Document: document 1 change

• document 0
• document 1

---

Canesten®

500mg Vaginal Pessary

Clotrimazole 500mg

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 500mg Vaginal Pessary and what is it used for?

2.    Before you use Canesten 500mg Vaginal Pessary

3.    How to use Canesten 500mg Vaginal Pessary

4.    Possible side effects

5.    How to store Canesten 500mg Vaginal Pessary

6.    Further information

1.    WHAT IS CANESTEN® 500mg VAGINAL PESSARY AND WHAT IS IT USED FOR?

Canesten 500mg Vaginal Pessary is a full course of treatment for vaginal thrush (candidiasis). It is inserted into the vagina for treatment at the site of infection.

The active substance in Canesten 500mg Vaginal Pessary 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® 500mg VAGINAL PESSARY

Do not use Canesten® 500mg Vaginal Pessary:

•    I f you are allergic (hypersensitive) to clotrimazole or any of the other ingredients of Canesten 500mg Vaginal Pessary (see Section 6. Further Information).

•    During your period as it may be less effective.

Special precautions:

As with other pessaries, 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).

Pregnancy and breast-feeding:

If you are pregnant, breast-feeding or trying for a baby, tell your doctor or midwife before using Canesten 500mg Vaginal Pessary. 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 the pessary without the help of an applicator.

3. HOW TO USE CANESTEN® 500mg VAGINAL PESSARY

Unless directed otherwise by your doctor, the pessary 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. Pull out the plunger A until it stops. Remove the pessary from the foil blister pack and place firmly into the applicator B.

2. To fit the pessary into the applicator, the holder of the applicator needs to be squeezed lightly at both sides. The pessary fits tightly into the applicator and needs to be squeezed into the holder to about 1cm.

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 pessary 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.

Since the pessary dissolves in the vagina, it may be helpful to wear a panty liner because it is quite common to notice a white chalky residue after using the pessary. This does not mean that the treatment has not worked. However, if you notice pieces of undissolved pessary, speak to your doctor or a pharmacist, as the treatment may not have worked properly.

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

81349053

Canesten® 500mg Vaginal Pessary is for use in the vagina only:

Do not put the pessary in your mouth or swallow it.

If the pessary 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 500mg Vaginal Pessary can cause side effects, although not everybody gets them.

As with all medicines, some people may be allergic to the pessary. 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 use the pessary you might experience:

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

•    Pain in the abdomen or pelvic area.

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

5.    HOW TO STORE CANESTEN® 500mg VAGINAL PESSARY

Keep out of the reach and sight of children.

Do not use Canesten 500mg Vaginal Pessary after the expiry date which is stated at one end of the carton and on the foil blister strip of the pessary. 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® 500mg Vaginal Pessary contains:

•    The active substance is clotrimazole at a strength of 500mg.

•    The other ingredients are lactose monohydrate, microcrystalline cellulose, lactic acid, maize starch, crospovidone, calcium lactate pentahydrate, magnesium stearate, colloidal anhydrous silica and hypromellose.

What Canesten® 500mg Vaginal Pessary looks like and contents of the pack:

Canesten 500mg Vaginal Pessary contains a white pessary held inside a foil blister and an applicator for insertion of the pessary into the vagina.

Marketing Authorisation Holder:

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

Manufacturer:

Bayer Pharma AG, D-51368, Leverkusen, Germany.

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® 500mg Vaginal Pessary 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:

3 Wear cotton knickers and loose clothing.

3 Wash daily.

3 After going to the toilet, wipe yourself from the front to back as a thrush infection may be transferred from the bowel.

3 Change your sanitary protection regularly.

7 Try to avoid wearing tights, nylon knickers and close fitting jeans.

7 Try to avoid washing with perfumed soaps or using vaginal deodorants.

7 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 2014.

Canesten is a registered trademark of Bayer AG, Germany.

Bayer

81349053

500mg Pessary & 2% 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 Combi and what is it used for?

2.    Before you use Canesten Combi

3.    How to use Canesten Combi

4.    Possible side effects

5.    How to store Canesten Combi

6.    Further information

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

Canesten Combi 500mg Pessary & 2% Cream is a full course of treatment for vaginal thrush (candidiasis) because it treats both the internal cause and external symptoms.

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 re-infection, even if they have no symptoms of thrush.

The active substance in Canesten 500mg Pessary & 2%

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® combi

Do not use Canesten® Combi 500mg Pessary &

2% Cream:

•    If you are allergic (hypersensitive) to clotrimazole or any of the other ingredients, including cetostearyl alcohol, of Canesten Combi 500mg Pessary & 2% Cream (see Section 6. Further Information).

•    During your period as it may be less effective.

Important information about some of the ingredients:

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

Special precautions:

As with other creams and pessaries, 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).

Pregnancy and breast-feeding:

If you are pregnant, breast-feeding or trying for a baby, tell your doctor or midwife before using Canesten Combi 500mg Pessary & 2% 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 the pessary without the help of an applicator.

3. HOW TO USE CANESTEN® COMBI

The Pessary:

Unless directed otherwise by your doctor, the pessary 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. Pull out the plunger A until it stops. Remove the pessary from the foil blister pack and place firmly into the applicator B.

2. To fit the pessary into the applicator, the holder of the applicator needs to be squeezed lightly at both sides. The pessary fits tightly into the applicator and needs to be squeezed into the holder to about 1cm.

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 pessary 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.

Since the pessary dissolves in the vagina, it may be helpful to wear a panty liner because it is quite common to notice a white chalky residue after using the pessary. This does not mean that the treatment has not worked. However, if you notice pieces of undissolved pessary, speak to your doctor or a pharmacist, as the treatment may not have worked properly.

The 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, 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.

The pessary is for use in the vagina only. The cream is for external use only:

Do not put the pessary or cream in your mouth or swallow them.

If the pessary or cream 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 Combi 500mg Pessary &

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

As with all medicines, some people may be allergic to the pessary or 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 use the pessary you might experience:

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

•    Pain in the abdomen or pelvic area.

After you apply the cream you might experience:

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

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

5.    HOW TO STORE CANESTEN® COMBI

Keep out of the reach and sight of children.

This product should be stored in the original carton.

Do not store above 25⁰C.

Do not use the pessary or cream after the expiry date which is stated at one end of the carton, on the foil blister strip of the pessary 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® Combi 500mg Pessary & 2% Cream contains:

Pessary:

•    The active substance is clotrimazole at a strength of 500mg.

•    The other ingredients are lactose monohydrate, microcrystalline cellulose, lactic acid, maize starch, crospovidone, calcium lactate pentahydrate, magnesium stearate, colloidal anhydrous silica and hypromellose.

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® Combi 500mg Pessary & 2% Cream looks like and contents of the pack:

Canesten Combi 500mg Pessary & 2% Cream contains a full course of treatment, which consists of a single white Canesten 500mg Vaginal Pessary held inside a foil blister pack, one applicator for insertion of the pessary into the vagina and one 10g tube of white Canesten® Thrush Cream.

Marketing Authorisation Holder:

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

Manufacturer:

Bayer Pharma AG, D-51368, Leverkusen, Germany.

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® Combi 500mg Pessary & 2% 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:

3 Wear cotton knickers and loose clothing.

3 Wash daily.

3 After going to the toilet, wipe yourself from the front to back as a thrush infection may be transferred from the bowel.

3 Change your sanitary protection regularly.

7 Try to avoid wearing tights, nylon knickers and close fitting jeans.

7 Try to avoid washing with perfumed soaps or using vaginal deodorants.

7 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 2013.

Canesten is a registered trademark of Bayer AG, Germany.

Bayer