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CANESTEN THRUSH COMBI PESSARY & EXTERNAL CREAM 500MG / 2% W/W PESSARY & CREAM

Active substance(s): CLOTRIMAZOLE / CLOTRIMAZOLE MICRONISED

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Thrush Combi Pessary &
External Cream

0

500mg pessary & 2% w/w cream
Clotrimazole
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 Thrush Combi Pessary & External Cream carefully to get
the best results from it.
• Keep this leafet. 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.
2.
3.
4.
5.
6.

What is Canesten Thrush Combi and what is it used for?
Before you use Canesten Thrush Combi
How to use Canesten Thrush Combi
Possible side effects
How to store Canesten Thrush Combi
Further information

1. WHAT IS CANESTEN® THRUSH COMBI AND
WHAT IS IT USED FOR?
Canesten Thrush Combi Pessary & External Cream is a complete
treatment for vaginal thrush because it treats both the internal cause and
external symptoms.
Only use this product if you have been previously diagnosed by your
doctor as having vaginal thrush.
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.

2. BEFORE YOU USE CANESTEN®
THRUSH COMBI

Do not use Canesten Thrush Combi Pessary & External Cream:




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

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 Pessary & External Cream.
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
pessary without the help of an applicator.

3. HOW TO USE CANESTEN® THRUSH COMBI
The 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.

1

If you are allergic (hypersensitive) to clotrimazole or any of the other
ingredients, including cetostearyl alcohol, of Canesten Thrush Combi
Pessary & External Cream (see Section 6. Further Information).
During your period as it may be less effective.
To treat nail and scalp infections.

Before using Canesten® Thrush Combi Pessary & 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.
This is because Canesten Thrush Combi Pessary & Cream may not be
the right treatment for you.

B

A

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.

2

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

Important information about some of the ingredients:

The cream contains cetostearyl alcohol which may cause local skin
irritation (e.g. rash, itching or redness).
82095748

PMR 82095748 (O8/03) Pantone: 485, Cool Gray 11

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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 Cream:

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

The pessary is for use in the vagina only. The cream is for external
use only:

6. FURTHER INFORMATION

What Canesten Thrush Combi Pessary & External Cream contains:
Pessary:



The active substance is clotrimazole at a strength of 500mg.
The other ingredients are lactose monohydrate, microcrystalline
cellulose, lactic acid, maize starch, crospovidone, calcium lactate
pentahydrate, magnesium stearate, colloidal anhydrous silica and
hypromellose.

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.

What Canesten Thrush Combi Pessary & External Cream
looks like and contents of the pack:

Canesten Thrush Combi Pessary & External Cream contains a full
course of treatment, which consists of a single white pessary held inside
a foil blister pack, one applicator for insertion of the pessary into the
vagina and one 10g tube of white external cream.

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:

4. POSSIBLE SIDE EFFECTS

Manufacturer:

Like all medicines Canesten Thrush Combi Pessary & 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.
If you experience any of the above effects, tell your doctor 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®
THRUSH COMBI

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
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.

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

Bayer Pharma AG,
D-51368, Leverkusen, Germany.
Remember: If you have any doubts about using Canesten Thrush
Combi Pessary & External Cream 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:

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.

U

82095748

PMR 82095748 (O8/03) Pantone: 485, Cool Gray 11

200x315-07508

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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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