Canesten Clotrimazole Thrush 1 Day Pessary

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Clotrimazole 500 mg (Micronised)
Available from:
Bayer New Zealand Limited
INN (International Name):
Clotrimazole 500 mg (Micronised)
Dosage:
500 mg
Pharmaceutical form:
Pessary
Composition:
Active: Clotrimazole 500 mg (Micronised) Excipient: Calcium lactate, hydrate as pentahydrate Colloidal silicon dioxide Crospovidone Hypromellose Lactic acid Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose
Units in package:
Blister pack, PE/Al/PVC, 1 dose unit
Class:
Restricted
Prescription type:
Restricted
Manufactured by:
Bayer Hispania SL
Therapeutic indications:
Canesten Clotrimazole Thrush 1 Day Pessary and 6 Day vaginal pessaries are indicated for the topical treatment of vaginal candidiasis.
Product summary:
Package - Contents - Shelf Life: Blister pack, PE/Al/PVC - 1 pessaries - 48 months from date of manufacture stored at or below 25°C 24 months from date of manufacture stored at or below 25°C. The product manufactured at Haupt Pharma Wulfing GmbH, GERMANY
Authorization number:
TT50-2363/9
Authorization date:
1982-03-02

Canesten Combo CMI

8 September 2017

Consumer Medicine Information

Canesten

Clotrimazole Thrush 1 Day

Pessary & Cream

Clotrimazole vaginal pessary 500 mg & external cream 10 mg/g

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 using

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

Canesten

Clotrimazole Thrush 1 Day Pessary & Cream is used to treat a fungal infection in

the vagina and vulval area (thrush). The pessary is used to treat the infection in the vagina

and vulval area, while 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

[hormone replacement therapy])

prolonged use of antibiotics or steroids

Canesten Combo CMI

8 September 2017

Consumer Medicine Information

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 unsure whether you have thrush or this is the first time you have had

thrush (see What is vaginal thrush?)

Canesten Combo CMI

8 September 2017

Consumer Medicine Information

you are under the age of 18 years or over the age of 60 years

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 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 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, do so 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

Wash your hands thoroughly.

Canesten Combo CMI

8 September 2017

Consumer Medicine Information

Pull out the plunger until it stops (A).

Remove the pessary from the blister. Squeeze the cup end of the applicator (B) between

your thumb and index finger to slightly flatten the cup.

Place the pessary into the flattened cup end of the applicator.

Inserting the applicator

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.

Hold the applicator in position and slowly push the plunger with the forefinger until it

stops. This places the pessary in the vagina.

Remove the applicator from the vagina.

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.

Canesten Combo CMI

8 September 2017

Consumer Medicine Information

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 use 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 accidentally 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

Canesten Combo CMI

8 September 2017

Consumer Medicine Information

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 your nearest Accident and Emergency centre 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.

If you take the pessary out of the blister pack it may not keep well.

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

Canesten Combo CMI

8 September 2017

Consumer Medicine Information

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 insertion of the pessary. The plastic

applicator is for use with Canesten

pessary only. Discard the 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

microcrystalline cellulose

lactic acid

maize starch

crospovidone

calcium lactate

magnesium stearate

silicon dioxide

hypromellose

The 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

Canesten Combo CMI

8 September 2017

Consumer Medicine Information

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 New Zealand by:

Bayer New Zealand Limited

3 Argus Place

Hillcrest

North Shore 0627

AUCKLAND

Toll Free: 0800 847 874

www.canesten.co.nz

This leaflet was prepared on 8 September 2017.

Reference: Canesten Data Sheet dated 8 September 2017

= Registered Trademark

Canesten Data Sheet

8 September 2017

New Zealand Data Sheet

Page 1 of 9

CANESTEN

®

Canesten Clotrimazole Thrush 6 Day Cream, internal vaginal cream 10 mg/g (1%)

Canesten Clotrimazole Thrush 3 Day Cream, internal vaginal cream 20 mg/g (2%)

Canesten Clotrimazole Thrush 1 Day Cream, internal vaginal cream 100 mg/g (10%)

Canesten Clotrimazole Thrush 6 Day Pessary, vaginal pessary 100 mg

Canesten Clotrimazole Thrush 1 Day Pessary, vaginal pessary 500 mg

Canesten Clotrimazole Thrush 1 Day Pessary & Cream, vaginal pessary 500 mg +

topical cream 10 mg/g (1%)

1.

Name of the Medicinal Product

Clotrimazole

1-(o-chloro- α, α - diphenylbenzyl) imidazole

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.

2.

Qualitative and Quantitative Composition

Qualitative Composition in terms of the active ingredient

All formulations: clotrimazole

Canesten Data Sheet

8 September 2017

Page 2 of 9

Quantitative Composition in terms of the active ingredient

Canesten Clotrimazole Thrush 6 Day Cream contains 10 mg/g (1% w/w) of clotrimazole in a vanishing cream

base.

Canesten Clotrimazole Thrush 3 Day Cream contains 20 mg/g (2% w/w) of clotrimazole in a vanishing cream

base.

Canesten Clotrimazole Thrush 1 Day Cream contains 100 mg/g (10% w/w) of clotrimazole in a vanishing cream

base

Canesten Clotrimazole Thrush 6 Day Pessary contains 100 mg of clotrimazole in each pessary.

Canesten Clotrimazole Thrush 1 Day Pessary contains 500 mg of clotrimazole in each pessary.

Canesten Clotrimazole Thrush 1 Day Pessary & Cream contains 500 mg of clotrimazole in each pessary and 10

mg/g clotrimazole in the cream.

For a full list of excipients, see section 6.1.

3.

Pharmaceutical Form

Canesten Clotrimazole Thrush 6 Day Cream

Vaginal cream.

A white, opaque cream.

Canesten Clotrimazole Thrush 3 Day Cream

Vaginal cream.

A white, opaque cream.

Canesten Clotrimazole Thrush 1 Day Cream

Vaginal cream

.

A white, opaque cream.

Canesten Clotrimazole Thrush 6 Day Pessary

Vaginal pessary.

White pellet-shaped pessaries.

Canesten Clotrimazole Thrush 1 Day Pessary

Vaginal pessary.

A white, pellet-shaped pessary.

Canesten Clotrimazole Thrush 1 Day Pessary & Cream

Combination product – vaginal pessary

and topical cream.

A white, pellet-shaped pessary and white, opaque cream.

4.

Clinical Particulars

4.1 Therapeutic Indications

Canesten Clotrimazole Thrush 6 Day, 3 Day and 1 Day creams are indicated for the topical treatment of

vulvovaginal candidiasis. Canesten cream may also be used in conjunction with Canesten 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.

Canesten Data Sheet

8 September 2017

Page 3 of 9

Canesten Clotrimazole Thrush 6 Day and 1 Day vaginal pessaries are indicated for the topical treatment of

vaginal candidiasis.

Canesten Clotrimazole Thrush 1 Day Pessary & Cream is indicated for the topical treatment of vulvovaginal

candidiasis. The cream can also be used 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.

4.2 Dose and Method of Administration

Canesten Clotrimazole Thrush 6 Day Cream

Once daily, preferably in the evening for six successive days, one applicator should be filled with cream (approx.

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 Clotrimazole Thrush 3 Day Cream

Once daily, preferably in the evening for three successive days, one applicator should be filled with cream

(approx. 5 g) 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 Thrush 1 Day Cream

The disposable applicator should be filled with Canesten Clotrimazole Thrush 1 Day cream, ensuring the entire

contents of the tube are used (approx. 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 Thrush Vaginal Pessaries

The pessaries should be inserted as deeply as possible into the vagina once daily, preferably in the evening

before going to bed. This is best achieved using the plastic applicator provided and when lying back with the

legs slightly drawn up. In pregnancy, digital insertion may be preferable to use of the applicator.

A course of treatment normally consists of either a single 500 mg pessary (Canesten Clotrimazole Thrush 1 Day

Pessary) or of six 100 mg pessaries (Canesten Clotrimazole Thrush 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.

Clotrimazole vaginal pessaries need moisture in the vagina to dissolve completely, otherwise undissolved

pieces of the vaginal pessary might crumble out of the vagina. To prevent this it is important to insert the

medication as deeply as possible into the vagina at bedtime. Should the vaginal pessary not dissolve

completely within one night, the use of a vaginal cream should be considered.

Generally:

If symptoms persist for more than 7 days or do not improve within 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 or they have had 3 or more infections within 6 months.

If the labia and adjacent areas are simultaneously infected, local treatment with an external cream should also

be given in addition to the intravaginal treatment (combination treatment). The sexual partner should also

undergo local treatment if symptoms e.g. pruritis, inflammation, etc. are present.

Treatment during the menstrual period should not be performed. The treatment should be finished before the

onset of menstruation.

Canesten Data Sheet

8 September 2017

Page 4 of 9

Do not use tampons, intravaginal douches, spermicides or other vaginal products while using this product.

Avoidance of vaginal intercourse is recommended in case of vaginal infection and while using this product as

the partner could become infected.

During pregnancy, the vaginal pessaries should be used and should be inserted without using an applicator.

Canesten vaginal products are intended for use by adults aged 18 – 60 years, unless use is advised by a

doctor.

Paediatric Population

Canesten vaginal products are intended for use by adults aged 18 – 60 years. There are no data available for

paediatric use.

4.3 Contraindications

Hypersensitivity to the active substance, clotrimazole, or to any of the excipients listed in section 6.1.

4.4 Special Warnings and Precautions for Use

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.

Generally:

Keep the medicine out of reach of children.

Avoid contact with eyes.

Do not swallow.

Clotrimazole

cream may

reduce

effectiveness

safety

latex

products

such

condoms

diaphragms when applied to the genital area (women: intravaginally, labia and adjacent area of the vulva; men:

prepuce and glans of the penis).

For products containing cetostearyl alcohol i.e. the cream presentations:

Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

4.5 Interactions with Other Medicines and Other Forms of Interaction

Concomitant medication with vaginal clotrimazole and oral tacrolimus (FK-506; immunosuppressant) might lead

to increased tacrolimus plasma levels, and similarly with sirolimus. Patients should thus be thoroughly

monitored for symptoms of tacrolimus or sirolimus overdosage, if necessary by determination of the respective

plasma levels.

4.6 Fertility, Pregnancy and Lactation

Fertility

No human studies of the effects of clotrimazole on fertility have been performed, however animal studies have

not demonstrated any effects of the medicine on fertility.

Canesten Data Sheet

8 September 2017

Page 5 of 9

Pregnancy (Category A)

Data from the use of clotrimazole in pregnant women is limited. Animal studies do not indicate direct or indirect

harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is

preferable to avoid the use of clotrimazole during the first trimester of pregnancy.

During pregnancy, the treatment should be carried out with Canesten clotrimazole vaginal pessaries since these

can be inserted without using an applicator.

Lactation

Available pharmacodynamic/toxicological data in animals have shown excretion of clotrimazole/metabolites in

milk (see section 5.3). Breast-feeding should be discontinued during treatment with clotrimazole.

4.7 Effects on Ability to Drive and Use Machines

The medication has no or negligible influence on the ability to drive or use machinery.

4.8 Undesirable Effects

The following adverse reactions have been identified during post-approval use of clotrimazole. Because these

reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably

estimate their frequency.

Immune System Disorders

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

Reproductive System and Breast Disorders

Genital

peeling,

pruritis,

rash,

oedema,

erythema,

discomfort,

burning,

irritation,

pelvic

pain,

vaginal

haemorrhage.

Gastrointestinal Disorders

Abdominal pain.

Reporting of Suspected Adverse Reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued

monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any

suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/.

4.9 Overdose

No risk of acute intoxication is seen as it is unlikely to occur following a single vaginal or dermal application of

an overdose (application over a large area under conditions favourable to absorption) or inadvertent oral

ingestion. There is no specific antidote.

For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON

(0800 764766).

Canesten Data Sheet

8 September 2017

Page 6 of 9

5.

Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group

Antifungals for topical use – imidazole and triazole derivatives.

ATC Code: D01A C01

Mechanism of Action

Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to

structural and functional impairment of the fungal cytoplasmic membrane.

Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes,

yeasts, moulds, etc.

Under appropriate test conditions, the MIC values for these types of fungi are in the region of less than 0.062 –

8.0 μg/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 gram-positive micro-organisms (Streptococci /

Staphylococci / Gardnerella vaginalis) and gram-negative micro-organisms (Bacteroides).

In vitro clotrimazole inhibits the multiplication of Corynebacteria and gram-positive cocci (with the exception of

Enterococci) in concentrations of 0.5 – 10 μg/mL substrate.

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.

5.2 Pharmacokinetic Properties

Pharmacokinetic investigations after vaginal application have shown that only a small amount of clotrimazole (3

– 10%) is absorbed. Due to the rapid hepatic metabolisation of absorbed clotrimazole into pharmacologically

inactive metabolites the resulting peak plasma concentrations of clotrimazole after vaginal application of a 500

mg dose were less than 10 ng/mL, suggesting that clotrimazole applied intravaginally is unlikely to lead to

measurable systemic effects or side effects.

5.3 Preclinical Safety Data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology,

repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development.

The local and systemic tolerance of clotrimazole in different dosage forms was assessed in intravaginal studies

in dogs and monkeys and in subacute dermal studies in rabbits. There was no evidence of treatment-related

local or systemic adverse effects in any of these studies.

The oral toxicity of clotrimazole has been well-studied.

Following a single oral administration, clotrimazole was slight-to-moderately toxic in experimental animals, with

LD50 values of 761 to 923 mg/kg bw for mice, 95 to 114 mg/kg bw for new born rats and 114 to 718 mg/kg bw

for adult rats, > 1000 mg/kg bw for rabbits and > 2000 mg/kg bw for dogs and cats.

Canesten Data Sheet

8 September 2017

Page 7 of 9

In repeated dose oral studies conducted in rats and dogs, the liver was found to be the primary target organ for

toxicity. This was evidenced by an increase in serum transaminase activities and the appearance of liver

vacuolation and fatty deposits starting at 50 mg/kg in the chronic (78-week) rat study and at 100 mg/kg in the

subchronic (13-week) dog study.

Clotrimazole has been extensively studied in in vitro and in vivo mutagencity assays, and no evidence of

mutagenic potential was found. A 78-week oral dosing study of clotrimazole in rats did not show any

carcinogenic effect.

In a rat fertility study, groups of FB30 rats received oral doses of clotrimazole up to 50 mg/kg bw for 10 weeks

prior to mating and either throughout a 3-week mating period (for males only) or, for females, until day 13 of

gestation or 4-week postpartum. Neonatal survival was reduced in the 50 mg/kg bw group. Clotrimazole at

doses up to 25 mg/kg bw did not impair the development of the pups. Clotrimazole at all doses did not affect

fertility.

No teratogenicity effects were demonstrated in studies in mice, rabbits and rats, given oral doses of up to 200,

180 and 100 mg/kg respectively.

A study with 3 lactating rats administered 30 mg/kg clotrimazole intravenously showed that the medicine was

secreted into milk at levels higher than in plasma by a factor of 10 to 20 at 4 hours after administration, followed

by a decline to a factor of 0.4 by 24 hours.

Given the limited absorption of clotrimazole after vaginal application (estimated to be 3% - 10%) no hazard is

expected from the use of vaginal clotrimazole.

6.

Pharmaceutical Particulars

6.1 List of Excipients

Canesten Clotrimazole Thrush 6 Day Cream contains 10 mg/g (1% w/w) of clotrimazole in a vanishing cream

base. The cream also contains sorbitan stearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol,

octyldodecanol, benzyl alcohol (2% w/w) and purified water.

Canesten Clotrimazole Thrush 3 Day Cream contains 20 mg/g (2% w/w) of clotrimazole in a vanishing cream

base.

cream

also

contains

sorbitan

stearate,

polysorbate

cetyl

palmitate,

cetostearyl

alcohol,

octyldodecanol, benzyl alcohol (2% w/w) and purified water.

Canesten Clotrimazole Thrush 1 Day Cream contains 100 mg/g (10% w/w) of clotrimazole in a vanishing cream

base. The cream also contains sorbitan stearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, isopropyl

myristate, benzyl alcohol (1% w/w) and purified water.

Canesten Clotrimazole Thrush 6 Day Pessary contains 100 mg of clotrimazole in each pessary. The pessaries

also

contain

lactose

monohydrate,

maize

starch,

magnesium

stearate,

silicon

dioxide,

calcium

lactate

pentahydrate, crospovidone, lactic acid, hypromellose, microcrystalline cellulose.

Canesten Clotrimazole Thrush 1 Day Pessary contains 500 mg of clotrimazole in each pessary. The pessaries

also contain lactose monohydrate, microcrystalline cellulose, lactic acid, maize starch, crospovidone, calcium

lactate; magnesium stearate, silicon dioxide, hypromellose.

Canesten Clotrimazole Thrush 1 Day Pessary & Cream contains 500 mg of clotrimazole in each pessary and 10

mg/g clotrimazole in the cream. The pessary also contains lactose monohydrate, microcrystalline cellulose,

lactic acid, maize starch, crospovidone, calcium lactate; magnesium stearate, silicon dioxide, hypromellose.

The cream also contains sorbitan stearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, octyldodecanol,

benzyl alcohol (2% w/w) and purified water.

Canesten Data Sheet

8 September 2017

Page 8 of 9

6.2 Incompatibilities

None known.

6.3 Shelf Life

Canesten Clotrimazole Thrush 6 Day Cream

48 months (4 years) from date of manufacture

Canesten Clotrimazole Thrush 3 Day Cream

48 months (4 years) from date of manufacture

Canesten Clotrimazole Thrush 1 Day Cream

36 months (3 years) from date of manufacture

Canesten Clotrimazole Thrush 6 Day Pessary

36 months (3 years) from date of manufacture

Canesten Clotrimazole Thrush 1 Day Pessary

48 months (4 years) from date of manufacture

Canesten Clotrimazole Thrush 1 Day Pessary & Cream 48 months (4 years) from date of manufacture

6.3 Special Precautions for Storage

Canesten Clotrimazole Thrush 6 Day Pessaries: Store at or below 30

All other presentations: Store at or below 25

Keep the medicine out of the reach of children.

6.4 Nature and Contents of Container

Canesten Clotrimazole Thrush 6 Day Cream

One tube containing 35 g of vaginal cream, 10 mg clotrimazole per gram (1% w/w) packed with six single-use

disposable applicators and patient instruction sheet.

Canesten Clotrimazole Thrush 3 Day Cream

One tube containing 20 g of vaginal cream, 20 mg clotrimazole per gram (2% w/w) packed with three single-use

disposable applicators and patient instruction sheet.

Canesten Clotrimazole Thrush 1 Day Cream

One tube containing 5 g of vaginal cream, 100 mg clotrimazole per gram (10% w/w) packed with a single-use

applicator and patient instruction sheet.

Canesten Clotrimazole Thrush 6 Day Pessary

Packs of six vaginal pessaries each sealed in a blister with plastic applicator and patient instruction sheet. Each

pessary contains 100 mg clotrimazole per tablet.

Canesten Clotrimazole Thrush 1 Day Pessary

One vaginal pessary sealed in a blister with plastic applicator and patient instruction sheet. Each pessary

contains 500 mg clotrimazole.

Canesten Clotrimazole Thrush 1 Day Pessary & Cream

One vaginal pessary sealed in a blister with plastic applicator, one tube containing 10 g topical cream and

patient instruction sheet. Each pessary contains 500 mg clotrimazole. Each gram of cream contains 10 mg

clotrimazole.

Canesten Data Sheet

8 September 2017

Page 9 of 9

6.5 Special Precautions for Disposal

Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of

medicines no longer required. These measures will help to protect the environment.

7.

Medicine Schedule

Pharmacist Only Medicines

8.

Sponsor

Bayer New Zealand Limited

3 Argus Place

Hillcrest

North Shore

Auckland 0627

Freephone 0800 847 874

www.canesten.co.nz

9.

Date of First Approval

6 March 1975

10.

Date of Revision of the Text

8 September 2017

Ref: Canesten Clotrimazole Vaginal Products Company Core Data Sheet Version 4.0, dated 1 October 2012

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