CLOTRIMAZOLE 2% CREAM, CANESTEN THRUSH CREAM - patient leaflet, side effects, dosage

S829 LEAFLET Canesten 20211006

PACKAGE LEAFLET: INFORMATION FOR THE USER

CANESTEN® THRUSH CREAM (clotrimazole 2%w/w)

Your medicine is known as Canesten Thrush Cream but will be referred to as Canesten Thrush Cream throughout the following leaflet.

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 information

• 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 re-infection, 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 or benzyl alcohol, of Canesten Thrush Cream (see Section 6. Further Information).
• 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 reactions (e.g. contact dermatitis). The medicine also contains 20mg benzyl alcohol in each gram of cream. Benzyl alcohol may cause allergic reactions and mild local irritation.

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 and breastfeeding:

Canesten Thrush Cream can be used in pregnancy and breastfeeding. If you are pregnant, breastfeeding 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.

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.

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, redness,

irritation, pins and needles, or peeling of skin.

If you experience any of the above effects, tell your doctor or pharmacist 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 in UK via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store canesten thrush cream

• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C.
• Do not use after the expiry date printed on the carton label or blister strip.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• 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

• Each 20g tube of Canesten Thrush Cream contains 2% w/w of the active ingredient, clotrimazole, as a cream for topical use.
• Canesten Thrush Cream also contains the following inactive ingredients: sorbitan stearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, 2-octyldodecanol, benzyl alcohol and water purified.

See Section 2 ‘Do not use’ and ‘Important information about some of the ingredients’ for cetostearyl alcohol advice.

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.

S829 LEAFLET Canesten 20211006

What Canesten Thrush Cream looks like and contents of the pack

Canesten Thrush Cream is a white cream in a sealed metal collapsible tube with a spiked white screw cap.

Canesten Thrush Cream is available in a tube of 20g.

Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd., Chemilines House, Alperton Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by Kern Pharma, S.L., Poligon Industrial Colon ll, Venus, 72 E-08228, Terrassa Barcelona, Spain.

[p PL No: 19488/0829

Leaflet revision date: 06 October 2021

Blind or partially sighted? Is this leaflet hard to see or read? Call 02087997607 to obtain the leaflet in large print, tape, CD or Braille.

Canesten® is a registered trade mark of Bayer AG, Germany.

S829 LEAFLET Clotrimazole 20211006

PACKAGE LEAFLET: INFORMATION FOR THE USER

CLOTRIMAZOLE 2% CREAM (clotrimazole 2%w/w)

Your medicine is known as Clotrimazole 2% Cream but will be referred to as Clotrimazole 2% Cream throughout the following leaflet.

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 2% 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 Clotrimazole 2% Cream and what is it used for?

• 2. Before you use Clotrimazole 2% Cream

• 3. How to use Clotrimazole 2% Cream

• 4. Possible side effects

• 5. How to store Clotrimazole 2% Cream

• 6. Further information

• 1. What is Clotrimazole 2% Cream and what is it used for?

Clotrimazole 2% 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 re-infection, even if they have no symptoms of thrush.

The active substance in Clotrimazole 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 clotrimazole 2% cream

Do not use Clotrimazole 2% Cream:

• If you are allergic (hypersensitive) to clotrimazole or any of the other ingredients, including cetostearyl alcohol or benzyl alcohol, of Clotrimazole 2% Cream (see Section 6. Further Information).
• Fever or chills.
• Feeling sick or vomiting.
• Diarrhoea.
• A foul smelling discharge from the vagina.

This is because Clotrimazole 2% 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 reactions (e.g. contact dermatitis). The medicine also contains 20mg benzyl alcohol in each gram of cream. Benzyl alcohol may cause allergic reactions and mild local irritation.

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 and breastfeeding:

Clotrimazole 2% Cream can be used in pregnancy and breastfeeding. If you are pregnant, breastfeeding or trying for a baby, tell your doctor or midwife before using Clotrimazole 2% Cream. If you have informed your doctor or midwife already, follow his/her instructions carefully.

3. how to use clotrimazole 2% cream

Women:

If Clotrimazole 2% 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.

Clotrimazole 2% 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.

Before using Clotrimazole 2% 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.

4. possible side effects

Like all medicines, Clotrimazole 2% 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, redness,

irritation, pins and needles, or peeling of skin.

If you experience any of the above effects, tell your doctor or pharmacist 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 in UK via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store clotrimazole 2% cream

• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C.
• Do not use after the expiry date printed on the carton label or blister strip.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• 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 2% Cream contains

• Each 20g tube of Clotrimazole 2% Cream contains 2% w/w of the active ingredient, clotrimazole, as a cream for topical use.
• Clotrimazole 2% Cream also contains the following inactive ingredients: sorbitan stearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, 2-octyldodecanol, benzyl alcohol and water purified.

What Clotrimazole 2% Cream looks like and contents of the pack

Clotrimazole 2% Cream is a white cream in a sealed metal collapsible tube with a spiked white screw cap.

Clotrimazole 2% Cream is available in a tube of 20g.

Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd., Chemilines House, Alperton Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by Kern Pharma, S.L., Poligon Industrial Colon ll, Venus, 72 E-08228, Terrassa Barcelona, Spain.

[p PL No: 19488/0829

Leaflet revision date: 06 October 2021

Blind or partially sighted? Is this leaflet hard to see or read? Call 02087997607 to obtain the leaflet in large print, tape, CD or Braille.

Remember: If you have any doubts about using Clotrimazole 2% Cream correctly, seek the advice of your doctor or pharmacist.