CANESTEN ORAL CAPSULE

Active substance: FLUCONAZOLE

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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.
•  sk your pharmacist if you need more information or
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advice.
•  ou must contact a doctor if your symptoms worsen or do
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not improve in 7 days.
•  f you have any unusual effects after using this product, tell
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your doctor or pharmacist.

IN THIS LEAFLET
1. 
What is Canesten Duo and what is it used for?
2. Before you use Canesten Duo
3. How to use Canesten Duo
4. Possible side effects
5. How to store Canesten Duo
6. 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.  EFORE YOU USE CANESTEN® DUO®
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Do not use Canesten® Oral & Cream Duo®:
•  f you are allergic (hypersensitive) to fluconazole,
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clotrimazole or any of the other ingredients, including
cetostearyl alcohol, of Canesten Oral & Cream Duo (see
Section 6. Further Information).
•  f you are taking the antihistamine terfenadine, the
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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.
•  bnormal vaginal bleeding or a blood-stained
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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.
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 ou 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.
Y
 ou 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).
•  efore use, pierce the tube seal by inverting the cap over
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the end of the tube and press.
•  he cream should be thinly and evenly applied to the area
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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:
•  eeling sick or being sick, stomach discomfort, change in
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sense of taste.
• Diarrhoea and wind.
• Headaches.
•  iver disorders with symptoms such as yellowing of the
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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.
•  evere condition with blistering of the skin, mouth, eyes
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or genitals.
• Rash, itching, hair loss.
• Seizures.
• Recurrent infections (e.g. cold and flu).
After you apply the cream you might experience:
•  tching, rash, blisters, burning, discomfort, swelling,
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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:



 he active substance is fluconazole at a strength of 150mg.
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 he 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.
 Section 2 ‘Important information about some of the
See
ingredients’ for lactose monohydrate advice.

The cream:






 he active substance is clotrimazole at a strength of 2% w/w.
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The other ingredients are benzyl alcohol, polysorbate
60, sorbitan stearate, cetyl palmitate, cetostearyl
alcohol, octyldodecanol and purified water.
S
 ee 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:
•  single light blue capsule with ‘Canesten®’ printed on it
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in black between two black lines. To be taken orally.
•  tube containing 10g of white external cream
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(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:
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  o not wash or rub yourself hard with sponges or flannels
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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 January 2012.

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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