CANESTEN 500 MG SOFT GEL PESSARY

Active substance: CLOTRIMAZOLE

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500mg Soft Gel Pessary
Clotrimazole 500mg
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 500mg Soft Gel Pessary and
what is it used for?
2. Before you use Canesten 500mg Soft Gel Pessary
3. How to use Canesten 500mg Soft Gel Pessary
4. Possible side effects
5. How to store Canesten 500mg Soft Gel Pessary
6. Further information

1. WHAT IS CANESTEN® 500mg VAGINAL
SOFT GEL PESSARY AND WHAT IS IT
USED FOR?
Canesten 500mg Soft Gel Pessary is a full course of
treatment for vaginal thrush (candidiasis). It is inserted
into the vagina for treatment at the site of infection. It
is also used to treat other vaginal infections such as
Trichomoniasis.
The active substance in Canesten 500mg Soft Gel
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, and also has anti-bacterial properties.

2. BEFORE YOU USE CANESTEN® 500mg
SOFT GEL PESSARY

Pregnancy:
If you are pregnant or trying for a baby, tell your doctor
or midwife before using Canesten 500mg Soft Gel
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.

3. HOW TO USE CANESTEN® 500mg
SOFT GEL 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 Soft Gel
Pessary from the foil blister pack and place firmly into
the applicator B.
1

B
A

2. Fix the Soft Gel Pessary firmly into the designated
holder of the applicator B, by a light twist. The pessary
fits tightly into the applicator.
2

Do not use Canesten® 500mg Soft Gel Pessary:
• If you are allergic (hypersensitive) to clotrimazole or
any of the other ingredients of Canesten 500mg Soft
Gel Pessary (see Section 6. Further Information).

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.
Do not use this product during your period as it may be
less effective.

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
Soft Gel 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 (used to
reduce the immune response to prevent rejection after
an organ transplant).

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.

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 500mg Soft Gel Pessary is not recommended
for use in children under 16 years old.

Canesten® 500mg Soft Gel 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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Canesten 500mg Soft Gel 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, 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 pessary in any other way not listed in this leaflet,
tell your doctor immediately.

5. HOW TO STORE CANESTEN® 500mg
SOFT GEL PESSARY
Keep out of the reach and sight of children.
This product should be stored in the original carton in a
dry place in order to protect from moisture.
Do not use Canesten 500mg Soft Gel 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.

6. FURTHER INFORMATION
What Canesten® 500mg Soft Gel Pessary
contains:
• The active substance is clotrimazole at a strength of
500mg.
• The other ingredients are white soft paraffin, liquid
paraffin, gelatin, glycerol, water, titanium dioxide
(E171), quinoline yellow (E104), sunset yellow
(E110), lecithin, medium-chain triglycerides.

What Canesten® 500mg Soft Gel Pessary looks
like and contents of the pack:
Canesten 500mg Soft Gel Pessary contains a yellow
teardrop-shaped soft vaginal capsule held inside a foil
blister and an applicator for insertion of the Soft Gel
Pessary into the vagina.

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

Manufacturer:
GP Grenzach Produktions GmbH,
79639 Grenzach-Wyhlen, 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
Soft Gel Pessary 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.
This leaflet was last revised in March 2011.
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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