SUMMARY CMI

CHEMISTS' OWN CLOZOLE Vaginal Cream

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 Clotrimazole 1%?

CHEMISTS' OWN CLOZOLE Vaginal Cream contains the active ingredient Clotrimazole 1% and is used to treat vaginal yeast infections such as Candida.

For more information, see Section 1. Why am I using Clotrimazole 1%? in the full CMI.

2. What should I know before I use Clotrimazole 1%?

Do not use if you have ever had an allergic reaction to Clotrimazole 1% 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.

For more information, see Section 2. What should I know before I use Clotrimazole 1%? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Clotrimazole 1% and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Clotrimazole 1%?

• Follow the instructions provided and use Clotrimazole 1% until your doctor tells you to stop.
• Your treatment pack contains a tube of cream containing 35g of Clotrimazole cream and six applicators. 5 grams of cream should be inserted in the vagina daily for six consecutive days.

More instructions can be found in Section 4. How do I use Clotrimazole 1%? in the full CMI.

5. What should I know while using Clotrimazole 1%?

For more information, see Section 5. What should I know while using Clotrimazole 1%? in the full CMI.

6. Are there any side effects?

Call your doctor if your symptoms do not disappear after using this medicine for the full time ordered by your doctor. If you have problems with the following side effects talk with your doctor. Vaginal itching or burning. Increased vaginal discharge.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

CHEMISTS' OWN CLOZOLE Vaginal Cream

Active ingredient(s): Clotrimazole 1%

Consumer Medicine Information (CMI)

This leaflet provides important information about using Clotrimazole 1%. 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 Clotrimazole 1%.

Where to find information in this leaflet:

1. Why am I using Clotrimazole 1%?
2. What should I know before I use Clotrimazole 1%?
3. What if I am taking other medicines?
4. How do I use Clotrimazole 1%?
5. What should I know while using Clotrimazole 1%?
6. Are there any side effects?
7. Product details

1. Why am I using Clotrimazole 1%?

CHEMISTS' OWN CLOZOLE Vaginal Cream contains the active ingredient Clotrimazole 1%. Clotrimazole 1% belongs to a class of drugs called antifungals and is used to treat vaginal yeast infections such as Candida.

Candida infections result from an overgrowth of yeast fungus and cause an imbalance of the natural microorganisms that are present in the vagina. Certain illnesses such as diabetes, obesity, and fatigue can increase the likelihood of infection.

Additionally hormonal changes during pregnancy, during certain times of the menstrual cycle, or due to the oral contraceptive pill, may also increase the chances of infection.

Certain medications such as antibiotics and steroids may cause overgrowth of Candida.

2. What should I know before I use Clotrimazole 1%?

Warnings

Do not use Clotrimazole 1% if:

• you are allergic to Clotrimazole, or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

• have any other medical conditions
• take any medicines for any other condition
• are pregnant or diabetic.

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.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Clotrimazole 1%.

4. How do I use Clotrimazole 1%?

How much to take

• Follow the instructions provided and use Clotrimazole 1% until your doctor tells you to stop.
• Your treatment pack contains a tube of cream containing 35g of Clotrimazole cream and six applicators. 5 grams of cream should be inserted in the vagina daily for six consecutive days.
• This medicine is best used at bedtime unless your doctor tells you otherwise.
• Wash your hands before and after using this medicine.
• Wear only clean cotton underwear.
• Continue using this medicine even if your symptoms disappear. It is important that the entire course is completed as advised for the treatment to be effective.
• Remove cap from the tube of cream. Pierce the diaphragm of tube with piercing end of the cap.
• Screw the open end of the applicator to the tube. Pull the applicator plunger out all the way until it stops.
• Squeeze the tube of cream until the applicator is full.
• The applicator will then hold approximately 5 grams of cream.
• Unscrew the applicator from the tube and replace the cap on the tube.

If you forget to use Clotrimazole 1%

Clotrimazole 1% should be used regularly at the same time each day.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

It is important to complete the course of treatment as incomplete courses may result in your symptoms returning.

Do not take a double dose to make up for the dose you missed.

If you use too much Clotrimazole 1%

If you think that you have used too much Clotrimazole 1%, 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 Clotrimazole 1%?

Things you should do

Remind any doctor, dentist or pharmacist you visit that you are using Clotrimazole 1%.

• If you are pregnant, talk to your doctor before using this medicine.
• Avoid using tampons while using clotrimazole.
• Avoid using douches or other vaginal products unless your doctor advises you to do so.
• Wear freshly washed cotton underpants while using this medicine.

Things you should not do

• Do not stop using this medicine suddenly.
• Do not use this medicine if you have ever had an allergic reaction to Clotrimazole or other antifungals.
• Do not stop using clotrimazole unless your doctor tells you to do so. If you stop using this medicine too soon, your infection may return. See a doctor if problem returns.

Looking after your medicine

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 windowsills.
• Store below 25°C.

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

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 Clotrimazole 1% contains

Do not take this medicine if you are allergic to any of these ingredients.

What CHEMISTS' OWN CLOZOLE Vaginal Cream looks like

CHEMISTS' OWN CLOZOLE Vaginal Cream (Clotrimazole 1%) is a white opaque cream in a 35 g tube with six single use disposable applicators

(Aust R 64917).

Who distributes CHEMISTS' OWN CLOZOLE Vaginal Cream

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121
Australia
www.arrotex.com.au

This leaflet was prepared in June 2024.

Published by MIMS August 2024