Consumer medicine information

Canesten Clotrimazole; Thrush Treatment; 6 Day Cream

Clotrimazole

BRAND INFORMATION

Brand name

Canesten Clotrimazole Thrush Treatment 6 Day Cream

Active ingredient

Clotrimazole

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Canesten Clotrimazole; Thrush Treatment; 6 Day Cream.

What is in this leaflet

This leaflet answers some common questions about Canesten Thrush Treatment.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your pharmacist has weighed the risks of you using Canesten Thrush Treatment against the benefits they expect it will have for you.

If you have any concerns about using this treatment, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Canesten Thrush Treatment is used for

Canesten Thrush Treatment is used to treat a fungal infection in the vagina and vulval area (thrush).

This medicine belongs to a group of medicines called azole antifungals.

What is vaginal thrush?

Candida albicans is a yeast fungus that can multiply rapidly and cause damage to the vagina when other micro-organisms aren't present in a normal balance.

Some situations which can increase susceptibility to thrush are:

  • Diabetes
  • Obesity
  • Illness
  • Fatigue
  • Hormonal fluctuations (pregnancy, menstrual cycle, oral contraceptive pill, HRT)
  • Prolonged use of antibiotics or steroids

Thrush may cause the following symptoms:

  • Vaginal itching
  • Vaginal soreness
  • A white odourless discharge from the vagina (like cottage cheese)
  • Pain during intercourse

The symptoms below are not usually signs of thrush:

  • Abnormal or irregular vaginal bleeding
  • Blood stained discharge
  • Vulva or vaginal sores, ulcers or blisters
  • Lower abdominal pain
  • Pain when passing urine
  • Fever or chills
  • Foul smelling and/or unusual coloured discharge

See your doctor if you experience any of the above symptoms.

Ask your doctor or pharmacist if you have any questions about whether this medicine is suitable for you.

This medicine is available without a doctor's prescription, only through your pharmacist.

Before you use Canesten Thrush Treatment

When you must not use it

Do not use Canesten Thrush Treatment if you have an allergy to:

  • any medicine containing clotrimazole
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include swelling of the parts of the body to which treatment has been applied; rash, itching or hives on the skin.

Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start using this medicine, talk to your doctor or pharmacist.

Before you start to use it

See your doctor if:

  • this is your first infection
  • you are under 18 years of age
  • you have had 3 or more infections in the last 6 months
  • you have allergies to any other topical treatments

Tell your doctor if you are pregnant.

You should see your doctor if you suspect you have thrush in the first three months of your pregnancy. Your doctor can discuss with you the risks and benefits involved with treatment.

Your doctor may also advise you use a pessary during pregnancy, instead of a cream, as this can be inserted without an applicator.

Tell your doctor if you are breast-feeding and want to use this treatment.

It is not known whether the active ingredient, clotrimazole, is excreted in breast milk. Your doctor will be able to discuss with you the risks or benefits involved with treatment.

Tell your doctor if you are diabetic.

Thrush in diabetics can mean that your blood sugar levels are not well controlled. Your doctor will be able to check this for you and advise treatment.

If you have not told your doctor about any of the above, tell him/her before you start using Canesten Thrush Treatment.

Taking other medicines

There are no reports of Canesten Thrush Treatment interfering with other medicines.

How to use Canesten Thrush Treatment

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How to use it

Wash your hands thoroughly before handling the cream or using the applicator.

To avoid the possibility of re-infection, strict personal hygiene must be observed.

The cream should preferably be inserted in the evening, just before bed time, with the use of an applicator. Using it before you go to sleep will have the best effect.

Use a new applicator for each nightly dose.

Loading an applicator

  1. Wash your hands thoroughly.
  2. Pull out the plunger of the disposable applicator until it stops.
  3. Open the Canesten cream tube. Attach the applicator to the tube and hold it firmly pressed against the tube.
  4. Squeeze the cream tube until the applicator is full.
  5. Remove the tube of cream and replace the cap.

Inserting the applicator

  1. Carefully insert the end of the applicator containing the cream as gently and deeply into the vagina as possible. This is best achieved when lying on your back with your knees bent.
  2. Hold the applicator in position and slowly push the plunger with the forefinger until it stops. This places the cream in the vagina.
  3. Remove the applicator from the vagina and dispose of the applicator.

How long to use it

Continue using the cream for 6 nights.

This treatment helps to relieve your condition. It is important to keep using it until the fungal infection is gone.

If you miss a dose, continue with the next dose as soon as you remember, or the next evening.

Continue using the cream until the course is finished. The 35g tube contains enough cream for 6 doses.

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

While you are using Canesten Thrush Treatment

Things you must do

Discontinue treatment and tell your doctor or pharmacist if you develop a local reaction to this product.

See your doctor if the symptoms are not gone within 4 days.

Things you must not do

Do not use Canesten Thrush Treatment to treat any other complaints unless your doctor tells you to.

Do not give your treatment to anyone else, even if you suspect they have the same condition as you.

Do not stop using this medicine until you have completed the course.

If you stop taking it suddenly, your condition may worsen.

Things to be careful of

Preferably the treatment should be timed to avoid the menstrual period.

This will allow the treatment to be most effective. Ask your doctor if you have questions about this.

Canesten Thrush Treatment may reduce the effectiveness and safety of latex products, such as condoms and diaphragms.

This effect is temporary and occurs only during treatment.

Things that may help to resolve Thrush

Some self help measures suggested below may help your condition. Your doctor or pharmacist can give you more information about these measures.

  • Blot with toilet paper after urinating (instead of wiping back to front).
  • Change underwear, night attire, towels and linen daily.

Avoid where possible:

  • perfumed toilet paper
  • fragrant soaps and bath oils
  • wearing tight or synthetic underwear
  • douches or vaginal deodorants

Side effects

Tell your doctor or pharmacist if you experience discomfort while you are using Canesten Thrush Treatment.

This medicine helps most people with thrush but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following side effect. You may not experience it.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • skin reaction to the cream (stinging, redness, blistering, peeling, swelling, itching)

Any of the above may be signs of an allergic reaction. Your doctor or pharmacist may recommend you discontinue treatment if you experience these effects.

After using Canesten Thrush Treatment

Storage

Keep your cream in the tube until it is time to use it.

If you take the cream out of the tube it may not keep well.

Keep your cream in a cool dry place where the temperature stays below 25°C.

Keep the treatment 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.

Expiry

The expiry date is marked on the end panel of the carton and is also printed on the crimp at the end of the tube. The date refers to the month and year of expiration eg 0805, refers to the eighth month of 2005. The product can be used until the end of this month.

Disposal

If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Discard the medicine out of the reach of children.

Product description

What it looks like

Canesten Thrush Treatment 6 Day Cream is a white opaque cream presented in a screw -cap tube containing 35 g of cream.

The package also contains 6 disposable plastic applicators.

Ingredients

Canesten Thrush Treatment 6 Day Cream contains 10 mg clotrimazole as the active ingredient in each gram of cream. It also contains:

  • Sorbitan monostearate
  • Polysorbate 60
  • Cetyl palmitate
  • Cetostearyl alcohol
  • Octyldodecanol
  • Benzyl alcohol
  • Purified water

This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

Manufacturer

Canesten® Thrush Treatment 6 Day Cream is made in Spain.

Canesten Thrush Treatment is distributed in Australia by:

Bayer Australia Limited
(ABN 22 000 138 714)
Consumer Care Business Group
875 Pacific Highway
PYMBLE NSW 2073

Toll Free:1800 023 884

Canesten® Thrush Treatment is distributed in New Zealand by:

Bayer New Zealand Limited
Consumer Care Business Group
Argus Place
Glenfield
AUCKLAND NZ

Toll Free: 0800 847 874

® = Registered Trademark

This leaflet was prepared in August 2005.

AUST R number 18699

BRAND INFORMATION

Brand name

Canesten Clotrimazole Thrush Treatment 6 Day Cream

Active ingredient

Clotrimazole

Schedule

S3

 

Name of the medicine

Clotrimazole.

Excipients.

Canesten Clotrimazole Cream, Canesten Clotrimazole Thrush Treatment 6 Day Cream, Canesten Clotrimazole Thrush Treatment 3 Day Cream.

Sorbitan monostearate, polysorbate 60, cetyl esters wax, cetostearyl alcohol, 2-octyldodecanol, benzyl alcohol and purified water.

Canesten Clotrimazole Thrush Treatment Once Cream.

Sorbitan monostearate, polysorbate 60, cetyl esters wax, cetostearyl alcohol, isopropyl myristate, benzyl alcohol and purified water; vanishing cream base.

Canesten Clotrimazole Solution.

Propylene glycol, isopropyl alcohol and polyethylene glycol.

Canesten Clotrimazole Thrush Treatment 6 Day Pessary.

Lactose, maize starch, magnesium stearate, colloidal anhydrous silica, calcium lactate pentahydrate, crospovidone, lactic acid, hypromellose, microcrystalline cellulose.

Canesten Clotrimazole Thrush Treatment Once Pessary.

Lactose, microcrystalline cellulose, lactic acid, maize starch, crospovidone, calcium lactate, magnesium stearate, silicon dioxide, hypromellose.

Description

Chemical name: 1-(o-chloro-α,α-diphenylbenzyl) imidazole. Molecular formula: C22H17ClN2. MW: 344.84. Clotrimazole is a colourless, crystalline, weakly alkaline substance, melting point 141 to 145°C, soluble in acetone, chloroform and ethanol and practically insoluble in water. It forms stable salts with both organic and inorganic acids. It is not photosensitive but is slightly hygroscopic, and may be hydrolysed in acid media.

Pharmacology

The primary mode of action of Canesten Clotrimazole cream appears to be on the cell membrane of the fungi, damaging the permeability barrier.
A single course of intravaginal Canesten Clotrimazole cream has produced mycological cure of vaginal candidiasis as follows: one 100 mg pessary daily for six days, 80%; two 100 mg pessaries daily for three days, 75%; one 500 mg pessary, 84%; 5 g of 1% cream daily for six days, approximately 75%. Where a first course proved unsuccessful, a second course produced success in 8 of 12 women treated.

Pharmacokinetics.

Studies using 14C-labelled clotrimazole have shown absorption of about 3% of the administered dose from normal or inflamed human vaginal mucosa (peak serum level of 0.03 microgram/mL) 24 hours after insertion of 100 mg tablet.
Studies in normal volunteers after vaginal insertion of one 500 mg pessary showed that plasma levels of clotrimazole up to 10 nanogram/mL were reached during the period of assay (up to 72 hours after insertion). Significant concentrations of clotrimazole were present in the vaginal secretion for up to 48 hours after insertion.
Canesten Clotrimazole cream containing 14C-labelled clotrimazole was administered intravaginally to five women (four without gynaecological disorder and one with Candida vaginitis). A maximum serum level of 0.01 microgram/mL was found between 10 and 30 hours after administration.
Six hours after application of labelled topical Canesten Clotrimazole cream the concentration of clotrimazole ranged from 100 microgram/cm3 in the stratum corneum to 0.05 to 1 microgram/cm3 in the stratum reticulare and 0.1 microgram/cm3 in the subcutis.
No measurable radioactivity was found in the serum within 48 hours after application of 0.8 g of the cream.
Studies of urinary excretion have shown that less than 0.5% of dermally applied Canesten Clotrimazole cream appears in the urine over a five day period of observation. Faecal excretion, the route by which most of the absorbed drug is likely to be eliminated, has not been studied in humans.

Indications

Canesten Clotrimazole Cream and Solution.

Topical treatment of the following dermal infections.
Tinea pedis, tinea cruris and tinea corporis due to Trichophyton rubrum, T. mentagrophytes, Epidermophyton floccosum and Microsporum canis.
Candidiasis due to Candida albicans including cutaneous candidiasis, paronychia, external genital candidiasis, candida balanitis.
Pityriasis versicolor due to Malassezia furfur.
Erythrasma.
Canesten Clotrimazole Cream is also indicated for the topical treatment of vulvovaginal candidiasis.

Canesten Clotrimazole Vaginal Pessaries.

Topical treatment of vaginal candidiasis.

Contraindications

Known hypersensitivity to clotrimazole and/or to any of the excipients.

Precautions

If evidence of local intolerance develops consider withdrawal of the drug and institution of appropriate therapy.
Canesten Clotrimazole Vaginal Pessaries are for intravaginal use only and are not to be taken orally.
Canesten Clotrimazole Cream and Solution are not intended for ophthalmic use.

Carcinogenesis, mutagenesis, impairment of fertility.

No carcinogenicity or mutagenicity has been observed in animal studies.

Use in pregnancy.

(Category A)
In the first trimester of pregnancy intravaginal Canesten Clotrimazole should be used only when the medical practitioner considers it essential for the welfare of the patient. Administration of Canesten Clotrimazole Vaginal Pessaries to a small number of women in the second and third trimesters of pregnancy has produced no obvious untoward effect on the course of the pregnancy or on the fetus. This limited experience is insufficient to detect with reasonable certainty events occurring with an incidence of less than 3%. If treatment is carried out during pregnancy, Canesten Clotrimazole Vaginal tablet/s (Pessary/ies) are the preferable choice as they can be inserted without the use of an applicator.

Use in lactation.

Although systemic absorption following topical or vaginal administration is low, caution should be exercised when clotrimazole is administered to breastfeeding mothers as there is no information on whether or not clotrimazole is excreted in breast milk.

Interactions

Interactions have not been reported with topical forms of Canesten Clotrimazole.

Interactions with latex.

Canesten Clotrimazole Vaginal Cream (Vaginal Pessaries) may reduce the effectiveness and safety of latex products, such as condoms and diaphragms. This effect is temporary and occurs only during treatment.

Effect on laboratory tests.

Not known.

Adverse Effects

Canesten Clotrimazole Cream and Solution are generally well tolerated after local application.
The following have been reported infrequently: erythema, stinging, blistering, peeling, oedema, pruritus, urticaria and general irritation.
Eleven (1.6%) of 689 patients treated with Canesten Clotrimazole Vaginal Pessaries complained of possibly drug related effects. Mild burning occurred in four patients while other complaints such as skin rash and lower abdominal cramps were mentioned. Slight urinary frequency and burning or irritation in the sexual partner occurred rarely. In no case was it necessary to discontinue Canesten Vaginal Pessaries.

Dosage and Administration

Canesten Clotrimazole Topical Cream and Solution.

Apply sparingly to the affected areas and rub in gently, two or three times daily.

Duration of treatment.

The following recommendations are made. Cutaneous candidiasis: two weeks. Dermatomycoses: two to four weeks. Onychia and paronychia due to C. albicans: four to eight weeks or more.
Regular application of Canesten Clotrimazole Cream or Solution is essential for successful treatment and, whether or not a cure is confirmed mycologically, treatment should be continued for two weeks after all clinical signs have disappeared.

Special remarks.

Attention to hygiene is important in the management of fungal diseases of the feet. After washing, the feet, especially between the toes, should be dried thoroughly. Canesten Clotrimazole Cream may be useful in mycotic paronchia or onychia following removal of the nail.

Canesten Vaginal Cream 1% (Canesten Clotrimazole Thrush Treatment 6 Day Cream).

Once daily, preferably in the evening for six successive days, one applicator should be filled with cream (approximately 5 g) and inserted as deeply as possible into the vagina with the patient lying on her back. The 35 g tube of cream for vaginal use provides for six such doses.

Canesten 3 Vaginal Cream 2% (Canesten Clotrimazole Thrush Treatment 3 Day Cream).

Once daily, preferably in the evening, for three successive days, one applicator should be filled with cream and inserted as deeply as possible into the vagina with the patient lying on her back. The 20 g tube of cream for vaginal use provides for three such doses.
Canesten Clotrimazole Cream may also be used in conjunction with Canesten Vaginal Pessaries 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 reinfection of the female.

Canesten Clotrimazole Thrush Treatment Once Cream (10%).

The disposable applicator should be filled with Canesten Cream, ensuring the entire contents of the tube are used (approximately 5 g). The cream is then inserted as gently and deeply as possible into the vagina with the patient lying on her back at bedtime as a single dose of treatment.

Canesten Clotrimazole Vaginal Pessaries.

The tablets should be inserted as deeply as possible into the vagina once daily, preferably in the evening. This is best achieved using the plastic applicator provided and following the directions on the patient instruction sheet. In late pregnancy digital insertion may be preferable to the use of the applicator.
A course of treatment normally consists of a single (Canesten Clotrimazole Thrush Treatment Once Pessary) or of six 100 mg pessaries (Canesten Clotrimazole Thrush Treatment 6 Day Pessary). The latter may be given either as 2 pessaries, inserted one after the other, daily for three days, or as 1 pessary daily for six days. Clinical investigations have shown comparable efficacy from either dosage scheme. Where a first course proved unsuccessful, a second course produced success in 8 of 12 women treated.
It is suggested that treatment be timed so as to avoid the menstrual period and to be complete before the onset of menstruation.

Overdosage

Not applicable.

Presentation

Canesten Clotrimazole Cream (for cutaneous and external genital mycoses).

Cream, 10 mg/g (1%): 20 g, 50 g.

Canesten Clotrimazole Thrush Treatment 6 Day Cream (Canesten Vaginal Cream 1%).

10 mg/g (1%): 35 g (with 6 single use disposable applicators and patient instruction sheet).

Canesten Clotrimazole Thrush Treatment 3 Day Cream (Canesten 3 Vaginal Cream 2%).

Cream, 20 mg/g (2%): 20 g (with 3 single use disposable applicators and patient instruction sheet).

Canesten Clotrimazole Thrush Treatment Once Cream (10%).

Cream, 100 mg/g (10%): 5 g (with single use applicator and patient instruction sheet).

Canesten Clotrimazole Solution.

Solution, 10 mg/mL (1% w/v), 20 mL.

Canesten Clotrimazole Thrush Treatment 6 Day Pessary (Canesten Clotrimazole Vaginal Pessaries).

Pessaries, 100 mg (white, rectangular, rounded at one end, marked BAYER one side, AD on reverse): 6's (with applicator and patient instruction sheet).

Canesten Clotrimazole Thrush Treatment Once Pessary (Canesten 1 Vaginal Pessary).

Pessary, 500 mg (white, rectangular, rounded at one end, marked BAYER one side, MU on reverse): 1's (with applicator and patient instruction sheet).

Poison Schedule

Gynaecological products (Canesten Clotrimazole Thrush Treatment 6 Day Pessary, Once Pessary, 6 Day Cream, 3 Day Cream, Once Cream 10%): S3.
Topical products (Canesten Clotrimazole Cream 1%, Canesten Clotrimazole Solution 1%): S2.