Canesten Hc Cream

Document: leaflet MAH BRAND_PL 00010-0120 change


Clotrimazole 1% w/w Hydrocortisone 1% w/w

Canesten* HC

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

j» Keep this leaflet. You may need to read it again. i> If you have any further questions, ask your doctor or 1 pharmacist.

k This medicine has been prescribed for you. Do not give it i to anyone else under any circumstances.

*    If you have any unusual effects after usingthis product, tell your doctor.



d. What is Canesten HC Cream and what is it used for?

2. Before you use Canesten HC Cream |3. How to use Canesten HC Cream

4.    Possible side effects

5.    How to store Canesten HC Cream )5. Further information



Canesten HC Cream is used to treat fungal skin infections when jthere are additionalsymptomsof inflammation (such as swelling, fedness and itching). Canesten HC treats the fungal skin 'infection and reduces the swelling and itching caused by it. Canesten HC Cream is used for the treatment of infection and irritation of the vulva or end of the penis (glans) caused by ^hrush. It is also used to treat nappy rash and fungal infection of the breast fold (intertrigo), as well as infections such as ringworm and athlete’s foot.

The active substances in Canesten HC Cream are clotrimazole bnd hydrocortisone. Clotrimazole belongs to a group of piedicines called imidazoles, which destroy the fungi and 6ome bacteria that cause skin infections. Hydrocortisone is a hiild steroid which reduces swelling, redness and itching jassociated with inflammation of the skin.



Do not use Canesten9 HC Cream:

p If you (oryour baby if treating nappy rash) are allergic i (hypersensitive) to clotrimazole, hydrocortisone or any of the other ingredients, including cetostearyl alcohol, of i Canesten HC Cream.

» On areas of broken skin.

k On large areas of skin (more than 5-10% of body surface). r For longer than 7 days.

■ To treat cold sores or acne.

k On any untreated bacterial skin infection, such as syphilis i    or tuberculosis.

   On vaccination reactions.

k On shingles, chicken pox, rosacea or herpes.

If you are unsure about any of these restrictions, speak to lyour doctor.

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:    i

•    As with all steroids, long-term, continuous use on large area^ of skin should be avoided, particularly in infants and children'

•    Do not cover the area being treated with a dressing or

bandage.    i

•    In infants, care should be taken not to fasten nappies

too tightly over the treated area, as this may increase the , absorption of the hydrocortisone.    '

•    Wash your hands immediately after applying the cream. |

•    As with other creams, this product may reduce the    1

effectiveness of rubber contraceptives, such as condoms | or diaphragms. Consequently, if you are usingthis cream i on the vulva or penis, you should use alternative precautions for at least five days after using this product. |


Pregnancy and breast-feeding:    '

If you are pregnant, breast-feeding or trying for a baby, tell    |

your doctor or midwife before using Canesten HC Cream. If you have informed your doctor or midwife already, follow his/her instructions carefully.    ,


Unless directed otherwise by your doctor, follow these directions closely:    i

•    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 i the cream.

•    Canesten HC Cream should be applied thinly and evenly to the affected areas twice daily and rubbed in gently. Approximately lcm of cream per application should be enough.

•    Do not cover the area being treated with a dressing or ' bandage.

•    As with all products containing hydrocortisone, you should' wash your hands immediately after applying the cream. '

Treatment should be continued for no more than 7 days.

The symptoms of skin infection, such as itching or soreness, 1 should improve within a few days of treatment although signs, such as redness and scaling may take longer to disappear. ' If the symptoms persist or you do not start to improve after [ 7 days, consult your doctor.    ,


Canesten9 HC Cream is for external use only:    1

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

If the cream is swallowed accidentally, tell your doctor straight away or contact the Accident and Emergency Department of , your nearest hospital.    '

If you accidentally get cream in your eyes or mouth, wash    i

immediately with water and contact your doctor.

If you forget to use Canesten9 HC Cream:    ,

Apply the cream as soon as possible and then continue the 1 rest of your treatment as usual.

You can herp tfie treatment to work if you follow these' jsimple self-help tips:

» Although the infected area will itch, try not to scratch.

Scratching will damage the surface of the skin and cause i the infection to spread further, i* Keep the affected skin areas clean.

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

i* 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 i 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 i    water to remove any shed skin or fungal spores.

» Change your footwear daily if possible.


like all medicines, Canesten HC Cream can cause side effects, [although not everybody gets them.

As with all medicines, some people may be allergic to the tream. 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 HC 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.

i* Swallowing or breathing problems, i* Swelling of your lips, face, throat or tongue.

[• Weakness, feeling dizzy or faint, i* Nausea.

[After you apply the cream you might experience: i* Itching, rash, blisters, burning, discomfort, swelling,

[ irritation or peeling of skin.

Treatment should be limited to 7 days unless advised otherwise by your doctor. If you apply the cream to a large area or under [a dressing, or if you use the cream for more than 2 weeks, you imay experience skin reactions such as:

[• Broken veins, i* Excess hair growth.

* Stretch marks.

[•    Thinning or whitening of skin,

i* Secondary infections.

» An acne-like rash.

Jf you or your baby experience any of the above effects or react badly to the cream in any other way not listed in this leaflet,

^ell your doctor immediately.

Reporting of side effects

[If you 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 the Yellow [Card Scheme at: By reporting Aide effects you can help provide more information on the safety of this medicine.


Keep out of the sight and reach of children.

[This product should be stored in the original carton.

'Do not store above 25°C.

iDo not use Canesten HC 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. iMedicines should not be disposed of via wastewater or household Waste. Ask your pharmacist howto dispose of medicines no longer [required. These measures wik help to protecttoe environment


What Canesten9 HC Cream contains:    1

•    The active substances are clotrimazole and    ,

hydrocortisone, each at a strength of 1% w/w.    '

•    The other ingredients are benzyl alcohol, cetostearyl

alcohol, triceteareth-4-phosphate, medium chain    i

triglycerides and purified water.    1

See Section 2'Do not use’ and' Important information about some of the ingredients’ for cetostearyl alcohol advice.    '

What Canesten9 HC Cream looks like and contents of! the pack:    1

Canesten HC Cream is available in tubes containing 5g or 30g [ of white cream. Not all pack sizes may be marketed.    i

Marketing Authorisation Holder:

Bayer pic, Consumer Care Division, Bayer House,    ,

Strawberry Hill, Newbury, Berkshire RG141JA, UK    i

Manufacturer:    [

Kern Pharma S.L.    i

Poligon Industrial Colon II, Calle Venus 72 08228 Terrassa, Barcelona, Spain Remember: This medicine has been prescribed for you.    1

Do not give It to anyone else under any circumstances.

If you have any doubts about using Canesten* HC Cream    '

correctly seek the advice of your doctor or pharmacist Further information    about fungal infections:    i

Fungal infections are very common and affect many people. 1 Some of the most common fungal skin infections include [ athlete’s foot, nappy rash, sweat rash, ringworm and thrush, i There are two main types of fungal infection:

•    The tinea group, also known as dermatophytes.    i

•    The Candida group, also known as yeasts.

The tinea group includes athlete’s foot and ringworm, both of i 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, i 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 childrenj 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.    i

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 occurwhere folds of skin rub against i 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 i 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 ad 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 rarelV a serious condition, the rash can be extremely distressing for , both you and your baby. Nappy rash which lasts longer than i three days may be fungal in origin and will require an antifungal treatment. The symptoms of fungal nappy rash include red patches on the babys bottom and genitals, burning and itching, For UK residents only: if you have any questions or would like more information, call our Canesten Advice Line on 0845 758 5030. Calls charged at local rate.    i

This leaflet was last revised in February 2015 -q    [

Canesten is a registered trademark of    lJa.y6r,

Bayer AG, Germany.______________8092052 J 3