Canesten Cream

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Clotrimazole
Available from:
Bayer Limited
ATC code:
D01AC; D01AC01
INN (International Name):
Clotrimazole
Dosage:
1 percent weight/weight
Pharmaceutical form:
Cream
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Imidazole and triazole derivatives; clotrimazole
Authorization status:
Marketed
Authorization number:
PA1410/039/002
Authorization date:
1977-04-01

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Canesten® Cream

Clotrimazole 1% w/w

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Canesten Cream

carefully to get the best results from it.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

You must contact a doctor if your symptoms worsen or do not improve.

If you have any unusual effects after using this product, tell your doctor or pharmacist.

IN THIS LEAFLET

1. What is Canesten Cream and what is it used for?

2. Before you use Canesten Cream

3. How to use Canesten Cream

4. Possible side effects

5. How to store Canesten Cream

6. Further information

1. WHAT IS CANESTEN® CREAM AND WHAT IS IT USED FOR?

Canesten Cream is used to treat fungal skin infections such as ringworm, athlete’s foot, fungal

nappy rash and fungal sweat rash. It is also used to relieve irritation of the vulva (external

thrush) or the end of the penis, which may be associated with thrush.

If you are unsure whether you (or your baby if treating nappy rash) have one of these fungal

skin infections, seek the advice of your doctor or pharmacist.

The active substance in Canesten Cream is clotrimazole. Clotrimazole belongs to a group of

medicines called imidazoles and is an antifungal agent which fights the cause of fungal skin

infections.

2. BEFORE YOU USE CANESTEN® CREAM

Do not use Canesten® Cream:

If you (or your baby if treating nappy rash) are allergic (hypersensitive) to clotrimazole or any

of the other ingredients of Canesten Cream.

Important information about some of the ingredients:

This product contains cetostearyl alcohol which may cause local skin irritation (e.g. rash, itching

or redness).

Special precautions:

As with other creams, Canesten Cream may reduce the effectiveness of rubber contraceptives,

such as condoms or diaphragms. Consequently, if you are using this cream on the vulva or penis,

you should use alternative precautions for at least five days after using this product.

Pregnancy and breast-feeding:

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Avoid using this medicine during the first trimester of pregnancy. If you are pregnant, breast-

feeding or trying for a baby, tell your doctor or midwife before using Canesten Cream. Breast-

feeding should be discontinued during treatment with this medicine.

3. HOW TO USE CANESTEN® CREAM

If Canesten Cream has been prescribed for you by your doctor, follow any instructions he/she

may have given you. If you purchased this product without a prescription, follow these

directions closely:

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

If the feet are infected, they should be washed and dried thoroughly, especially between the

toes, before applying the cream.

Canesten Cream should be applied thinly and evenly to the affected areas two or three times

daily and rubbed in gently.

The duration of the treatment depends upon the type of infection. Generally a minimum of

two weeks is required, although up to four weeks may be necessary.

If you have athlete’s foot, it may help to use an antifungal dusting powder as well. Ask your

doctor or pharmacist to recommend one.

The symptoms of skin infection, such as itching or soreness, should improve within a few days of

treatment although signs such as redness and scaling may take longer to disappear. If no

improvement is seen after four weeks, you must tell your doctor.

Canesten® Antifungal Cream is for external use only:

Do not put the cream in your mouth or swallow it.

If the cream is swallowed accidentally, tell your doctor straight away or contact the Accident

and Emergency Department of your nearest hospital.

Avoid contact with the eyes. If you accidentally get cream in your eyes or mouth, wash

immediately with water and contact your doctor.

If you forget to use Canesten® Cream:

Apply the cream as soon as possible and then continue the rest of your treatment as usual.

You can help the treatment to work if you follow these simple self-help tips:

Although the infected area will itch, try not to scratch. Scratching will damage the surface of

the skin and cause the infection to spread further.

Keep the affected skin areas clean.

Pay particular attention to drying the skin, but avoid excessive rubbing.

Do not share towels, bath mats, etc. with other people as you could spread the infection to

them.

Always wash your hands after treating the infection to prevent it from spreading.

If you have athlete’s foot:

Remember to dry the skin between the toes thoroughly.

Wash your socks, stockings and tights thoroughly in hot water to remove any shed skin or

fungal spores.

Change your footwear daily if possible.

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4. POSSIBLE SIDE EFFECTS

Like all medicines, Canesten Cream can cause side effects, although not everybody gets them.

As with all medicines, some people may be allergic to the cream. If you or your baby are allergic,

a reaction will occur soon after you start using it. If you or your baby experience an allergic

reaction, stop using Canesten Antifungal Cream and tell your doctor straight away or contact the

Accident and Emergency Department of your nearest hospital. Signs of an allergic reaction may

include:

Rash.

Swallowing or breathing problems.

Swelling of your lips, face, throat or tongue.

Weakness, feeling dizzy or faint.

Nausea.

Rarely, immediately after you apply the cream you or your baby might experience the following

symptoms:

Mild burning.

Irritation.

If this is intolerable, stop treatment and see your doctor as soon as possible.

Very rarely, Canesten Antifungal Cream may cause side effects which can be very similar to the

symptoms of the infection. If any of these symptoms gets worse, stop treatment and see your

doctor as soon as possible. These symptoms may include:

Burning, pain or itching.

Redness.

Rash.

Swelling.

Other potential side effects that have been reported:

Peeling skin, blisters, low blood pressure.

Reporting of side effects

If you or your baby gets any side effects, talk to your doctor, pharmacist or nurse. This includes

any possible side effects not listed in this leaflet. You can also report side effects directly via

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1

6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie

. By reporting side effects you can

help provide more information on the safety of this medicine.

5. HOW TO STORE CANESTEN® CREAM

Keep out of the reach and sight of children.

This product should be stored in the original carton.

Do not store above 25°C.

Do not use Canesten Cream after the expiry date which is stated at one end of the carton and on

the end of the tube of cream. The expiry date refers to the last day of that month.

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Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist

how to dispose of medicines no longer required. These measures will help to protect the

environment.

6. FURTHER INFORMATION

What Canesten® Cream contains:

The active substance is clotrimazole at a strength of 1% w/w.

The other ingredients are benzyl alcohol, polysorbate 60, sorbitan stearate, cetyl palmitate,

cetostearyl alcohol, octyldodecanol and purified water.

See Section 2 ‘Important information about some of the ingredients’ for cetostearyl alcohol

advice.

What Canesten® Cream looks like and contents of the pack:

Canesten Cream is available in tubes containing 20g and 50g of white cream. Not all pack sizes

may be marketed.

Marketing Authorisation Holder:

Bayer Ltd, The Atrium, Blackthorn Road, Dublin 18.

Manufacturer:

Kern Pharma S.L.

Poligon Industrial Colon II, Calle Venus 72

08228 Terrassa, Barcelona, Spain

GP Grenzach Produktions GmbH,

Germany.

Remember: If you have any doubts about using Canesten® Cream correctly, seek the advice of

your doctor or pharmacist.

Further information about fungal infections:

Fungal infections are very common and affect many people. Some of the most common fungal

skin infections include athlete’s foot, nappy rash, sweat rash and ringworm.

There are two main types of fungal infection:

The tinea group, also known as dermatophytes.

The candida group, also known as yeasts.

The tinea group includes athlete’s foot and ringworm, both of which are easily spread by

contact. The fungus that causes athlete’s foot usually lives harmlessly on our skin and in our

environment. The natural balance that normally keeps it under control can be upset by factors

such as damp moist conditions. This could happen, for example, through regularly wearing

training shoes that keep the feet hot and sweaty. Since this fungus is contagious, it can also

often be picked up in changing rooms. Ringworm is usually passed on from animals to children.

Ringworm is not actually a worm, its name comes from the circular worm-like shape that it

forms on the skin. The main symptom for both is an itchy, scaly and irritating rash.

The candida group can be responsible for conditions such as sweat rash and thrush. Sweat rash

can appear anywhere on the body, but is more likely to occur where folds of skin rub against

each other, such as: under the breasts, under arms, around the groin and on the back. Candida

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is a yeast-like fungus that usually lives harmlessly on our skin. However, the natural balance that

normally keeps it under control can be upset by factors such as sweating, tight or synthetic

clothing and cosmetic preparations such as bath additives. When levels of the yeast increase,

the skin can develop the following symptoms: persistent burning and itching, soreness and a

variety of patches or blemishes as well as a softened and soggy appearance.

The candida group can also be responsible for nappy rash. Most babies develop nappy rash at

some stage. Although this is rarely a serious condition, the rash can be extremely distressing for

both you and your baby. Nappy rash which lasts longer than three days may be fungal in origin

and will require an antifungal treatment. The symptoms of fungal nappy rash include red

patches on the baby’s bottom and genitals, burning and itching.

This leaflet was last approved in November 2018.

Canesten is a registered trademark of Bayer AG, Germany.

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Canesten Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Contains clotrimazole 1% w/w (equivalent to 10mg/g).

Excipients: Contains 10% w/w cetostearyl alcohol.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Cream

A white oil-in-water type cream.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

A broad spectrum antifungal for use in the topical treatment of infections due to superficial dermatophytes, Candida

species and other fungi sensitive to the anti-infective: Staphylococcus and Bacteroides.

The drug has no effect on

Lactobacilli.

4.2 Posology and method of administration

Canesten Cream should be applied to the affected area 2 or 3 times daily. To prevent relapse, treatment should be

continued for at least two weeks after the disappearance of all signs of infection.

Patients should notify their physician if there is no improvement after 4 weeks of treatment.

4.3 Contraindications

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

4.4 Special warnings and precautions for use

All possibly infected areas should be treated at the same time.

This product contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

Avoid contact with eyes and do not swallow.

4.5 Interaction with other medicinal products and other forms of interaction

Laboratory tests have suggested that, when used together, this product may cause damage to latex contraceptives.

Consequently the effectiveness of such contraceptives may be reduced. Patients should be advised to use alternative

precautions for at least five days after using this product.

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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 drug on fertility.

Pregnancy:

There are limited amount of data from the use of clotrimazole in pregnant women.

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.

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 (ME) (with symptoms such as urticaria (ME), dyspnoe (PT), hypotension (PT) and syncope (PT)).

Skin and subcuteaneous tissue disorders

Pruritus (ME), rash (ME), blisters (PT), peeling/exfoliation (PT), discomfort/pain (PT), stinging/burning (PT), edema

(PT), burning (PT), irritation, erythema (PT).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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 via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

4.9 Overdose

In the event of accidental oral ingestion, routine measures such as gastric lavage should be performed only if clinical

symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting).

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antifungals for topical use – imidazole and triazole derivates.

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 cytoplasmic membrane.

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Pharmacodynamic Effects:

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 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 microorganisms

(streptococci/staphylococci/ Gardnerella vagiinalis) and gram-negative microorganisms (Bacteroides). It has no effect

on Lactobacilli.

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 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 0.001µg/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

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

Sorbitan Stearate

Polysorbate 60

Cetyl Palmitate

Cetostearyl alcohol

Octyldodecanol

Benzyl alcohol

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C.

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6.5 Nature and contents of container

Aluminium tubes with internal lacquer coating and HPDE screw-on caps containing a smooth white oil-in-water type

cream supplied in 20g and 50g presentations.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

Medicines should not

be disposed of via wastewater or household waste.

Ask your pharmacist

how to dispose of

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

7 MARKETING AUTHORISATION HOLDER

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

8 MARKETING AUTHORISATION NUMBER

PA 1410/039/002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of authorisation: 01 April 1977

Date of last renewal: 01 April 2007

10 DATE OF REVISION OF THE TEXT

March 2015

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