CANESTEN CREAM

Active substance: CLOTRIMAZOLE

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Internal Cream
Clotrimazole 10% w/w
Read all of this leaflet carefully because it contains
important information for you.

Important information about some of the
ingredients:

This medicine is available without prescription. However,
you still need to use Canesten Internal 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.

This product contains cetostearyl alcohol which may cause
local skin irritation (e.g. rash, itching or redness).
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.
Do not use tampons, intravaginal douches, spermicides or
other vaginal products while using this product.

Using other medicines:

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

Special precautions:

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

1. WHAT IS CANESTEN INTERNAL CREAM
AND WHAT IS IT USED FOR?
Canesten Internal Cream is a single application, full course
treatment for vaginal thrush. It is a soothing intravaginal
cream in a prefilled applicator for treatment at the site of
infection.
Only use this product if you have been previously
diagnosed by your doctor as having vaginal thrush.
The active substance in Canesten Internal 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® INTERNAL
CREAM
Do not use Canesten® Internal Cream:
• If you are allergic (hypersensitive) to clotrimazole or any
of the other ingredients, including cetostearyl alcohol,
of Canesten Internal Cream (see Section 6. Further
Information).
• During your period as it may be less effective.

Before using Canesten® Internal 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 Internal Cream may not be the
right treatment for you.

Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Inform your doctor if you are taking tacrolimus (used to
reduce the immune response to prevent rejection after an
organ transplant).

Pregnancy:
If you are pregnant or trying for a baby, tell your doctor or
midwife before using Canesten Internal Cream. If you have
informed your doctor or midwife already, follow his/her
instructions carefully.
To treat internal thrush, your doctor may recommend that
you use a treatment that can be inserted in the vagina
without the help of an applicator, such as a clotrimazole
pessary.

3. HOW TO USE CANESTEN® INTERNAL
CREAM
If Canesten Internal 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:
The cream should be inserted as high as possible into
the vagina, preferably before going to sleep at night for
convenient and comfortable treatment.
Wash your hands before removing the foil from the blister
pack and again afterwards when you have used the
applicator.
1. Remove the applicator from the packaging. Keeping
the red cap in place, insert the tip of plunger A into the
applicator B (approximately 1cm).

1

B

A

2. Twist and pull to remove the red cap C. Be careful not to
press the plunger in any further before you have inserted the
applicator into the vagina. This will avoid wasting any cream.

2
C

3. Carefully put the applicator as deep as is comfortable into
the vagina (this is easiest when lying on your back with your
knees bent up). Holding the applicator in place, slowly press
the plunger until it stops so that the pre-measured dose of
cream is deposited into the vagina.

6. FURTHER INFORMATION
What Canesten® Internal Cream contains:



3
Bladder
A
Womb
B

Vagina
Rectum

The active substance is clotrimazole at a strength of
500mg (10% w/w).
The other ingredients are benzyl alcohol, polysorbate
60, sorbitan stearate, cetostearyl alcohol, isopropyl
myristate, cetyl palmitate and water.
See Section 2 ‘Do not use’ and ‘Important information
about some of the ingredients’ for cetostearyl alcohol
advice.

What Canesten® Internal Cream looks like and
contents of the pack:
Canesten Internal Cream is available in single-dose packs
containing 5g of white cream in a pre-filled applicator.

Marketing Authorisation Holder:
4. Remove the applicator. Dispose of the applicator in a safe
place, out of the reach of children. The applicator cannot be
flushed down the toilet.
The cream is deposited in the vagina, but it is quite common
to notice a slight discharge after using the cream and
therefore it may be helpful to wear a panty liner. This does
not mean that the treatment has not worked.
The symptoms of thrush should disappear within three days
of treatment. If no improvement is seen after seven days
you must tell your doctor. If the infection returns after seven
days you may use one further treatment, but if you have
more than two infections within six months you should see
your doctor.

Canesten® Internal Cream is for use in the vagina
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 Internal 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 Canesten Internal Cream you might
experience:
• Itching, rash, swelling, discomfort, burning, irritation or
vaginal peeling.
• Pain in the abdomen or pelvic area.
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.

5. HOW TO STORE CANESTEN® INTERNAL
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 Internal Cream after the expiry date
which is stated at one end of the carton, on the applicator
and on the applicator foil wrapping. 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.

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: If you have any doubts about using Canesten®
Internal 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.
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 2009.
Canesten is a registered trademark of Bayer AG, Germany.

Bayer

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.
2.
3.
4.
5.
6.

What is Canesten Thrush Cream and what is it used for?
Before you use Canesten Thrush Cream
How to use Canesten Thrush Cream
Possible side effects
How to store Canesten Thrush Cream
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 reinfection, 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:
If you are pregnant 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,
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.

5. HOW TO STORE CANESTEN® THRUSH
CREAM
Keep out of the reach and sight of children.
This product should be stored in the original carton.
Do not store above 25ºC.
Do not use Canesten Thrush 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® Thrush Cream contains:



The active substance is clotrimazole at a strength of
2% w/w.
The other ingredients are 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:
Canesten Thrush Cream is available in tubes containing 10g
or 20g 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: 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.
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 approved in December 2009.
Canesten is a registered trademark of
Bayer
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.

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