CANESTEN 1% Cream

Зміст інструкції

1. Canesten 1% cream
   1. What is Canesten and what is it used for
   2. What you need to know before you use Canesten
   3. How to use Canesten
   4. Possible side effects
   5. How to store Canesten
   6. Contents of the pack and other information
2. Canesten 1% spray cutaneo, soluzione
   1. What is Canesten and what is it used for
   2. What you need to know before you use Canesten
   3. How to use Canesten
   4. Possible side effects
   5. How to store Canesten
   6. Contents of the pack and other information
3. Canesten 1% cutaneous powder
   1. What is Canesten and what is it used for
   2. What you need to know before using Canesten
   3. How to use Canesten
   4. Possible side effects
   5. How to store Canesten
   6. Contents of the pack and other information

Canesten 1% cream

clotrimazole

Read this leaflet carefully before you start using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want any further information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if your symptoms do not improve or get worse after 3-4 weeks.

Contents of this leaflet:

• 1. What Canesten is and what it is used for
• 2. What you need to know before you use Canesten
• 3. How to use Canesten
• 4. Possible side effects
• 5. How to store Canesten
• 6. Contents of the pack and other information

1. What is Canesten and what is it used for

Canesten contains clotrimazole which is an antifungal (antimycotic) for dermatological use, i.e. that
acts locally eliminating skin fungi.
Canesten is used for the treatment of skin and skin fold fungal infections, such as
pityriasis versicolor, cutaneous candidiasis, tinea pedis or athlete's foot, tinea corporis.

2. What you need to know before you use Canesten

Do not use Canesten

• if you are allergic to clotrimazole, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before using Canesten if you have suffered from these
conditions in the past (recurrences of fungal infections).
The use of non-breathable diapers is not recommended after applying the medicine
in diaper dermatitis.
Avoid contact with eyes. Do not ingest.
The use, especially if prolonged, of products for topical use (applied to the skin), can give rise to
sensitization phenomena such as erythema (localized redness in the area of skin where the
medicine is applied) and itching. If this occurs, stop treatment and consult your doctor or
pharmacist.

Other medicines and Canesten
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
No medicines are known to modify the effect of Canesten.

Canesten with food
No foods are known to modify the effect of Canesten.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with milk
ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
During the first 3 months of pregnancy, you should consult your doctor before using Canesten.

Breastfeeding
Canesten can be used during breastfeeding. If used locally on the nipple area, wash your breast before breastfeeding your baby.

Driving and operating machinery
The medicine does not or negligibly alters the ability to drive vehicles or operate machinery.

Canesten contains cetostearyl alcohol
It may cause local skin reactions (e.g. contact dermatitis).

Canesten contains 20 mg/g of benzyl alcohol:

• it may cause allergic reactions;
• it may cause mild local irritation

3. How to use Canesten

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The cream is particularly suitable for the treatment of glabrous skin areas (hairless).
Canesten cream should be applied in small amounts 2-3 times a day, corresponding to the parts to
be treated.
Considering the high fungicidal activity of Canesten, it is usually sufficient to apply a small
amount of cream to treat an area the size of the palm of your hand.
Canesten cream should be applied with light rubbing, after washing and thoroughly drying the
area to be treated.

Warning: do not exceed the indicated doses without the advice of your doctor.

Duration of treatment
Generally, a treatment period of three to four
weeks is sufficient for the disappearance of symptoms.
Continue therapy with Canesten cream for at least 2 weeks after the symptoms disappear
in order to consolidate the therapeutic results obtained and avoid reinfections.
If you do not notice appreciable results after 3-4 weeks of continuous use, consult your
doctor.
Consult your doctor if the disorder recurs or if you have noticed any recent change
in its characteristics.

Health education notes
To prevent fungal infection and its recurrences, it is useful to follow some hygienic-health rules, such as:

• Avoid walking barefoot in public places such as swimming pools, gyms, hotel rooms etc..
• If you play sports, use breathable and comfortable footwear, the insoles of which should be changed or washed periodically.
• Limit the use of clothing containing synthetic fibers.
• Change the baby's diaper frequently to avoid urine or feces stagnating on the skin.
• Have dogs and cats examined by a veterinarian before welcoming them into the home environment.
• Observe further hygiene precautions, such as keeping clothes separate and washing them at high temperature, if a family member shows signs of fungal infection.

If you use more Canesten than you should
There is no risk of acute poisoning as it is unlikely to occur after a single cutaneous application of an excessive dose (extended application
under conditions favorable to absorption) or due to involuntary oral intake. There is no
specific antidote.
In case of ingestion/accidental intake of Canesten cream, immediately inform your doctor or
go to the nearest hospital.

If you forget to use Canesten
Continue the treatment following the dose prescribed by your doctor. Do not use a double dose to
compensate for forgetting a dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With Canesten, the following side effects have been reported, their frequency is unknown:

Immune system disorders: angioedema (swelling), anaphylactic reaction, hypersensitivity

Vascular disorders:hypotension (low blood pressure), syncope.

Respiratory, thoracic and mediastinal disorders:shortness of breath

Skin and subcutaneous tissue disorders: blisters, contact dermatitis, erythema
(redness of the skin), paraesthesia, skin peeling (loss of cells from the
most superficial layer of the skin), itching, rash, urticaria, skin stinging pain,
skin burning sensation.

Systemic disorders and conditions related to the site of administration:irritation at the site of
application, reaction at the site of application, edema, pain.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist .You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help to provide more information on the safety of
this medicine.

5. How to store Canesten

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date that is reported on the packaging. The expiry date
refers to the last day of that month. The expiry date applies to the product in
intact packaging correctly stored.
Do not use Canesten 1% cream after 3 months from first opening.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.
It is important to always have the information about the medicine available, therefore keep both the

6. Contents of the pack and other information

What Canesten contains

• the active substance is: clotrimazole. 100 g of cream contains 1g of clotrimazole.
• The other ingredients are: sorbitan monostearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol, purified water.

Description of the appearance of Canesten and contents of the pack
Canesten is presented in the form of a cream for cutaneous use.
The pack contains 30 g.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Bayer S.p.A. - Viale Certosa 130 - Milan

Manufacturer
Kern Pharma S.L. – Terrassa - Spain
or
GP Grenzach Produktions GmbH -Germany

Canesten 1% spray cutaneo, soluzione

clotrimazolo

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not improve or if your symptoms worsen after 3-4 weeks of treatment.

Contents of this leaflet:

• 1. What Canesten is and what it is used for
• 2. What you need to know before you use Canesten
• 3. How to use Canesten
• 4. Possible side effects
• 5. How to store Canesten
• 6. Contents of the pack and other information

1. What is Canesten and what is it used for

Canesten contains clotrimazole which is an antifungal (antimycotic) for dermatological use, i.e. that
acts locally eliminating skin fungi.
Canesten is used for the treatment of skin and skin fold fungal infections, such as
pityriasis versicolor, cutaneous candidiasis, tinea pedis or athlete's foot, tinea corporis.

2. What you need to know before you use Canesten

Do not use Canesten

• if you are allergic to clotrimazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before using Canesten if you have suffered from these
disorders in the past (recurrences of fungal infections).
The use of non-breathable diapers is not recommended after applying the medicine in diaper dermatitis.
Avoid contact with eyes. Do not ingest.
The use, especially if prolonged, of products for topical use (applied to the skin), can give rise to
sensitization phenomena such as erythema (localized redness in the area of skin where the
medicine is applied) and itching. If this happens, stop treatment and consult your doctor or
pharmacist.

Other medicines and Canesten
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
No medicines are known to alter the effect of Canesten spray.

Canesten with food
No foods are known to alter the effect of Canesten spray.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
.
During the first 3 months of pregnancy, you should consult your doctor before using Canesten.

Breastfeeding
Canesten can be used during breastfeeding. If used locally on the nipple area, wash your breasts before breastfeeding your baby.

Driving and operating machinery
The medicine does not or negligibly alters the ability to drive vehicles or operate machinery.

Canesten cutaneous spray contains propylene glycol
Canesten spray contains 546 mg/g of propylene glycol.

• it may cause skin irritation.

As this medicine contains propylene glycol, do not use it on open wounds or large areas of
damaged skin (such as burns) without talking to your doctor or pharmacist

3. How to use Canesten

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The spray is particularly useful for treating skin areas covered with hair, and in skin folds.
It is also indicated for application to large areas of the body (back, abdomen, chest).
Canesten spray should be applied in small amounts twice a day, corresponding to the parts to be
treated.
Considering the high antifungal activity of Canesten, it is usually sufficient to apply a small
amount of solution to treat an area the size of the palm of your hand.
Canesten spray should be sprayed evenly onto the area to be treated, after washing and drying it
thoroughly.

Warning:do not exceed the indicated doses without consulting your doctor.

Duration of treatment
Generally, a treatment period of three to four
weeks is sufficient for the symptoms to disappear.
Continue therapy with Canesten spray for at least 2 weeks after the symptoms have disappeared
in order to consolidate the therapeutic results obtained and avoid reinfection.
If, after 3-4 weeks of continuous use, you do not notice appreciable results, consult your
doctor.
Consult your doctor if the disorder recurs or if you have noticed any recent change
in its characteristics.

Health education notes
To prevent fungal infection and its recurrence, it is useful to follow some hygienic-health rules, such as:

• avoid walking barefoot in public places such as swimming pools, gyms, hotel rooms etc.;
• if you practice sports, use breathable and comfortable footwear, the insoles of which should be changed or washed periodically;
• limit the use of clothing containing synthetic fibers;
• change the baby's diaper frequently to avoid urine or feces from stagnating on the skin;
• have dogs and cats examined by a veterinarian before welcoming them into the home;
• observe further hygiene precautions, such as keeping clothes separate and washing them at high temperature if a family member develops a fungal infection.

If you use more Canesten than you should
There is no risk of acute poisoning as it is unlikely to occur after a single cutaneous application of an excessive dose (extended application
under conditions favorable to absorption) or accidental oral intake. There is no
specific antidote.
In case of ingestion/accidental intake of Canesten spray, immediately inform your doctor or go to the nearest hospital.

If you forget to use Canesten
Continue the treatment following the recommended dose. Do not use a double dose to compensate for
forgetting a dose.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With Canesten, the following side effects have been reported, the frequency of which is not known:

Immune system disorders:angioedema (swelling), anaphylactic reaction, hypersensitivity.

Vascular disorders:hypotension (low blood pressure), syncope.

Respiratory, thoracic and mediastinal disorders:shortness of breath

Skin and subcutaneous tissue disorders:blisters, contact dermatitis, erythema
(redness of the skin), paresthesia, skin peeling (loss of cells from the
superficial layer of the skin), itching, rash, urticaria, skin stinging pain,
skin burning sensation.

Systemic disorders and conditions related to the site of administration:irritation at the site of
application, reaction at the site of application, edema, pain.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through the national reporting system
at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Canesten

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date
refers to the last day of that month. The expiry date applies to the product in
intact packaging correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.
It is important to always have the information about the medicine available, therefore keep both the
Do not use Canesten cutaneous spray solution in multi-dose bottle after 3 months from first opening

6. Contents of the pack and other information

What Canesten cutaneous spray, solution in a multi-dose polyethylene bottle with dosing pump contains

• The active ingredient is clotrimazole. 100 ml contain 1 g of clotrimazole.
• The other ingredients are: macrogol, isopropanol, propylene glycol.

Description of the appearance of Canesten and contents of the pack
Canesten is presented in the form of a cutaneous spray solution.
The content is 40 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bayer S.p.A. - Viale Certosa 130 - Milan

Manufacturer
KVP Pharma+Veterinar Produkte Gmbh- Kiel – Germany

Canesten 1% cutaneous powder

clotrimazole

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3-4 weeks.

Contents of this leaflet:

• 1. What Canesten is and what it is used for
• 2. What you need to know before using Canesten
• 3. How to use Canesten
• 4. Possible side effects
• 5. How to store Canesten
• 6. Contents of the pack and other information

1. What is Canesten and what is it used for

Canesten contains clotrimazole which is an antifungal (antifungino) for dermatological use, i.e. that
acts locally eliminating skin fungi.
Canesten powder is used for the treatment of moist skin fungal infections (micosi) and skin folds
especially if located in covered or poorly ventilated areas (for example: tinea pedis or
athlete's foot, tinea cruris, tinea inguinalis).

2. What you need to know before using Canesten

Do not use Canesten

• if you are allergic to clotrimazole or to any of the other ingredients of this medicine (listed in section 6) .

Warnings and precautions
Consult your doctor or pharmacist before using Canesten if you have suffered from these
conditions in the past (recurrences of fungal infections).
The use of non-breathable diapers is not recommended after applying the medicine in diaper dermatitis.
Avoid contact with eyes. Do not ingest.
The use, especially if prolonged, of products for cutaneous use (applied to the skin), can give rise to
sensitization phenomena such as erythema (localized redness in the area of skin where the
medicine is applied) and itching. In this case, discontinue treatment and consult your doctor or
pharmacist.

Other medicines and Canesten
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
No medicines are known to modify the effect of Canesten powder.

Canesten with food
No foods are known to modify the effect of Canesten powder.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or
pharmacist for advice before using this medicine.

Pregnancy
During the first 3 months of pregnancy, you should consult your doctor before using Canesten.

Breastfeeding
Canesten can be used during breastfeeding. If used locally on the nipple area, wash your breast before
breastfeeding your baby.

Driving and operating machinery
The medicine does not alter or negligibly alters the ability to drive vehicles or operate
machinery.

3. How to use Canesten

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Canesten powder is particularly suitable for the treatment of covered or poorly ventilated areas of the skin and skin folds.
Canesten powder should be applied in small quantities 2-3 times a day, corresponding to the parts to be
treated.
Canesten powder should be applied after washing and thoroughly drying the affected area.
In athlete's foot, it is recommended to sprinkle Canesten powder also inside socks and shoes.

Warning: do not exceed the indicated doses without the advice of your doctor.

Duration of treatment
Generally, a treatment period of 3-4 weeks is sufficient for the disappearance of symptoms.
Continue therapy with Canesten powder for at least 2 weeks after the disappearance of symptoms in order to consolidate the therapeutic results obtained and avoid reinfection.
If, after 3-4 weeks of continuous use, you do not notice appreciable results, consult your
doctor.
Consult your doctor if the disorder recurs or if you have noticed any recent change in its characteristics.

Health education notesTo prevent fungal infection and its recurrences, it is useful to follow some hygienic-health rules, such as:

• Avoid walking barefoot in public places such as swimming pools, gyms, hotel rooms etc.
• If you practice sports, use breathable and comfortable footwear, the insoles of which should be changed or washed periodically.
• Limit the use of clothing containing synthetic fibers.
• Change the baby's diaper frequently to avoid stagnation of urine or feces on the skin.
• Subject dogs and cats to a veterinary examination before welcoming them into the home environment.
• Observe further hygiene precautions, such as keeping clothes separate and washing them at high temperature, if a family member shows a fungal infection.

If you use more Canesten than you should
There is no risk of acute intoxication as it is unlikely to occur after single cutaneous application of an excessive dose (extended application in conditions favorable to absorption) or due to involuntary oral intake. There is no
specific antidote.
In case of ingestion/accidental intake of Canesten powder, immediately inform your doctor or
go to the nearest hospital.

If you forget to use Canesten
Continue the treatment adhering to the dose recommended by your doctor. Do not use a double dose to
compensate for the forgotten dose.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With Canesten, the following side effects have been reported, their frequency is unknown:

Immune system disorders: angioedema (swelling), anaphylactic reaction, hypersensitivity

Vascular disorders:hypotension (low blood pressure), syncope.

Respiratory, thoracic and mediastinal disorders:shortness of breath

Skin and subcutaneous tissue disorders: blisters, contact dermatitis, erythema
(redness of the skin), paraesthesia, skin peeling (loss of cells from the
most superficial layer of the skin), itching, rash, urticaria, skin stinging pain,
skin burning sensation.

Systemic disorders and conditions related to the site of administration:irritation at the site of
application, reaction at the site of application, oedema, pain.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Canesten

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date that is reported on the packaging. The expiry date
refers to the last day of that month. The expiry date refers to the product in
intact packaging, correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.
It is important to always have information about the medicine available, therefore keep both the

6. Contents of the pack and other information

What Canesten contains

• The active ingredient is clotrimazole. 100 g of cutaneous powder contains 1g of clotrimazole
• The other ingredient is: rice starch.

Description of the appearance of Canesten and contents of the pack
Canesten is presented in the form of a powder for cutaneous use.
The pack contains 30 g.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bayer S.p.A. - Viale Certosa 130 - Milan

Manufacturer
KVP Pharma + Veterinar Produkte GmbH, Projensdorfer Strasse 324_24106 Kiel, Germany

Sigmar Italia S.p.A,Via Sombreno, 11 24011 Almè (BG), Italy