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CANESTEN THRUSH COMBI SOFT GEL PESSARY & EXTERNAL CREAM 500MG / 2% W/W VAGINAL CAPSULE & CREAM

Active substance(s): CLOTRIMAZOLE

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Before using Canesten® Thrush Combi Soft Gel Pessary and External
Cream, 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.
• 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.

The Soft Gel Pessary:
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.
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. 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.

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

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1

COMBI

If Canesten Thrush Combi 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.

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9 pt

Do not use Canesten® Thrush Combi Soft Gel Pessary and External
Cream:
• If you are allergic (hypersensitive) to clotrimazole or any of the other
ingredients, including cetostearyl alcohol, of Canesten Thrush
Combi Soft Gel Pessary and External Cream (see Section 6.
Further Information).
• To treat nail and scalp infections.

3. HOW TO USE CANESTEN® THRUSH

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COMBI

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

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2. BEFORE YOU USE CANESTEN® THRUSH

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

210 x 297 mm

The active substance in Canesten Thrush Combi 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.

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

Pantone Cool Gray 11 U

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

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.

CAN Soft Gel Pessary Combi GB

AND WHAT IS IT USED FOR?

Canesten Thrush Combi Soft Gel Pessary and External Cream is a
complete treatment for vaginal thrush because it treats both the internal
cause and external symptoms.

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

Pantone 485 U

1. WHAT IS CANESTEN® THRUSH COMBI

Avoid vaginal intercourse while you have thrush and during use of this
product because your partner could become infected.

84283150

1. What is Canesten Thrush Combi and what is it used for?
2. Before you use Canesten Thrush Combi
3. How to use Canesten Thrush Combi
4. Possible side effects
5. How to store Canesten Thrush Combi
6. Further information

Do not use tampons, intravaginal douches, spermicides or other vaginal
products while using this product.

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IN THIS LEAFLET

Special precautions:
As with other creams and 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.

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This medicine is available without prescription. However, you still need to use
Canesten Thrush Combi Soft Gel Pessary and External Cream 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.

Important information about some of the ingredients:
The cream contains cetostearyl alcohol which may cause local skin irritation
(e.g. rash, itching or redness).



Read all of this leaflet carefully because it contains important
information for you.

500mg vaginal capsule & 2% w/w cream
Clotrimazole

Grenzach Produktions GmbH

Canesten

Thrush Combi Soft Gel Pessary &
External Cream

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.

Do not use the pessary or cream after the expiry date which is stated at one
end of the carton, on the foil blister strip of the pessary and on the end of
the tube of cream. 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

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

5. HOW TO STORE CANESTEN® THRUSH
COMBI

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
This product should be stored in the original carton in a dry place in order to
protect from moisture.

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How to avoid future recurrences:
3 Wear cotton knickers and loose clothing.
3 Wash daily.
3 After going to the toilet, wipe yourself from the front to back as a thrush
infection may be transferred from the bowel.
3 Change your sanitary protection regularly.
7 Try to avoid wearing tights, nylon knickers and close fitting jeans.
7 Try to avoid washing with perfumed soaps or using vaginal deodorants.
7 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 June 2014.
Canesten is a registered trademark of Bayer AG, Germany.
84283150

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1
461

210 x 297 mm

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.

9 pt

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

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.

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If you experience any of the above effects, tell your doctor or pharmacist
immediately.

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.

Pantone Cool Gray 11 U

Like all medicines, Canesten Thrush Combi Soft Gel Pessary and External
Cream can cause side effects, although not everybody gets them. As with
all medicines, some people may be allergic to the pessary or cream. 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.
After you apply the cream you might experience:
• Itching, rash, blisters, burning, discomfort, swelling, redness, irritation or
peeling of skin.

Remember: If you have any doubts about using Canesten® Thrush Combi
Soft Gel Pessary and External Cream correctly, seek the advice of your
doctor or pharmacist.

CAN Soft Gel Pessary Combi GB

4. POSSIBLE SIDE EFFECTS

Manufacturer:
GP Grenzach Produktions GmbH,
79639 Grenzach-Wyhlen, Germany.

Pantone 485 U

The Soft Gel Pessary is for use in the vagina only.
The cream is for external use only:
Do not put the pessary or cream in your mouth or swallow them.
If the pessary or cream are swallowed accidentally, tell your doctor straight away
or contact the Accident and Emergency Department of your nearest hospital.

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

84283150

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.

What Canesten® Thrush Combi Soft Gel Pessary and External Cream
looks like and contents of the pack:
Canesten Thrush Combi Soft Gel Pessary and External Cream contains a
full course of treatment, which consists of a single yellow teardropshaped
soft vaginal capsule held inside a foil blister pack, one applicator for insertion
of the pessary into the vagina and one 10g tube of white external cream.
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To treat the itching and soreness of the vulva (vulvitis), the cream should be
thinly and evenly applied to the area around the entrance of the vagina, 2 or
3 times a day and smoothed in gently. Treatment should be continued until
the symptoms of the infection disappear.

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The Cream:
Before use, pierce the tube seal by inverting the cap over the end of the
tube and press.



Since the pessary dissolves in the vagina, it may be helpful to wear a panty
liner.

Cream:
• The active substance is clotrimazole at a strength of 2% w/w.
• The other ingredients are benzyl alcohol, polysorbate 60, sorbitan
stearate, cetyl palmitate, cetostearyl alcohol, octyldodecanol and
purified water.
See Section 2 ‘Do not use’ and ‘Important information about some of the
ingredients’ for cetostearyl alcohol advice.

Grenzach Produktions GmbH

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.

What Canesten® Thrush Combi Soft Gel Pessary and Cream contains:
Soft Gel Pessary:
• 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), quinolone yellow (E104), sunset
yellow (E110), lecithin, medium-chain triglycerides.

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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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