CANESTEN CREAM COMBI INTERNAL & EXTERNAL CREAMS

Active substance: CLOTRIMAZOLE

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CREAM COMBI

Internal & External Creams
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 Cream Combi Internal & External
Creams carefully to get the best results from it.

• Keep this leaflet. You may need to read it again.
•  your pharmacist if you need more information or advice.
Ask
•  must contact a doctor if your symptoms worsen or do
You
not improve in 7 days.
•  you have any unusual effects after using this product, tell
If
your doctor or pharmacist.

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

1.  HAT IS CANESTEN® CREAM COMBI
W
AND WHAT IS IT USED FOR?
Canesten Cream Combi Internal & External Creams is a
complete treatment for vaginal thrush because it treats both
the internal cause and external symptoms.
Only use this product if you have been previously diagnosed
by your doctor as having vaginal thrush.
The active substance in Canesten Cream Combi Internal &
External Creams 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.  EFORE YOU USE CANESTEN® CREAM
B
COMBI
Do not use Canesten® Cream Combi Internal &
External Creams:
•  you are allergic (hypersensitive) to clotrimazole or any
If
of the other ingredients, including cetostearyl alcohol,
of Canesten Cream Combi Internal & External Creams
(see Section 6. Further Information).
• During your period as it may be less effective.
• To treat nail and scalp infections.

Important information about some of the ingredients:
The creams contain 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 Canesten Cream Combi Internal
& External Creams. 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.  OW TO USE CANESTEN® CREAM COMBI
H
The 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).

1

Before using Canesten® Cream Combi Internal &
External Creams, you should see your doctor if:
• You are unsure whether you have thrush or this is the
first time you have had these symptoms.
•  have had more than two infections of thrush in the last
You
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 Cream Combi Internal & External
Creams may not be the right treatment for you.

15979_Bayer_Can_CreComIntEx(GSL)_Leaflet v1.6.indd 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



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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.

3
Bladder
A
Womb
B

Vagina
Rectum

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 External Cream:

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.
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.

The internal cream is for use in the vagina only
and the external cream is for external use only:
Do not put the creams in your mouth or swallow them.
If the creams are 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 Combi Internal &
External Creams can cause side effects, although not
everybody gets them.
As with all medicines, some people may be allergic to the
creams. 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.
After you apply Canesten External Cream you might
experience:
• 
Itching, rash, blisters, burning, redness, discomfort,
swelling, irritation or peeling of skin.
If you experience any of the above effects or react badly
to the creams in any other way not listed in this leaflet,
tell your doctor or pharmacist immediately.

5.  HOW TO STORE CANESTEN® CREAM

COMBI
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 the creams after the expiry date which is stated at
one end of the carton, on the end of the tube of cream, on the
applicator and on the applicator foil wrapping. The expiry date
refers to the last day of that month.

15979_Bayer_Can_CreComIntEx(GSL)_Leaflet v1.6.indd 2

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® Cream Combi Internal & External
Creams contains:
Applicator of internal cream:
• The active substance is clotrimazole at a strength of
10% w/w.
•  other ingredients are benzyl alcohol, polysorbate 60,
The
sorbitan stearate, cetostearyl alcohol, isopropyl myristate,
cetyl palmitate and purified water.

External cream:









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® Cream Combi Internal & External
Creams looks like and contents of the pack:
Canesten Cream Combi Internal & External Creams contains a
full course of treatment, which consists of a pre-filled applicator
containing 5g of white internal cream and one 10g tube of white
external cream.
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®
Cream Combi Internal & External Creams 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:

3 Wear cotton knickers and loose clothing.
3 Wash daily.
3  fter going to the toilet, wipe yourself from the front to back
A
as a thrush infection may be transferred from the bowel.
3 Change your sanitary protection regularly.
7  to avoid wearing tights, nylon knickers and close
Try
fitting jeans.
7 Try to avoid washing with perfumed soaps or using
vaginal deodorants.
7  not wash or rub yourself hard with sponges or
Do
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 2013.
Canesten is a registered trademark of Bayer AG, Germany.

Bayer
14/10/2013 10:27

This artwork
is compliant
with the Bayer
Consumer Care
ReBranding
Guidelines.
DATE 24/7/12
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Component
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WTD Job No.
SKU No.
Dimensions
Text size (pts)
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Date

Canesten
10%VC PIL
UK
15979
XXXXX
174 x 297 mm
8.5pts
Meta Plus
TBA
14/10/13

Version 1.6

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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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