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CANESTEN INTERNAL CREAM

Active substance(s): CLOTRIMAZOLE / CLOTRIMAZOLE / CLOTRIMAZOLE

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PATIENT INFORMATION LEAFLET

2277-Internal Cream
04.09.14[7]

Canesten® Internal 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 Internal Cream 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. What is Canesten Internal Cream and what is it used for?
2. Before you use Canesten Internal Cream
3. How to use Canesten Internal Cream
4. Possible side effects
5. How to store Canesten Internal Cream
6. Further information
1. What is Canesten Internal Cream and what is it used for?
Canesten Internal Cream is a single application, full course treatment for
vaginal thrush. It is a soothing intravaginal cream in a prefilled applicator
for treatment at the site of infection.
Only use this product if you have been previously diagnosed by
your doctor as having vaginal thrush.
The active substance in Canesten Internal 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. Before you use Canesten Internal Cream
Do not use Canesten Internal Cream:
 If you are allergic (hypersensitive) to clotrimazole or any of the other
ingredients, including cetostearyl alcohol, of Canesten Internal Cream
(see Section 6. Further Information).
 During your period as it may be less effective.
Before using Canesten Internal 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.

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. Keeping the red cap in
place, insert the tip of plunger A into the applicator B (approximately
1cm).

This is because Canesten Internal Cream may not be the right treatment
for you.
Important information about some of the ingredients:
This product 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.
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).

2. Twist and pull to remove the red cap C. Be careful not to press the
plunger in any further before you have inserted the applicator into the
vagina. This will avoid wasting any cream.

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 pre-measured dose of cream is deposited into the vagina.

Pregnancy and breast-feeding:
If you are pregnant, breast-feeding or trying for a baby, tell your doctor or
midwife before using Canesten Internal 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 a
treatment that can be inserted in the vagina without the help of an
applicator, such as a clotrimazole pessary.
3. How to use Canesten Internal Cream
If Canesten Internal Cream 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:

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.

The cream should be inserted as high as possible into the vagina,
preferably before going to sleep at night for convenient and comfortable
treatment.

The cream is deposited in the vagina, but it is quite common to notice a
slight discharge after using the cream and therefore it may be helpful to
wear a panty liner. This does not mean that the treatment has not worked.
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.

Canesten Internal Cream is for use in the vagina 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.
4. Possible side effects
Like all medicines, Canesten Internal Cream can cause side effects,
although not everybody gets them.
As with all medicines, some people may be allergic to the 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 apply Canesten Internal Cream you might experience:
 Itching, rash, swelling, redness, discomfort, burning, irritation or vaginal
peeling or bleeding.
 Pain in the abdomen or pelvic area.
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 Internal Cream
Keep out of the sight and reach of children.
Do not store above 25oC
Do not use Canesten Internal Cream after the expiry date, which is stated
at one end of the carton, on the applicator and on the applicator foil
wrapping. 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.
If your medicines show any other signs of deterioration or become
discoloured, consult your pharmacist who will tell you what to do.
6. Further information
What Canesten Internal Cream contains:
 The active substance is clotrimazole. Contents: 5 g of vaginal cream
contains clotrimazole 500 mg (10% w/w).
 The other ingredients are benzyl alcohol, polysorbate 60, sorbitan
monostearate, cetostearyl alcohol, isopropyl myristate, cetyl palmitate
and purified water.
See Section 2 ‘Do not use’ and ‘Important information about some of the
ingredients’ for cetostearyl alcohol advice.

What Canesten Internal Cream looks like and contents of the pack:
Canesten Internal Cream is available in single-dose packs containing 5 g
of white cream in a pre-filled applicator.
Product Licence Holder and Manufacturer:
Canesten internal cream is manufactured by Quimica farmaceutica
Bayer, S.L. Av. Baix Llobregat, 3-5, E-08970 Sant Joan Despi, Barcelona,
Spain and is procured from the EU by product licence holder Star
Pharmaceuticals Ltd. 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd
P

PL 20636/2277

Leaflet issue and revision date (Ref): 04.09.14[7]
Canesten is a trademark of Bayer AG, Germany.
Remember: If you have any doubts about using Canesten Internal
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:
 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.

Expand Transcript

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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