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Zidoval

Metronidazole 0.75%
Consumer Medicine Information
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Zidoval. It does not contain all the information that is known about Zidoval. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What Zidoval Vaginal Gel is used for

Zidoval Vaginal Gel contains an active ingredient, metronidazole. Metronidazole is an antibacterial agent.
Zidoval Vaginal Gel is used to treat infection of the vagina (bacterial vaginosis) caused by certain bacteria. It is not suitable for all types of vaginal infections. By applying Zidoval Vaginal Gel directly into the vagina, metronidazole can kill the bacteria at the site of the infection.
Zidoval Vaginal Gel is not recommended for use in children (under the age of 12 years), as there have been no studies of its effects in children.
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 available only with a doctor's prescription.
This medicine has been prescribed by your doctor for you only. Do not let someone else use it, as it may be harmful to them.

Before you use Zidoval Vaginal Gel

When you must not use it

Do not use Zidoval Vaginal Gel if you have an allergy to:
any medicine containing metronidazole
any of the ingredients listed at the end of this leaflet.
Some of the 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 on the skin
Do not give this medicine to a child under the age of 12 years.
Safety and effectiveness in children younger than 12 years have not been established.
Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to use 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:
a disease of the blood, liver, kidneys or central nervous system
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell him/her before you start using Zidoval Vaginal Gel.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Zidoval Vaginal Gel may interfere with each other. These include:
medicine to prevent blood clotting (e.g. Warfarin)
lithium or disulfiram or cyclosporin or 5-fluorouracil
Carmustine (BCNU) or cyclophosphamide
These medicines may be affected by Zidoval Vaginal Gel or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.
Before using Zidoval Vaginal Gel, discuss with your doctor whether you may consume alcohol while using Zidoval. There have been reports of unpleasant reaction (flushing, headache, feeling of being sick, fast heart beat) associated with drinking alcohol whilst taking metronidazole tablets by mouth. However, when using Zidoval by vaginal application, only very small amounts of metronidazole are getting into the blood, making any reaction with alcohol unlikely, although it cannot be ruled out.

How to use Zidoval Vaginal Gel

Follow all directions given to you by your doctor or 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 use

Disposable applicators are provided to help you apply the gel into the vagina. When filled with gel, each applicator contains one single dose (5g) of Zidoval Vaginal Gel.
Insert one applicator full of Zidoval Vaginal Gel into the vagina at bed time. Repeat this procedure using a new applicator at bedtime for 5 consecutive days or as directed by your doctor

How to use it

Your tube of Zidoval Vaginal Gel is packed in a box which also contains five disposable (throw away) 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
Immediately throw away the used applicator in the waste bin
Opening the tube
Before using Zidoval Vaginal Gel for the first time, you will need to puncture the metal seal on the tube. To do this, simply 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 the 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 this whilst lying on your back with your knees bent; alternately, 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 throw it in the waste bin immediately.

When to use it

Insert one applicator full of Zidoval Vaginal Gel into the vagina at bed time.
Use your medicine at about the same time each day.
Using it at the same time each day will have the best effect. It will also help you remember when to use it.

How long to use it

Continue using your medicine for as long as your doctor tells you.
It is important to keep using your medicine as directed by your doctor.

If you forget to use it

If you miss a bed time dose of Zidoval Vaginal Gel, apply the missed dose as soon as you remember the next morning and then continue to use the next dose at bedtime until the full course, as prescribed by your doctor, has been used.
Do not double the dose at any time to make up for the missed dose. If it is almost the time to apply the next dose when you remember that you have missed a dose, skip the missed dose, apply the next dose at bedtime and continue treatment until the full course, as prescribed by your doctor, has been used
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you use too much(overdose)

Immediately telephone your doctor or the 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 taken too much Zidoval Vaginal Gel. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
It is important to keep to the dose as prescribed by your doctor. But if you accidentally apply more than one full applicator of Zidoval Vaginal Gel in one day, there is no need to worry. The use of more than one dose in a day is not expected to cause you any problems, although you may be more likely to experience side effects as described below.
If the cream is accidentally swallowed, contact your nearest hospital casualty department or tell your doctor immediately.

While you are using Zidoval Vaginal Gel

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Zidoval Vaginal Gel.
Tell any other doctors, dentists, and pharmacists who treat you that you are using this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are using this medicine.
It may affect other medicines used during surgery.
If you become pregnant while using this medicine, tell your doctor immediately.
If you start breastfeeding while using this medicine, stop using it and tell your doctor immediately.
If you are about to have any blood tests, tell your doctor that you are using this medicine.
It may interfere with the results of some tests.
Keep all of your doctor's appointments so that your progress can be checked.

Things you must not do

Do not use Zidoval Vaginal Gel to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not stop using your medicine or lower the dosage without checking with your doctor.
If you stop using it suddenly, your condition may worsen or you may have unwanted side effects. If possible, your doctor will gradually reduce the amount you use each day before stopping the medicine completely.
Zidoval Vaginal Gel is for vaginal use only. You should not use it in any other way.

Things to be careful of

Zidoval Vaginal Gel contains ingredients that may cause burning and irritation of the eye. In case of accidental contact with the eye, rinse the eye immediately with plenty of cool tap water.
Be careful when drinking alcohol while you are using this medicine.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Zidoval Vaginal Gel.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following list of side effects. You may not experience any of them.
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:
abnormal vaginal discharge
itching, burning or swelling in or around the vagina
a feeling of increased pressure in the pelvic area
stomach cramp or pain, feeling of being sick, vomiting, unusual taste, diarrhoea (loose stools), reduced appetite, stomach bloating (gas), feeling thirsty, dry mouth
headache, dizziness, feeling depressed
skin itch or rash, feeling tired, darkened urine
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 people.

After using Zidoval Vaginal Gel

Storage

Keep your Zidoval Vaginal Gel and the vaginal applicator together in their box until it is time to use them.
If you take the Zidoval Vaginal Gel out of the pack it may not keep well.
Keep your Zidoval Vaginal Gel in a cool dry place where the temperature stays below 25°C.
Exposure to extreme heat or cold can spoil the gel.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Zidoval Vaginal Gel is a colourless to straw-coloured transparent, slightly hazy gel, packed in an aluminium tube.
Each tube contains 40g of Zidoval Vaginal Gel.

Ingredients

Each 5 g of Zidoval Vaginal Gel (full applicator) contains 37.5 mg of metronidazole as the active ingredient.
Excipients
carbomer 974P
propylene glycol
methyl hydroxy benzoate
propyl hydroxy benzoate
disodium edetate
sodium hydroxide
purified water

Manufacturer/Distributor/ Supplier

Zidoval Vaginal Gel is distributed in Australia by:
iNova Pharmaceutical (Australia) Pty. Limited
Level 10, 12 Help St
Chatswood, NSW 2067
Australia
This leaflet was prepared in Jan 2014
AUST R 73743
Approved PI:
20140106_Zidoval PI