Consumer medicine information

Canesten Clotrimazole Thrush 1 Day Pessary & Cream

Clotrimazole

BRAND INFORMATION

Brand name

Canesten Clotrimazole Thrush Treatment Once Pessary + Cream

Active ingredient

Clotrimazole

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Canesten Clotrimazole Thrush 1 Day Pessary & Cream.

What is in this leaflet

This leaflet answers some common questions about Canesten® Clotrimazole Thrush 1 Day Pessary & Cream.

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 taking Canesten® Clotrimazole Thrush 1 Day Pessary & Cream 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® Clotrimazole Thrush 1 Day Pessary & Cream is used for

The pessary is used to treat a fungal infection in the vagina and vulval area (thrush). The cream works to relieve the symptoms of external irritation.

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 symptoms in 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® Clotrimazole Thrush 1 Day Pessary & Cream

When you must not use it

Do not use Canesten® Clotrimazole Thrush 1 Day Pessary & Cream 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 to the area 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:

  • you are under the age of 18 years or over the age of 60 years
  • you are unsure whether you have thrush or this is the first time you have had thrush (see What is vaginal thrush?)
  • you have had 3 or more infections in the last 6 months
  • your symptoms include pain, fever or a foul smelling, unusual coloured or blood stained discharge
  • you have allergies to any other topical treatments

Tell your doctor if you are pregnant, or think you might be. 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. To treat internal thrush, your doctor may recommend that you use the pessary without the help of an applicator.

Tell your doctor if you are breastfeeding 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 and 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® Clotrimazole Thrush 1 Day Pessary & Cream.

Taking other medicines

Tell your doctor or pharmacist if you are taking or using any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.

Tell your doctor or pharmacist if you are taking tacrolimus (e.g. Prograf®), a medicine used to prevent organ transplant rejection or to treat certain problems with the immune system.

How to use Canesten® Clotrimazole Thrush 1 Day Pessary & Cream

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 below, or on the box, ask your doctor or pharmacist for help.

How to use it

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

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

Pessary

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

Loading the applicator

  1. Wash your hands thoroughly.
  2. Pull out the plunger until it stops (A).
  3. Remove the pessary from the blister. Squeeze the cup end of the applicator (B) between thumb and index finger to slightly flatten the cup.
  4. Place the pessary into the flattened cup end of the applicator.

Inserting the applicator

  1. Carefully insert the end of the applicator containing the pessary 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 pessary in the vagina.
  3. Remove the applicator from the vagina.
  4. Discard the applicator.

Anti-fungal cream

Apply the cream thinly to the external irritated area 2-3 times a day to relieve the symptoms of itching.

How long to use it

Insert one pessary, once.

Continue using the cream for as long as you experience itching or your doctor or pharmacist tells you to.

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

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

DO NOT TAKE THE PESSARY OR CREAM BY MOUTH.

Seek medical advice if you or anyone else has taken Canesten® Clotrimazole Thrush 1 Day Pessary & Cream by mouth. Do this even if there are no signs of discomfort or poisoning. You may need medical attention.

While you are using Canesten® Clotrimazole Thrush 1 Day Pessary & Cream

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 do not improve within 4 days or if the problem returns within 2 months.

Things you must not do

Do not take Canesten® Clotrimazole Thrush 1 Day Pessary & Cream 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.

Things to be careful of

Canesten® Clotrimazole Thrush 1 Day Pessary & Cream may reduce the effectiveness and safety of latex products, such as condoms and diaphragms, if it comes into contact with them. Therefore you should prevent Canesten® Clotrimazole Thrush 1 Day Pessary & Cream from coming into contact with these products. If Canesten® Clotrimazole Thrush 1 Day Pessary & Cream does accidently come into contact with a condom or diaphragm, replace the condom or diaphragm before using it as contraception.

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 clothing
  • Douches or vaginal deodorants
  • Soaking in baths

Side effects

Tell your doctor or pharmacist if you experience discomfort while you are using Canesten® Clotrimazole Thrush 1 Day Pessary & Cream.

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 list of side effects. You may not experience any of them.

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 pessary (burning, stinging, redness)
  • Skin reaction to the cream (stinging, redness, blistering, peeling, swelling, itching)
  • Pain in the abdomen or pelvic area

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you experience any of the following:

  • Rash
  • Swallowing or breathing problems
  • Swelling of your lips, face, throat or tongue
  • Nausea, weakness, feeling dizzy or faint

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® Clotrimazole Thrush 1 Day Pessary & Cream

Storage

Keep the pessary in the protective blister pack until it is time to use it.

Keep the 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 pessary and 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

Pessary: The expiry date is marked on the end panel of the carton and is also printed on the back of the blister. The date refers to the month and year of expiration e.g. 0817 refers to the eighth month of 2017. The product can be used until the end of this month.

Cream: 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 e.g. 0817 refers to the eighth month of 2017. 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

The pessary is a white pellet-shaped pessary packaged in an aluminium blister.

The package also contains 1 plastic applicator for the insertion of the pessary. The plastic applicator is for use with the Canesten pessary only. Discard applicator after use.

The cream is a white opaque cream presented in a screw –cap tube containing 10 g of cream.

Ingredients

Canesten® Clotrimazole Thrush 1 Day Pessary & Cream
The pessary contains 500 mg clotrimazole as the active ingredient. It also contains:

  • Lactose monohydrate
  • Cellulose-microcrystalline
  • Lactic acid
  • Starch-maize
  • Crospovidone
  • Calcium lactate
  • Magnesium stearate
  • Silicon dioxide
  • Hypromellose

The cream contains 10 mg clotrimazole per gram of cream as the active ingredient. 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.

Supplier/Distributor

Canesten® Clotrimazole Thrush 1 Day Pessary & Cream is distributed in Australia by:

Bayer Australia Ltd
875 Pacific Highway
Pymble NSW 2073
Toll Free: 1800 008 757
www.canesten.com.au

Canesten® Clotrimazole Thrush 1 Day Pessary & Cream is distributed in New Zealand by:

Bayer New Zealand Limited
3 Argus Place
Hillcrest, Auckland 0627
Toll Free: 0800 229 376
www.canesten.co.nz

® = Registered Trademark

AUST R number 92426

This leaflet was prepared in August 2017.

Published by MIMS July 2022

BRAND INFORMATION

Brand name

Canesten Clotrimazole Thrush Treatment Once Pessary + Cream

Active ingredient

Clotrimazole

Schedule

S3

 

Name of the medicine

Clotrimazole.

Excipients.

Vaginal creams.

Canesten Clotrimazole Thrush 6 Day Cream.

Sorbitan monostearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol and purified water.

Canesten Clotrimazole Thrush 3 Day Cream.

Sorbitan monostearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol and purified water.

Canesten Clotrimazole Thrush 1 Day Cream.

Sorbitan monostearate, polysorbate 60, cetylpalmitate, cetostearyl alcohol, isopropyl myristate, benzyl alcohol and purified water.
Vaginal tablets (compressed pessaries).

Canesten Clotrimazole Thrush 6 Day Pessary.

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

Canesten Clotrimazole Thrush 1 Day Pessary.

Lactose monohydrate, maize starch, magnesium stearate, silica-colloidal anhydrous, calcium lactate pentahydrate, crospovidone, lactic acid, hypromellose and cellulose-microcrystalline.
Composite pack: '1 day' compressed pessary plus antifungal cream.

Canesten Clotrimazole Thrush 1 Day Pessary + Cream.

One Canesten compressed pessary also contains lactose monohydrate, maize starch, magnesium stearate, silica-colloidal anhydrous, calcium lactate pentahydrate, crospovidone, lactic acid, hypromellose and cellulose microcrystalline.
One tube of Canesten antifungal cream also contains sorbitan monostearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol and purified water.

Description

Chemical name: 1-(o-chloro-α,α-diphenylbenzyl) imidazole. CAS number: 23593-75-1. Molecular formula: C22H17ClN2. Molecular weight: 344.84.
Clotrimazole is a colourless, crystalline, weakly alkaline substance, melting point 141°-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.

Vaginal creams.

Canesten Clotrimazole Thrush 6 Day Cream.

This product contains 10 mg/g (1%) of clotrimazole in a vanishing cream base. It also contains sorbitan monostearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol and purified water.

Canesten Clotrimazole Thrush 3 Day Cream.

This product contains 20 mg/g (2%) of clotrimazole in a vanishing cream base. It also contains sorbitan monostearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol and purified water.

Canesten Clotrimazole Thrush 1 Day Cream.

This product contains 100 mg/g (10%) of clotrimazole in a vanishing cream base. It also contains sorbitan monostearate, polysorbate 60, cetylpalmitate, cetostearyl alcohol, isopropyl myristate, benzyl alcohol and purified water.

Vaginal tablets (compressed pessaries).

Canesten Clotrimazole Thrush 6 Day Pessary.

This product contains 100 mg of clotrimazole in each compressed pessary. It also contains lactose monohydrate, maize starch, magnesium stearate, silica-colloidal anhydrous, calcium lactate pentahydrate, crospovidone, lactic acid, hypromellose and cellulose-microcrystalline.

Canesten Clotrimazole Thrush 1 Day Pessary.

This product contains 500 mg of clotrimazole in one compressed pessary. It also contains lactose monohydrate, maize starch, magnesium stearate, silica-colloidal anhydrous, calcium lactate pentahydrate, crospovidone, lactic acid, hypromellose and cellulose-microcrystalline.

Composite pack: '1 day' compressed pessary plus antifungal cream.

Canesten Clotrimazole Thrush 1 Day Pessary + Cream.

This composite pack includes:
One Canesten compressed pessary containing 500 mg of clotrimazole. It also contains lactose monohydrate, maize starch, magnesium stearate, silica-colloidal anhydrous, calcium lactate pentahydrate, crospovidone, lactic acid, hypromellose and cellulose microcrystalline;
One tube of Canesten antifungal cream containing 10 mg/g (1%) of clotrimazole in a vanishing cream base. It also contains sorbitan monostearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol and purified water.

Pharmacology

Pharmacotherapeutic group (ATC code): G01A F02.
Clotrimazole is an imidazole derivative with a broad spectrum antimycotic activity.

Mechanism of action.

Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the cytoplasmic membrane.

Pharmacodynamic properties.

Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc.
Under appropriate test conditions, the minimum inhibitory concentration (MIC) values for these types of fungi are in the region of less than 0.062-8.0 microgram/mL substrate. The mode of action of clotrimazole is primarily fungistatic or fungicidal depending on the concentration of clotrimazole at the site of infection. In vitro activity is limited to proliferating fungal elements; fungal spores are only slightly sensitive.
In addition to its antimycotic action, clotrimazole also acts on Trichomonas vaginalis, gram-positive microorganisms (streptococci/staphylococci), and gram-negative microorganisms (bacteroides/Gardnerella vaginalis).
In vitro clotrimazole inhibits the multiplication of corynebacteria and gram-positive cocci - with the exception of Enterococci - in concentrations of 0.5-10 microgram/mL substrate and exerts a trichomonacidal action at 100 microgram/mL.
Primarily resistant variants of sensitive fungal species are very rare; the development of secondary resistance by sensitive fungi has so far only been observed in very isolated cases under therapeutic conditions.

Pharmacodynamic effects.

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 pessary daily for three days - 75%;
one 500 mg pessary - 84%;
5 g of 1% cream daily for six days - approx 75%.
When a first course proved unsuccessful, a second course produced success in 8 of 12 women treated.

Pharmacokinetic properties.

Absorption and distribution.

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 a 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 labeled topical Canesten clotrimazole cream the concentrations of clotrimazole ranged from 100 microgram/cm3 in the stratum corneum to 0.05-1.0 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.
Pharmacokinetic investigations after dermal application have shown that only a small amount of clotrimazole (< 2 % of the dose) is absorbed. The resulting peak plasma concentrations of the active ingredient are < 10 nanogram/mL (i.e. below the detection limit) and do not lead to measurable side effects.

Metabolism and excretion.

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 man.

Preclinical safety data.

Toxicological studies in rats, dogs and primates given clotrimazole cream or tablet intravaginally showed good vaginal tolerance, and skin applications of clotrimazole cream/lotion were well tolerated in rabbits. Although limited liver toxicity was observed in rats given clotrimazole orally for 18 months; overall, preclinical data reveal no special hazard for humans based on the totality of findings from single- and repeat-dose, genotoxicity, carcinogenicity and reproductive toxicity studies.

Indications

Vaginal creams.

Canesten clotrimazole vaginal creams are indicated for the topical treatment of vulvovaginal candidiasis.

Vaginal tablets (compressed pessaries).

Canesten clotrimazole vaginal pessaries are indicated for the topical treatment of vaginal candidiasis.

Composite pack: '1 day' compressed pessary plus antifungal cream.

Canesten clotrimazole composite pack is indicated for the treatment of candidal infections of the vagina and vulvovagina and sexual partner.

Contraindications

Known hypersensitivity to clotrimazole, cetostearyl alcohol (only for products containing cetostearyl alcohol), and/or to any other excipients.

Precautions

If evidence of local intolerance develops, consider withdrawal of the drug and institution of appropriate therapy.
Canesten clotrimazole vaginal creams and vaginal pessaries are for intravaginal use only and are not to be taken orally. Avoid contact with eyes.
If the patient has a fever (temperature of 38°C or above), lower abdominal pain, back pain, foul smelling vaginal discharge, nausea, vaginal haemorrhage, and/or associated shoulder pain the patient should consult a doctor.
Only for products containing cetostearyl alcohol (see Description): cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Canesten clotrimazole creams are not intended for ophthalmic use.
If symptoms persist for more than 4 days the patient may have a medical condition that requires treatment by a doctor.
The treatment can be repeated if necessary, however, recurrent infections may indicate an underlying medical cause, including diabetes or HIV infection. Patients should seek medical advice if symptoms return within 2 months.
Since the vagina and vulva are usually both affected, a combination treatment (treatment of both of these areas) should be performed.
lf the labia and adjacent areas are simultaneously infected, local treatment with an external cream should also be given. The sexual partner should also undergo local treatment if symptoms, e.g. pruritus, inflammation, etc. are present.
Treatment during the menstrual period should not be performed. The treatment should be finished before the onset of menstruation.
Do not use tampons, intravaginal douches, spermicides or other vaginal products while using these products.
Avoidance of vaginal intercourse is recommended while using this product because the infection could be transferred to the partner, and the effectiveness and safety of latex products such as condoms and diaphragms may be reduced (see Interactions with latex).

Carcinogenicity/mutagenicity.

No carcinogenicity or mutagenicity has been observed in animal studies.

Use in pregnancy.

(Category A)
In the first trimester of pregnancy, intravaginal Canesten products 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 2nd and 3rd trimesters of pregnancy has produced no obvious untoward effect on the course of the pregnancy or on the foetus. 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 pessaries are the preferable choice as they can be inserted without the use of an applicator. Sanitation of the birth canal should be ensured particularly during the last 4-6 weeks of pregnancy.

Use in lactation.

Although systemic absorption following topical or 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.

Effects on ability to drive and use machines.

No effects on ability to drive and use machines have been observed.

Effects on laboratory tests.

Not known.

Interactions

Concomitant medication with vaginal clotrimazole and oral tacrolimus (FK-506, an immunosuppressant) might lead to increased tacrolimus plasma levels. Patients should thus be thoroughly monitored for symptoms of tacrolimus overdosage, if necessary by determination of the respective plasma levels.

Interactions with latex.

Canesten clotrimazole vaginal creams and 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.

Adverse Effects

The listed adverse drug reactions are based on spontaneous reports, thus, an organisation according to CIOMS III categories of frequency is not possible.

Immune system disorders.

Allergic reaction (syncope, hypotension, dyspnoea, urticaria).

Reproductive system and breast disorders.

Genital peeling, pruritus, rash, oedema, discomfort, burning, irritation, pelvic pain.

Gastrointestinal disorders.

Abdominal pain.
Canesten clotrimazole creams 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 clotrimazole vaginal pessaries.

Dosage and Administration

No dosage adjustment is necessary in patients with renal or hepatic impairment due to limited systemic absorption following topical or vaginal application.

Vaginal creams.

Canesten Clotrimazole Thrush 6 Day Cream.

Once daily, preferably at bedtime 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 with the legs slightly drawn up. The 35 g tube of cream for vaginal use provides for six such doses.

Canesten Clotrimazole Thrush 3 Day Cream.

Once daily, preferably at bedtime for three 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 with the legs slightly drawn up. The 20 g tube of cream for vaginal use provides for three such doses.

Canesten Clotrimazole Thrush 1 Day Cream.

The disposable applicator should be filled with the vaginal 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 with the legs slightly drawn up. The cream should be used preferably at bedtime as a single dose of treatment.
Canesten clotrimazole vaginal creams may also be used in conjunction with Canesten clotrimazole vaginal pessaries in the management of Candida vulvovaginitis or infection of the peri-anal area while application of the cream to the glans penis of the partner may help prevent re-infection of the female.

Vaginal tablets (compressed pessaries).

Canesten Clotrimazole Thrush 6 Day Pessary, Canesten Clotrimazole Thrush 1 Day Pessary.

A course of treatment normally consists of either a single 500 mg pessary (1 Day Pessary) or of six 100 mg pessaries (6 Day Pessary). The latter may be given either as two pessaries, inserted one after the other, daily for three days or as one 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.
Canesten clotrimazole vaginal tablets (pessaries) should be inserted as deeply as possible into the vagina once daily, preferably at bedtime. This is best achieved using the plastic applicator provided and following the directions on the patient instruction sheet. In late pregnancy digital insertion is preferable to use instead of the applicator.
The vaginal tablets need moisture in the vagina to dissolve completely, otherwise undissolved pieces of the vaginal tablet might crumble out of the vagina. To prevent this it is important to insert the pessaries as deeply as possible into the vagina preferably at bedtime. Should the vaginal tablet not dissolve completely within one night the use of a vaginal cream should be considered.
It is suggested that treatment be timed so as to avoid the menstrual period and to be complete before the onset of menstruation.

Composite pack: '1 day' compressed pessary plus antifungal cream.

Canesten Clotrimazole Thrush 1 Day Pessary + Cream.

The pessary should be inserted gently and as deeply as possible into the vagina, preferably at bedtime. This is best achieved using the plastic applicator provided and following the directions on the instruction leaflet. In late pregnancy digital insertion is preferable to use instead of the applicator. The 500 mg pessary provides therapy for three to four days as it creates high intravaginal concentrations of clotrimazole, however the symptoms may persist for these three to four days.
The antifungal cream may be used in conjunction with the pessary in the management of candidal vulvovaginitis or infection of the peri-anal area while application of the cream to the glans penis of the partner may help prevent reinfection of the female. This should be applied thinly to the affected areas (external genital organs to the anus in the woman; glans and prepuce in men) 2 - 3 times daily and rubbed in.
It is suggested that the treatment be timed so as to avoid the menstrual period and to be complete before the onset of menstruation. If the treatment does coincide with a menstrual period, use sanitary pads not tampons during therapy.
A doctor should be consulted before use in the following instances:
If it is the first occurrence of the problem;
If there have been three or more thrush infections in the previous six months;
If pregnant;
If diabetic;
If under 18 years of age or over the age of 60 years;
If not better in four days.

Overdosage

There have been no reports of overdosage with clotrimazole. In the event of overdosage, contact the Poisons Information Centre on 13 11 26 for advice.

Presentation

Vaginal creams.

Canesten Clotrimazole Thrush 6 Day Cream.

Presented in a 35 g tube containing 10 mg clotrimazole per gram of cream (1%), and packed with six single-use disposable applicators and an instruction leaflet (Consumer Medicine Information).

Canesten Clotrimazole Thrush 3 Day Cream.

Presented in a 20 g tube containing 20 mg clotrimazole per gram of cream (2%), and packed with three single-use disposable applicators and an instruction leaflet (Consumer Medicine Information).

Canesten Clotrimazole Thrush 1 Day Cream.

Presented in a 5 g tube containing 100 mg clotrimazole per gram of cream (10%), and packed with one single-use disposable applicator and an instruction leaflet (Consumer Medicine Information).

Vaginal tablets (compressed pessaries).

Canesten Clotrimazole Thrush 6 Day Pessary.

Presented in a blister pack of six compressed pessaries, and packed with a plastic applicator and an instruction leaflet (Consumer Medicine Information). Each pessary contains 100 mg clotrimazole.

Canesten Clotrimazole Thrush 1 Day Pessary.

Presented in a blister pack containing one compressed pessary, and packed with a plastic applicator and an instruction leaflet (Consumer Medicine Information). Each pessary contains 500 mg clotrimazole.

Composite pack: '1 day' compressed pessary plus antifungal cream.

Canesten Clotrimazole Thrush 1 Day Pessary + Cream.

Presented in a carton that includes a blister pack of one Canesten compressed pessary containing 500 mg clotrimazole, and packed with a plastic applicator. Plus, it includes one 10 g tube of Canesten antifungal cream containing 10 mg clotrimazole per gram of cream (1%). An instruction leaflet (Consumer Medicine Information) is also included.

Storage

Vaginal creams.

Canesten Clotrimazole Thrush 6 Day Cream.

Store below 25°C.

Canesten Clotrimazole Thrush 3 Day Cream.

Store below 25°C.

Canesten Clotrimazole Thrush 1 Day Cream.

Store below 25°C.

Vaginal tablets (compressed pessaries).

Canesten Clotrimazole Thrush 6 Day Pessary.

Store below 30°C.

Canesten Clotrimazole Thrush 1 Day Pessary.

Store below 25°C.

Composite pack: '1 day' compressed pessary plus antifungal cream.

Canesten Clotrimazole Thrush 1 Day Pessary + Cream.

Store below 25°C.

Poison Schedule

Pharmacist Only Medicine.