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Canesten Hc Cream

Document: leaflet MAH BRAND_PL 00010-0643 change

14Bmm

14Bmm


Canesten* \HC

Cream

Clotrimazole Hydrocortisone acetate

210 mm


Read all of this leaflet carefully because It contains Important Information for you.

Keep this leaflet You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

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

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

IN THIS LEAFLET

jl. 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 !6. Further Information

II. WHAT IS CANESTEN® HC CREAM AND WHAT IS IT USED FOR?

jcanesten HC Cream is used to treat fungal skin infections when there are additional symptoms of inflammation (such as [swelling, redness and itching). Canesten HC treats the fongal jskin 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 (jgtans) caused by thrush. It is also used to treat nappy rash and fungal infection Jofthe breast fold (intertrigo), as well as infections such as ringworm and athlete’s foot

[The active substances in Canesten HC Cream are clotrimazole and hydrocortisone acetate. Clotrimazole belongs to a group of medicines called imidazoles, which destroy the fungi and some [bacteria that cause skin infections. Hydrocortisone acetate is a mild steroid which reduces swelling, redness and itching associated with inflammation of the skin.

2. BEFORE YOU USE CANESTEN® HC CREAM

Do not use Canesten* HC Cream:

[* if you (or your baby if treating nappy rash) are allergic i (hypersensitive) to clotrimazole, hydrocortisone or any i    of the other ingredients, including cetostearyl alcohol, of

[ Canesten HC Cream, i* On areas of broken skin.

[• On large areas of skin (mote than 5-10% of body surface).

» For longer than 7 days.

[• To treat cold sores or acne.

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

» On vaccination reactions.

!• On shingles, chicken pox, rosacea or herpes.

|lf you are unsure about any of these restrictions, speak to your doctor.

Special precautions:

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

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

•    I n infants, care should be taken not to fasten nappies too tightly over the treated area, as this may increase the absorption of the hydrocortisone acetate.

•    Wash your hands immediately after applying the cream.

•    As with other creams, this product may reduce the effectiveness of rubber contraceptives, such as condoms or diaphragms. Consequently, if you are usingthis cream on the vulva or penis, you should use alternative precautions for at (east five days after usingthis 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.

Important Information about some of the Ingredients:

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

3. HOW TO USE CANESTEN® HC CREAM

Unless directed otherwise by your doctor, 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 HC Cream should be applied thinly and evenly to the affected areas twice daily and rubbed in gently. Approximately 1cm 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, 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.

Canesten* HC Cream is for external use only:

Do not put the cream In ynur 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

If you accidentally get cream in your eyes or mouth, wash immediately with water and contact your doctor.

If you forget to use Canesten* HC Cream:

Apply the cream as soon as possible and then continue the rest _o_f your treatment as usual__________________

D)

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210 mm


lYoucaiT KeTptfie” treafmenfto work IT youTollow these [simple self-help tips:

w 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, 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 wasn 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.

jfc POSSIBLE SIDE EFFECTS

■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 Cream. If you or your baby are allergic, a reaction will occur [soon after you start using it If you oryour 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. Sips of an allergic ■reaction may include:

[• Rash.

i®    Swallowing or breathing problems,

i* Swelling of your lips, face, throat or tonpe. j* Weakness, reeling dizzy or faint, i* Nausea.

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

' irritation, redness 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 ■may experience skin reactions such as:

[• Broken veins.

■• Excess hair growth.

» Stretch marks.

[•    Thinning or whitening of skin.

Secondary infections.

» An acne-ifke rash.

[if you oryour baby experience any of the above effects or react ■badly to the cream in any other way not listed in this leaflet, tell [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: www.mhra.goy.uk/vellowcard. By reporting side effects you can help provide more Information on the safety of this medicine.

[5. HOW TO STORE CANESTEN® HC CREAM

■Keep out of the sight and reach of children.

[This product should be stored in the original carton.

■Do not store above 25°C.

[Do 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 after [“Exp”. The expiry date refers to the last day of that month. ■Medicines should not be disposed of via wastewater or household Waste. Ask your pharmacist now to dispose of medicines no longer [required. [These measure wil[help to prot^ the environment^ _


e. FURTHER INFORMATION

What Canesten* HC Cream contains:

•    The active substances are clotrimazole and hydrocortisone acetate. Each gram of cream contains lOmg clotrimazole and 11.2mg hydrocortisone acetate (equivalent to lOmg hydrocortisone).

•    The other ingredients are benzyl alcohol, cetosteatyl alcohol, triceteareth-4-phosphate, medium chain triglycerides, ■ purified water, sodium hydroxide and hydrochloric acid.

See Section 2 ‘Do not use’ and ’Important information about some of the ingredients’ fbrcetostearyl alcohol advice.

What Canesten* HC Cream looks like and contents of the pack:

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

Marketing Authorisation Holder:

Bayer pic, Consumer Care Division, Bayer House,

Strawberry Hill, Newbury, Berkshire Rel41JA, UK

Manufacturer:

Kern Pharma S.L.

Pottgon Industrial Colon 11, Calle Venus 72

08228 Terrassa, Barcelona, Spain

Remember: This medicine has been prescribed for you.

Do not give It to anyone else under any circumstances.

If you have any doubts about using Canesten* HC Cream correctly seek the advke 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, ringworm and thrush. 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^ toot 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 tongus 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 tor both is an itchy, scaly and irritating rash.

The Candida group can be responsible tor 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 tongus that usually lives harmlessly on our skin. However, the naturalbalance 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 tor 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. For U K residents only: if you have any questions or would like more information, call our Canesten Advice line on 0845 758 5030. Calls chaiged at local rate.

This leaflet was last revised in Februaiy 2015. B3V6T! Canesten is a registered trademark of    „„„„„„„ ■

Bayer AG, Germany._______________8080980-0?



FONT SIZE PANEL

Font Size Main Text (body copy):

7 point

Font Size Height (based on lower case x):

1.345 mm