Canesoral Duo

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Fluconazole 150 mg; Clotrimazole 10 mg/g
Available from:
Bayer New Zealand Limited
INN (International Name):
Fluconazole 150 mg
Dosage:
150mg & 10mg/g
Pharmaceutical form:
Combination
Composition:
Active: Fluconazole 150 mg Excipient: Colloidal silicon dioxide Gelatin Lactose monohydrate Magnesium stearate Maize starch Opacode black S-1-17823 Sodium laurilsulfate Titanium dioxide Water Active: Clotrimazole 10 mg/g Excipient: Benzyl alcohol Cetostearyl alcohol Cetyl palmitate Octyldodecanol Polysorbate 60 Purified water Sorbitan stearate
Prescription type:
Restricted
Manufactured by:
Mylan Laboratories Limited
Therapeutic indications:
Vaginal candidiasis. Cream can be used for relief of external itching/irritation and the management of candida vulvovaginitis or infection of the peri-anal area.
Product summary:
Package - Contents - Shelf Life: Blister pack, white opaque PVC/PVdC-aluminium - 1 capsules - 0 days Not applicable - Combination pack, 1 tube plus one capsule - 1 dose units - 36 months from date of manufacture stored at or below 25°C 3 months opened stored at or below 25°C. cream - Tube, aluminium, PE screw cap with spike - 10 g - 0 months Not applicable
Authorization number:
TT50-9676/1
Authorization date:
2014-11-28

Read the complete document

Canesoral Duo CMI

13 July 2015

Consumer Medicine Information

Canesoral

Fluconazole Capsule &

Clotrimazole Cream Duo

Fluconazole oral capsule 150 mg & Clotrimazole cream 10 mg/g

What is in this leaflet

This leaflet answers some common questions about Canesoral Fluconazole Capsule &

Clotrimazole Cream Duo (referred to in the rest of this leaflet as Canesoral Duo).

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 doctor or pharmacist has weighed the risks of

you using Canesoral Duo against the benefits expected for you.

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

Keep this leaflet with the medicine.

You may need to read it again.

What Canesoral Duo is used for

Canesoral Duo is used to treat a type of fungal infection called vaginal thrush.

Canesoral Duo contains two components: Canesoral Fluconazole Capsule is an oral capsule

which contains the active ingredient fluconazole; Canesten cream contains the active

ingredient clotrimazole. Both of these ingredients belong to a group of medicines called

azole antifungals.

Canesoral Fluconazole Capsule is taken by mouth and works from the inside to prevent the

growth of the fungi causing your infection. Canesten cream is applied to the irritated area

and provides soothing relief from external itching and irritation.

What is vaginal thrush?

Vaginal thrush is a common name for vaginal candidiasis, an infection caused by a yeast-like

fungus called Candida. Candida is one of many organisms that live in the vagina. Your

body’s natural balance (immune system) normally keeps Candida under control, but when

this natural balance is upset Candida can multiply and can cause thrush symptoms.

Common symptoms of vaginal thrush include:

itching, burning or soreness around the vagina

cottage cheese-like discharge

Canesoral Duo CMI

13 July 2015

Consumer Medicine Information

swelling or irritation of the infected area

Things that may help you to avoid thrush in future

wear cotton briefs, stockings and loose fitting clothing rather than tight synthetic

clothing

wash regularly, but do not wash and dry yourself harshly

avoid perfumed soaps, bath additives and vaginal deodorants

Your doctor or pharmacist may have more information on things you can do to avoid thrush

in the future.

Ask your doctor or pharmacist if you have any questions about why this medicine has

been recommended for you.

Your doctor or pharmacist may have recommended it for another reason.

There is no evidence that either component in Canesoral Duo is addictive.

Canesoral Duo is a “Pharmacist Only Medicine”. It is available without a doctor’s

prescription, but your pharmacist’s advice is required.

Canesoral Duo is not recommended for children under 18 years of age except under doctor

supervision.

Before you use Canesoral Duo

When you must not use it

Do not use Canesoral Duo if you have an allergy to:

any medicine containing fluconazole

any medicine containing clotrimazole

any other azole antifungals related to fluconazole or clotrimazole such as

miconazole (e.g. Daktarin

), ketoconazole (e.g. Nizoral

) or itraconazole (e.g.

Sporonox

any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue or other parts of the body

rash, itching or hives on the skin

Do not use Canesoral Duo if you are taking:

cisapride (e.g. Prepulsid

) – a medicine used to treat stomach problems.

astemizole

pimozide (e.g. Orap

quinidine

Canesoral Duo CMI

13 July 2015

Consumer Medicine Information

erythromycin (e.g. E-Mycin

Combining Canesoral Duo with the above medicines may cause serious side effects such as

an abnormal heart rhythm.

Do not use Canesoral Duo if you are pregnant, suspect you may be pregnant or if you

may become pregnant during treatment.

It may affect your developing baby if you take it during pregnancy.

Do not use Canesoral Duo if you are breast-feeding.

The active ingredient fluconazole passes into breast milk and there is a possibility that your

baby may be affected.

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

Tell your doctor or pharmacist if you have allergies to any other medicines, foods,

dyes or preservatives.

Tell your doctor or pharmacist if you have, or have had, any of the following medical

conditions:

thrush more than twice in the last six months

liver problems

heart problems

kidney problems

HIV infection or AIDS

diabetes

Your doctor or pharmacist may want to take special care if you have any of these conditions.

Tell your doctor or pharmacist before using Canesoral Duo if you are taking warfarin

(e.g. Marevan

, Coumadin

), as bleeding or bruising may occur.

Tell your doctor or pharmacist if you are experiencing any of the following:

abnormal or irregular vaginal bleeding or blood-stained discharge

foul smelling or unusual coloured discharge

vulval or vaginal sores, ulcers or blisters

lower abdominal pain or burning when passing urine

fever or chills

If you have not told your doctor or pharmacist about any of the above, do so before

you start using Canesoral Duo.

Canesoral Duo CMI

13 July 2015

Consumer Medicine Information

Using the Canesten cream component of Canesoral Duo may reduce the effectiveness

and safety of latex products such as condoms and diaphragms. This effect is

temporary and only occurs during treatment.

Taking other medicines

Do not use Canesoral Duo if you are taking:

cisapride (e.g. Prepulsid

®

) – a medicine used to treat stomach problems.

astemizole

pimozide (e.g. Orap

®

)

quinidine

erythromycin (e.g. E-Mycin

)

Tell your doctor or pharmacist if you are taking any other medicines, including any

you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and Canesoral Duo may interfere with each other. These include:

warfarin (e.g. Coumadin

, Marevan

), a medicine used to prevent blood clots

phenytoin (e.g. Dilantin

) or carbamazepine (e.g. Tegretol

), medicines used to

treat epilepsy or bipolar disorder

cyclosporin (e.g. Neoral

), sirolimus (e.g. Rapamune

) or tacrolimus (e.g.

Prograf

), medicines used to prevent organ transplant rejection or to treat certain

problems with the immune system

certain medicines used to treat diabetes such as glipizide, glimepiride, gliclazide,

pioglitazone, rosiglitazone or glibenclamide

rifampicin (e.g. Rifadin

) or rifabutin (e.g. Mycobutin

), antibiotics used to treat

infections

theophylline (e.g. Nuelin

), a medicine used to treat asthma

midazolam (e.g. Hypnovel

) and triazolam (e.g. Halcion

), medicines used as

sedatives or to treat anxiety

zidovudine (e.g. Retrovir

) and saquinavir (e.g. Invirase

), medicines used to treat

AIDS patients

hydrochlorothiazide, a medicine used for treating fluid problems and high blood

pressure

the contraceptive pill (birth control pill)

amphotericin B (e.g. Fungilin

) and voriconazole (e.g. Vfend

), medicines used to

treat fungal infection

azithromycin (e.g. Zithromax

), an antibiotic used to treat certain types of bacterial

infections

anticancer medicines such as cyclophosphamide, vincristine and vinblastine

NSAIDs such as naproxen, diclofenac and celecoxib

opioid painkillers such as alfentanil, fentanyl and methadone

losartan, a medicine used to treat high blood pressure

calcium channel blockers such as nifedipine, amlodipine and felodipine used in

relieving high blood pressure and certain heart conditions

statins such as atorvastatin, simvastatin and fluvastatin used to control high

cholesterol levels

antidepressants such as amitriptyline and nortriptyline

Talk to your doctor about the need for an additional method of contraception while

Canesoral Duo CMI

13 July 2015

Consumer Medicine Information

using Canesoral Duo.

It may decrease the effectiveness of some birth control pills.

Your doctor can tell you what to do if you are taking any of these medicines.

These medicines may be affected by Canesoral Duo or may affect how well it works. You

may need different amounts of your medicines or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid

while using this medicine.

How to use Canesoral Duo

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

They may differ from the information contained in this leaflet.

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

for help.

How to use it

For vaginal thrush in adults only a single dose (1 capsule) is needed.

Swallow the capsule whole with a glass of water.

The capsule can be taken with or without food.

Use the cream thinly on the external irritated area 2 – 3 times a day to relieve the symptoms

for as long as they last, usually not more than 3 days.

Do not give Canesoral Duo to children under 18 years of age except under doctor

supervision.

If you use too much (overdose)

Immediately telephone your doctor or the National Poisons Information Centre (0800

POISON or 0800 764 766) for advice or go to your nearest Accident and Emergency

Centre if you think you or anyone else may have used too much Canesoral Duo.

Do this even if there are no signs of discomfort or poisoning.

You may need medical attention.

While you are using Canesoral Duo

Things you must do

If you are about to be started on any new medicine, remind your doctor and

pharmacist that you are using Canesoral Duo.

Tell any other doctors, dentists and pharmacists who treat you that you are using this

medicine.

Use effective contraception to prevent pregnancy while using Canesoral Duo.

Canesoral Duo CMI

13 July 2015

Consumer Medicine Information

If you become pregnant while using this medicine, tell your doctor immediately.

If your symptoms do not improve after three days, tell your doctor or pharmacist.

Things you must not do

Do not use Canesoral Duo to treat any other complaints unless your doctor or

pharmacist tells you to.

Do not give your medicine to anyone else, even if they have the same condition as

you.

Things to be careful of

Tell your doctor immediately if you develop a rash while using Canesoral Duo.

People with HIV, AIDs or a weak immune system may be more prone to serious side effects

of the skin.

Be careful when driving vehicles or operating machinery as occasional dizziness or seizures

may occur.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well or

experience discomfort while you are using Canesoral Duo.

This medicine helps most people and is generally well tolerated. However, it may have

unwanted side effects in some people.

All medicines can have side effects. Sometimes they are serious, most of the time they are

not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by the following list of possible 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:

nausea (feeling sick), vomiting

headache

stomach pain, indigestion

diarrhoea

rash

itching

The list above includes the more common side effects of your medicine. They are usually

mild and short-lived.

Tell your doctor as soon as possible if you notice any of the following:-

unusual muscle stiffness causing poor control of movement

Canesoral Duo CMI

13 July 2015

Consumer Medicine Information

signs of frequent or worrying infections such as fever, severe chills, sore throat or

mouth ulcers

swelling of the face, lips or tongue which may cause difficulty swallowing or

breathing

asthma, wheezing, shortness of breath

sudden or severe itching, skin rash, hives

fainting, seizures or fits

flaking of the skin

bleeding or bruising more easily than normal, reddish or purplish blotches under

the skin

passing more urine than normal, kidney pain (pain on the sides of the body)

symptoms of liver disease such as yellowing of the skin or eyes, dark urine, pale

stools, loss of appetite, unusual tiredness

irregular heart beat or palpitations

increased sweating

This list above includes serious side effects that may require medical attention. Serious side

effects are rare.

The list above includes very serious side effects. You may need urgent medical attention or

hospitalisation. These side effects are very rare.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After using Canesoral Duo

Storage

Keep your capsule and cream in the pack until it is time to use them.

If you take the capsule or cream out of the pack it may not keep well.

Keep Canesoral Duo in a cool dry place where the temperature stays below 25

C.

Do not store Canesoral Duo in the bathroom or near a sink. Do not leave it on a

window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it 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.

Disposal

If your doctor or pharmacist tells you to stop using this medicine or its expiry date has

passed, ask your pharmacist what to do with it.

Product description

What Canesoral Duo looks like

Canesoral Duo CMI

13 July 2015

Consumer Medicine Information

Canesoral Duo contains two components:

Canesoral Fluconazole Capsule is a hard white gelatin capsule marked with “CAN

150” in black ink. Each pack contains 1 capsule.

Canesten cream is a white opaque cream, provided in an aluminium tube with a

screw cap containing 10 g.

Ingredients

The active ingredient in the Canesoral Fluconazole Capsule is fluconazole 150 mg. Each

capsule also contains the following inactive ingredients:

lactose

maize starch

colloidal anhydrous silica

sodium lauryl sulfate

magnesium stearate

titanium dioxide (E171)

gelatin

Opacode S-1-17823 black printing ink

The active ingredient in the Canesten cream is clotrimazole 10 mg/g. The cream 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.

Distributor

Canesoral Duo 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 13 July 2015.

Reference: Canesoral Fluconazole Capsule & Clotrimazole Cream Duo Data Sheet dated 13 July 2015.

= Registered Trademark

Read the complete document

Canesoral Duo Data Sheet

18 September 2020

New Zealand Data Sheet

Page 1 of 14

CANESORAL

®

DUO

Fluconazole Oral Capsule 150 mg

Clotrimazole Topical Cream 10 mg/g

1.

Name of the Medicinal Product

Canesoral Duo

A powder-filled capsule containing 150 mg fluconazole and a topical cream containing 10 mg/g clotrimazole.

2.

Qualitative and Quantitative Composition

Each capsule contains 150 mg fluconazole. Each gram of cream contains 10 mg clotrimazole (10 mg/g, 1% w/w).

For a full list of excipients, see section 6.1.

3.

Pharmaceutical Form

Hard gelatine capsule, powder-filled and topical cream in a vanishing cream base.

4.

Clinical Particulars

4.1 Therapeutic Indications

Canesoral Duo is indicated for vaginal candidiasis.

The cream can also be used for relief of external itching/irritation and the management of Candida vulvovaginitis

or infection of the peri-anal area.

4.2 Dose and Method of Administration

The fluconazole capsule must be used as a single dose treatment only.

The clotrimazole cream should be used in conjunction with the fluconazole capsule for relief of external

itching/irritation and the management of Candida vulvovaginitis or infection of the peri-anal area.

Adults

One fluconazole 150 mg capsule, swallowed whole, in a single dose. Consult a healthcare professional if over

60 years of age.

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

Canesoral Duo Data Sheet

18 September 2020

Page 2 of 14

Paediatric Population

Canesoral Duo should not be taken by children under 18 years of age unless directed by their physician.

Patients with Impaired Renal Function

There is no separate dosage schedule in patients with renal impairment for the single dose fluconazole treatment.

4.3 Contraindications

Canesoral Duo should not be used in patients with known sensitivity to fluconazole; clotrimazole; to related azole

compounds; or to any of the excipients listed in section 6.1.

Coadministration of other medicines known to prolong the QT interval and which are metabolised via the enzyme

CYP3A4 such as cisapride, astemizole, erythromycin, pimozide and quinidine are contraindicated (see section

4.4 Special Warnings and Precautions for Use).

4.4 Special Warnings and Precautions for Use

Fluconazole should be administered with caution to patients with liver dysfunction. Fluconazole has been

associated with rare cases of serious hepatic toxicity including fatalities, primarily in patients with serious

underlying medical conditions. In cases of fluconazole-associated hepatotoxicity, no obvious relationship to total

daily dose, duration of therapy, sex or age of patient has been observed. Canesoral Fluconazole capsule should

not be used again if clinical signs and symptoms consistent with liver disease develop that may be attributable to

fluconazole (see section 4.8 Undesirable Effects).

Patients have rarely developed exfoliative cutaneous reactions, such as Stevens-Johnson Syndrome and toxic

epidermal necrolysis, during treatment with fluconazole. AIDS patients are more prone to the development of

serious cutaneous reactions to many medicines. Fluconazole should not be used again if a rash develops which

is attributable to fluconazole.

In rare cases, as with other azoles, anaphylaxis has been reported.

Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the

electrocardiogram. During post-marketing surveillance, there have been very rare cases of QT prolongation and

torsades de pointes in patients taking fluconazole. These reports included seriously ill patients with multiple

confounding risk factors, such as structural heart disease, electrolyte abnormalities and concomitant medications

that may have been contributory. Fluconazole should be administered with caution to patients with these

potentially proarrhythmic conditions (see section 4.8 Undesirable Effects).

The coadministration of fluconazole at doses lower than 400 mg per day with terfenadine should be carefully

monitored.

Fluconazole is a potent CYP2C9 inhibitor and a moderate CYP3A4 inhibitor. Fluconazole treated patients who

are concomitantly treated with medicines with a narrow therapeutic window metabolised through CYP2C9 and

CYP3A4 should be monitored.

Canesoral Fluconazole capsule contains lactose and should not be given to patients with the rare hereditary

problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Clotrimazole cream may reduce the effectiveness and safety of latex products such as condoms and diaphragms

when applied to the genital area (women: labia and adjacent area of the vulva; men: prepuce and glans of the

penis). The effect is temporary and occurs only during treatment.

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

Canesoral Duo Data Sheet

18 September 2020

Page 3 of 14

4.5 Interactions with Other Medicines and Other Forms of Interaction

Fluconazole

The relevance of the following medicine interactions to single-dose fluconazole is unknown. Patients on

other medications should be advised to consult their doctor or pharmacist before starting fluconazole.

Fluconazole is an inhibitor of the cytochrome P450 system, particularly the CYP 2C and to a lesser extent the

CYP 3A isoforms. There are possibilities that other medicines may affect the metabolism of fluconazole and that

fluconazole may affect the metabolism of other medicines. In vitro studies conducted in human hepatic

microsomes demonstrate that the extent of inhibition of CYP 3A isoforms is lowest with fluconazole, when

compared with ketoconazole and itraconazole.

Alfentanil

A study observed a reduction in clearance and distribution volume as well as prolongation of T

of alfentanil

following concomitant treatment with fluconazole. A possible mechanism of action is fluconazole’s inhibition of

CYP3A4. Dosage adjustment of alfentanil may be necessary.

Amitriptyline, Nortriptyline

Fluconazole increases the effect of amitriptyline and nortriptyline. 5-nortriptyline and/or S-amitriptyline may be

measured at initiation of the combination therapy and after one week. Dosage of amitriptyline /nortriptyline should

be adjusted, if necessary.

Amphotericin B

Concurrent administration of fluconazole and amphotericin B in infected normal and immunosuppressed mice

showed the following results: a small additive antifungal effect in systemic infection with C. albicans, no interaction

in intracranial infection with Cryptococcus neoforms, and antagonism of the two medicines in systemic infection

with A. fumigatus. The clinical significance of results obtained in these studies is unknown.

Anticoagulants

In an interaction study, fluconazole increased the prothrombin time (12%) after warfarin administration in healthy

males. In post-marketing experience, as with other azole antifungals, bleeding events (bruising, epistaxis,

gastrointestinal bleeding, haematuria and melena) have been reported, in association with increases in

prothrombin time in patients receiving fluconazole concurrently with warfarin. Prothrombin time in patients

receiving coumarin-type anticoagulants should be carefully monitored. Dose adjustment of warfarin may be

necessary.

Astemizole

Concomitant administration of fluconazole with astemizole may decrease the clearance of astemizole. Resulting

increased plasma concentrations of astemizole can lead to QT prolongation and rare occurrences of torsades de

pointes. Coadministration of fluconazole and astemizole is contraindicated (see section 4.3 Contraindications).

Azithromycin

An open-label, randomised, three-way crossover study in 18 healthy subjects assessed the effect of a single 1200

mg oral dose of azithromycin on the pharmacokinetics of a single 800 mg oral dose of fluconazole as well as the

effects of fluconazole on the pharmacokinetics of azithromycin. There was no significant interaction between

fluconazole and azithromycin.

Carbamazepine

Fluconazole inhibits the metabolism of carbamazepine and an increase in serum carbamazepine of 30% has been

observed. There is a risk of developing carbamazepine toxicity. Dosage adjustment of carbamazepine may be

necessary depending on concentration measurements/effect.

Canesoral Duo Data Sheet

18 September 2020

Page 4 of 14

Calcium Channel Blockers

Certain calcium channel antagonists (nifedipine, isradipine, amlodipine, verapamil and felodipine) are metabolised

by CYP3A4. Fluconazole has the potential to increase the systemic exposure of the calcium channel antagonists.

Frequent monitoring for adverse events is recommended.

Celecoxib

During concomitant treatment with fluconazole (200 mg daily) and celecoxib (200 mg) the celecoxib C

AUC increased by 68% and 134% respectively. Half the celecoxib dose may be necessary when combined with

fluconazole.

Cisapride

Cardiac events including torsades de pointes have been reported in patients receiving fluconazole and cisapride

concomitantly. In most of these cases, the patients appear to have been predisposed to arrhythmias or had

serious underlying illness. A controlled study found that concomitant fluconazole 200 mg once daily and cisapride

20 mg four times a day yielded a significant increase in cisapride plasma levels and prolongation of QTc interval.

Coadministration

cisapride

contraindicated

patients

receiving

fluconazole

(see

section

Contraindications).

Cyclophosphamide

Combination therapy with cyclophosphamide and fluconazole results in an increase in serum bilirubin and serum

creatinine. The combination may be used while taking increased consideration to the risk of increased serum

bilirubin and serum creatinine.

Cyclosporin

A kinetic study in renal transplant patients found fluconazole 200 mg daily to slowly increase cyclosporin

concentrations. However, in another multiple dose study with 100 mg daily, fluconazole did not affect cyclosporin

levels in patients with bone marrow transplants. Cyclosporin plasma concentration monitoring in patients, with or

without impaired renal function, receiving fluconazole is recommended.

Erythromycin

Concomitant use of fluconazole and erythromycin has the potential to increase the risk of cardiotoxicity (prolonged

QT interval, torsades de points) and consequently sudden heart death. Coadministration of fluconazole and

erythromycin is contraindicated (see section 4.3 Contraindications).

Fentanyl

One fatal case of possible fentanyl-fluconazole interaction was reported. The author judged that the patient died

from fentanyl intoxication. Furthermore, in a randomised crossover study with 12 healthy volunteers it was shown

that fluconazole delayed the elimination of fentanyl significantly. Elevated fentanyl concentration may lead to

respiratory depression.

Halofrantine

Fluconazole can increase halofrantine plasma concentration due to an inhibitory effect on CYP3A4.

HMG-CoA Reductase Inhibitors

The risk of myopathy and rhabdomyolysis increases when fluconazole is coadministered with HMG-CoA

reductase inhibitors metabolised through CYP3A4, such as atorvastatin and simvastatin, or through CYP2C9,

such as fluvastatin. If concomitant therapy is necessary, the patient should be observed for symptoms of

myopathy and rhabdomyolysis, and creatinine kinase should be monitored. HMG-CoA reductase inhibitors should

be discontinued if a marked increase in creatinine kinase is observed or myopathy/rhabdomyolysis is diagnosed

or suspected.

Canesoral Duo Data Sheet

18 September 2020

Page 5 of 14

Hydrochlorothiazide

Concomitant oral administration of 100 mg fluconazole and 50 mg hydrochlorothiazide for 10 days in normal

volunteers resulted in an increase of 41% in C

and an increase of 43% in AUC of fluconazole, compared to

fluconazole given alone. An effect of this magnitude should not necessitate a change in the fluconazole dose

regimen in subjects receiving diuretics, although the prescriber should bear it in mind.

Losartan

Fluconazole inhibits the metabolism of losartan to its active metabolite (E-3174) which is responsible for most of

the angiotensin II-receptor antagonism which occurs during treatment with losartan. Patients should have their

blood pressure monitored continuously.

Methadone

Fluconazole may enhance the serum concentration of methadone. Dosage adjustment of methadone may be

necessary.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

The C

and AUC of flurbiprofen were increased by 23% and 81% respectively when coadministered with

fluconazole,

compared

administration

flurbiprofen

alone.

Similarly,

pharmacologically active isomer [S-(+)-ibuprofen] were increased by 15% and 82% respectively when fluconazole

was coadministered with racemic ibuprofen (400 mg), compared to administration of racemic ibuprofen alone.

Although not specifically studied, fluconazole has the potential to increase the systemic exposure of other NSAIDs

that are metabolised by CYP2C9 (e.g. naproxen, lornoxicam, meloxicam, diclofenac). Frequent monitoring for

adverse events and toxicity related to NSAIDs is recommended. Adjustment of dosage of NSAIDs may be

needed.

Olaparib:

Moderate inhibitors of CYP3A4 such as fluconazole increase olaparib plasma concentrations.

Concomitant use is not recommended. If the combination cannot be avoided, limit the dose of olaparib to 200 mg

twice daily.

Oral Contraceptives

Three kinetic studies with a combined oral contraceptive have been performed using multiple doses of

fluconazole. There were no relevant effects on either hormone level in the 50 mg fluconazole study, while at 200

mg daily the AUCs of ethinyl estradiol and levonorgestrel were increased 40% and 24% respectively. In a 300 mg

once weekly fluconazole study, the AUCs of ethinyl estradiol and norethindrone were increased by 24% and 13%

respectively. Thus, multiple dose use of fluconazole at these doses is unlikely to have an effect on the efficacy of

the combined oral contraceptive.

Oral Hypoglycaemic Agents

The effects of fluconazole on the pharmacokinetics of the sulphonylurea oral hypoglycaemic agents tolbutamide,

glipizide and glibenclamide were examined in three placebo-controlled crossover studies in normal volunteers. All

subjects received the sulphonylurea alone and following treatment with 100mg of fluconazole as a single daily

oral dose for 7 days. Fluconazole administration resulted in significant increases in C

and AUC of the

sulphonylurea. Several subjects in these three studies experienced symptoms consistent with hypoglycaemia. In

the glibenclamide study, several volunteers required oral glucose treatment. As fluconazole is a potent inhibitor

of CYP2C8 and CYP2C9, it may also interact with other sulphonylureas (eg. glimepiride and gliclazide) and the

thiazolidinediones (eg. pioglitazone and rosiglitazone), which are metabolised by these enzymes. When

fluconazole and sulphonylureas or thiazolidinediones are coadministered, blood glucose concentrations should

be monitored carefully. The possibility of a hypoglycaemic episode should be borne in mind.

Phenytoin

Concomitant administration of oral fluconazole (200 mg) with phenytoin at steady state resulted in an average

increase of 75% of phenytoin AUC values in normal volunteers. Careful monitoring of phenytoin concentrations

in patients receiving fluconazole and phenytoin is recommended.

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Rifampicin

Administration of a single oral 200 mg dose of fluconazole after chronic rifampicin administration resulted in a

25% decrease in AUC and a 20% shorter half-life of fluconazole in normal volunteers. Depending on clinical

circumstances, an increase of the dose of fluconazole should be considered when it is administered with

rifampicin.

Pimozide

Although not studied in vitro or in vivo, concomitant administration of fluconazole with pimozide may result in

inhibition of pimozide metabolism. Increased pimozide plasma concentrations can lead to QT prolongation and

rare occurrences of torsade de pointes. Coadministration of fluconazole and pimozide is contraindicated.

Prednisone

There was a case report that a liver-transplanted patient treated with prednisone developed acute adrenal cortex

insufficiency when a three month therapy with fluconazole was discontinued. The discontinuation of fluconazole

presumably caused an enhanced CYP3A4 activity which led to increased metabolism of prednisone. Patients on

long-term treatment with fluconazole and prednisone should be carefully monitored for adrenal cortex insufficiency

when fluconazole is discontinued.

Quinidine

Although not studied in vitro or in vivo, concomitant administration of fluconazole with quinidine may result in

inhibition of quinidine metabolism. Use of quinidine has been associated with QT prolongation and rare

occurrences of torsades de points. Coadministration of fluconazole and quinidine is contraindicated (see section

4.3 Contraindications).

Short Acting Benzodiazepines

Studies in human subjects have reported changes in midazolam pharmacokinetics and clinical effects that are

dependent on dosage and route of administration. Single doses of fluconazole 150 mg resulted in modest

increases in midazolam concentrations and psychomotor effects following oral administration of 10 mg that may

not be clinically significant. At doses used to treat systemic mycoses, fluconazole resulted in substantial increases

in midazolam concentrations and psychomotor effects following oral administration of midazolam 7.5 mg, but only

modest increases that are not likely to be clinically significant following intravenous infusion of midazolam 0.05

mg/kg.

concomitant

benzodiazepine

therapy

necessary

patients

being

treated

with

fluconazole,

consideration should be given to decreasing the benzodiazepine dosage, and the patients should be appropriately

monitored.

Rifabutin

There have been reports that an interaction exists when fluconazole is administered concomitantly with rifabutin,

leading to increased serum levels of rifabutin. There have been reports of uveitis in patients to whom fluconazole

and rifabutin were coadministered. Patients receiving rifabutin and fluconazole concomitantly should be carefully

monitored.

Saquinavir

Fluconazole increases the AUC of saquinavir by approximately 50%, increases C

by approximately 55% and

decreases clearance of saquinavir by approximately 50% due to inhibition of saquinavir’s hepatic metabolism by

CYP3A4 and inhibition of P-glycoprotein. Dosage adjustments of saquinavir may be necessary.

Sirolimus

Fluconazole increases plasma concentrations of sirolimus presumably by inhibiting the metabolism of sirolimus

via CYP3A4 and P-glycoprotein. This combination may be used with a dosage adjustment of sirolimus depending

on the effect/concentration measurements.

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Sulfonylureas

Fluconazole has been shown to prolong the serum half-life of concomitantly administered oral sulfonylureas (e.g.

chlorpropamide, glibenclamide, glipizide, tolbutamide) in healthy volunteers. Freguent monitoring of blood

glucose and appropriate reduction of sulfonylurea dosage is recommended during coadministration.

Tacrolimus

There have been reports that an interaction exists when fluconazole is administered concomitantly with tacrolimus,

leading to increased serum levels of tacrolimus. There have been reports of nephrotoxicity in patients to whom

fluconazole and tacrolimus were coadministered. Patients receiving tacrolimus and fluconazole concomitantly

should be carefully monitored.

Terfenadine

Because of the occurrence of serious cardiac dysrhythmias secondary to prolongation of the QTc interval in

patients receiving azole antifungals in conjunction with terfenadine, interaction studies have been performed. One

study at a 200 mg daily dose of fluconazole failed to demonstrate a prolongation in QTc interval. Another study

at a 400 mg and 800 mg daily dose of fluconazole demonstrated that fluconazole taken in doses of 400 mg per

day or greater significantly increases plasma levels of terfenadine when taken concomitantly. The combined use

of fluconazole at doses of 400 mg or greater with terfenadine is contraindicated. The coadministration of

fluconazole at doses lower than 400 mg per day with terfenadine should be carefully monitored.

Theophylline

In a placebo controlled interaction study, the administration of fluconazole 200 mg for 14 days resulted in an 18%

decrease in the mean plasma clearance of theophylline. Patients who are receiving high dose theophylline or who

are otherwise at increased risk of theophylline toxicity should be observed for signs of theophylline toxicity while

receiving fluconazole, and therapy modified appropriately if signs of toxicity develop.

Tofacitinib

Exposure is increased when tofacitinib is coadministered with medications that result in both moderate inhibition

of CYP3A4 and potent inhibition of CYP2C19 (e.g. fluconazole). Dosage adjustment of tofacitinib may be

necessary..

Triazolam

Fluconazole increases the AUC of triazolam (single dose) by approximately 50%, C

by 20% - 32% and

increases t

by 25% - 50% due to the inhibition of metabolism of triazolam. Dosage adjustments of triazolam may

be necessary.

Vinca Alkaloids

Although not studied, fluconazole may increase the plasma levels of the vinca alkaloids (e.g. vincristine and

vinblastine) and lead to neurotoxicity, which is possibly due to an inhibitory effect on CYP3A4.

Vitamin A

Based on a case report in one patient receiving combination therapy with all-trans-retinoid acid (an acid form of

vitamin A) and fluconazole, CNS-related undesirable effects have developed in the form of pseudotumour cerebri,

which disappeared after discontinuation of fluconazole treatment. This combination may be used but the

incidence of CNS-related undesirable effects should be borne in mind.

Voriconazole

CYP2C9, CYP2C19 and CYP3A4 inhibitor: Concurrent administration of oral voriconazole (400 mg every 12 h

for 1 day, then 200 mg every 12 h for 2.5 days) and oral fluconazole (400 mg on day 1, then 200 mg every 24 h

for 4 days) to 6 healthy male subjects results in an increase in C, and AUC, of voriconazole by an average of 57%

(90% CI: 20%, 107%), and 79% (90% CI: 40%, 128%), respectively. In a follow-on clinical study involving 8

healthy male subjects, reduced dosing and/or frequency of voriconazole and fluconazole did not eliminate or

diminish this effect. Concomitant administration of voriconazole and fluconazole at any dose is not recommended.

Canesoral Duo Data Sheet

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Warfarin

A single dose of warfarin (15 mg) given to normal volunteers, following 14 days of orally administered fluconazole

(200 mg) resulted in a 12% increase in the prothrombin time response (area under the prothrombin time-time

curve). One of 13 subjects experienced a 2-fold increase in his prothrombin time response. In post-marketing

experience, as with other azole antifungals, bleeding events (bruising, epistaxis, gastrointestinal bleeding,

haematuria and melena) have been reported, in association with increases in prothrombin time in patients

receiving fluconazole concurrently with warfarin. Careful monitoring of prothrombin time in patients receiving

fluconazole and coumarin-type anticoagulants is recommended.

Zidovudine

The AUC of zidovudine significantly increased (74%) during coadministration with fluconazole. Patients receiving

this combination should be monitored for the development of zidovudine-related adverse reactions.

Gastrointestinal Medicines

In fasted normal volunteers, absorption of orally administered fluconazole does not appear to be affected by

agents that increase gastric pH. Single dose administration of fluconazole (100 mg) with cimetidine (400 mg)

resulted in a 13% reduction in AUC and 21% reduction in C

of fluconazole. Administration of an antacid

containing aluminium and magnesium hydroxides immediately prior to a single dose of fluconazole (100 mg) had

no effect on the absorption or elimination of fluconazole.

Physicians should be alert to the potential for interactions with other medicines for which pharmacokinetic

interaction studies have not been conducted.

Clotrimazole Cream

There are no reported medicinal interactions with topical clotrimazole cream.

4.6 Fertility, Pregnancy and Lactation

Pregnancy (Category D)

There are no adequate and well controlled studies in pregnant women. There have been reports of multiple

congenital abnormalities in infants whose mothers were being treated for 3 or more months with high dose (400 -

800 mg/day) fluconazole therapy for coccidiomycosis. The relationship between fluconazole use and these events

is unclear. A study found any maternal exposure to fluconazole during pregnancy may increase the risk of

spontaneous abortion and that doses higher than 150 mg during the first trimester may increase the risk of cardiac

septal closure anomalies.

Adverse foetal effects have been seen in animals only at high dose levels associated with maternal toxicity.

Canesoral Duo should not be used in women who are pregnant, or in women of childbearing potential unless

adequate contraception is employed (see section 4.4 Special Warnings and Precautions for Use and section 4.5

Interactions with Other Medicines and Other Forms of Interaction, oral contraceptives).

Lactation

Fluconazole

been

found

human

breast

milk

concentrations

similar

plasma.

Available

pharmacodynamics/toxicological data in animals have shown excretion of clotrimazole/metabolites in milk (see

section 5.3 Preclinical Safety Data). Hence the use of Canesoral Duo in nursing mothers is not recommended.

Fertility

Fluconazole did not affect the fertility of male or female rats treated orally with daily doses of 5, 10 or 20 mg/kg or

with parenteral doses of 5, 25 or 75 mg/kg, although the onset of parturition was slightly delayed at 20 mg/kg p.o.

In an intravenous perinatal study in rats at 5, 20 and 40 mg/kg, dystocia and prolongation of parturition were

observed in a few dams at 20 mg/kg and 40 mg/kg, but not at 5 mg/kg. The disturbances in parturition were

reflected by a slight increase in the number of stillborn pups and decrease of neonatal survival at these dose

Canesoral Duo Data Sheet

18 September 2020

Page 9 of 14

levels. The effects on parturition in rats are consistent with the species specific oestrogen-lowering property

produced by high doses of fluconazole. Such a hormone change has not been observed in women treated with

fluconazole.

For clotrimazole, non-clinical data reveal no special hazard for humans based on conventional studies of toxicity

to reproduction and development.

4.7 Effects on Ability to Drive and Use Machines

Therapy with Canesoral Duo is unlikely to impair a patient's ability to drive or use machinery.

4.8 Undesirable Effects

Clotrimazole

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)

Skin and Subcutaneous Tissue Disorders

Blisters, discomfort/pain, oedema, erythema, irritation, peeling/exfoliation, pruritis, rash, stinging/burning.

Fluconazole

Fluconazole is generally well tolerated.

The most common undesirable effects observed during vaginal candidiasis clinical trials and associated with

fluconazole with an incidence > 1% are:

Nervous System Disorders

Headache

Gastrointestinal Disorders

Nausea, abdominal pain, diarrhoea, dyspepsia

In addition, the uncommon undesirable effects observed during vaginal candidiasis clinical trials associated with

fluconazole are:

Dermatological

Pruritus, genital pruritus, rash, erythematous rash, dry skin, abnormal skin odour, urticaria

Nervous System Disorders

Dizziness, flushing, dry mouth, vertigo, hyperkinesia, hypertonia, taste perversion

Gastrointestinal Disorders

Vomiting, anorexia, flatulence, constipation, loose stools

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18 September 2020

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Metabolic

Thirst

Psychiatric

Insomnia, nervousness, female sexual dysfunction

Reproductive

Intermenstrual bleeding, dysmenorrhoea, leucorrhoea, menorrhagia, uterine spasm, vaginal disorder

Respiratory

Pharyngitis

Special Senses

Taste perversion, abnormal vision, visual field defect

Urinary

Polyuria, renal pain

General

Fatigue, hot flushes, malaise, back pain, herpes simplex, pain, rigors

The following adverse events have occurred during experience with overall fluconazole use:

Blood and Lymphatic System Disorders

Leukopenia including neutropenia and agranulocytosis, thrombocytopenia

Cardiovascular Disorders

QT prolongation, torsades de pointes (see section 4.4 Special Warnings and Precautions for Use)

Nervous System Disorders

Seizures

Immune System Disorders

Anaphylaxis (including face oedema, angioedema, urticaria and pruritus)

Metabolic and Nutritional Disorders

Hypercholesterolaemia, hypertriglyceridaemia and hypokalaemia

Hepatobiliary Disorders

Hepatic failure, hepatitis, hepatocellular necrosis, jaundice

Skin and Subcutaneous Tissue Disorders

Alopecia, exfoliative skin disorders including Stevens-Johnson Syndrome and toxic epidermal necrolysis, drug

reaction with Eosinophilia and systemic symptoms (DRESS)

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/

Canesoral Duo Data Sheet

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4.9 Overdose

Fluconazole

There have been reports of overdosage with fluconazole, and in one case a 42-year-old patient infected with

human immunodeficiency virus developed hallucinations and exhibited paranoid behaviour after reportedly

ingesting 8,200 mg of fluconazole. The patient was admitted to hospital, and his condition resolved within 48

hours.

In the event of overdosage, symptomatic treatment (with supportive measures and gastric lavage if necessary)

should be undertaken.

Fluconazole is largely excreted in the urine; forced volume diuresis would probably increase the elimination rate.

A three-hour haemodialysis session decreases plasma levels by approximately 50%.

Clotrimazole

No risk of acute intoxication is seen as it is unlikely to occur following a single 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).

5.

Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group

Fluconazole: Antimycotics for systemic use – triazole derivatives. ATC Code: J02A C01

Clotrimazole: Antifungals for topical use – imidazole and triazole derivatives. ATC Code: D01A C01

Mechanism of Action

Fluconazole is a member of the bis-triazole class of antifungal agents. Fluconazole is a highly selective inhibitor

of fungal cytochrome P-450 sterol C-14 alpha demethylation. Mammalian cell demethylation is much less sensitive

to fluconazole inhibition. The subsequent loss of normal sterols correlates with the accumulation of 14 alpha-

methyl sterols in fungi and may be responsible for the fungistatic activity of fluconazole. Interaction studies with

antipyrine indicate that single or multiple doses of fluconazole 50 mg do not affect its metabolism.

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

structural and functional impairment of the 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).

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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.

Microbiology

Fluconazole administered orally or intravenously was active in a variety of animal models of fungal infections

using standard laboratory strains of fungi.

Fluconazole exhibits in vitro activity against Cryptococcus neoformans and Candida spp. Activity has been

demonstrated in vivo in normal and immunocompromised animals against infections with Candida spp, including

systemic candidiasis and in normal animals with C. neoformans, including intracranial infections. One case of

cross-resistance of Candida to fluconazole in a patient (non-HIV) previously treated with ketoconazole has been

reported. The efficacy of fluconazole in vivo is greater than would be apparent from in vitro testing against the

above-mentioned fungi.

Concurrent administration of fluconazole and amphotericin B in infected normal and immuno-compromised mice

showed antagonism of the two medicines in systemic infection with Aspergillus fumigatus. The clinical significance

of results obtained in these studies is unknown.

5.2 Pharmacokinetic Properties

In normal volunteers, the bioavailability of orally administered fluconazole is over 90% compared with intravenous

administration. Oral administration is not affected by concomitant food intake. In fasted normal volunteers, peak

plasma concentrations occur between 1 and 2 hours post dose with a terminal plasma elimination half-life of

approximately 30 hours (range 20 - 50 hours). The apparent volume of distribution approximates to total body

water. Plasma protein binding is low (11 - 12%).

Fluconazole has been found to achieve good penetration into all tissues and body fluids studied. The levels of

fluconazole in saliva and sputum are similar to plasma levels.

The major route of excretion is renal, with approximately 80% of the administered dose appearing in the urine as

unchanged medicine. About 11% of the dose is excreted in the urine as metabolites. The pharmacokinetics of

fluconazole are markedly affected by reduction in renal function, however, no adjustments in single-dose therapy

are necessary. There is an inverse relationship between the elimination half-life and creatinine clearance.

The long plasma elimination half-life provides the basis for single dose therapy for vaginal candidiasis.

There are differences in the pharmacokinetics between adults and children, with children after the neonatal period

generally having a faster elimination rate and larger volume of distribution than adults.

Pharmacokinetic investigations after dermal application have shown that clotrimazole is minimally absorbed from

the intact or inflamed skin into the human blood circulation. The resulting peak serum concentrations of

clotrimazole were below the detection limit of 0.001 μg/mL, suggesting that clotrimazole applied topically on the

skin is unlikely to lead to measurable systemic effects or side effects.

5.3 Preclinical Safety Data

Carcinogenesis and Mutagenesis

Fluconazole showed no evidence of carcinogenic potential in mice and rats treated orally for 24 months at doses

of 2.5, 5 or 10 mg/kg/day (approximately 2 - 7 times the recommended human dose). Male rats treated with 5 and

10 mg/kg/day had an increased incidence of hepatocellular adenomas.

Canesoral Duo Data Sheet

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Page 13 of 14

Fluconazole, with or without metabolic activation, was negative in tests for mutagenicity in 4 strains of Salmonella

typhimurium and in the mouse lymphoma system. Cytogenetic studies in vivo and in vitro showed no evidence of

chromosomal mutations.

For clotrimazole, 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.

6.

Pharmaceutical Particulars

6.1 List of Excipients

Fluconazole Capsule

Lactose monohydrate

Maize starch

Colloidal silicon dioxide

Magnesium stearate

Sodium lauryl sulphate

Capsule shells contain:

Titanium dioxide (E171)

Gelatin

Water

Printing ink contains:

Black iron oxide (E712), N-butyl alcohol, propylene glycol, ethanol, isopropyl alcohol, shellac glaze (esterified),

ammonium hydroxide.

Clotrimazole Cream

Sorbitan stearate

Polysorbate 60

Cetyl palmitate

Cetostearyl alcohol

Octyldodecanol

Benzyl alcohol (2% w/w)

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

36 months (3 years) from date of manufacture

6.3 Special Precautions for Storage

Store at or below 25

Canesoral Duo Data Sheet

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Page 14 of 14

6.4 Nature and Contents of Container

Canesoral blister pack: Packs of one fluconazole 150 mg capsule.

6.5 Special Precautions for Disposal

No special requirements.

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 Medicine

8.

Sponsor

Bayer New Zealand Limited

3 Argus Place

Hillcrest

North Shore

Auckland 0627

P. O. Box 2825

Shortland Street

Auckland 1140

Freephone 0800 229 376

www.canesten.co.nz

9.

Date of First Approval

30 April 2015

10.

Date of Revision of the Text

18 September 2020

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