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CLOTRIMAZOLE 10% W/W INTERNAL CREAM

Active substance(s): CLOTRIMAZOLE

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Canesten® Internal 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 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.

IN THIS LEAFLET

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.
Do not use tampons, intravaginal douches, spermicides or other
vaginal products while using this product.
Avoid vaginal intercourse while you have thrush and during use of
this product because your partner could become infected.

1.
2.
3.
4.
5.
6.

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

Using other medicines:
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.

1.

WHAT IS CANESTEN INTERNAL CREAM AND
WHAT IS IT USED FOR?

Pregnancy and breast-feeding:
If you are pregnant, breast-feeding 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.

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.

Inform your doctor if you are taking tacrolimus or sirolimus (used
to reduce the immune response to prevent rejection after an
organ transplant).

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).

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.

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.

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.

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 Internal Cream contains:




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, redness, discomfort, burning, irritation,
vaginal peeling or bleeding.
• Pain in the abdomen or pelvic area.
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.

5g of vaginal cream contains clotrimazole 500mg (10%w/w).
The other ingredients are benzyl alcohol, polysorbate 60,
sorbitan monostearate, cetostearyl alcohol, isopropyl
myristate, cetyl palmitate and purified water.
See Section 2 ‘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 smooth cream in a pre-filled applicator with
a separate plunger in a blister pack.

Manufactured by: Kern Pharma S.L. Poligono Ind. Colon II
C/Venus, 72 08228 Terrassa, Spain.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK
®

Canesten Internal Cream

PL No: 18799/2021

P

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.

Keep out of the sight and reach of children.

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.

This product should be stored in the original carton.

Leaflet date: 12.03.2014

Do not store above 25°C.

Canesten is a registered trademark of Bayer AG, Germany.

5.

HOW TO STORE CANESTE INTERNAL CREAM

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.

Clotrimazole 10%w/w Internal 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 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.
The name of your medicine is Clotrimazole 10%w/w Internal
Cream but will be referred to as Clotrimazole Internal Cream
throughout this leaflet.

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

1.

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

WHAT IS CLOTRIMAZOLE INTERNAL CREAM AND
WHAT IS IT USED FOR?

Clotrimazole 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 Clotrimazole 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 CLOTRIMAZOLE INTERNAL
CREAM
Do not use Clotrimazole Internal Cream:
• If you are allergic (hypersensitive) to clotrimazole or any of the
other ingredients, including cetostearyl alcohol, of Clotrimazole
Internal Cream (see Section 6. Further Information).
During your period as it may be less effective.


Before using Clotrimazole 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 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 Internal 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.
Do not use tampons, intravaginal douches, spermicides or other
vaginal products while using this product.
Avoid vaginal intercourse while you have thrush and during use of
this product because your partner could become infected.
Using other medicines:
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 or sirolimus (used
to reduce the immune response to prevent rejection after an
organ transplant).
Pregnancy and breast-feeding:
If you are pregnant, breast-feeding or trying for a baby, tell your
doctor or midwife before using Clotrimazole 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 CLOTRIMAZOLE INTERNAL CREAM

If Clotrimazole 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).

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.

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.

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 Clotrimazole Internal Cream contains:




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.

Clotrimazole 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, Clotrimazole 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.






The other ingredients are benzyl alcohol, polysorbate 60,
sorbitan monostearate, cetostearyl alcohol, isopropyl
myristate, cetyl palmitate and purified water.
See Section 2 ‘Important information about some of the
ingredients’ for cetostearyl alcohol advice.

What Clotrimazole Internal Cream looks like and
contents of the pack:
Clotrimazole Internal Cream is available in single-dose packs
containing 5g of white smooth cream in a pre-filled applicator with
a separate plunger in a blister pack.

Manufactured by: Kern Pharma S.L., Poligono Ind. Colon II
C/Venus, 72 08228 Terrassa, Spain.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK
Clotrimazole 10%w/w Internal Cream PL No: 18799/2021 P
Remember: If you have any doubts about using Clotrimazole
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.

Swelling of your lips, face, throat or tongue.

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.

Weakness, feeling dizzy or faint.

How to avoid future recurrences:

Swallowing or breathing problems.

Nausea.
After you apply Canesten Internal Cream you might
experience:
• Itching, rash, swelling, redness, discomfort, burning,
irritation, vaginal peeling or bleeding.
• Pain in the abdomen or pelvic area.
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.

5g of vaginal cream contains clotrimazole 500mg (10%w/w).

HOW TO STORE CLOTRIMAZOLE INTERNAL
CREAM

Keep out of the sight and reach of children.
This product should be stored in the original carton.
Do not store above 25°C.
Do not use Clotrimazole 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.

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.
Leaflet date: 12.03.2014

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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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