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Canesten Internal Cream

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Document: leaflet MAH BRAND_PLPI 18799-2021 change

Canesten® Internal Cream

(clotrimazole)

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.

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 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, 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.

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

5.    HOW TO STORE CANESTE 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.

6. FURTHER INFORMATION

What Canesten Internal Cream contains:

•    5g of vaginal cream contains clotrimazole 500mg (10%w/w).

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

See Section 2 '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 smooth cream in a pre-filled applicator with a separate plunger in a blister pack.

Manufactured by: Kern Pharma S.L. Poligono Ind. Colon II C/Venus, 72 08228 Terrassa, Spain.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK

Canesten® Internal Cream PL No: 18799/2021    fn

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.

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.

Leaflet date: 12.03.2014

Canesten is a registered trademark of Bayer AG, Germany.

Clotrimazole 10%w/w Internal Cream


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 Clotrimazole 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.

The name of your medicine is Clotrimazole 10%w/w Internal Cream but will be referred to as Clotrimazole Internal Cream throughout this leaflet.

IN THIS LEAFLET

1.    What is Clotrimazole Internal Cream and what is it used for?

2.    Before you use Clotrimazole Internal Cream

3.    How to use Clotrimazole Internal Cream

4.    Possible side effects

5.    How to store Clotrimazole Internal Cream

6.    Further information

1.    WHAT IS CLOTRIMAZOLE INTERNAL CREAM AND WHAT IS IT USED FOR?

Clotrimazole 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 Clotrimazole 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 CLOTRIMAZOLE INTERNAL CREAM

Do not use Clotrimazole Internal Cream:

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

   During your period as it may be less effective.

Before using Clotrimazole 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 Clotrimazole 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 Clotrimazole 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.

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 Clotrimazole 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 CLOTRIMAZOLE INTERNAL CREAM

If Clotrimazole 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.

Clotrimazole 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, Clotrimazole 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, 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.

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

5.    HOW TO STORE CLOTRIMAZOLE 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 Clotrimazole 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 Clotrimazole Internal Cream contains:

•    5g of vaginal cream contains clotrimazole 500mg (10%w/w).

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

See Section 2 'Important information about some of the ingredients’ for cetostearyl alcohol advice.

What Clotrimazole Internal Cream looks like and contents of the pack:

Clotrimazole Internal Cream is available in single-dose packs containing 5g of white smooth cream in a pre-filled applicator with a separate plunger in a blister pack.

Manufactured by: Kern Pharma S.L., Poligono Ind. Colon II C/Venus, 72 08228 Terrassa, Spain.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK

Clotrimazole 10%w/w Internal Cream PL No: 18799/2021 0

Remember: If you have any doubts about using Clotrimazole 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.

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.

Leaflet date: 12.03.2014