Consumer medicine information

Chemists' Own Clozole 2% Vaginal Cream

Clotrimazole

BRAND INFORMATION

Brand name

Chemists' Own Clozole 2% Vaginal Cream

Active ingredient

Clotrimazole

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Chemists' Own Clozole 2% Vaginal Cream.

What is in this leaflet

This leaflet answers some common questions about Chemists’ Own Clozole Vaginal Cream. It does not contain all the available information.

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

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

Product description

What it looks like

CHEMISTS’ OWN Clozole Vaginal Cream contains a white opaque cream in a tube with three single use disposable applicators.

Active Ingredients

  • Clotrimazole 20mg/g

Inactive Ingredients

  • Propylene glycol
  • Cetomacrogol 1000
  • Cetostearyl alcohol
  • Paraffin – liquid and soft white
  • Dimethicone 100
  • Glyceryl monostearate
  • Benzyl alcohol
  • Disodium edetate
  • Purified water

What is Chemists’ Own Clozole Vaginal Cream

Chemists’ Own Clozole Vaginal cream belongs to a class of drugs called antifungals and is used to treat the vaginal yeast infections 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 increase the chances of infection. Certain medications such as antibiotics and steroids may cause overgrowth of Candida.

What CHEMISTS’ OWN CLOZOLE Vaginal Cream is used for

CHEMISTS’ OWN CLOZOLE Vaginal Cream is for the treatment of vaginal candidiasis (commonly referred to thrush) and for the relief of the associated symptoms of itching, burning and vaginal discharge.

Your doctor or pharmacist may recommend this medication for another use. If you want more information, ask your doctor or Pharmacist.

Before you use CHEMISTS’ OWN CLOZOLE Vaginal Cream

When you must not to use it

Do not use CHEMISTS’ OWN CLOZOLE Vaginal cream if you have had an allergic reaction to clotrimazole, other antifungals or any of the excipients listed under ‘Product description’.

Before you start to use it

Tell your doctor before using this medicine if you are pregnant or suffer from diabetes.

Seek medical advice before the first course of treatment.

CHEMISTS’ OWN CLOZOLE Vaginal cream is available from your pharmacist. You may consult with your pharmacist for further information before starting treatment.

How to use CHEMISTS’ OWN Clozole Vaginal Cream

  • Your treatment pack contains a tube of cream containing 20g clotrimazole and three single use applicators. 5 grams of the 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.
  • 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. 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.
  • 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 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 CHEMISTS’ OWN Clozole Vaginal Cream

Precautions while 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 the medicine. Do not stop using clotrimazole unless your doctor or Pharmacist tells you do so. If you stop using this medicine too soon, your infection may return.

If you are pregnant, talk to your doctor before using this medicine. See your doctor if no improvement occurs after 4 days or if problem returns.

Side effects

All medicine can have side effects. Sometimes they are serious, most of the time they are minor and temporary. Talk to your doctor if you have problems with Vaginal itching or burning or increased vaginal discharge. Tell your doctor if your symptoms do not disappear after using this medicine for the full time as advised by your doctor or pharmacist.

Tell your doctor or pharmacist as soon as possible if you notice any of the common side effects or if you do not feel well while taking CHEMISTS’ OWN CLOZOLE Vaginal Cream.

Storage

Keep it in a cool dry place where the temperature stays below 25°C. Do not store any medicines in the bathroom or in moist areas, or do not leave them in the car on hot days.

Keep it where children cannot reach it. A locked cupboard or at least one and half metres above the ground is a good place to store 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 months of 1996.

Do not use after the expiry date.

Sponsor

Arrotex Pharmaceuticals Pty Ltd
15 – 17 Chapel Street
Cremorne, VIC 3121
www.chemistsown.com.au

www.arrotex.com.au

This leaflet was Prepared in April 2024.

The Australian Registration number is
AUST R 115389

Published by MIMS June 2024

BRAND INFORMATION

Brand name

Chemists' Own Clozole 2% Vaginal Cream

Active ingredient

Clotrimazole

Schedule

S3

 

Name of the medicine

Clotrimazole.

Excipients.

Cetomacrogol 1000, liquid paraffin, white soft paraffin, dimeticone 100, cetostearyl alcohol, disodium edetate, self-emulsifying glyceryl monostearate, purified water, propylene glycol and benzyl alcohol.

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.

(Category A)
These are drugs, which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.
However, in the first trimester of pregnancy, clotrimazole vaginal cream should only be used if considered essential. Administration in the second and third trimester of pregnancy has not produced any untoward effects on the course of the pregnancy or on the fetus.
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.

Use in lactation.

Use of this product during lactation is acceptable. Please contact your doctor for further advice.

Carcinogenicity/mutagenicity.

An 18-month study has not revealed any carcinogenic effect. Clotrimazole has no mutagenic effect.

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.