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 CHEMISTS' OWN CLOZOLE VAGINAL CREAM?

CHEMISTS' OWN CLOZOLE VAGINAL CREAM contains the active ingredient Clotrimazole (20mg/g) and is used to treat vaginal yeast infections such as Candida.

For more information, see Section 1. Why am I using CHEMISTS' OWN CLOZOLE VAGINAL CREAM? in the full CMI.

2. What should I know before I use CHEMISTS' OWN CLOZOLE VAGINAL CREAM?

Do not use if you have ever had an allergic reaction to Clotrimazole 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 CHEMISTS' OWN CLOZOLE VAGINAL CREAM? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with CHEMISTS' OWN CLOZOLE VAGINAL CREAM 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 CHEMISTS' OWN CLOZOLE VAGINAL CREAM?

• Follow the instructions provided and use CHEMISTS' OWN CLOZOLE VAGINAL CREAM until your doctor tells you to stop.
• Your treatment pack contains one tube of cream containing 20g of CHEMISTS' OWN CLOZOLE VAGINAL CREAM and three single use applicators. 5 grams of cream should be inserted into the vagina daily for three consecutive days.

More instructions can be found in Section 4. How do I use CHEMISTS' OWN CLOZOLE VAGINAL CREAM? in the full CMI.

5. What should I know while using CHEMISTS' OWN CLOZOLE VAGINAL CREAM?

For more information, see Section 5. What should I know while using CHEMISTS' OWN CLOZOLE VAGINAL CREAM? in the full CMI.

6. Are there any side effects?

Call your doctor if your symptoms do not disappear after using CHEMISTS' OWN CLOZOLE VAGINAL CREAM as 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

Consumer Medicine Information (CMI)

This leaflet provides important information about using CHEMISTS' OWN CLOZOLE VAGINAL CREAM. 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 CHEMISTS' OWN CLOZOLE VAGINAL CREAM.

Where to find information in this leaflet:

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

1. Why am I using CHEMISTS' OWN CLOZOLE VAGINAL CREAM?

CHEMISTS' OWN CLOZOLE VAGINAL CREAM contains the active ingredient Clotrimazole (20mg/g). CHEMISTS' OWN CLOZOLE VAGINAL CREAM belongs to a class of drugs called antifungals and is used to treat vaginal yeast infections such as Candida.

2. What should I know before I use CHEMISTS' OWN CLOZOLE VAGINAL CREAM?

Warnings

Do not use CHEMISTS' OWN CLOZOLE VAGINAL CREAM 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 CHEMISTS' OWN CLOZOLE VAGINAL CREAM.

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 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 CHEMISTS' OWN CLOZOLE VAGINAL CREAM.

4. How do I use CHEMISTS' OWN CLOZOLE VAGINAL CREAM?

How much to use

• Follow the instructions provided and use CHEMISTS' OWN CLOZOLE VAGINAL CREAM until your doctor tells you to stop.
• Your treatment pack contains a tube of cream containing 20g of CHEMISTS' OWN CLOZOLE VAGINAL CREAM and three single use applicators. 5 grams of cream should be inserted in the vagina daily for three consecutive days.
• CHEMISTS' OWN CLOZOLE VAGINAL CREAM is best used at bedtime unless your doctor tells you otherwise.
• Wash your hands before and after using CHEMISTS' OWN CLOZOLE VAGINAL CREAM.
• Wear only clean cotton underwear.
• Continue using CHEMISTS' OWN CLOZOLE VAGINAL CREAM 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 g of cream.
• Unscrew the applicator from the tube and replace the cap on the tube.
• Gently insert the applicator (open end first) high into the vagina and push the plunger all the way in. This is best done by lying on the back with the knees bent.
• Discard the used applicator.
• Treatment should be avoided during menstruation. However, if menstruation occurs during the treatment, the course should be completed.
• Applicators are for single use only and should be discarded after use.
• If you are sexually active your partner may also require treatment. Seek the advice of your doctor or Pharmacist.
• It is important to continue treatment and complete the course even if you feel better.

If you forget to use CHEMISTS' OWN CLOZOLE VAGINAL CREAM

Use your medicine as soon as you remember that you have missed your dose. If it is nearly time for your next dose, wait until then to use the medicine and skip the missed dose.

Do not double up on doses at any time to make up for missed doses.

CHEMISTS' OWN CLOZOLE VAGINAL CREAM 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.

If you use too much CHEMISTS' OWN CLOZOLE VAGINAL CREAM

If you think that you have used too much CHEMISTS' OWN CLOZOLE VAGINAL CREAM, 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 CHEMISTS' OWN CLOZOLE VAGINAL CREAM?

Things you should do

Remind any doctor, dentist or pharmacist you visit that you are using CHEMISTS' OWN CLOZOLE VAGINAL CREAM.

• If you are pregnant, talk to your doctor before using CHEMISTS' OWN CLOZOLE VAGINAL CREAM.
• Avoid using tampons while using CHEMISTS' OWN CLOZOLE VAGINAL CREAM.
• Avoid using douches or other vaginal products unless your doctor advises you to do so.
• Wear freshly washed cotton underpants while using CHEMISTS' OWN CLOZOLE VAGINAL CREAM.
• Do not stop using CHEMISTS' OWN CLOZOLE VAGINAL CREAM unless your doctor or Pharmacist tells you to do so. If you stop using CHEMISTS' OWN CLOZOLE VAGINAL CREAM too soon, your infection may return.

See your doctor if no improvement occurs after 4 days or if problem returns.

Things you should not do

• Do not stop using CHEMISTS' OWN CLOZOLE VAGINAL CREAM suddenly.
• Do not use this medicine if you have ever had an allergic reaction to CHEMISTS' OWN CLOZOLE VAGINAL CREAM or other antifungals.
• Do not stop using CHEMISTS' OWN CLOZOLE VAGINAL CREAM unless your doctor tells you to do so. If you stop using CHEMISTS' OWN CLOZOLE VAGINAL CREAM too soon, your infection may return. See a doctor if the 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 CHEMISTS' OWN CLOZOLE VAGINAL CREAM or it is out of date, take it to any pharmacy for safe disposal.

Do not use CHEMISTS' OWN CLOZOLE VAGINAL CREAM 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 CHEMISTS' OWN CLOZOLE VAGINAL CREAM.

7. Product details

What CHEMISTS' OWN CLOZOLE VAGINAL CREAM contains

Do not take CHEMISTS' OWN CLOZOLE VAGINAL CREAM if you are allergic to any of these ingredients.

What CHEMISTS' OWN CLOZOLE VAGINAL CREAM looks like

CHEMISTS' OWN CLOZOLE VAGINAL CREAM (20mg/g Clotrimazole) is a white smooth cream in a 20 g tube with three single use disposable applicators

(AUST R 115389).

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 May 2025.

Published by MIMS July 2025

Name of the medicine

Clotrimazole.

Excipients.

Description

CAS no: 23593-75-1. Chemical name: 1-[(2-Chlorophenyl)diphenylmethyl]-1H-imidazole. Empirical formula: C₂₂H₁₇ClN₂. Molecular weight: 344.84.
Active: clotrimazole 20 mg/g (2%).
Also contains: cetomacrogol 1000, liquid paraffin, white soft paraffin, dimeticone 100, cetostearyl alcohol, disodium edetate, self-emulsifying glyceryl monostearate, purified water, propylene glycol and benzyl alcohol.
Clotrimazole is a white to pale yellow crystalline powder, practically insoluble in water, soluble in chloroform and ethanol.

Pharmacology

Clotrimazole is an imidazole antifungal agent and interacts with the cell membrane of sensitive fungi alternating its permeability and eventually causing the activation of autolytic enzymes. A single course of intravaginal clotrimazole is usually required to produce mycological cure of vaginal candidiasis. A second course may be required if the first course is unsuccessful. However, other pathogens should be considered and investigated before a second course is recommended. Topical clotrimazole penetrates the epidermis but there is little systemic absorption and slight absorption from the vagina.
Clotrimazole inhibits Candida albicans and, in in vitro studies, Blastomyces dermatitidis, Candida spp, Coccidioides immitis, Cryptococcus neoformans (Torula histolytica), dermatophytes (Trichophyton, Microsporum, Epidermophyton), Histoplasma capsulatum, Nocardias spp (less sensitive than true fungi), Paracoccidioides brasiliensis, Sporotchum schenckii. Clotrimazole has little or no activity against Haemophilus vaginalis or Trichomonas vaginalis.

Indications

Clotrimazole is indicated for the effective treatment of vaginal candidiasis and relief of associated symptoms such as itching, burning and vaginal discharge.

Contraindications

Known hypersensitivity to clotrimazole or any of the ingredients listed under composition. Not for ophthalmic use.

Precautions

Not intended to be used in the mouth. Local irritation and contact dermatitis may occur.

Use in pregnancy.

Use in lactation.

Carcinogenicity/mutagenicity.

Interactions

Synergism or antagonism between clotrimazole and nystatin, or amphotericin B, or flucytosine against strains of C. albicans has not been reported.

Adverse Effects

Generally well tolerated after local application. Erythema, stinging, blistering, peeling, oedema, pruritus, urticaria and general irritation have been reported infrequently. There have been rare reports of mild burning, skin rash and lower abdominal cramps and burning or slight irritation in the sexual partner.

Dosage and Administration

5 g intravaginally using the applicator once a day at bedtime for three successive days inserted as deeply as possible into the vagina with the patient lying down on her back. May also be used in the management of candidal vulvovaginitis or infection of the peri anal area. Application to the glans penis of the partner may help prevent reinfection of the female. Treatment during menstruation should be avoided.

Overdosage

Acute overdosage with either vaginal or topical application of clotrimazole is unlikely and not expected to be life threatening.

Presentation

Vaginal cream 20 mg/g (2% w/w) is smooth and white in colour.
20 g tube with 3 applicators (HDPE Container).
AUST R 115389.

Storage

Store below 25°C.

Poison Schedule

Poisons Schedule: S3 - Pharmacist Only Medicine.