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Canesten Cream

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Document: leaflet MAH BRAND 4 POM_PL 00010-0136 change

Canesten

CREAM COMBI

10% VC & 2% External Cream

Clotrimazole

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

•    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.

IN THIS LEAFLET

1.    What is Canesten Cream Combi and what is it used for?

2.    Before you use Canesten Cream Combi

3.    How to use Canesten Cream Combi

4.    Possible side effects

5.    How to store Canesten Cream Combi

6.    Further information

1.    what is canesten® cream combi and what is it used for?

Canesten Cream Combi 10% VC & 2% External Cream is a complete treatment for vaginal thrush (candidiasis) because it treats both the internal cause and external symptoms. It is also used to treat other vaginal infections such as Trichomoniasis.

Some women suffer from recurrent attacks of thrush. To reduce the frequency of these attacks, the sexual partner’s penis can be treated with the external cream to prevent re-infection, even if they have no symptoms of thrush.

The active substance in Canesten Cream Combi 10% VC & 2% External 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® cream combi

Do not use Canesten® Cream Combi 10% VC &

2% External Cream:

•    If you are allergic (hypersensitive) to clotrimazole or any of the other ingredients, including cetostearyl alcohol, of Canesten Cream Combi 10% VC & 2% External Cream (see Section 6. Further Information).

•    During your period as it may be less effective.

Important information about some of the ingredients:

The creams contain cetostearyl alcohol which may cause local skin irritation (e.g. rash, itching or redness).

Special precuations:

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.

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 (used to reduce the immune response to prevent rejection after an organ transplant).

Pregnancy:

If you are pregnant or trying for a baby, tell your doctor or midwife before using Canesten Cream Combi 10% VC &

2% External 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® CREAM COMBI

The Internal Cream (Canesten® 10% VC):

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.

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).

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.

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 External Cream (Canesten® Thrush Cream): Women:

Before use, pierce the tube seal by inverting the cap over the end of the tube and press.

To treat the itching and soreness of the vulva (vulvitis), 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.

The symptoms of thrush should disappear within three days of treatment. If no improvement is seen after seven days you must tell your doctor.

Treating your sexual partner:

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.

Canesten® 10% VC is for use in the vagina only and Canesten® Thrush Cream is for external use only:

Do not put the creams in your mouth or swallow them.

If the creams are 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 Cream Combi 10% VC &

2% External Cream can cause side effects, although not everybody gets them.

As with all medicines, some people may be allergic to the creams. 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 the internal cream you might experience:

•    Itching, rash, swelling, discomfort, burning, irritation or vaginal peeling.

•    Pain in the abdomen or pelvic area.

After you apply the external cream you might experience:

•    Itching, rash, blisters, burning, discomfort, swelling, irritation or peeling of skin.

If you experience any of the above effects or react badly to the creams in any other way not listed in this leaflet, tell your doctor immediately.

5.    HOW TO STORE CANESTEN® CREAM COMBI

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 the creams after the expiry date which is stated at one end of the carton, on the end of the tube of cream, 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.

6.    FURTHER INFORMATION

What Canesten® Cream Combi 10% VC &

2% External Cream contains:

Applicator of internal cream:

•    The active substance is clotrimazole at a strength of 10% w/w.

•    The other ingredients are benzyl alcohol, polysorbate 60, sorbitan stearate, cetostearyl alcohol, isopropyl myristate, cetyl palmitate and purified water.

External 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® Cream Combi 10% VC & 2% External Cream looks like and contents of the pack:

Canesten Cream Combi 10% VC & 2% External Cream contains a full course of treatment, which consists of a pre-filled applicator containing 5g of white internal cream and one 10g tube of white external cream. Marketing Authorisation Holder:

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

Manufacturer:

Kern Pharma S.L.

Poligon Industrial Colon II, Calle Venus 72 08228 Terrassa, Barcelona, Spain.

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® Cream Combi 10% VC & 2% External 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.

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.

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 2009.

Canesten is a registered trademark of Bayer AG, Germany. Bayer