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

Active substance(s): CLOTRIMAZOLE

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Unless directed otherwise by your doctor, the Soft Gel 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. WHAT IS CANESTEN® COMBI AND WHAT
IS IT USED FOR?

Canesten Combi Soft Gel 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.

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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.
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The active substance in Canesten Combi Soft Gel 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.

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.
Do not use this product during your period as it may be less effective.
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 Soft Gel Pessary & External Cream.
If you have informed your doctor or midwife already, follow his/her
instructions carefully.

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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.
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. Treatment should be continued until the
symptoms of the infection disappear.

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210 x 297 mm

CAN Soft Gel Pessary
Combi (POM)GB

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

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 Soft Gel Pessary & External Cream:
• If you are allergic (hypersensitive) to clotrimazole or any of the other
ingredients, including cetostearyl alcohol, of Canesten Combi Soft Gel
Pessary & External Cream (see Section 6. Further Information).

Grenzach Produktions GmbH

2. BEFORE YOU USE CANESTEN® COMBI

9 pt

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

The Soft Gel Pessary:

Verlag Book, Book Italic, Bold, Bold Italic, Zapf Dingbats Regular, Bliss Pro Medium

IN THIS LEAFLET

3. HOW TO USE CANESTEN® COMBI

Pantone Cool Gray 11 U

• 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.

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

Pantone 485 U

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

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

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Canesten

Combi Soft Gel Pessary
& External Cream

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

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.

5. HOW TO STORE CANESTEN® COMBI

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.

This product should be stored in the original carton in a dry place in order to
protect from moisture.

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.

Keep this medicine out of the sight and reach of children.

Do not store above 30°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.

This leaflet was last revised in June 2014.
Canesten is a registered trademark of Bayer AG, Germany.

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 Soft Gel Pessary & External 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), quinoline yellow (E104), sunset
yellow (E110), lecithin, medium-chain triglycerides.

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1
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

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.

Verlag Book, Book Italic, Bold, Bold Italic, Zapf Dingbats Regular, Bliss Pro Medium

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

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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After you apply the cream you might experience:
• Itching, rash, blisters, burning, discomfort, swelling, redness, irritation or
peeling of skin.

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.

210 x 297 mm

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 have any doubts about using Canesten® Combi Soft Gel Pessary &
External Cream correctly, seek the advice of your doctor or pharmacist.

Pantone Cool Gray 11 U

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.

Remember: This medicine has been prescribed for you. Do not give it to
anyone else under any circumstances.

CAN Soft Gel Pessary
Combi (POM)GB

Like all medicines, Canesten Combi Soft Gel Pessary & External Cream can
cause side effects, although not everybody gets them.

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

Pantone 485 U

4. POSSIBLE SIDE EFFECTS

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

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

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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.

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Canesten Combi Soft Gel Pessary & External Cream is not recommended
for use in children under 16 years old.

What Canesten® Combi Soft Gel Pessary & External Cream looks like
and contents of the pack:
Canesten Combi Soft Gel Pessary & External Cream contains a full course of
treatment, which consists of a single yellow teardrop-shaped 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 cream.



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.

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

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.

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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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