Consumer medicine information

Canesten Plus Antifungal Anti-inflammatory Cream

Clotrimazole; Hydrocortisone

BRAND INFORMATION

Brand name

Canesten Plus Antifungal Anti-Inflammatory Cream

Active ingredient

Clotrimazole; Hydrocortisone

Schedule

S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Canesten Plus Antifungal Anti-inflammatory Cream.

What is in this leaflet

This leaflet answers some common questions about CANESTEN® Plus Antifungal Anti-Inflammatory 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® Plus Antifungal Anti-Inflammatory Cream against the benefits they expect it will have for you.

If you have any concerns about this medicine, ask your doctor or pharmacist. Keep this leaflet with your medicine, You may need to read it again.

What is CANESTEN® Plus Antifungal Anti-Inflammatory Cream used for?

CANESTEN® Plus Antifungal Anti-Inflammatory Cream is used on the skin to treat and soothe inflamed fungal skin conditions such as:

  • Tinea pedis (athlete‘s foot)
  • Jock itch
  • Ringworm
  • Fungal skin rash.

CANESTEN® Plus Antifungal Anti-Inflammatory Cream is a broad spectrum anti-fungal and anti-inflammatory cream. It contains two active ingredients; clotrimazole and hydrocortisone. Clotrimazole belongs to a group of medicines called imidazole antifungals which are used to treat fungal skin infections. Hydrocortisone is a mild steroid which reduces the swelling, redness and itching associated with inflammation of the skin. For conditions without inflammation use an antifungal agent without hydrocortisone, such as CANESTEN® Clotrimazole Antifungal Cream.

This product should not be used in children under 12 years of age.

Before using CANESTEN® Plus Antifungal Anti-Inflammatory Cream

Do not use CANESTEN® Plus Antifungal Anti-Inflammatory Cream if:

  • you have an allergy to any of the ingredients of CANESTEN® Plus Antifungal Anti-Inflammatory Cream listed at the end of this leaflet
  • the skin on the area to be treated is cracked or broken
  • you have a viral skin infection (such as cold sores, shingles or chicken pox)
  • you have other infections of the skin (such as acne, rosacea, perioral dermatitis, lues, tuberculosis)
  • you have a reaction of the skin resulting from a vaccination.

Do not use CANESTEN® Plus Antifungal Anti-Inflammatory Cream if the packaging is torn or shows signs of tampering.

Do not use CANESTEN® Plus Antifungal Anti-Inflammatory Cream if the expiry date (EXP) printed on the pack has passed. If you use this medicine after the expiry date has passed, it may not work as well.

Do not use CANESTEN® Plus Antifungal Anti-Inflammatory Cream just before having a bath, shower or going swimming. If you do, you may reduce the effectiveness of CANESTEN® Plus Antifungal Anti-Inflammatory Cream.

Consult your doctor or pharmacist first if:

  • you have allergies to any other medicine or any other substances such as foods, preservatives or colours
  • you have cuts or abrasions at or near the area to be treated. The chance of unwanted effects may be increased.

Tell your doctor before use if you are pregnant or breastfeeding. Your doctor will discuss with you the risks and benefits of using this product while pregnant or breastfeeding.

Tell your doctor or pharmacist if you are using other creams, ointments or lotions or taking any medicine.

This includes any that you buy without a prescription from a pharmacy, supermarket or health food shop.

How do I use CANESTEN® Plus Antifungal Anti-Inflammatory Cream?

Follow all directions given to you by your doctor or pharmacist carefully. These directions may differ from the information contained in this leaflet.

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

It is important to use CANESTEN® Plus Antifungal Anti-Inflammatory Cream exactly as your doctor or pharmacist has told you. If you use it less often than you should, it may not work as well and your skin problem may not improve. Using it more often than you should may not improve your skin problem any faster and may cause or increase side effects.

Before use, pierce the seal on the tube by inverting the cap over the end of the tube and pressing.

A small amount of CANESTEN® Plus Antifungal Anti-Inflammatory Cream should be applied thinly and evenly with gentle rubbing to the affected area(s) twice daily.

Use only until inflammation, itching, and redness have subsided, and not for more than 7 days (unless a doctor has told you to). Then use a clotrimazole-only cream, such as CANESTEN® Clotrimazole Anti-fungal Cream for 14 days after symptoms disappear to avoid recurrence of the infection.

If you use too much (overdose)

Telephone your doctor or the Poisons Information Centre (Australia 131 126) or go to the nearest Accident and Emergency department immediately if you think that you or anyone else may have used too much CANESTEN® Plus Antifungal Anti-Inflammatory Cream. Do this even if there are no signs of discomfort or poisoning. You may need medical attention.

While you are using CANESTEN® Plus Antifungal Anti-Inflammatory Cream

Tell your doctor if you become pregnant, are breastfeeding or intend to breast feed while using CANESTEN® Plus Antifungal Anti-Inflammatory Cream.

Do not use CANESTEN® Plus Antifungal Anti-Inflammatory Cream in or near the eyes.

Do not give CANESTEN® Plus Antifungal Anti-Inflammatory Cream to anyone else, even if they have the same symptoms as yours. Do not use CANESTEN® Plus Antifungal Anti-Inflammatory Cream to treat other complaints unless your doctor or pharmacist tells you to.

Do not use CANESTEN® Plus Antifungal Anti-Inflammatory Cream under dressings or on large areas of the skin unless your doctor tells you to.

Do not use large amounts of CANESTEN® Plus Antifungal Anti-Inflammatory Cream for a long time. If you use large amounts for a long time, the chance of absorption through the skin and the chance of side effects increases.

Ask your doctor or pharmacist if you are concerned about the length of time you have been using CANESTEN® Plus Antifungal Anti-Inflammatory Cream.

Are there any unwanted effects when using CANESTEN® Plus Antifungal Anti-Inflammatory Cream?

CANESTEN® Plus Antifungal Anti-Inflammatory Cream helps most people but a few people may experience unwanted effects.

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.

After the application of CANESTEN® Plus Antifungal Anti-Inflammatory Cream a slight stinging sensation may occasionally be noticed. This will most likely disappear after several applications.

Skin reactions (such as hypersensitivity reactions e.g. burning, stinging, swelling or redness) can occasionally occur. Particularly after use on large areas (more than 10% of the body surface) and/or after long term use (longer than 2-4 weeks) or under occlusive (air and watertight) dressings, local skin changes may occur.

If you experience blurred vision or other visual disturbances contact your doctor.

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

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After Using CANESTEN® Plus Antifungal Anti-Inflammatory Cream

Storage:

Store CANESTEN® Plus Antifungal Anti-Inflammatory Cream below 25°C in a cool, dry place. Do not store in the bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep CANESTEN® Plus Antifungal Anti-Inflammatory Cream where young children cannot reach it. A locked cupboard or at least one-and-a-half meters above the ground is a good place to store medicines.

Do not use after the expiry date printed on the pack.

Disposal:

If your doctor tells you to stop using CANESTEN® Plus Antifungal Anti-Inflammatory Cream or it has passed its expiry date, ask your pharmacist what to do with any that is left over.

Product Description

What is looks like:

CANESTEN® Plus Antifungal Anti-Inflammatory Cream is a white to slightly yellowish cream.

Ingredients:

CANESTEN® Plus Antifungal Anti-Inflammatory Cream contains 10 mg/g of clotrimazole and 11.2 mg/g of hydrocortisone acetate as the active ingredients. It also contains:

  • benzyl alcohol
  • cetosteryl alcohol
  • triceteareth-4-phosphate
  • triglycerides medium-chain
  • sodium hydroxide
  • water.

Sponsor

CANESTEN® Plus Antifungal Anti-Inflammatory Cream is supplied in Australia by:

Bayer Australia Ltd
875 Pacific Highway
Pymble NSW 2073
Ph: 1800 008 757

CANESTEN® Plus Antifungal Anti-Inflammatory Cream is supplied in New Zealand by:

Bayer New Zealand Limited
Auckland, New Zealand
Ph: 0800 229 376

Date of Preparation: September 2021

® Registered Trademark of Bayer

Aust R 192113

88423577

Published by MIMS July 2022

BRAND INFORMATION

Brand name

Canesten Plus Antifungal Anti-Inflammatory Cream

Active ingredient

Clotrimazole; Hydrocortisone

Schedule

S2

 

1 Name of Medicine

Clotrimazole and hydrocortisone acetate.

2 Qualitative and Quantitative Composition

Canesten Plus Antifungal Anti-Inflammatory Cream contains 10 mg/g of clotrimazole and 11.2 mg/g of hydrocortisone acetate as the active ingredients.
Contains benzyl alcohol as a preservative.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Canesten Plus Antifungal Anti-Inflammatory Cream is a white to slightly yellowish cream.

4 Clinical Particulars

4.1 Therapeutic Indications

For dermatophytes and yeast infections of the skin when inflammation is prominent. This includes conditions, such as fungal infected intertrigo.

4.2 Dose and Method of Administration

Dosage.

A small amount of Canesten Plus Antifungal Anti-Inflammatory Cream should be applied twice daily.

Method of administration.

Apply thinly and evenly with gentle rubbing to the affected area(s). Use only until inflammation, itching and redness have subsided and not for more than 7 days (unless directed by the doctor). Then use an antifungal-only cream such as Canesten Clotrimazole Anti-fungal Cream for 14 days after symptoms disappear to avoid recurrence of the infection.

4.3 Contraindications

Canesten Plus Antifungal Anti-Inflammatory Cream is contraindicated in the following cases:
hypersensitivity to any of the ingredients;
use on broken skin;
diseases affecting the skin (such as acne, rosacea, perioral dermatitis, lues, tuberculosis, etc.);
in or near the eyes;
viral skin diseases;
dermal vaccination reactions.

4.4 Special Warnings and Precautions for Use

For external use only. Canesten Plus Antifungal Anti-Inflammatory Cream should not be applied in the eyes.
Because of its corticosteroid content, Canesten Plus Antifungal Anti-Inflammatory Cream should not be applied:
to large areas (more than 10%) of the body surface;
for a long period during pregnancy, particularly in the first three months;
under occlusive dressing due to increased absorption;
If hypersensitivity reactions occur, use should be discontinued.
If an associated infection develops during use and does not respond to therapy, use should be discontinued until the infection is controlled.

Interactions with latex.

The effectiveness and safety of latex products such as condoms and diaphragms may be reduced by Canesten Plus Antifungal Anti-Inflammatory Cream when applied on the genital area (women: labia and adjacent area of the vulva; men: prepuce and glans of the penis). The effect is temporary and may occur only during treatment.

Hypothalamic-pituitary axis suppression and atrophic striae.

Long term corticosteroid use may increase the risk of hypothalamic-pituitary axis suppression, especially under occlusion. Use for longer than 4 weeks can cause atrophic striae, and prolonged use on flexures and in intertriginous areas is undesirable.

Visual disturbance.

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Use in the elderly.

No data available.

Paediatric use.

The risk of systemic absorption, and hence systemic toxicity, is greater in children due to the higher permeation properties of the skin and a larger skin surface to body weight ratio than adults. Do not use on children under 12 years of age.
Bandages may act as an occlusive dressing and may increase systemic absorption.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
While controlled clinical studies in pregnant women do not exist, epidemiological investigations give no indication that harmful effects on the mother and child should be anticipated when Canesten Plus Antifungal Anti-Inflammatory Cream is used during pregnancy. It is recommended not to apply Canesten Plus Antifungal Anti-Inflammatory Cream for a long period during pregnancy particularly in the first three months. However, Canesten Plus Antifungal Anti-Inflammatory Cream should only be used in the first 3 months of pregnancy after first consulting a doctor.
[Category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without an increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.]
 Although systemic absorption following topical administration is low, there is no information on whether or not Canesten Plus Antifungal Anti-Inflammatory Cream is excreted in breast milk. Caution should be exercised when this product is administered to nursing mothers and it should not be applied on the breasts.

4.7 Effects on Ability to Drive and Use Machines

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

4.8 Adverse Effects (Undesirable Effects)

Skin reactions (such as hypersensitivity reactions e.g. burning, stinging, oedema or redness) can occur occasionally. Particularly after use on large areas (more than 10% of the body surface) and/or after long-term use (longer than 2-4 weeks) or under occlusive conditions, local skin alterations such as skin atrophy, telangiectasia, hypertrichosis, striations, hypopigmentation, secondary infection and acneiform symptoms may occur.

Post marketing.

Eye disorders.

Vision blurred.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

No reports are available on cases of overdosage with Canesten Plus Antifungal Anti-Inflammatory Cream. For overdosage, treatment should be symptomatic and supportive. In the case of oral overdose, emesis or activated charcoal is not usually indicated unless multiple ingestions are suspected. Excessive chronic exposure results in adverse systemic and dermal effects. In such cases, the use of topical corticosteroid should be discontinued, with consideration given to tapering the dose.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Canesten Plus Antifungal Anti-Inflammatory Cream is a combination of clotrimazole, which is an imidazole derivative, and hydrocortisone acetate, which is a glucocorticoid.

Mechanism of action.

Clotrimazole.

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 0.062-4 (-8) microgram/mL substrate. The mode of action of clotrimazole is 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 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. 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.

Hydrocortisone.

Hydrocortisone is a weak corticosteroid with both glucocorticoid and to a lesser extent mineralocorticoid activity when used. As an active ingredient in a topical cream, it exerts antiphlogistic, antipruriginous, antiexudative and antiallergic effects. Hydrocortisone - as for other topically applied glucocorticoids - exerts an anti-inflammatory, immunosuppressive, antimitotic (antiproliferative), antipruriginous and vasoconstrictive effect on skin. Thus, it provides symptomatic treatment of inflammation and pruritus associated with minor skin irritations and rashes.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Clotrimazole.

Pharmacokinetic investigations after dermal application have shown that only a small amount of clotrimazole (< 2% of the dose) is absorbed. The resulting peak serum concentrations of clotrimazole were below the detection limit of 0.01 microgram/mL, reflecting that clotrimazole applied topically on the skin does not lead to measurable systemic effects or undesirable effects.

Hydrocortisone.

Dermal absorption of hydrocortisone depends on the thickness and condition of the skin. In the case of inflamed or damaged skin, cutaneous absorption may be increased depending on the site of application, use of occlusive dressings, the degree of skin damage, and size of the treated area. Systemic effects cannot be ruled out under such conditions. An increase in the skin temperature or moisture content, e.g. in skin folds or under an occlusive dressing, also promotes absorption. Children are more susceptible to transcutaneous uptake of drugs because they have a greater area to body mass ratio. The occurrence of systemic effects depends partly on the dose and, to a much greater extent, on the duration of treatment. More than 90% of the hydrocortisone absorbed is bound to plasma proteins.
No relevant absorption of hydrocortisone needs to be expected after its use for a short period on limited skin inflammation areas.

Metabolism.

Hydrocortisone.

Hydrocortisone is metabolized in the liver and tissues.

Excretion.

Hydrocortisone.

The metabolites are excreted in the urine. The biological half-life is approximately 100 minutes.

5.3 Preclinical Safety Data

Clotrimazole.

Toxicological studies in different animals with local or intravaginal application showed good local and vaginal tolerability. Preclinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity and toxicity to reproduction.

Hydrocortisone.

As an adrenocortical hormone, hydrocortisone is classified as relatively non-toxic on topical use. So far there is no evidence of any reproduction toxicity for corticoids used topically in accordance with the instructions.

Genotoxicity.

Clotrimazole.

Preclinical data reveal no special hazard for humans based on conventional studies of genotoxicity.

Hydrocortisone.

Teratogenic effects of high doses of glucocorticosteroids such as cleft palate formation, growth retardation, etc. are known after systemic use in animal studies; there are no data on teratogenic damage after dermal use. Years of therapeutic experience in man with topical use of hydrocortisone have not yielded any evidence of teratogenicity.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Canesten Plus Antifungal Anti-Inflammatory Cream also contains benzyl alcohol, cetostearyl alcohol, triceteareth-4-phosphate, triglycerides medium chain, sodium hydroxide and purified water.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry data can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Epoxy-coated aluminium tubes containing 15 g of cream.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

Clotrimazole.


Hydrocortisone acetate.


CAS number.

Clotrimazole: 23593-75-1.
Hydrocortisone acetate: 50-03-3.

7 Medicine Schedule (Poisons Standard)

Schedule 2 - Pharmacy Medicine.

Summary Table of Changes