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CANESTEN 10% W/W VAGINAL CREAM

Active substance(s): CLOTRIMAZOLE / CLOTRIMAZOLE

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174 mm

10 mm

BAYER ARTWORK PANEL
Bayer Ref No:
Trident Reference No:
Brand:
Range:
Product:
Pack Type:
Pack Size:

BAY255981
TR1209604
Canesten
Cream
10percent vaginal cream
Leaflet
5g

Action:
Date:
Country:

10/01/17
Malta/UK

Finished Goods Code:
Synaps Request Code:
Component Code:

04384044
TL017668
8092739-14

CAD Ref No:
Printer:
Packaging Site:
Substrate:

PIL 174 x 297 folded 174 x 38 (P039)
Generic Bayer
Kern Pharma
White Paper

Barcode 1 Type:
Barcode 1 Mag:
Barcode 2 Type:
Barcode 2 Mag:
Pharmacode No/NE:

N/A
N/A
N/A
N/A
10001(48)

Canesten

A

Clotrimazole

Guides

If you have informed your doctor or midwife already, follow
his/her instructions carefully.

• 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 a treatment that can be inserted in the vagina without the
help of an applicator, such as a clotrimazole pessary

1.
2.
3.
4.
5.
6.

Colours
PANTONE Cool Gray 11 C
PANTONE 485 C
1
2
LTH
LTH

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

IN THIS LEAFLET

Technical & Non Printing Items
Cutter

Process Black
3
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What is Canesten Vaginal Cream and what is it used for?
Before you use Canesten Vaginal Cream
How to use Canesten Vaginal Cream
Possible side effects
How to store Canesten Vaginal Cream
Further information

1. WHAT IS CANESTEN® VAGINAL
CREAM AND WHAT IS IT USED
FOR?

260 mm

Please note that any low resolution paper Canon colour
copies associated with this job should be referred to for
content, layout and colour separation only.

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

The active substance in Canesten Vaginal 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. Twist and pull to remove the 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.

Do not use Canesten® Vaginal Cream:
• If you are allergic (hypersensitive) to clotrimazole or any of
the other ingredients, including cetostearyl alcohol, of
Canesten Vaginal Cream (see Section 6. Further
Information).
• During your period as it may be less effective.

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Main Text (body copy):

Unless directed otherwise by your doctor, the cream should be
inserted as high as possible into the vagina, preferably before
going to sleep at night for convenient and comfortable
treatment.

2.BEFORE YOU USE CANESTEN®
VAGINAL CREAM

UNDER NO CIRCUMSTANCES SHOULD THIS
ARTWORK BE ALTERED WITHOUT PRIOR
PERMISSION FROM TRIDENT.
James Clayton

3.HOW TO USE CANESTEN®
VAGINAL CREAM

Canesten Vaginal Cream is a single application, full course
treatment for vaginal thrush (candidiasis). It is a soothing
intravaginal cream in a pre-filled applicator for treatment at the
site of infection.

Connaught House, Connaught Road,
Kingswood Business Park, Hull, HU7 3AP, England.
T: +44 (0) 1482 828100

STUDIO USE ONLY

10% w/w
Vaginal Cream

Important information about some of the
ingredients:

9 pt

Height (based on lower case x): 1.338 mm

This product contains cetostearyl alcohol which may cause
local skin irritation (e.g. rash, itching or redness).

ARTWORK
APPROVAL PANEL

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.

Packaging Site Approval:
Name:

Do not use tampons, intravaginal douches, spermicides or
other vaginal products while using this product.

Date:

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

Action:

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.

Country Approval:
Name:
Date:

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

Action:

10 mm

Pregnancy and breast-feeding:
If you are pregnant, breast-feeding or trying for a baby, tell
your doctor or midwife before using Canesten Vaginal 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.
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.

174 mm

10 mm

BAYER ARTWORK PANEL
Bayer Ref No:
Trident Reference No:
Brand:
Range:
Product:
Pack Type:
Pack Size:

BAY255981
TR1209604
Canesten
Cream
10percent vaginal cream
Leaflet
5g

Action:
Date:
Country:

10/01/17
Malta/UK

Finished Goods Code:
Synaps Request Code:
Component Code:

04384044
TL017668
8092739-14

CAD Ref No:
Printer:
Packaging Site:
Substrate:

PIL 174 x 297 folded 174 x 38 (P039)
Generic Bayer
Kern Pharma
White Paper

Barcode 1 Type:
Barcode 1 Mag:
Barcode 2 Type:
Barcode 2 Mag:
Pharmacode No/NE:

N/A
N/A
N/A
N/A
10001(48)

Canesten® Vaginal 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.

A

4.POSSIBLE SIDE EFFECTS
Like all medicines, Canesten Vaginal 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.

Technical & Non Printing Items
Cutter

Guides

After you apply Canesten Vaginal Cream you might
experience:
• Itching, rash, swelling, redness, discomfort, burning,
irritation, vaginal peeling or bleeding.
• Pain in the abdomen or pelvic area.

Colours
PANTONE Cool Gray 11 C
PANTONE 485 C
1
2
LTH
LTH

Process Black
3
LTH

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

Connaught House, Connaught Road,
Kingswood Business Park, Hull, HU7 3AP, England.
T: +44 (0) 1482 828100
Please note that any low resolution paper Canon colour
copies associated with this job should be referred to for
content, layout and colour separation only.

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

UNDER NO CIRCUMSTANCES SHOULD THIS
ARTWORK BE ALTERED WITHOUT PRIOR
PERMISSION FROM TRIDENT.
STUDIO USE ONLY

James Clayton

Do not store above 25°C.
Do not use Canesten Vaginal 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.

v1.0

Sm•Art check results: G=1; O=0; R=1; - JC - 10/01/17 08:30:03

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.

FONT SIZE PANEL
Main Text (body copy):

5.HOW TO STORE CANESTEN®
VAGINAL CREAM

9 pt

Remember: This medicine has been prescribed for you.
Do not give it to anyone else under any circumstances.
If you have any doubts about using Canesten® Vaginal 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.
This leaflet was last revised in January 2017.
Canesten is a registered trademark of Bayer AG, Germany.

6.FURTHER INFORMATION

Height (based on lower case x): 1.338 mm

What Canesten® Vaginal Cream contains:
• The active substance is clotrimazole at a strength of
500mg (10% w/w).
• The other ingredients are benzyl alcohol, polysorbate 60,
sorbitan stearate, cetostearyl alcohol, isopropyl myristate,
cetyl palmitate and water.
See Section 2 ‘Do not use’ and ‘Important information about
some of the ingredients’ for cetostearyl alcohol advice.

ARTWORK
APPROVAL PANEL
Packaging Site Approval:
Name:

What Canesten® Vaginal Cream looks like and
contents of the pack:

Date:
Action:

Canesten Vaginal Cream is available in single-dose packs
containing 5g of white cream in a pre-filled applicator.

Country Approval:

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

Name:
Date:

Manufacturer:
Kern Pharma S.L.
Poligon Industrial Colon II, Calle Venus 72
08228 Terrassa, Barcelona, Spain.

Action:

10 mm

8092739-14

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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