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CANESTEN HC CREAM

Active substance(s): CLOTRIMAZOLE / HYDROCORTISONE / HYDROCORTISONE ACETATE / CLOTRIMAZOLE / HYDROCORTISONE ACETATE / CLOTRIMAZOLE / HYDROCORTISONE ACETATE

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HC
Cream

Clotrimazole 1% w/w
Hydrocortisone 1% w/w
Read all of this leaflet carefully because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
•  f you have any further questions, ask your doctor or
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pharmacist.
•  his medicine has been prescribed for you. Do not give it to
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anyone else under any circumstances.
•  f you have any unusual effects after using this product, tell
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your doctor.

IN THIS LEAFLET
1.
2.
3.
4.
5.
6.

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 hat is Canesten HC Cream and what is it used for?
Before you use Canesten HC Cream
How to use Canesten HC Cream
Possible side effects
How to store Canesten HC Cream
Further information

1.  HAT IS CANESTEN® HC CREAM AND
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WHAT IS IT USED FOR?
Canesten 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 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
thrush. 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
and hydrocortisone. Clotrimazole belongs to a group of
medicines called imidazoles, which destroy the fungi and some
bacteria that cause skin infections. Hydrocortisone is a mild
steroid which reduces swelling, redness and itching associated
with inflammation of the skin.

2.  EFORE YOU USE CANESTEN® HC CREAM
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Do not use Canesten® HC Cream:
•  f you (or your baby if treating nappy rash) are allergic
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(hypersensitive) to clotrimazole, hydrocortisone or any
of the other ingredients, including cetostearyl alcohol, of
Canesten HC Cream.
• On areas of broken skin.
• On large areas of skin (more than 5–10% of body surface).
• For longer than 7 days.
• To treat cold sores or acne.
• On your face, eyes, mouth or around it.
•  n any untreated bacterial skin infection, such as syphilis
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or tuberculosis.
• On vaccination reactions.
• On shingles, chicken pox, rosacea or herpes.
If you are unsure about any of these restrictions, speak to your
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:
•  s with all steroids, long-term, continuous use on large areas
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of skin should be avoided, particularly in infants and children.
•  o not cover the area being treated with a dressing or
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bandage.
•  n infants, care should be taken not to fasten nappies
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too tightly over the treated area, as this may increase the
absorption of the hydrocortisone.
• Wash your hands immediately after applying the cream.
•  s with other creams, this product may reduce the
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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:

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.

3. HOW TO USE CANESTEN® HC CREAM
Unless directed otherwise by your doctor, follow these
directions closely:
•  efore use, pierce the tube seal by inverting the cap over
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the end of the tube and press.
•  f the feet are infected, they should be washed and dried
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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.
•  o not cover the area being treated with a dressing or
D
bandage.
•  s with all products containing hydrocortisone, you should
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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 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.
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
of your treatment as usual.

You can help the treatment to work if you follow these
simple self-help tips:
•  lthough the infected area will itch, try not to scratch.
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Scratching will damage the surface of the skin and cause
the infection to spread further.
•  eep the affected skin areas clean.
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•  ay particular attention to drying the skin, but avoid
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excessive rubbing.
•  o not share towels, bath mats, etc. with other people as
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you could spread the infection to them.
•  lways wash your hands after treating the infection to
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prevent it from spreading.

If you have athlete’s foot:
•  emember to dry the skin between the toes thoroughly.
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•  ash your socks, stockings and tights thoroughly in hot
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water to remove any shed skin or fungal spores.
•  hange your footwear daily if possible.
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4. 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 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.
• Swallowing or breathing problems.
• Swelling of your lips, face, throat or tongue.
• Weakness, feeling dizzy or faint.
• Nausea.
After you apply the cream you might experience:
•   tching, rash, blisters, burning, discomfort, swelling,
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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-like rash.
If 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, tell
your doctor immediately.

5. HOW TO STORE CANESTEN® HC 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 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.
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® HC Cream contains:
•  he active substances are clotrimazole and
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hydrocortisone, each at a strength of 1% w/w.
•  he other ingredients are benzyl alcohol, cetostearyl
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alcohol, triceteareth-4-phosphate, medium chain
triglycerides and purified water.
 ee Section 2 ‘Do not use’ and ‘Important information about
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some of the ingredients’ for cetostearyl alcohol advice.

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

Canesten HC Cream is available in tubes containing 5g or 30g
of white cream. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Bayer plc, Consumer Care Division, Bayer House,
Strawberry Hill, Newbury, Berkshire RG14 1JA, UK
Manufacturer:
Kern Pharma S.L.
Poligon Industrial Colon II, 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 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, 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’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.
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.
This leaflet was last revised in October 2013.
Canesten is a registered trademark of
Bayer AG, Germany.

Bayer

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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