CLOTRIMAZOLE VAGINAL TABLETS 100MG

Active substance: CLOTRIMAZOLE MICRONISED

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S1411 LEAFLET Canesten 20120611

PACKAGE LEAFLET: INFORMATION FOR THE USER

CANESTEN VAGINAL TABLET 100mg
CLOTRIMAZOLE VAGINAL TABLET 100mg
(clotrimazole)
Your medicine is known with either of the above names but will be
referred to as Canesten throughout the following leaflet.

Special precautions:
As with other tablets, 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.
Using other medicines:

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 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.

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).
Pregnancy:
If you are pregnant or trying for a baby, tell your doctor or midwife
before using Canesten. 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 tablet without the help of an applicator.

In this leaflet
1. What is Canesten and what is it used for?
2. Before you use Canesten
3. How to use Canesten
4. Possible side effects
5. How to store Canesten
6. Further information
1. WHAT IS CANESTEN AND WHAT IS IT USED FOR
Canesten is indicated for the treatment of vaginal thrush. It is
inserted into the vagina for treatment at the site of infection.
Only use this product if you have been previously diagnosed
by your doctor as having vaginal thrush.
The active substance in Canesten 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.

3. HOW TO USE CANESTEN
If Canesten 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 tablet as high as
possible into the vagina, preferably before going to sleep on six
consecutive nights for convenient and comfortable treatment.
Alternatively, two tablets may be inserted into the vagina before
going to sleep on three consecutive nights.
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 tablet from the foil blister pack and
place firmly into the applicator B.

2. BEFORE YOU USE CANESTEN
Do not use Canesten:


If you are allergic (hypersensitive) to clotrimazole or any of the
other ingredients of Canesten (see Section 6. Further
Information).



During your period as it may be less effective.

Before using Canesten, you should see your doctor if:


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.



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

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.

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

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 tablet is deposited into the
vagina.

4. Remove the applicator. After use, remove plunger A completely
by pulling it out of the applicator B. Then wash it in warm (not
boiling) soapy water, rinse and dry carefully.
5. After completing the treatment, dispose of the applicator in a
safe place, out of the reach of children. The applicator cannot
be flushed down the toilet.
Since the tablet 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 tablet. This does not mean that the treatment
has not worked. However, if you notice pieces of undissolved tablet,
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 is for use in the vagina only:
Do not put the tablet in your mouth or swallow it.

5. HOW TO STORE CANESTEN


KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop using the tablets, please take
them back to the pharmacist for safe disposal. Only keep the
tablets if your doctor tells you to.



If the Canesten become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

6. FURTHER INFORMATION
What Canesten contains


Each tablet contains 100mg of the active ingredient clotrimazole
micronised.



Canesten Vaginal Tablets also contain the following: lactose
monohydrate, maize starch, lactic acid, microcrystalline
cellulose, magnesium stearate, hypromellose, anhydrous
colloidal silica, crospovidone and calcium lactate pentahydrate.

If the tablet is swallowed accidentally, tell your doctor straight away
or contact the Accident and Emergency Department of your nearest
hospital.

What Canesten looks like and contents of the pack
If you forget to use Canesten:
Canesten should be used for six consecutive nights if one tablet is
used, or three consecutive nights if two tablets are used. However,
if you forget to insert a tablet, follow the advice given below:
When you remember, continue with your course of treatment. If you
have forgotten for more than one day, your infection may not be
fully treated, so if symptoms persist upon completion of this course,
see your doctor.

Canesten tablets are large rectangular white tablets with a rounded
end marked ‘P3’ on one side and ‘Bayer’ on the other.
Canesten tablets are available as blister packs of 6 tablets together
with an applicator.
Product Licence holder
Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Canesten can cause side effects, although not
everybody gets them.
As with all medicines, some people may be allergic to the tablet. 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:

Manufacturer
This product is manufactured by either of the below maufacturers

Bayer Healthcare AG, Leverkusen, Germany



Bayer Schering Pharma AG, Leverkusen, Germany.

POM

PL No. 19488/1411



Rash.

Leaflet revision date: 11 June 2012



Swallowing or breathing problems.

Canesten is a registered trade mark of Bayer AG, Germany.



Swelling of your lips, face, throat or tongue.



Weakness, feeling dizzy or faint.



Nausea.

After you use the tablet 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
tablet in any other way not listed in this leaflet, tell your doctor or
pharmacist immediately.

S1411 LEAFLET Canesten 20120611

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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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