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CANESTEN 2% W/W THRUSH CREAM

Active substance(s): CLOTRIMAZOLE / CLOTRIMAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CANESTEN® 2% W/W

This is because Canesten Cream may not be the right treatment for
you.

THRUSH CREAM

Important information about some of the ingredients:
This product contains cetostearyl alcohol which may cause local skin
irritation (e.g. rash, itching or redness).

clotrimazole
The name of your medicine is Canesten 2% w/w Thrush Cream, but
will be referred to as Canesten Cream throughout this 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 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. What is Canesten Cream and what is it used for?
2. Before you use Canesten Cream
3. How to use Canesten Cream
4. Possible side effects
5. How to store Canesten Cream
6. Further information

1. WHAT IS CANESTEN® CREAM AND WHAT IS IT
USED FOR?
Canesten 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 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® CREAM
Do not use Canesten Cream:
• if you are allergic (hypersensitive) to clotrimazole or any of the
other ingredients, including cetostearyl alcohol, of Canesten
Cream (see Section 6: Further Information).
Before using Canesten 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.

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 Cream. If you have
informed your doctor or midwife already, follow his/her instructions
carefully.

3. HOW TO USE CANESTEN® CREAM
Women:
If Canesten 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 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 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 side 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® CREAM

✓ 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.

Keep this medicine out of the sight and reach of children.
Do not use Canesten Cream after the expiry date stated on the
carton and tube. The expiry date refers to the last day of that month.

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.

Do not store above 25oC.
If your medicine becomes discoloured or shows any signs of
deterioration consult your pharmacist who will advise you what to do.
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

Date of preparation: 01st August 2017

What Canesten Cream contains:
• One 20g tube of Canesten 2% w/w 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 Cream looks like and contents of the pack:
Canesten Cream is available in tubes containing 20g of white-off
white cream.
Manufactured by KERN PHARMA S.L., Poligono Ind. Colon II.
C/Venus, 72, 08228 Terrassa, Barcelona and procured from within
the EU and repackaged in the UK by the Product Licence holder: CD
Pharma Ltd, Unit 3, Manor Point, Manor Way, Borehamwood, Herts
WD6 1EE.
Canesten® is a registered trademark of Bayer AG, Germany.
Canesten® Thrush External Cream 2% w/w cream
PL:20492/0567
P

Remember: If you have any doubts about using Canesten®
Thrush External 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.

Blind or partially sighted? Is this
leaflet hard to see or read?
Call 020 8236 3190 to obtain a
leaflet in a format suitable for you.

PACKAGE LEAFLET: INFORMATION FOR THE USER

CLOTRIMAZOLE 2% W/W CREAM
The name of your medicine is Clotrimazole 2% w/w cream, but will be
referred to as Clotrimazole Cream throughout this leaflet.
Read all of this leaflet carefully before 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.
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.

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.
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 side 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 this medicine out of the sight and reach of children.
Do not use Clotrimazole Cream after the expiry date stated on the
carton and tube. The expiry date refers to the last day of that month.
Do not store above 25oC.
If your medicine becomes discoloured or shows any signs of
deterioration consult your pharmacist who will advise you what to do.
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 Cream contains:
• One 20g tube of Clotrimazole 2% w/w 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 available in tubes containing 20g of white to
off white cream.
Manufactured by KERN PHARMA S.L., Poligono Ind. Colon II.
C/Venus, 72, 08228 Terrassa, Barcelona and procured from within
the EU and repackaged in the UK by the Product Licence holder: CD
Pharma Ltd, Unit 3, Manor Point, Manor Way, Borehamwood, Herts
WD6 1EE.
Clotrimazole Cream 2% w/w cream

PL:20492/0567

P

Remember: If you have any doubts about using Clotrimazole
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.

Blind or partially sighted? Is this
leaflet hard to see or read?
Call 020 8236 3190 to obtain a
leaflet in a format suitable for you.
Date of preparation: 01st August 2017

Expand Transcript

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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