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CANESTEN 500MG PESSARY

Active substance(s): CLOTRIMAZOLE MICRONISED

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Oral & Cream
Duo
®

Oral capsule: Fluconazole 150mg Thrush cream: Clotrimazole 2% w/w
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 Oral & Cream Duo 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.

IN THIS LEAFLET
1.
2.
3.
4.
5.
6.

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

1. WHAT IS CANESTEN® DUO® AND WHAT
IS IT USED FOR?
Canesten Oral & Cream Duo is a complete and convenient
treatment for vaginal or penile thrush.
Only use this product if you have been previously diagnosed by
your doctor as having thrush.
The active substances in the capsule and cream are fluconazole and
clotrimazole, respectively. Fluconazole and clotrimazole belong to
a group of medicines called azoles and are antifungal agents which
fight the cause of infections such as thrush.

2. BEFORE YOU USE CANESTEN® DUO®
Do not use Canesten® Oral & Cream Duo®:
• If you are allergic (hypersensitive) to fluconazole, clotrimazole
or any of the other ingredients, including cetostearyl alcohol,
of Canesten Oral & Cream Duo (see Section 6. Further
Information).
• If you are taking the antihistamine terfenadine, the medicine
cisapride or an ergot-derivative (e.g. ergotamine used for
migraine).

Women:
If you have any of the following symptoms do not use Canesten Oral
& Cream Duo and see your doctor as soon as possible:
• 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 Oral & Cream Duo may not be the right
treatment for you.

Men:
Do not use Canesten Oral & Cream Duo without talking to
your doctor first if:
• Your sexual partner does not have thrush.
• You have sores, ulcers or blisters on your penis.
• You have an abnormal discharge from your penis.
• Your penis has started to smell.
• You have pain or difficulty in passing urine.
This is because Canesten Oral & Cream Duo may not be the right
treatment for you.

Before using Canesten® Oral & Cream Duo®, 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 fluconazole,
clotrimazole or any other vaginal antifungal products.
• You have had any disease or illness affecting the liver
or kidneys, or have had any unexplained jaundice.
• You have heart problems, including heart rhythm problems.
• You suffer from any other chronic disease or illness.

Important information about some of the ingredients:
The capsule contains lactose monohydrate, so if you have been told
by your doctor that you have an intolerance to some sugars contact
your doctor before taking this medicinal product.
The cream contains cetostearyl alcohol which may cause local skin
irritation (e.g. rash, itching or redness).

Special precautions:
As with other creams, 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.

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.
Do not use Canesten Oral & Cream Duo if you are taking the
antihistamine terfenadine, the medicine cisapride or an
ergot-derivative (e.g. ergotamine used for migraine).
Inform your doctor if you are taking: Anticoagulants
(to prevent blood clots), Sulphonylureas (to control diabetes),
Hydrochlorothiazide (used to treat fluid retention and high blood
pressure), Benzodiazepines (used as tranquilisers), Phenytoin,
Carbamazepine or Phenobarbital (used to control epilepsy),
Rifampicin, Rifabutin or Rifapentine (antibiotics), Ciclosporin,
Sirolimus or Tacrolimus (used to reduce the immune response),
Theophylline (used to control asthma), Zidovudine (used to treat
HIV infection), Astemizole (antihistamine), Anti-arrhythmics (to
control irregular heart beats), Losartan (to reduce blood pressure),
Fentanyl or Methadone (to treat pain).

Taking Canesten® Oral & Cream Duo® with food and drink:
The oral capsule should be swallowed whole with a glass of water.
It can be taken with or without food.
There is no known interaction with alcohol or nicotine.

Pregnancy and breast-feeding:
Do not use Canesten Oral & Cream Duo if you are pregnant, trying
for a baby or breast-feeding.

Driving and using machines:
Canesten Oral Capsule may cause dizziness. If dizziness occurs
after taking your capsule, you should not drive or use machines.

3. HOW TO USE CANESTEN® DUO®
If Canesten Oral & Cream Duo 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:
The capsule is to treat thrush at the site of infection and should be
swallowed whole with a glass of water (with or without food).
The cream is to treat the itching and soreness of the vulva (vulvitis).
• Before use, pierce the tube seal by inverting the cap over the
end of the tube and press.

• 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. It should be used until symptoms of the
infections disappear.
The symptoms of thrush should disappear within two days of
treatment. If no improvement is seen after seven days, you must tell
your doctor. If the infection returns after seven days another capsule
may be taken but if you have more than two infections within six
months you should see your doctor.
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.
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.

The cream is for external use only:
Do not put the cream in your mouth or swallow it.
If the cream is swallowed accidentally, tell your doctor straight away
or contact the Accident and Emergency Department of your nearest
hospital.
®

®

If you take more Canesten Oral & Cream Duo than
you should:
If more than one capsule is taken, tell your doctor straight away or
contact the Accident and Emergency Department of your nearest
hospital.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Canesten Oral & Cream Duo can cause side
effects, although not everybody gets them.
As with all medicines, some people may be allergic to the capsule
or the cream. If you are allergic, a reaction will occur soon after
you have taken or 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.
For the capsule the following side effects have also been reported:
• Feeling sick or being sick, stomach discomfort, change in sense
of taste.
• Diarrhoea and wind.
• Headaches.
• Liver disorders with symptoms such as yellowing of the skin or
eyes, dark urine or pale stools.
• Change in heart rhythm or rate.
• Abnormal ECG (electrocardiogram) heart tracing.
• High blood levels of cholesterol or fat.
• Reduction in number of blood cells and platelets.
• Low levels of potassium.
• Severe condition with blistering of the skin, mouth, eyes or
genitals.
• Rash, itching, hair loss.
• Seizures.
• Recurrent infections (e.g. cold and flu).
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 or react badly to the
capsule or cream in any other way not listed in this leaflet, tell your
doctor or pharmacist immediately.

5. HOW TO STORE CANESTEN® DUO®
Keep out of the reach and sight of children.
This product should be stored in the original carton.
Do not store above 25°C.
Do not use Canesten Oral & Cream Duo after the expiry date which
is stated at one end of the carton, on the blister pack 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® Oral & Cream Duo® contains:
The oral capsule:
• The active substance is fluconazole at a strength of 150mg.
• The other ingredients are colloidal silicon dioxide, lactose
monohydrate, magnesium stearate, maize starch and sodium
lauryl sulphate. The capsule shell contains brilliant blue FCF
(E133), titanium dioxide (E171) and gelatine. The printing ink
contains shellac, black iron oxide (E172) and propylene glycol.
See Section 2 ‘Important information about some of the
ingredients’ for lactose monohydrate advice.

The 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® Oral & Cream Duo® looks like and
contents of the pack:
Canesten Oral & Cream Duo contains:
• A single light blue capsule with ‘Canesten®’ printed on
it in black between two black lines. To be taken orally.
• A tube containing 10g of white external cream
(Canesten® Thrush Cream).

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

Manufacturer:
Wasdell Packaging Ltd., Units 6-8, Euroway Industrial Estate,
Blagrove, Swindon, Wiltshire, SN5 8YW, UK
Remember: If you have any doubts about using Canesten® Oral &
Cream Duo® correctly, seek the advice of your doctor or pharmacist.

Further information about 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.
In men, Candida can also cause thrush - a condition called balanitis
(inflammation of the end of the penis). It causes any of the following
symptoms: soreness and redness of the penis, tightness of the foreskin
and a white, odourless discharge from the penis.

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.
" 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 our Canesten Advice Line on 0845 758 5030.
Calls charged at local rate.
This leaflet was last revised in October 2013.
Canesten and Duo are registered trademarks.

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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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