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

Active substance(s): CLOTRIMAZOLE

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Combi Pessary & External Cream
500mg pessary & 2% w/w cream

0

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

3. HOW TO USE CANESTEN® COMBI



Unless directed otherwise by your doctor, the pessary should be inserted
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.





Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not give it to anyone
else under any circumstances.
If you have any unusual effects after using this product, tell your
doctor.

IN THIS LEAFLET

1.
2.
3.
4.
5.
6.

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

1. WHAT IS CANESTEN® COMBI AND
WHAT IS IT USED FOR?

The Pessary:

1

B

A

Canesten Combi Pessary & External Cream is a full course of treatment
for vaginal thrush (candidiasis) because it treats both the internal cause
and external symptoms.
Some women suffer from recurrent attacks of thrush. To reduce the
frequency of these attacks, the sexual partner’s penis can be treated with
this cream to prevent re-infection, even if they have no symptoms of
thrush.
The active substance in Canesten Combi Pessary & External Cream 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. 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. BEFORE YOU USE CANESTEN® COMBI

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 Canesten Combi Pessary & External Cream:



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

2

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).

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 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.

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:

Women:
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, 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.
Treating your sexual partner:
If your sexual partner is treated with this cream, the cream should be
applied to the end of the penis 2 or 3 times a day for up to two weeks.

82092021

PMR 82092021 (O8/02) Pantone: 485, Cool Gray 11

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

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

4. POSSIBLE SIDE EFFECTS

Marketing Authorisation Holder:

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.
Like all medicines, Canesten 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® 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.

6. FURTHER INFORMATION

What Canesten 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.

Canesten Combi Pessary & External Cream contains a full course of
treatment, which consists of a single white Canesten 500mg Vaginal
Pessary held inside a foil blister pack, one applicator for insertion of the
pessary into the vagina and one 10g tube of white Canesten® External
Cream.
Bayer plc, Consumer Care Division
Bayer House, Strawberry Hill
Newbury, Berkshire RG14 1JA, UK.

Manufacturer:

Bayer Pharma AG,
D-51368, Leverkusen, Germany.
Remember: This medicine has been prescribed for you.
Do not give it to anyone else under any circumstances.
If you have any doubts about using Canesten 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

82092021

PMR 82092021 (O8/02) 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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