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CANESTEN 500MG PESSARY

Active substance(s): CLOTRIMAZOLE MICRONISED / CLOTRIMAZOLE MICRONISED / CLOTRIMAZOLE MICRONISED

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500mg Pessary
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.
2.
3.
4.
5.
6.

What is Canesten 500mg Pessary and what is it used for?
Before you use Canesten 500mg Pessary
How to use Canesten 500mg Pessary
Possible side effects
How to store Canesten 500mg Pessary
Further information

3. HOW TO USE CANESTEN® 500mg
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

1. WHAT IS CANESTEN® 500mg PESSARY
AND WHAT IS IT USED FOR?
Canesten 500mg Pessary is a full course of treatment for vaginal
thrush (candidiasis). It is inserted into the vagina for treatment at
the site of infection.
The active substance in Canesten 500mg Pessary 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. 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. BEFORE YOU USE CANESTEN® 500mg
PESSARY
Do not use Canesten® 500mg Pessary:




If you are allergic (hypersensitive) to clotrimazole or any of the
other ingredients of Canesten 500mg Pessary (see Section 6.
Further Information).
During your period as it may be less effective.

Special precautions:

As with other 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.

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

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 500mg Pessary. 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 the pessary without the help of an applicator.

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 symptoms of thrush should disappear within three days of
treatment. If no improvement is seen after seven days you must
tell your doctor.

Canesten® 500mg Pessary is for use in the vagina only:

Do not put the pessary in your mouth or swallow it.
If the pessary is swallowed accidentally, tell your doctor straight
away or contact the Accident and Emergency Department of
your nearest hospital.

85861271

PMR 85861271 (O8/00-C) Pantone: 485, Cool Gray 11

200x315-7508

4. POSSIBLE SIDE EFFECTS

Like all medicines, Canesten 500mg Pessary can cause side effects,
although not everybody gets them.
As with all medicines, some people may be allergic to the pessary.
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.
If you experience any of the above effects tell your doctor
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® 500mg
PESSARY

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use Canesten 500mg Pessary after the expiry date which
is stated at one end of the carton and on the foil blister strip of
the pessary. 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.

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 April 2017.
Canesten is a registered trademark of Bayer AG, Germany.

U

6. FURTHER INFORMATION

What Canesten® 500mg Pessary contains:



The 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.

What Canesten® 500mg Pessary looks like and contents of
the pack:

Canesten 500mg Pessary contains a white pessary held inside a foil
blister and an applicator for insertion of the pessary into the vagina.

Marketing Authorisation Holder:

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

Manufacturer:

Bayer AG, 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® 500mg Pessary
correctly, seek the advice of your doctor or pharmacist.

85861271

PMR 85861271 (O8/00-C) Pantone: 485, Cool Gray 11

200x315-7508

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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