CANESTEN INTERNAL CREAM

Active substance: CLOTRIMAZOLE

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S1607 LEAFLET Canesten 20130813

PACKAGE LEAFLET: INFORMATION FOR THE USER

CANESTEN INTERNAL CREAM
(clotrimazole)
Read all of this leaflet carefully because it contains important
information 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.

This medicine is available without prescription. However, you still
need to use Canesten Internal Cream carefully to get the best
results from it.

Do not use tampons, intravaginal douches, spermicides or other
vaginal products while using this product.



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

Using other medicines:



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.

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



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

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

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

Pregnancy:

2. Before you use Canesten Internal Cream

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.

3. How to use Canesten Internal Cream
4. Possible side effects
5. How to store Canesten Internal Cream
6. 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

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).

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.

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.

6. FURTHER INFORMATION
What Canesten Internal Cream contains


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



It also contains sorbitan stearate, polysorbate 60, cetyl
palmitate, cetostearyl alcohol, isopropyl myristate, 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 Internal Cream looks like and contents of the
pack
Canesten Internal Cream is available as single dose packs
containing 5g of white cream in a pre-filled applicator with a
separate plastic plunger in a blister pack.
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 available in a pack of 5g.
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.
Manufacturer
This product is manufactured by Kern Pharma, S.L. Poligono Ind.
Colon II, C/Venus, 72, 08228 Barcelona, Spain.
P

PL No: 19488/1607

Leaflet revision date: 13 August 2013
Canesten is a registered trade mark of Bayer AG, Germany

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.

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:

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 sight and reach of children.



Do not store above 25°C. Store in original package.



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.

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.
S1607 LEAFLET Canesten 20130813

S1607 LEAFLET Clotrimazole 20130813

PACKAGE LEAFLET: INFORMATION FOR THE USER

Important information about some of the ingredients:

CLOTRIMAZOLE 10% w/w INTERNAL CREAM

This product contains cetostearyl alcohol which may cause local
skin irritation (e.g. rash, itching or redness).

Your medicine is known as Clotrimazole 10% w/w Internal Cream
but would be referred to as Clotrimazole Internal Cream throughout
the 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 Internal Cream carefully to get the best
results from it.

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.



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.



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

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

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

Using other medicines:

IN THIS LEAFLET
1. What is Clotrimazole Internal Cream and what is it used for?
2. Before you use Clotrimazole Internal Cream
3. How to use Clotrimazole Internal Cream
4. Possible side effects
5. How to store Clotrimazole Internal Cream
6. Further information

Pregnancy:
If you are pregnant 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.

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

3. HOW TO USE CLOTRIMAZOLE INTERNAL CREAM

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.

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:

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

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).

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.

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.

6. FURTHER INFORMATION
What Clotrimazole Internal Cream contains


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



It also contains sorbitan stearate, polysorbate 60, cetyl
palmitate, cetostearyl alcohol, isopropyl myristate, 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 Internal Cream looks like and contents of
the pack
Clotrimazole Internal Cream is available as single dose packs
containing 5g of white cream in a pre-filled applicator with a
separate plastic plunger in a blister pack.
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.

Clotrimazole Internal Cream is available in a pack of 5g.
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.
Manufacturer

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.

This product is manufactured by Kern Pharma, S.L. Poligono Ind.
Colon II, C/Venus, 72, 08228 Barcelona, Spain.

Clotrimazole Internal Cream is for use in the vagina only:

Remember: If you have any doubts about using Clotrimazole
Internal Cream correctly, seek the advice of your doctor or
pharmacist.

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:

P

PL No: 19488/1607

Leaflet revision date: 13 August 2013

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.



Rash.



Swallowing or breathing problems.



Swelling of your lips, face, throat or tongue.



Weakness, feeling dizzy or faint.

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.



Nausea.

How to avoid future recurrences:

After you apply Clotrimazole 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.

 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.



Keep out of the sight and reach of children.



Do not store above 25°C. Store in original package.



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.



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.

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


5. HOW TO STORE CLOTRIMAZOLE INTERNAL CREAM



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 Clotrimazole Advice Line on 0845 758 5030.
Calls charged at local rate.
S1607 LEAFLET Clotrimazole 20130813

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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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