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CANESTEN INTERNAL CREAM

Active substance: CLOTRIMAZOLE

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CANESTEN® INTERNAL CREAM
(Clotrimazole)
Patient Information Leaflet

27mm

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.

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

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.

WARNING!

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.
This is because Canesten Internal Cream may not be the right treatment for you.

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.

DATE:
12/05/14

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.

TVT CHECKED

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:
UK PIL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS

DATE OF PROOF:

Inform your doctor if you are taking tacrolimus or sirolimus (used to reduce the immune response to prevent
rejection after an organ transplant).

6464/2445 D

DT
ARTWORKER:
PRODUCT: Canesten internal cream

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.

CODE:

Q.A.
APPROVED:
05-0269
PRE-PRESS NO.:
CUSTOMER: Waymade

Avoid vaginal intercourse while you have thrush and during use of this product because your partner could
become infected.

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

1

B

2

C

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.
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.

A

Colour
Swatch

Black

3
Bladder
A
Womb
B

Vagina
Rectum

WARNING!

DATE:

Important information about some of the ingredients:
This product contains cetostearyl alcohol which may cause local skin irritation (e.g. rash, itching or redness).
WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

CUSTOMER
APPROVED:

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.

PROOF HISTORY:
v.1 - waymade - 12/05/14

Leaflet Flat Size = 148 x 400

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

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

After you apply Canesten Internal Cream you might experience:
• Itching, rash, swelling, redness, discomfort, burning, irritation, 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.

WARNING!

5. HOW TO STORE CANESTEN INTERNAL CREAM
• Keep out of the sight and reach of children.
• This product should be stored in the original carton.
• Do not store above 25°C.
• 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 the cream becomes discoloured or shows any other signs of deterioration, you should consult your
pharmacist who will advise you what to do.

What Canesten Internal Cream looks like and contents of the pack:
Canesten Internal Cream is available in single-dose packs containing 5g of white cream in a pre-filled
applicator.
Marketing Authorisation Holder and Manufacturer:

DATE:

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.

TVT CHECKED

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.
UK PIL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS

6464/2445 D
CODE:

DT

PL No: 6464/2445

This product is manufactured by Bayer Hispania, S.L., Av. Baix Llobregat, 3-5 08970 Sant Joan Despi,
Barcelona, Spain and/or Kern Pharma, S.L., Poligono Ind. Colon II, C/Venus, 72,08228 Terrassa,
Barcelona, Spain and is procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR

12/05/14
DATE OF PROOF:

ARTWORKER:
Canesten internal cream
PRODUCT:

CUSTOMER: Waymade

PRE-PRESS NO.:

05-0269

Q.A.
APPROVED:

P

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.
X Try to avoid wearing tights, nylon knickers and close fitting jeans.
X Try to avoid washing with perfumed soaps or using vaginal deodorants.
X 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.
Leaflet revision and issue date (Ref.) 12.05.2014

Colour
Swatch

CANESTEN is a registered trademark of Bayer AG.
For UK residents only: if you have any questions or would like more information, call the Canesten Advice
Line on 0845 758 5030. Calls charged at local rate.

Black

WARNING!

6. FURTHER INFORMATION
What Canesten Internal Cream contains:
• Contents of the applicator: 5g of vaginal cream containing clotrimazole 500mg (10%w/w)
• The other ingredients are benzyl alcohol, polysorbate 60, sorbitan monostearate, cetostearyl alcohol,
isopropyl myristate, cetyl palmitate and water.
See Section 2 ‘Important information about some of the ingredients’ for cetostearyl alcohol advice.

DATE:

CUSTOMER
APPROVED:

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

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

Notes:

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.

PROOF HISTORY:
v.1 - waymade - 12/05/14

Leaflet Flat Size = 148 x 400

4. POSSIBLE SIDE EFFECTS
Like all medicines, Canesten Internal Cream can cause side effects, although not everybody gets them.

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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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