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CLOTRIMAZOLE 2% W/W CREAM

Active substance(s): CLOTRIMAZOLE

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Canesten ® Thrush Cream

Ref:1466/160915/1/F

(clotrimazole)
Patient Information Leaflet
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
* 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

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.

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 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.

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 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.

Ref:1466/160915/1/B

Canesten® Thrush Cream
(clotrimazole)
Patient Information Leaflet (continued)
5

*
*
*
*
*

How to store Canesten Thrush Cream

Do not store above 25°C.
Keep out of the sight and reach of children.
Do not use Canesten Thrush Cream after the expiry date which is stated
on the the tube or carton. 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.
If your medicine becomes discoloured or shows any other signs of
deterioration, ask your pharmacist who will advise you what to do.
6

Further information

What Canesten Thrush Cream contains:
The active substance is clotrimazole at a strength of 2% w/w.
Each 20g tube contains clotrimazole (2% w/w) 400mg. Also contains benzyl
alcohol, polysorbate 60, sorbitan stearate, cetyl palmitate, cetostearyl alcohol,
octyldodecanol 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
Each pack contains a 20g tube of cream
Manufacturer and Licence Holder
Manufactured by Kern Pharma, S.L. Poligono Ind II, C/ Venus, 72 08228
Terrassa (Barcelona) Spain and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
Canesten is a registered trademark of Bayer Aktiengesellschaft
P

PL 15184/1466
Leaflet revision date: 16/09/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
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,
swellingm 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.
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.

Clotrimazole 2% w/w Cream
Patient Information Leaflet
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
* 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
Your medicine is called Clotrimazole Cream, but will be referred to as
Clotrimazole Cream throughout the rest 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 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.
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 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 Clotrimazole Cream may not be the right treatment for you.

Ref:1466/160915/2/F

This is because Clotrimazole 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 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

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 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.

Ref:1466/160915/2/B

Clotrimazole 2% w/w Cream
Patient Information Leaflet (continued)
5

*
*
*
*
*

How to store Clotrimazole Cream

Do not store above 25°C.
Keep out of the sight and reach of children.
Do not use Clotrimazole Cream after the expiry date which is stated
on the the tube or carton. 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.
If your medicine becomes discoloured or shows any other signs of
deterioration, ask your pharmacist who will advise you what to do.

6

Further information

What Clotrimazole Cream contains:
The active substance is clotrimazole at a strength of 2% w/w.
Each 20g tube contains clotrimazole (2% w/w) 400mg. Also contains benzyl
alcohol, polysorbate 60, sorbitan stearate, cetyl palmitate, cetostearyl alcohol,
octyldodecanol 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
Each pack contains a 20g tube of cream
Manufacturer and Licence Holder
Manufactured by Kern Pharma, S.L. Poligono Ind II, C/ Venus, 72 08228
Terrassa (Barcelona) Spain and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

P

PL 15184/1466

Leaflet revision date: 16/09/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

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,
swellingm 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.

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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