CANESTEN BIFONAZOLE CREAM

Active substance: BIFONAZOLE

View full screen / Print PDF » Download PDF ⇩

Transcript
Bifonazole Cream
Bifonazole 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.
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 using this
product, tell your doctor.

IN THIS LEAFLET
1. What is Canesten Bifonazole Cream and what is it
used for?
2. Before you use Canesten Bifonazole Cream
3. How to use Canesten Bifonazole Cream
4. Possible side effects
5. How to store Canesten Bifonazole Cream
6. Further information

1. WHAT IS CANESTEN® BIFONAZOLE

CREAM AND WHAT IS IT USED FOR?
Canesten Bifonazole Cream is used to treat fungal skin
infections such as ringworm, athlete’s foot and fungal
sweat rash.
The active substance in Canesten Bifonazole Cream is
bifonazole. Bifonazole 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®

BIFONAZOLE CREAM
Do not use Canesten® Bifonazole Cream:



If you are allergic (hypersensitive) to bifonazole or any
of the other ingredients of Canesten Bifonazole Cream
(see section 6, Further Information).
To treat nappy rash. If your baby has nappy rash, seek
your doctor’s advice for a suitable treatment.

Before using Canesten Bifonazole Cream,
see your doctor if:

3. HOW TO USE CANESTEN®
BIFONAZOLE 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.
• Before applying the cream, the infected skin
should be washed and dried thoroughly, especially
between the toes if the feet are infected.
• The cream should be applied thinly and evenly to
the affected areas once daily, preferably at night
before going to bed, and rubbed in gently.
• Treatment should be continued for 2-3 weeks,
depending on the type of infection.
• 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 symptoms persist,
consult your doctor.

Canesten® Bifonazole 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® Bifonazole
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:


®



You have ever had an allergic reaction to any
antifungal product.

Important information about some of the
ingredients:
This product contains cetostearyl alcohol which may
cause local skin irritation (e.g. rash, itching or redness).

Pregnancy and breast-feeding:
Do not use Canesten Bifonazole Cream if you are
pregnant or breast-feeding.






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 Bifonazole Cream can
cause side effects, although not everybody gets them.
As with all medicines, some people may be allergic to
the cream. If you are allergic, a reaction will occur soon
after you start using it. If you experience an allergic
reaction, stop using Canesten Bifonazole 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 the
following symptoms:
• Slight irritation or burning.
• Reddening of the skin.
• Peeling.
If this is intolerable, stop treatment and see your doctor
as soon as possible.
Canesten Bifonazole Cream may cause a local skin
irritation which can be very similar to the symptoms of
the infection. If any of your symptoms gets worse, stop
treatment and see your doctor as soon as possible.
These symptoms may include:
• Burning, pain or itching.
• Redness.
• Rash.
• Swelling.
If you 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®
BIFONAZOLE CREAM
Keep out of the reach and sight of children.
This product should be stored in the original carton.
Do not use Canesten Bifonazole 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® Bifonazole Cream contains:



The active substance is bifonazole at a strength of
1% w/w.
The other ingredients are sorbitan stearate,
polysorbate 60, cetyl palmitate, cetostearyl alcohol,
2-octyldodecanol, benzyl alcohol, and purified
water.
See Section 2 ‘Important information about some of
the ingredients’ for cetostearyl alcohol advice.

What Canesten® Bifonazole Cream looks like
and contents of the pack:
Canesten Bifonazole Cream is available in tubes
containing 15g and 50g of white cream.

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®
Bifonazole 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, ringworm and sweat
rash. 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. 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.
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 August 2008.
Canesten is a registered trademark of Bayer AG,
Germany.

Expand view ⇕

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.

Hide
(web5)