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CANESTEN 2 % THRUSH CREAM/ CLOTRIMAZOLE 2 % W/WCREAM

Active substance(s): CLOTRIMAZOLE

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Package Leaflet: Information for the User

Canesten® 2% Thrush Cream
(clotrimazole)
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.
 The name of your medicine is Canesten 2% Thrush Cream but will be
referred to as Canesten Thrush Cream throughout the remainder of
this leaflet.
In this leaflet
1. What is Canesten Thrush Cream and what is it used for?
2. Before you use Canesten Thrush Cream
3. How to use Canesten Thrush Cream
4. Possible side effects
5. How to store Canesten Thrush Cream
6. Further information
1. What is Canesten Thrush Cream and what is it used for?
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.
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.
2. Before you use Canesten Thrush Cream
Do not use Canesten Thrush Cream:
 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).
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.
 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.
3. How to use Canesten Thrush Cream
Women:
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:
 Before use, pierce the tube seal by inverting the cap over the end of
the tube and press.
 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.
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:
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, 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:
 Itching, rash, blisters, burning, discomfort, swelling, redness, irritation
or peeling of skin.
If you experience any of the above effects, 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 25oC.
 Do not use your cream after the expiry date which is stated on the
carton/label and tube. The expiry date refers to the last day of the
month.
 If your medicine becomes discoloured or shows any sign of
deterioration return it to your pharmacist.
 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 protect the environment.
6. Further information
What Canesten Thrush Cream contains:
One 20g tube of Canesten Thrush Cream contains clotrimazole 400mg
(2% w/w).
The other ingredients are sorbitan stearate, polysorbate 60, cetyl
palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol and
purified water.
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 available in 20g tubes.
Manufactured by
KERN PHARMA, S.L., Poligono Ind. Colon II. C/ Venus, 72,
08228 Terrassa (Barcelona), Spain.
Procured from within the EU by Product Licence holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER, UK.
Repackaged by MPT Pharma Ltd.
PL: 33532/0691

P

Leaflet dated 18th July 2016
Leaflet coded XXXXXXXXXX
Canesten® is a registered trademark of Bayer Aktiengesellschaft.
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.
How to avoid future recurrences:
 Wear cotton knickers and loose clothing.
 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.

Package Leaflet: Information for the User

Clotrimazole 2% w/w cream
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 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.
 The name of your medicine is Clotrimazole 2% w/w cream but will be
referred to as Clotrimazole cream throughout the remainder of this
leaflet.
In this leaflet
1. What is Clotrimazole cream and what is it used for?
2. Before you use Clotrimazole cream
3. How to use Clotrimazole cream
4. Possible side effects
5. How to store Clotrimazole cream
6. Further information
1. What is Clotrimazole cream and what is it used for?
Clotrimazole 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.
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 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.

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 Clotrimazole cream. If you have informed your
doctor or midwife already, follow his/her instructions carefully.
3. How to use Clotrimazole cream
Women:
If Clotrimazole 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:
 Before use, pierce the tube seal by inverting the cap over the end of
the tube and press.
 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.
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.
Clotrimazole 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

2. Before you use Clotrimazole cream
Do not use Clotrimazole cream:
 If you are allergic (hypersensitive) to clotrimazole or any of the other
ingredients, including cetostearyl alcohol, of Clotrimazole cream (see
Section 6. Further Information).
Before using Clotrimazole 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 Clotrimazole 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.
 Feeling sick or vomiting.
 Diarrhoea.
 A foul smelling discharge from the vagina.
This is because Clotrimazole cream may not be the right treatment for
you.

Like all medicines, Clotrimazole 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:
 Itching, rash, blisters, burning, discomfort, swelling, redness, irritation
or peeling of skin.
If you experience any of the above effects, 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 Clotrimazole cream
 Keep out of the sight and reach of children.
 Do not store above 25oC.
 Do not use your cream after the expiry date which is stated on the
carton/label and tube. The expiry date refers to the last day of the
month.
 If your medicine becomes discoloured or shows any sign of
deterioration return it to your pharmacist.
 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 protect the environment.
6. Further information
What Clotrimazole cream contains:
One 20g tube of Clotrimazole cream contains clotrimazole 400mg (2%
w/w).
The other ingredients are sorbitan stearate, polysorbate 60, cetyl
palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol and
purified water.
See Section 2 ‘Do not use’ and ‘Important information about some of the
ingredients’ for cetostearyl alcohol advice.
What Clotrimazole cream looks like and contents of the pack
Clotrimazole cream is a white cream available in 20g tubes.
Manufactured by
KERN PHARMA, S.L., Poligono Ind. Colon II. C/ Venus, 72,
08228 Terrassa (Barcelona), Spain.
Procured from within the EU by Product Licence holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER, UK.
Repackaged by MPT Pharma Ltd.
PL: 33532/0691

P

Leaflet dated 18th July 2016
Leaflet coded XXXXXXXXXX
Remember: If you have any doubts about using Clotrimazole
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.
How to avoid future recurrences:
 Wear cotton knickers and loose clothing.
 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.

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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