Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Clonea Clotrimazole Thrush Treatment 3 Day Cream.

It does not contain all of the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor or pharmacist has weighed the risks of you using this medicine against the benefits expected for you.

If you have any concerns about using this medicine, talk to your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What is Clonea Clotrimazole Thrush Treatment 3 Day Cream and what is it used for?

Clonea Clotrimazole Thrush Treatment 3 Day Cream belongs to a class of drugs called antifungals and is used to treat the vaginal yeast infection known 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.

When you should not use this medicine

Do not use this medicine if you have ever had an allergic reaction to Clotrimazole or other antifungals or any ingredients listed under the "Ingredients" section below.

Before using Clonea Clotrimazole Thrush Treatment 3 Day Cream

Seek medical advice before the first course of treatment. Clonea Clotrimazole Thrush Treatment 3 Day Cream is available from your pharmacist. You may consult with your pharmacist for further information before starting treatment.

See a doctor if you are under 18 years of age, pregnant or suffer from diabetes.

How to use Clonea Clotrimazole Thrush Treatment 3 Day Cream

Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained on this leaflet.

• Your treatment pack contains a tube of cream containing 20 g of clotrimazole cream and three single use applicators. 5 grams (1 applicator-full) of cream should be inserted in the vagina daily for three 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.

If you do not understand the instructions on the pack, ask your doctor or pharmacist.

How to use it

• 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.
• 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.
• Use this medicine for three consecutive days. It is important that the entire course is completed as advised for the treatment to be effective.
• Treatment should be avoided during menstruation. However if menstruation occurs during treatment the course should be completed.
• The use of condoms and diaphragms for contraception should be avoided during treatment as Clonea Clotrimazole Thrush Treatment 3 Day Cream may reduce the effectiveness of these products.
• 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 miss a dose

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.

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

While you are using Clonea Clotrimazole Thrush Treatment 3 Day Cream

Warnings

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.

If you stop using this medicine too soon, your infection may return.

See a doctor if no improvement occurs after 3 days of treatment or if the problem returns.

Side effects

If you have problems with the following side effects while using this medicine, talk with your pharmacist or doctor:

• Vaginal itching or burning.
• Increased vaginal discharge.

After using Clonea Clotrimazole Thrush Treatment 3 Day Cream

Storage

Keep Clonea Clotrimazole Thrush Treatment 3 Day Cream 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.

Store the cream below 25°C

Do not leave your medicine in the car or on windowsills. Heat and dampness can destroy some medicines.

Check the expiry date marked on the end panel of the carton and on the crimp at the end of the tube, which refers to the month and year of the expiration, e.g. 11 96 refers to the eleventh month of 1996. Do not use after the expiry date.

Disposal

If your doctor or pharmacist tells you to stop using Clonea Clotrimazole Thrush Treatment 3 Day Cream, or your medicine has passed its expiry date, ask your pharmacist what to do.

Product description

Clonea Clotrimazole Thrush Treatment 3 Day Cream is a white opaque cream in a 20g tube with three single use disposable applicators.

Ingredients

The active ingredient in Clonea Clotrimazole Thrush Treatment 3 Day Cream is Clotrimazole 20 mg/g.

This cream also contains the following 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

This cream contains benzyl alcohol 1% w/w (as a preservative).

Sponsor

Cipla Australia Pty Ltd
Level 1 / 132-136 Albert Road,
SOUTH MELBOURNE VIC 3205
[email protected]
Phone no: 1800 569 074

Distributor

Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au

Australian registration number:

AUST R 230936

This leaflet was prepared in April 2022.

Clonea Clotrimazole Thrush Treatment 3 Day Cream_cmi\Apr22/00

Published by MIMS September 2022

1 Name of Medicine

Clotrimazole.

2 Qualitative and Quantitative Composition

Clonea Clotrimazole Thrush Treatment 3 Day Cream contains clotrimazole 20 mg/g (2%).

Excipients with known effect.

3 Pharmaceutical Form

Vaginal cream, clotrimazole 20 mg/g (2%): white, smooth semi-solid cream.

4 Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Dose and Method of Administration

5 g intravaginally using the applicator once daily 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 perianal area. Application to the glans penis of the partner may help prevent reinfection of the female. Treatment during menstruation should be avoided.
This medicine is not recommended for use in children and adolescents under 18 years of age unless on medical advice.

4.3 Contraindications

Known hypersensitivity to clotrimazole or any of the ingredients listed, see Section 6.1 List of Excipients. Not for ophthalmic use.

4.4 Special Warnings and Precautions for Use

Not intended for use in the mouth. Local irritation and contact dermatitis may occur.

Interactions with latex.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

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

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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)

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.

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 Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Clonea Clotrimazole Thrush Treatment 3 Day Cream contains the following excipients: propylene glycol, disodium edetate, cetomacrogol 1000, cetostearyl alcohol, liquid paraffin, dimeticone 100, white soft paraffin, self-emulsifying glyceryl monostearate, benzyl alcohol, purified water.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

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

Container type: Cream tube (3 applicators provided).
Pack size: 20 g.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Clotrimazole is a white to pale yellow crystalline powder, practically insoluble in water, soluble in chloroform and ethanol.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S3 (Pharmacist Only Medicine).

Summary Table of Changes