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CANESTEN 500 MG PESSARY

Active substance(s): CLOTRIMAZOLE

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PATIENT INFORMATION LEAFLET

2279
09.08.16[8]

Canesten® 500 mg Pessary
(clotrimazole)
Your medicine is available using the above name but will be referred to
as Canesten pessary throughout the following 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 Pessary 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 Pessary and what is it used for?
2. Before you use Canesten Pessary
3. How to use Canesten Pessary
4. Possible side effects
5. How to store Canesten Pessary
6. Further information
1. What is Canesten Pessary and what is it used for?
Canesten Pessary is a single application for the treatment of vaginal
thrush. It is inserted into the vagina for treatment at the site of infection.

 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.

1

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

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.

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.

Only use this product if you have been previously diagnosed by
your doctor as having vaginal thrush.

Inform your doctor if you are taking tacrolimus or sirolimus (used to
reduce the immune response to prevent rejection after an organ
transplant).

The active substance in Canesten 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.

Pregnancy and breast-feeding:
If you are pregnant, breast-feeding or trying for a baby, tell your doctor or
midwife before using Canesten Pessary. If you have informed your doctor
or midwife already, follow his/her instructions carefully.

2. Before you use Canesten Pessary
Do not use Canesten Pessary:
 If you are allergic (hypersensitive) to clotrimazole or any of the other
ingredients of Canesten Pessary (see Section 6. Further Information).
 During your period as it may be less effective.

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

Before using Canesten Pessary, 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.

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.

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. How to use Canesten Pessary
If Canesten Pessary 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:
The applicator should be used to insert the pessary 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.

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. 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 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 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 Canesten 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 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 Pessary
Keep out of the sight and reach of children.
Do not store above 30ºC.
Do not use Canesten 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 Pessary contains:
 The active substance is clotrimazole at strength of 500 mg.
 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 Pessary looks like and contents of the pack:
Canesten Pessary contains a white convex pessary debossed with ' M U '
on one side and plain on reverse.
Manufacturer and Product Licence Holder
Manufactured by Bayer Pharma AG, Bayerwerk, Leverkusen, D-51368,
Germany and procured from within EU by product licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex
HA1 1XD. Repackaged by Servipharm Ltd.
P

PL 20636/2279

Leaflet issue and revision date (Ref): 09.08.16[8]
Canesten is a trademark of Bayer AG, Germany.
Remember:
If you have any doubts about using Canesten 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.

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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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