Canesten 10 mg/g Cream

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Clotrimazole
Available from:
PCO Manufacturing Ltd.
ATC code:
D01AC; D01AC01
INN (International Name):
Clotrimazole
Dosage:
10 milligram(s)/gram
Pharmaceutical form:
Cream
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Imidazole and triazole derivatives; clotrimazole
Authorization status:
Authorised
Authorization number:
PPA0465/048/001
Authorization date:
2000-04-14

Canesten

®

10 mg/g cream

clotrimazole

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.

What is in this leaflet

What is Canesten Cream and what is it used for?

Before you use Canesten Cream

How to use Canesten Cream

Possible side effects

How to store Canesten Cream

Contents of the pack and other information

1.

What is Canesten Cream and what it is 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).

This product contains benzyl alcohol. Benzyl alcohol may cause

allergic reactions. Benzyl alcohol may cause mild local irritation.

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:

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.

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 get 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 this medicine out of the sight and reach of children.

Do not store above 25 °C.

Do not use this medicine after the expiry date which is stated on

the carton and tube after EXP. The expiry date refers to the last

day of that month.

Do not throw away any medicines via wastewater or household

waste. Ask your pharmacist how to throw away medicines you no

longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Canesten Cream contains:

The active substance is clotrimazole. Each gram of cream

contains 10 mg clotrimazole (1% w/w).

The other ingredients are benzyl alcohol, polysorbate 60,

sorbitan stearate, cetyl palmitate, cetostearyl alcohol,

2- octyldodecanol and purified water.

See Section 2 ‘Important information about some of the

ingredients’ for benzyl alcohol and cetostearyl alcohol advice.

What Canesten Cream looks like and contents of the pack:

Canesten Cream is available in tubes containing 20 g of white

cream.

Product procured from within the EU, repackaged and

distributed by the Parallel Product Authorisation Holder:

PCO Manufacturing Ltd., Unit 10, Ashbourne Business Park,

Rath, Ashbourne, Co. Meath, Ireland.

Parallel Product Authorisation Number: PPA 465/48/1

Manufacturer

Bayer AG, Leverkusen, Germany or FAMAR A.B.E., Avlonas,

Athens, Greece or Kern Pharma S.L/

Kern Pharma S.A.,

Terrassa, Spain or 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 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.

Canesten is a registered trademark of

Bayer Aktiengesellschaft

This leaflet was last revised in: August 2019

Health Products Regulatory Authority

13 May 2019

CRN008Y1N

Page 1 of 2

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Canesten 10 mg/g Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gram of cream contains 10 mg clotrimazole (1% w/w)

Excipient(s) with known effect: cetostearyl alcohol and benzyl alcohol.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Cream.

Product imported from Greece, Portugal, UK

A white oil-in water type cream.

4 CLINICAL PARTICULARS

As per PA1410/039/002

5 PHARMACOLOGICAL PROPERTIES

As per PA1410/039/002

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sorbitan Stearate

Polysorbate 60

Cetyl Palmitate

Cetostearyl alcohol

2-Octyldodecanol

Benzyl alcohol

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The shelf life expiry date of this product shall be the date on the container and outer package of the product in the market in

the country of origin.

6.4 Special precautions for storage

Do not store above 25 °C.

6.5 Nature and contents of container

Aluminium tubes with screw on caps containing 20 g of cream. Each tube is contained within a cardboard carton.

Health Products Regulatory Authority

13 May 2019

CRN008Y1N

Page 2 of 2

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 PARALLEL PRODUCT AUTHORISATION HOLDER

PCO Manufacturing Ltd.

Unit 10, Ashbourne Business Park

Rath

Ashbourne

Co. Meath

Ireland

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA0465/048/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 14 April 2000

Date of last renewal: 14 April 2010

10 DATE OF REVISION OF THE TEXT

May 2019

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