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Canesten Cream

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Document: leaflet MAH BRAND 2 P_PL 00010-0136 change

Canesten®


Clotrimazole 10% 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 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.

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.

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 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:

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 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, discomfort, burning, irritation or vaginal peeling.

•    Pain in the abdomen or pelvic area.

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

5.    HOW TO STORE CANESTEN® INTERNAL CREAM

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 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.

6. FURTHER INFORMATION

What Canesten® Internal 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.

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:

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: 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.

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

Canesten

®



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 Thrush 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 Thrush Cream and what is it used for?

2.    Before you use Canesten Thrush Cream

3.    How to use Canesten Thrush Cream

4.    Possible side effects

5.    How to store Canesten Thrush Cream

6.    Further i nformation

1.    what is canesten® thrush cream

AND WHAT IS IT USED FOR?

Canesten Thrush Cream relieves irritation of the vulva (vulvitis) which is caused by vaginal thrush (candidiasis). Although this cream provides relief from the external irritation caused by vaginal thrush, it cannot treat any internal (vaginal) cause of the infection. Ask your doctor or pharmacist to recommend a treatment for this.

Only use this product if you have been previously diagnosed by your doctor as having vaginal thrush.

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 reinfection, even if they have no symptoms of thrush.

The active substance in Canesten Thrush 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® THRUSH CREAM

Do not use Canesten® Thrush Cream:

•    If you are allergic (hypersensitive) to clotrimazole or any of the other ingredients, including cetostearyl alcohol, of Canesten Thrush Cream (see Section 6. Further Information).

Before using Canesten® Thrush 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 Thrush 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.

Pregnancy:

If you are pregnant or trying for a baby, tell your doctor or midwife before using Canesten Thrush Cream. If you have informed your doctor or midwife already, follow his/her instructions carefully.

3. HOW TO USE CANESTEN® THRUSH CREAM

Women:

If Canesten Thrush 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:

•    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. A product to treat the internal (vaginal) infection should be used at the same time.

Treatment should be continued until symptoms of the infections disappear. Consult your doctor if the symptoms of your infection do not improve within seven days of finishing treatment for the internal infection.

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® Thrush 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.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Canesten Thrush 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 the 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 cream in any other way not listed in this leaflet, tell your doctor or pharmacist immediately.

5.    HOW TO STORE CANESTEN® THRUSH CREAM

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 Thrush Cream after the expiry date which is stated at one end of the carton 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® Thrush Cream contains:

•    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® Thrush Cream looks like and contents of the pack:

Canesten Thrush Cream is available in tubes containing 10g or 20g of white cream. Not all pack sizes may be marketed.

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: If you have any doubts about using Canesten® Thrush 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 U K 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 approved in December 2009.

Canesten is a registered trademark of

Bayer AG, Germany.    Bayer