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CANESTEN 500MG VAGINAL PESSARY

Active substance(s): CLOTRIMAZOLE / CLOTRIMAZOLE MICRONISED

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Assessed against UK PIL dated November 2005

By keddies at 11:59 am, 6/27/06

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CanestenĀ® 500mg Vaginal Pessary /
Clotrimazole 500mg Vaginal Pessary
(Clotrimazole)
PATIENT INFORMATION LEAFLET
Your medicine is available using either of the above two names but will be
referred to us as Canesten 500mg Vaginal Pessary throughout this leaflet.
PLEASE READ THIS LEAFLET CAREFULLY BEFORE USING
CANESTEN 500MG VAGINAL PESSARY.
Thrush is a common infection that most women have some time in their
lives and is not caused by a lack of personal hygiene.
Thrush is caused by a yeast (fungus) called Candida which may live
harmlessly in the vagina without you even noticing it. However, the natural
pH balance of the vagina 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.

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.
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.

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 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.
If this is the first time you have had these symptoms, talk to your doctor
before using any treatment.
What does Canesten 500mg Vaginal Pessary contain?
The pessary contains 500mg of the active ingredient clotrimazole.
Other ingredients in the pessary are lactose monohydrate, microcrystalline
cellulose, lactic acid, maize starch, crospovidone, calcium lactate,
magnesium stearate, silica colloidal anhydrous and hypromellose.
Your medicine is available in a single pack. The single pessary is a full
course of treatment.
Clotrimazole is an antifungal agent, which fights the cause of infections
such as thrush.
Your medicine is Manufactured by: Bayer HealthCare AG,
D-51368 Leverkusen, Germany.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder:
Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.
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If no improvement is seen after seven days, speak to your doctor as a
second course of treatment may be necessary.
Since the pessary dissolves in the vagina, it may be helpful to wear a panty
liner because it is quite common to notice a slight white residue (chalky)
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.

Canesten 500mg Vaginal Pessary should be used in the vagina
only. Do not put it in your mouth or swallow it. If you do accidentally
swallow it, tell your doctor straight away or contact the Accident and
Emergency Department of your nearest hospital.

PL No: 04423/0462

What is Canesten 500mg Vaginal Pessary?
Canesten 500mg Vaginal Pessary is a single application for the treatment
of thrush. It can also be used to treat other vaginal infections such as
Trichomaniasis.
When not to use Canesten 500mg Vaginal Pessary
Do not use this Canesten 500mg Vaginal Pessary if you have previously
had an allergic reaction to the active ingredient, clotrimazole, or any of the
other ingredients in the product.
Do not use this product during your period, as it may be less effective.
What special precautions should be taken?
If you are pregnant or are trying for a baby, tell your doctor or midwife
before using Canesten 500mg Vaginal Pessary. If your doctor then
recommends that you use Canesten 500mg Vaginal Pessary, extra care
should be taken when using the applicator.
As with other creams and pessaries, this product may reduce the
effectiveness of rubber contraceptives, such as condoms and diaphragms,
when used together. Consequently, you should use alternative
precautions for at least five days after using this product.
When and how to use Canesten 500mg Vaginal Pessary
The full course of treatment consists of a pessary held inside a foil blister
pack and an applicator for insertion of the pessary into the vagina.
Unless directed otherwise by your doctor, the pessary should be inserted
into the vagina preferably at night so that it can work whilst you sleep.
Remove the applicator from the packaging. Pull out the plunger until it
stops. Remove the pessary from the foil sachet and place firmly into the
applicator. To fit the pessary into the applicator, the holder of the applicator
needs to be squeezed lightly at either side. The pessary fits tightly into the
applicator and needs to be squeezed into the holder to about 1cm.

What side-effects may I experience?
Rarely, you may experience mild burning or irritation immediately after you
insert the Canesten 500mg Vaginal Pessary. Canesten 500mg Vaginal
Pessary may also cause side effects, which can be very similar to the
symptoms of thrush. If the redness, burning, pain, itching, irritation or
swelling get worse, see your doctor as soon as possible.
As with all medicines, some people may be allergic to Canesten 500mg
Vaginal Pessary. If you are allergic, a reaction will occur soon after you
start using it. You may have a local reaction similar to those described
above or very rarely a generalised allergic reaction which may appear as a
rash, nausea, faintness, facial swelling, low blood pressure, diarrhoea and
shortness of breath.
If you experience any of these effects, tell your doctor immediately.
If you feel you are reacting badly to this medicine in any other way, speak
to your doctor.
Important:
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not use this product after the expiry date, printed at one end of the
carton, on the applicator and the applicator foil wrapping.
If your medicine appears to be discoloured or shows any signs of
deterioration, please return this to your pharmacist who will advise you.
Leaflet revision and issue date: 22.05.06
CanestenĀ® is a registered trademark of Bayer AG

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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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