CANESTEN VAGINAL TABLETS 100MG

Active substance: CLOTRIMAZOLE MICRONISED

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CANESTEN® VAGINAL TABLETS 100mg
(Clotrimazole)
Patient Information 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 Vaginal Tablets
100mg 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.

Only use this product if you have been previously diagnosed by your doctor as having vaginal
thrush.
The active substance in Canesten Vaginal Tablets 100mg 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. BEFORE YOU USE CANESTEN VAGINAL TABLETS 100MG
Do not use Canesten Vaginal Tablet 100mg:
• If you are allergic (hypersensitive) to clotrimazole or any of the other ingredients of Canesten Vaginal
Tablets 100mg (see Section 6. Further Information).
• During your period as it may be less effective.

WARNING!

Before using Canesten Vaginal Tablet 100mg, 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.
• 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 Vaginal Tablets 100mg may not be the right treatment for you.
DATE:

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.

DATE:
TVT CHECKED

3. HOW TO USE CANESTEN VAGINAL TABLETS 100MG
If Canesten Vaginal Tablets 100mg 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:

Canesten 100mg vaginal tabs

6464/0731D
CODE:

UK PIL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS

DT

30/01/14

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

The applicator should be used to insert the pessary as high as possible into the vagina, preferably before
going to sleep on six consecutive nights for convenient and comfortable treatment. Alternatively, two
pessaries may be inserted into the vagina before going to sleep on three consecutive nights.

PRODUCT:

ARTWORKER:

Pregnancy and breast-feeding:
If you are pregnant, breast-feeding or trying for a baby, tell your doctor or midwife before using Canesten
Vaginal Tablets 100mg. If you have informed your doctor or midwife already, follow his/her instructions
carefully.

Waymade

DATE OF PROOF:

Q.A.
APPROVED:

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

CUSTOMER:

PRE-PRESS NO.:

05-0269

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.

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.

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.

1
2

B

A

2
3
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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.
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.

3

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WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

Notes:

CUSTOMER
APPROVED:

4. Possible side effects
5. How to store Canesten Vaginal
Tablets 100mg
6. Further information

1. WHAT IS CANESTEN VAGINAL TABLETS 100MG AND WHAT IS IT USED FOR?
Canesten Vaginal Tablets 100mg (also referred to as a pessary in this leaflet), is indicated for the treatment
of vaginal thrush. It is inserted into the vagina for treatment at the site of infection.

PROOF HISTORY:
v.1 - waymade - 30/01/14

Leaflet Flat Size = 148 x 400

In this leaflet
1. What is Canesten Vaginal Tablets 100mg
and what is it used for?
2. Before you use Canesten Vaginal Tablets 100mg
3. How to use Canesten Vaginal Tablets 100mg

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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 Vaginal Tablets 100mg is for use in the vagina only:
Do not put the tablet 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 Vaginal Tablets 100mg can cause side effects, although not everybody gets
them.
As with all medicines, some people may be allergic to Canesten Vaginal Tablets 100mg. 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 or react badly to Canesten Vaginal Tablets 100mg in any other
way not listed in this leaflet, tell your doctor or pharmacist immediately.

WARNING!

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.

30/01/14
TVT CHECKED

Leaflet revision and issue date (Ref.) 30.01.2014
Canesten is a registered trademark of Bayer AG
Remember: If you have any doubts about using Canesten Vaginal Tablets 100mg correctly, seek the
advice of your doctor or pharmacist.

UK PIL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS

6464/0731D
CODE:

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.

Canesten 100mg vaginal tabs

DT

PL No: 6464/0731

This product is manufactured by Bayer Pharma AG, Leverkusen, Germany and is procured from within the
EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR

PRODUCT:

DATE OF PROOF:

P

Waymade

ARTWORKER:

DATE:

What Canesten Vaginal Tablets 100mg looks like and contents of the pack:
Canesten Vaginal Tablets 100mg is a large white, rectangular tablet with a rounded end and marked ‘P3’ on
one side and ‘Bayer’ on the reverse.
Canesten Vaginal Tablets 100mg are available as a pack of 6 tablets and one applicator.

CUSTOMER:

PRE-PRESS NO.:

05-0269

Q.A.
APPROVED:

6. FURTHER INFORMATION
What Canesten Vaginal Tablets 100mg contains:
• The active substance is clotrimazole at a strength of 100mg.
• The other ingredients are lactose monohydrate, maize starch, lactic acid, microcrystalline cellulose,
magnesium stearate, hypromellose, anhydrous colloidal silica, crospovidone and calcium lactate
pentahydrate.

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.

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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 the Canesten Advice
Line on 0845 758 5030. Calls charged at local rate.
This is a service provided by Bayer plc and is not associated with Waymade plc.

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WARNING!

5. HOW TO STORE CANESTEN VAGINAL TABLETS 100MG
• Keep all medicines out of the sight and reach of children.
• Canesten Vaginal Tablets 100mg should not be stored above 25°C.
• Do not use after the expiry date printed on the carton or blister strip. The expiry date refers to the last day
of that month.
• If the vaginal tablets become discoloured or show any other signs of deterioration, you should consult your
pharmacist who will advise you what to do.
• 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.

DATE:

CUSTOMER
APPROVED:

By reporting side effects you can help provide more information on the safety of this medicine.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

Notes:

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.

PROOF HISTORY:
v.1 - waymade - 30/01/14

Leaflet Flat Size = 148 x 400

If you forget to use Canesten Vaginal Tablets 100mg:
Canesten Vaginal Tablets 100mg should be used for six consecutive nights if one pessary is used, or three
consecutive nights if two pessaries are used. However, if you forget to insert a pessary, follow the advice
given below:

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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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