Consumer medicine information

APOHEALTH Thrush 3 and 6 Day Cream (was APO-Clotrimazole)

Clotrimazole

BRAND INFORMATION

Brand name

APOHEALTH Thrush 3 and 6 Day Cream (was APO-Clotrimazole)

Active ingredient

Clotrimazole

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using APOHEALTH Thrush 3 and 6 Day Cream (was APO-Clotrimazole).

FULL CMI

APOHEALTH Thrush 3 Day Cream
APOHEALTH Thrush 6 Day Cream

Active ingredient: Clotrimazole


Consumer Medicine Information (CMI)

This leaflet provides important information about using APOHEALTH Thrush 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 APOHEALTH THRUSH Cream.

Where to find information in this leaflet:

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

1. Why am I using APOHEALTH Thrush Cream?

APOHEALTH Thrush Cream contains the active ingredient Clotrimazole.

Clotrimazole is used to treat the vaginal yeast infection known as Candida. Candida infections of the vagina are commonly referred to as “thrush”.

Symptoms of thrush include vaginal discomfort, itchiness, and discharge.

How it works

Clotrimazole belongs to a group of medicines called anti-fungals. It works by killing the fungi that cause the Candida infection.

Candida infections result from an imbalance of the natural micro-organisms that are present in the vagina. This then causes an. overgrowth of yeast fungus.

Certain conditions may increase the chance of infection:

  • diabetes
  • obesity
  • fatigue
  • hormonal changes during pregnancy or during certain times of the menstrual cycle or due to the oral contraceptive pill
  • certain medicines, such as antibiotics and steroids.

This medicine may be recommended by a pharmacist without a prescription.

2. What should I know before I use APOHEALTH Thrush Cream?

Warnings

Do not use APOHEALTH Thrush 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 this medicine.
    Symptoms of an allergy may include rash, itching, burning swelling or redness in the area where the cream has been applied.

Do not use this cream in your eyes.

Check with your doctor if:

  • This is your first course of treatment.
  • You are under 18 years of age
  • You have had three or more infections within the last six months
  • You have diabetes. Your doctor will check that your sugar levels are under control
  • You have allergies to any other cream, gel or ointment

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.

Your doctor will discuss with you the risks and benefits of using this cream and may recommend other treatments which don't involve the use of an applicator.

Talk to your doctor if you are breast feeding or intend to breastfeed.

It is not known if this medicine passes into breast milk. Your doctor can discuss this with you.

Use in children

This medicine should not be used in children.

3. What if I am taking other medicines?

There is no evidence that this cream interferes with any other medicines.

As this medicine is available from your pharmacist, you can ask them for further information before you start to use it.

4. How do I use APOHEALTH Thrush Cream?

How much to use

  • Use one applicator fully filled with 5 g cream once daily.
  • Use one applicator each consecutive day.

How to use it

Insert one fully filled applicator into the vagina once daily by following the directions below.

  1. Wash your hands thoroughly.
  2. Remove the cap from the tube of cream.
  3. Pierce the aluminum seal of the tube using the spike on the cap.
  4. Screw the open end of the applicator to the tube.
  5. Pull the applicator plunger all the way out, until it stops.

  1. Squeeze the tube of cream until the applicator is full. (The applicator will then hold approximately 5 g of cream).

  1. Unscrew the applicator from the tube and replace the cap on the tube.
  2. Lie on your back with your knees bent. Gently insert the applicator (open end first) deep into the vagina.

  1. Hold the applicator in position and slowly push the plunger all the way in.
  2. Remove the applicator from the vagina and discard it.
    Applicators are for single use only.
  3. Wash your hands thoroughly.

When to use APOHEALTH Thrush cream

  • It is best to use this medicine at bedtime, preferably after a bath or shower.
  • Use it 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.
  • If possible, try to time the treatment so as to avoid your menstrual period.
    However, if your period occurs during treatment, the course should be completed.
  • Avoid using tampons while using this medicine.

How long to use it for

  • Use this medicine on consecutive days or as directed by your doctor or pharmacist.
  • Do not stop using this medicine unless your doctor tells you to do so. If you stop using this medicine too soon, your infection may return.
  • See your doctor if no improvements occur after four days or if the infection returns.

If you forget a dose

Use your medicine as soon as you remember that you have missed a dose.

If it is nearly time for your next dose, wait until then to use the medicine and skip the missed dose.

Do not apply two does at any time to make up for the missed doses.

If you are not sure what to do, ask your doctor or pharmacist.

If you use too much APOHEALTH Thrush Cream

If you think that you have used too much APOHEALTH Thrush 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 APOHEALTH Thrush Cream?

Things you should do

If you are about to start any new medicine, tell your doctor and pharmacist that you are using APOHEALTH Thrush Cream.

Tell any doctors, dentists and pharmacists who treat you that you are using this medicine.

If you become pregnant while using this medicine, tell your doctor or pharmacist immediately.

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

Tell your doctor or pharmacist if you have problems with vaginal itching or burning and/or increased vaginal discharge.

If you are sexually active, ask your doctor or pharmacist if it is necessary to treat your partner as well.

Be careful if you are using latex products such as condoms and diaphragms. They may not work as well, since the mineral oil in this cream may weaken them.

This effect is temporary and happens only whilst this cream is still in your vagina.

It is advisable to wait until 72 hours after the last dose of cream before using condoms or diaphragms.

Hygienic Considerations

  • Maintain strict personal hygiene while using this medicine to avoid the possibility of re-infection.
  • Wash your hands thoroughly before and after inserting the applicator into the vagina.

In addition to your usual hygiene routine, follow the measures listed below to help prevent re-infection:

  • After urinating, use toilet tissue as a blotter; avoid a forward or backward motion.
  • When using toilet tissue after a bowel motion, use a wiping motion away from the vagina to avoid the possibility of spreading organisms from the rectum to the vaginal tract.
  • Wear only clean cotton underwear.
  • Change underwear, night attire, towels and linen daily while using this medicine.

Discard each applicator after use.

Things you should not do

  • Do not use this medicine to treat any other complaints unless your doctor or pharmacist tells you to.
  • Do not give it to anyone else, even if they have the same symptoms as you.
  • Do not douche or use tampons during the course of your treatment.
  • Do not wear tight clothing or synthetic underwear.
    Loose fitting clothing and cotton underwear will help prevent thrush.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how APOHEALTH Thrush Cream affects you.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

Looking after your medicine

  • Keep your cream in the manufacturer's tube until immediately before use.
    If you take your cream out of the tube it may not keep well.
  • Keep the applicators in the carton until needed. Use the cream immediately once it has been dispensed into the applicator.
  • Keep APOHEALTH Thrush Cream in a cool dry place, where the temperature stays below 25°C.

Follow instructions in the carton on how to take care of your medicine properly.

Store 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 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.

Less serious side effects

Less serious side effectsWhat to do
  • Stinging
  • Burning
  • General irritation
Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • Symptoms of an allergic reaction (e.g. 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).
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these 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.

Seek urgent medical advice if this product is swallowed.

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.

7. Product details

This medicine is available over-the-counter without a doctor's prescription.

What APOHEALTH Thrush Cream contains

Active ingredient
(main ingredient)
APOHEALTH Thrush 3 Day Cream contains 20 mg/g (2% w/w) of clotrimazole as the active ingredient.
APOHEALTH Thrush 6 Day Cream contains 10 mg/g (1% w/w) of clotrimazole as the active ingredient.
Other ingredients
(inactive ingredients)
  • propylene glycol
  • cetomacrogol 1000
  • cetostearyl alcohol
  • liquid paraffin
  • dimeticone 100
  • white soft paraffin
  • self emulsifying glyceryl monostearate
  • benzyl alcohol
  • disodium edetate
  • purified water
Potential allergensBenzyl alcohol (preservative)

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

What APOHEALTH Thrush Cream looks like

APOHEALTH Thrush 3 Day Cream (AUST R 150662) is a soft, shiny, white cream.

The tube contains 20 g of cream and comes with 3 single-use disposable applicators.

APOHEALTH Thrush 6 Day Cream (AUST R 150663) is a soft, shiny, white cream.

The tube contains 35 g of cream and comes with 6 single-use disposable applicators.

Who distributes APOHEALTH Thrush Cream

Arrotex Pharmaceuticals
15 - 17 Chapel Street
Cremorne VIC 3121

This leaflet was prepared in September 2022

Published by MIMS January 2024

BRAND INFORMATION

Brand name

APOHEALTH Thrush 3 and 6 Day Cream (was APO-Clotrimazole)

Active ingredient

Clotrimazole

Schedule

S3

 

1 Name of Medicine

Clotrimazole.

2 Qualitative and Quantitative Composition

Clotrimazole is a white to pale yellow, crystalline powder, practically insoluble in water, soluble in chloroform and ethanol.
Clotrimazole 3 Day Cream contains 20 mg/g (2% w/w) clotrimazole.
Clotrimazole 6 Day Cream contains 10 mg/g (1% w/w) clotrimazole.
In addition the creams also contain propylene glycol, disodium edetate, cetomacrogol 1000, cetostearyl alcohol, liquid paraffin, dimeticone 100, white soft paraffin, self emulsifying glyceryl monostearate, benzyl alcohol and purified water.

3 Pharmaceutical Form

APOHEALTH Thrush 3 Day Cream (20 g).

Soft, shiny, white cream.

APOHEALTH Thrush 6 Day Cream (35 g).

Soft, shiny, white cream.

4 Clinical Particulars

4.1 Therapeutic Indications

Effective treatment of vaginal candidiasis and relief of associated symptoms such as itching, burning and vaginal discharge.

4.2 Dose and Method of Administration

The cream (5 g) should be inserted as deeply as possible into the vagina once daily, at bedtime - for three successive days if using clotrimazole 3 day cream, or six consecutive days if using clotrimazole 6 day cream. This is best achieved using the plastic applicator provided and following the directions in the Consumer Medicine Information.
It is suggested that treatment be timed so as to avoid the menstrual period and to be complete before the onset of menstruation.
The clotrimazole cream may also be used in the management of Candida vulvovaginitis or infection of the perianal area, while application of the cream to the glans penis of the partner may help prevent re-infection of the female.

4.3 Contraindications

Known hypersensitivity to clotrimazole or any of the excipients.
Not for ophthalmic use.

4.4 Special Warnings and Precautions for Use

Clotrimazole vaginal cream is for intravaginal use only and is not to be taken orally.
Local irritation and contact dermatitis may occur.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

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

Interaction with barrier contraceptives.

The mineral oil in this cream may weaken condoms or vaginal contraceptive diaphragms and reduce their effectiveness. It is recommended that these contraceptives are not used whilst using this cream, and for 72 hours after the end of treatment.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Although systemic absorption following vaginal administration is low, caution should be exercised when clotrimazole is administered to nursing mothers as there is no information on whether or not clotrimazole is excreted in breast milk.
(Category A)
Category A definition: drugs which have been taken by a large number of pregnant women and women of child-bearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.
In the first trimester of pregnancy, clotrimazole should only be used when the medical practitioner considers it essential for the welfare of the patient.
Administration in the second and third trimester of pregnancy has not produced any untoward effects on the course of the pregnancy or on the foetus.
In the third trimester of pregnancy, extreme caution should be observed when using applicators due to the risk of rupturing the membranes and inducing miscarriage or premature birth, or introducing infection. Using pessaries without an applicator is recommended during the third trimester.
No data available.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Clotrimazole cream is 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.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems.

4.9 Overdose

Acute overdosage with either vaginal or topical application of clotrimazole is unlikely and not expected to be life threatening.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clotrimazole is an imidazole antifungal agent and interacts with the cell membrane of sensitive fungi altering 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 commenced.
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, Sporotrichum schenckii.
Clotrimazole has little or no activity against Haemophilus vaginalis or Trichonomas vaginalis.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

Clotrimazole has no mutagenic effect.

Carcinogenicity.

An 18-month study has not revealed any carcinogenic effect.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine. See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

APOHEALTH Thrush 3 Day Cream (20 g).

Tube with 3 single use disposable applicators.
AUST R 150662.

APOHEALTH Thrush 6 Day Cream (35 g).

Tube with 6 single use disposable applicators.
AUST R 150663.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.


Chemical Name: 1-(o-chloro- α,α-diphenylbenzyl) imidazole.
Molecular Formula: C22H17ClN2.
Molecular Weight: 344.84.

CAS number.

23593-75-1.

7 Medicine Schedule (Poisons Standard)

S3 - Pharmacist Only Medicine.

Summary Table of Changes