in your eye, rinse the eye immediately with plenty of cool
tap water.
After you have finished your course of Zidoval, see your doctor to check your progress.
This is to ensure that the infection has cleared up.
Things you should not do
Zidoval is for vaginal use only. Do not use it in any other way.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop using Zidoval or change the dose with checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Zidoval
affects you.
Whilst Zidoval is not expected to affect your ability to drive or use machinery, caution
is appropriate.
Tell your doctor if you drink alcohol.
Drinking alcohol during treatment with Zidoval may make you feel dizzy or sick.
Looking after your medicine
Follow the instructions on the carton on how to take care of your medicine properly.
Store Zidoval below 25°C 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
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 Zidoval contains
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Active ingredient
(main ingredient)
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Metronidazole
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Other ingredients
(inactive ingredients)
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Carbomer 974P
Propylene glycol
Methyl hydroxybenzoate
Propyl hydroxybenzoate
Disodium edetate
Sodium hydroxide
Purified water
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Potential allergens
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Methyl hydroxybenzoate
Propyl hydroxybenzoate
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Do not take this medicine if you are allergic to any of these ingredients.
What Zidoval looks like
Zidoval is a colourless to straw-coloured gel contained in an aluminium tube. Each
5 g of Zidoval vaginal gel (one full applicator) contains 37.5 mg of metronidazole
as the active ingredient.
Registration number: AUST R 73743.
Who distributes Zidoval
iNova Pharmaceuticals (Australia) Pty Limited
ABN: 13 617 871 539
Level 10, 12 Help Street
Chatswood NSW 2067
Tel: 1800 630 056
This leaflet was prepared in November 2022.