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CLOTRIMAZOLE 2% CREAM

Active substance(s): CLOTRIMAZOLE

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S829 LEAFLET Canesten 20140627

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

CANESTEN THRUSH CREAM
(clotrimazole 2%w/w)
Read all of this leaflet carefully because it contains important
information for you.
This medicine is available without prescription. However, you still
need to use Canesten Thrush Cream carefully to get the best
results from it.


Keep this leaflet. You may need to read it again.



Ask your pharmacist if you need more information or advice.



You must contact a doctor if your symptoms worsen or do not
improve in 7 days.



If you have any unusual effects after using this product, tell your
doctor or pharmacist.

IN THIS LEAFLET
1. What is Canesten Thrush Cream and what is it used for?



Feeling sick or vomiting.



Diarrhoea.



A foul smelling discharge from the vagina.

This is because Canesten Thrush Cream may not be the right
treatment for you.
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:
As with other creams, this product may reduce the effectiveness of
rubber contraceptives, such as condoms or diaphragms.
Consequently, 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 Thrush Cream. If you have
informed your doctor or midwife already, follow his/her instructions
carefully.

2. Before you use Canesten Thrush Cream
3. How to use Canesten Thrush Cream

3. HOW TO USE CANESTEN THRUSH CREAM

4. Possible side effects

Women:

5. How to store Canesten Thrush Cream

If Canesten Thrush Cream has been prescribed for you by your
doctor, follow any instructions he/she may have given you. If you
purchased this product without a prescription, follow these
directions closely:

6. Further information
1. WHAT IS CANESTEN THRUSH CREAM AND WHAT IS IT
USED FOR?



Before use, pierce the tube seal by inverting the cap over the
end of the tube and press.

Canesten Thrush Cream relieves irritation of the vulva (vulvitis)
which is caused by vaginal thrush (candidiasis). Although this
cream provides relief from the external irritation caused by vaginal
thrush, it cannot treat any internal (vaginal) cause of the infection.
Ask your doctor or pharmacist to recommend a treatment for this.
Only use this product if you have been previously diagnosed
by your doctor as having vaginal thrush.



To treat the itching and soreness of the vulva (vulvitis), the
cream should be thinly and evenly applied to the area around
the entrance of the vagina, 2 or 3 times a day and smoothed in
gently. A product to treat the internal (vaginal) infection should
be used at the same time.

Some women suffer from recurrent attacks of thrush. To reduce the
frequency of these attacks, the sexual partner’s penis can be
treated with this cream to prevent re-infection, even if they have no
symptoms of thrush.
The active substance in Canesten Thrush Cream is clotrimazole.
Clotrimazole belongs to a group of medicines called azoles and is
an antifungal agent which fights the cause of infections such as
vaginal thrush.

Treatment should be continued until symptoms of the infections
disappear. Consult your doctor if the symptoms of your infection do
not improve within seven days of finishing treatment for the internal
infection.
Treating your sexual partner:
If your sexual partner is treated with this cream, the cream should
be applied to the end of the penis 2 or 3 times a day for up to two
weeks.
Canesten Thrush Cream is for external use only:

2. BEFORE YOU USE CANESTEN THRUSH CREAM

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

Do not use Canesten Thrush Cream:

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



If you are allergic (hypersensitive) to clotrimazole or any of the
other ingredients, including cetostearyl alcohol, of Canesten
Thrush Cream (see Section 6. Further Information).

4. POSSIBLE SIDE EFFECTS
Before using Canesten Thrush Cream, you should see your
doctor if:


You are unsure whether you have thrush or this is the first time
you have had these symptoms.



You have had more than two infections of thrush in the last six
months.



You or your partner have ever had a sexually transmitted
disease.



You are aged under 16 or over 60.



You have ever had an allergic reaction to Canesten or any
other vaginal antifungal products.



You have any of the following symptoms:


Irregular vaginal bleeding.



Abnormal vaginal bleeding or a blood stained discharge.



Ulcers, blisters or sores of the vagina or vulva.



Lower abdominal pain.



Pain or difficulty in passing urine.



Fever or chills.

Like all medicines, Canesten Thrush 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 have used the
medicine. If you experience an allergic reaction or the redness,
burning, pain, itching or swelling get worse, stop using this product
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:

Manufacturer



This product is manufactured by Kern Pharma, S.L., Poligon
Industrial Colon ll, Venus, 72 E-08228, Terrassa Barcelona, Spain.

Itching, rash, blisters, burning, discomfort, swelling, redness,
irritation or peeling of skin.
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 or
pharmacist 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.gov.uk/yellowcard
By reporting side effects you can help provide more information on
the safety of this medicine.
5. HOW TO STORE CANESTEN THRUSH CREAM


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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.

P

PL No: 19488/0829

Leaflet revision date: 27 June 2014
Canesten is a registered trade mark of Bayer AG, Germany.
Remember: If you have any doubts about using Canesten
Thrush Cream correctly, seek the advice of your doctor or
pharmacist.
Further information about vaginal thrush:
Vaginal thrush (candidiasis) is a common infection that most
women suffer from at some time in their lives and is not caused by
lack of personal hygiene.
Thrush is caused by a yeast (fungus) called Candida which lives
harmlessly in the vagina and other parts of the body, without you
even noticing it. However, the natural balance that keeps Candida
under control can be upset by many factors such as hormonal
changes (menstruation, contraceptive pill, pregnancy, menopause),
poor health, antibiotics, perfumed soaps, bath additives and tight
clothing.
If the natural pH balance is altered, the level of yeast increases and
can develop into a thrush infection causing any of the following
symptoms: persistent burning and/or itching around the vagina and
vulva, redness, swelling and soreness of the tissues of the vagina
and vulva and a whitish, odourless discharge from the vagina.
Not everybody who has thrush has all these symptoms; you may
have only one of them.

6. FURTHER INFORMAT ION
What Canesten Thrush Cream contains

How to avoid future recurrences:



 Wear cotton knickers and loose clothing.



Each 20g tube of Canesten Thrush Cream contains 2% w/w of
the active ingredient, clotrimazole, as a cream for topical use.
Canesten Thrush Cream also contains the following inactive
ingredients: sorbitan stearate, polysorbate 60, cetyl palmitate,
cetostearyl alcohol, 2-octyldodecanol, benzyl alcohol and water
purified.
See Section 2 ‘Do not use’ and ‘Important information about
some of the ingredients’ for cetostearyl alcohol advice.

What Canesten Thrush Cream looks like and contents of the
pack
Canesten Thrush Cream is a white cream in a sealed metal
collapsible tube with a spiked white screw cap.
Canesten Thrush Cream is available in a tube of 20g.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

 Wash daily.
 After going to the toilet, wipe yourself from the front to back as a
thrush infection may be transferred from the bowel.
 Change your sanitary protection regularly.


Try to avoid wearing tights, nylon knickers and close fitting
jeans.



Try to avoid washing with perfumed soaps or using vaginal
deodorants.



Do not wash or rub yourself hard with sponges or flannels and
avoid hot baths with strong perfumed oils.

If you are still worried or have any questions about the symptoms or
the treatment of thrush, do not hesitate to ask your doctor or
pharmacist for advice.
S829 LEAFLET Canesten 20140627

S829 LEAFLET Clotrimazole 20140627

PACKAGE LEAFLET: INFORMATION FOR THE USER

CLOTRIMAZOLE 2% CREAM
(clotrimazole 2%w/w)
Read all of this leaflet carefully because it contains important
information for you.
This medicine is available without prescription. However, you still
need to use Clotrimazole 2% Cream carefully to get the best results
from it.



Feeling sick or vomiting.



Diarrhoea.



A foul smelling discharge from the vagina.

This is because Clotrimazole 2% Cream may not be the right
treatment for you.
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:



Keep this leaflet. You may need to read it again.



Ask your pharmacist if you need more information or advice.



You must contact a doctor if your symptoms worsen or do not
improve in 7 days.

As with other creams, this product may reduce the effectiveness of
rubber contraceptives, such as condoms or diaphragms.
Consequently, you should use alternative precautions for at least
five days after using this product.



If you have any unusual effects after using this product, tell your
doctor or pharmacist.

Pregnancy and breast-feeding:

IN THIS LEAFLET
1. What is Clotrimazole 2% Cream and what is it used for?

If you are pregnant, breast-feeding or trying for a baby, tell your
doctor or midwife before using Clotrimazole 2% Cream. If you have
informed your doctor or midwife already, follow his/her instructions
carefully.

2. Before you use Clotrimazole 2% Cream
3. How to use Clotrimazole 2% Cream

3. HOW TO USE CLOTRIMAZOLE 2% CREAM

4. Possible side effects
5. How to store Clotrimazole 2% Cream

Women:

6. Further information

If Clotrimazole 2% Cream has been prescribed for you by your
doctor, follow any instructions he/she may have given you. If you
purchased this product without a prescription, follow these
directions closely:

1. WHAT IS CLOTRIMAZOLE 2% CREAM AND WHAT IS IT
USED FOR?



Before use, pierce the tube seal by inverting the cap over the
end of the tube and press.

Clotrimazole 2% Cream relieves irritation of the vulva (vulvitis)
which is caused by vaginal thrush (candidiasis). Although this
cream provides relief from the external irritation caused by vaginal
thrush, it cannot treat any internal (vaginal) cause of the infection.
Ask your doctor or pharmacist to recommend a treatment for this.



To treat the itching and soreness of the vulva (vulvitis), the
cream should be thinly and evenly applied to the area around
the entrance of the vagina, 2 or 3 times a day and smoothed in
gently. A product to treat the internal (vaginal) infection should
be used at the same time.

Only use this product if you have been previously diagnosed
by your doctor as having vaginal thrush.

Treatment should be continued until symptoms of the infections
disappear. Consult your doctor if the symptoms of your infection do
not improve within seven days of finishing treatment for the internal
infection.

Some women suffer from recurrent attacks of thrush. To reduce the
frequency of these attacks, the sexual partner’s penis can be
treated with this cream to prevent re-infection, even if they have no
symptoms of thrush.
The active substance in Clotrimazole 2% Cream is clotrimazole.
Clotrimazole belongs to a group of medicines called azoles and is
an antifungal agent which fights the cause of infections such as
vaginal thrush.
2. BEFORE YOU USE CLOTRIMAZOLE 2% CREAM
Do not use Clotrimazole 2% Cream:


If you are allergic (hypersensitive) to clotrimazole or any of the
other ingredients, including cetostearyl alcohol, of Clotrimazole
2% Cream (see Section 6. Further Information).

Before using Clotrimazole 2% Cream, you should see your
doctor if:


You are unsure whether you have thrush or this is the first time
you have had these symptoms.



You have had more than two infections of thrush in the last six
months.



You or your partner have ever had a sexually transmitted
disease.



You are aged under 16 or over 60.



You have ever had an allergic reaction to Canesten or any
other vaginal antifungal products.



You have any of the following symptoms:


Treating your sexual partner:
If your sexual partner is treated with this cream, the cream should
be applied to the end of the penis 2 or 3 times a day for up to two
weeks.
Clotrimazole 2% 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Clotrimazole 2% 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 have used the
medicine. If you experience an allergic reaction or the redness,
burning, pain, itching or swelling get worse, stop using this product
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.

Irregular vaginal bleeding.



Weakness, feeling dizzy or faint.



Abnormal vaginal bleeding or a blood stained discharge.



Nausea.



Ulcers, blisters or sores of the vagina or vulva.



Lower abdominal pain.



Pain or difficulty in passing urine.



Fever or chills.

After you apply the cream you might experience:

Manufacturer



This product is manufactured by Kern Pharma, S.L., Poligon
Industrial Colon ll, Venus, 72 E-08228, Terrassa Barcelona, Spain.

Itching, rash, blisters, burning, discomfort, swelling, redness,
irritation or peeling of skin.
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 or
pharmacist 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.gov.uk/yellowcard

P

PL No: 19488/0829

Leaflet revision date: 27 June 2014
Remember: If you have any doubts about using Clotrimazole
2% Cream correctly, seek the advice of your doctor or
pharmacist.

By reporting side effects you can help provide more information on
the safety of this medicine.

Further information about vaginal thrush:

5. HOW TO STORE CLOTRIMAZOLE 2% CREAM

Vaginal thrush (candidiasis) is a common infection that most
women suffer from at some time in their lives and is not caused by
lack of personal hygiene.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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.

Thrush is caused by a yeast (fungus) called Candida which lives
harmlessly in the vagina and other parts of the body, without you
even noticing it. However, the natural balance that keeps Candida
under control can be upset by many factors such as hormonal
changes (menstruation, contraceptive pill, pregnancy, menopause),
poor health, antibiotics, perfumed soaps, bath additives and tight
clothing.
If the natural pH balance is altered, the level of yeast increases and
can develop into a thrush infection causing any of the following
symptoms: persistent burning and/or itching around the vagina and
vulva, redness, swelling and soreness of the tissues of the vagina
and vulva and a whitish, odourless discharge from the vagina.
Not everybody who has thrush has all these symptoms; you may
have only one of them.
How to avoid future recurrences:

6. FURTHER INFORMAT ION

 Wear cotton knickers and loose clothing.

What Clotrimazole 2% Cream contains

 Wash daily.



Each 20g tube of Clotrimazole 2% Cream contains 2% w/w of
the active ingredient, clotrimazole, as a cream for topical use.

 After going to the toilet, wipe yourself from the front to back as a
thrush infection may be transferred from the bowel.



Clotrimazole 2% Cream also contains the following inactive
ingredients: sorbitan stearate, polysorbate 60, cetyl palmitate,
cetostearyl alcohol, 2-octyldodecanol, benzyl alcohol and water
purified.
See Section 2 ‘Do not use’ and ‘Important information about
some of the ingredients’ for cetostearyl alcohol advice.

What Clotrimazole 2% Cream looks like and contents of the
pack
Clotrimazole 2% Cream is a white cream in a sealed metal
collapsible tube with a spiked white screw cap.
Clotrimazole 2% Cream is available in a tube of 20g.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

 Change your sanitary protection regularly.


Try to avoid wearing tights, nylon knickers and close fitting
jeans.



Try to avoid washing with perfumed soaps or using vaginal
deodorants.
Do not wash or rub yourself hard with sponges or flannels and
avoid hot baths with strong perfumed oils.



If you are still worried or have any questions about the symptoms or
the treatment of thrush, do not hesitate to ask your doctor or
pharmacist for advice.
S829 LEAFLET Clotrimazole 20140627

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.

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