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CANESTEN 500MG VAGINAL PESSARY

Active substance(s): CLOTRIMAZOLE MICRONISED

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COMBI

500mg Pessary & 2% Cream
Clotrimazole
Read all of this leaflet carefully because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not give it
to anyone else under any circumstances.
• If you have any unusual effects after using this product,
tell your doctor.

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

1. WHAT IS CANESTEN® COMBI AND WHAT
IS IT USED FOR?
Canesten Combi 500mg Pessary & 2% Cream is a full course
of treatment for vaginal thrush (candidiasis) because it treats
both the internal cause and external symptoms.
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 500mg Pessary & 2%
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.

To treat internal thrush, your doctor may recommend that
you use the pessary without the help of an applicator.

3. HOW TO USE CANESTEN® COMBI
The Pessary:

Unless directed otherwise by your doctor, the pessary
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. Pull out the
plunger A until it stops. Remove the pessary from the foil
blister pack and place firmly into the applicator B.

1
B

A

2. To fit the pessary into the applicator, the holder of the
applicator needs to be squeezed lightly at both sides. The
pessary fits tightly into the applicator and needs to be
squeezed into the holder to about 1cm.

2

2. B
 EFORE YOU USE CANESTEN COMBI
®

Do not use Canesten® Combi 500mg Pessary &
2% Cream:

• I f you are allergic (hypersensitive) to clotrimazole or any
of the other ingredients, including cetostearyl alcohol, of
Canesten Combi 500mg Pessary & 2% Cream (see Section
6. Further Information).
• During your period as it may be less effective.

Important information about some of the ingredients:

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

Special precautions:

As with other creams and pessaries, 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 Combi 500mg
Pessary & 2% Cream. If you have informed your doctor or
midwife already, follow his/her instructions carefully.

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 pessary
is deposited into the vagina.

3
Bladder

Womb
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.
Since the pessary dissolves in the vagina, it may be helpful
to wear a panty liner because it is quite common to notice
a white chalky residue after using the pessary. This does
not mean that the treatment has not worked. However, if
you notice pieces of undissolved pessary, speak to your
doctor or a pharmacist, as the treatment may not have
worked properly.

The Cream:

Women:
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, 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.
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.

The pessary is for use in the vagina only. The cream
is for external use only:

Do not put the pessary or cream in your mouth or swallow
them.
If the pessary or cream 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 Combi 500mg Pessary &
2% Cream can cause side effects, although not everybody
gets them.
As with all medicines, some people may be allergic to the
pessary or 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 use the pessary you might experience:
• Itching, rash, swelling, redness, discomfort, burning,
irritation, vaginal peeling or bleeding.
• Pain in the abdomen or pelvic area.
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 effects or react badly to
the pessary or cream in any other way not listed in this leaflet,
tell your doctor immediately.

5. HOW TO STORE CANESTEN 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 pessary or cream after the expiry date which is
stated at one end of the carton, on the foil blister strip of the
pessary 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® Combi 500mg Pessary & 2% Cream
contains:
Pessary:

• T he active substance is clotrimazole at a strength of
500mg.
• The other ingredients are lactose monohydrate,
microcrystalline cellulose, lactic acid, maize starch,
crospovidone, calcium lactate pentahydrate, magnesium
stearate, colloidal anhydrous silica and hypromellose.

Cream:

• T he 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® Combi 500mg Pessary & 2% Cream
looks like and contents of the pack:

Canesten Combi 500mg Pessary & 2% Cream contains a full
course of treatment, which consists of a single white Canesten
500mg Vaginal Pessary held inside a foil blister pack, one
applicator for insertion of the pessary into the vagina and one
10g tube of white Canesten® Thrush Cream.

Marketing Authorisation Holder:
Bayer plc, Consumer Care Division
Bayer House, Strawberry Hill
Newbury, Berkshire RG14 1JA, UK.

Manufacturer:

Bayer Pharma AG, D-51368, Leverkusen, Germany.
Remember: This medicine has been prescribed for you.
Do not give it to anyone else under any circumstances.
If you have any doubts about using Canesten® Combi 500mg
Pessary & 2% 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:
3 Wear cotton knickers and loose clothing.
3 Wash daily.
3 After going to the toilet, wipe yourself from the front to back
as a thrush infection may be transferred from the bowel.
3 Change your sanitary protection regularly.
7 Try to avoid wearing tights, nylon knickers and close fitting
jeans.
7 Try to avoid washing with perfumed soaps or using vaginal
deodorants.
7 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 2013.
Canesten is a registered trademark of Bayer AG, Germany.

Bayer

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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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