1451

ARTWORK TEXT SIZE

Information for the user

Thrush 1 % w/w Cream

(Clotrimazole)

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

This medicine is available without prescription to treat the external symptoms of thrush. However, you still need to use it 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

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What this medicine is for

This medicine contains Clotrimazole which belongs to a group of medicines called anti-fungals, which act to treat infections caused by fungi.

It can be used to treat the external symptoms of thrush (vulval candidiasis). It may also be used by the woman’s sexual partner to treat associated penile thrush (candidal balanitis).

Thrush is a common infection caused by a yeast (or fungus), which may live harmlessly in the vagina without you even noticing it. However, in certain circumstances, it may develop into an infection in the vagina and symptoms may spread to the surrounding area. These symptoms may include one or more of the following:

•    Itching of the vagina and surrounding area (the vulva)

•    Redness and swelling of the tissues of the vagina and vulva

•    Soreness of the vagina and vulva

•    A white, non-smelling discharge from the vagina

Thrush may be aggravated by sexual intercourse, but is not a sexually transmitted disease. Sometimes however, thrush can be passed to your partner through sexual intercourse.

If your partner has penile thrush he may have one or more of the following symptoms:

•    Soreness and redness of the penis

•    Tightness of the foreskin

•    A white non-smelling penile discharge

Before you use this medicine

This medicine can be used by adults between the ages of 16 and 60 years.

However, some people should not use this medicine or should seek the advice of their pharmacist or doctor first.

XDo not use:

•If you are allergic to any of the ingredients in the medicine or any other anti-fungal medicine

•If you are pregnant or breastfeeding,

unless your doctor tells you to

f Talk to your pharmacist or doctor:

•If this is the first time you have had these symptoms

•    If you have had thrush more than twice in the last 6 months

•    If you are under 16 years, or 61 years or older

•If you or your partner have ever been exposed to a sexually transmitted disease •If you have lower stomach pain, or pain or a burning sensation on passing urine

•    If you are a man and:

-    Your sexual partner does not have thrush

-    You have an abnormal discharge or leakage from your penis

-    You have sores, ulcers or blisters on your penis

•    If you are a woman and:

-    You have abnormal or irregular vaginal bleeding, or a blood-stained discharge

-    You have sores, ulcers or blisters on your vulva or vagina

Other important information

Information about some of the ingredients in this medicine: Cetyl alcohol and stearyl alcohol in the cream may cause local skin reactions (e.g. contact dermatitis). The ingredients in the cream may affect the latex used in contraceptives such as condoms and diaphragms. This may reduce the effectiveness of the contraceptives.

You should therefore use other methods of contraception for at least 5 days after using the cream.

You can help the treatment to work if you follow these simple self-help tips:

i • Although the infected area will"itch, do not ] scratch as this will damage the surface of the i skin and cause the infection to spread further ¹ • Keep the affected areas of skin clean | • Pay particular attention to drying the skin i but avoid excessive rubbing | To help prevent thrush from coming back i once you have treated it, follow these | simple steps: i • Wash daily

| • Wear cotton underwear and loose fitting i clothing

¹ • Try to avoid wearing tights, nylon | underwear and tight fitting clothing i • After going to the toilet, wipe yourself from | the front to the back, as a thrush infection i may be transferred from the bowel | • Try to avoid washing with perfumed soaps i or using vaginal deodorants i • Do not rub hard with sponges or flannels | and avoid hot baths with strong perfumed i oils

| • Change your sanitary protection regularly

j If you take other medicines

i Before you use this medicine, make sure | that you tell your pharmacist about ANY i other medicines you might be using at the ' same time. If you are unsure about | interactions with any medicines, talk to your i pharmacist. This includes medicines | prescribed by your doctor and medicine you i have bought for yourself, including herbal ¹ and homeopathic remedies.

/How to use this medicine

| Check the tube seal is not broken before i first use.

| If it is, do not use the cream.

¹ Pierce tube seal with end of cap.

For use on the skin only. For women, apply the cream to the vulva and surrounding area. For men, apply the cream to the penis. Do not use on children under 16 years, or if you are an adult of 61 years or older, unless your doctor tells you to.

Do not use more than the amount recommended above.

If symptoms do not go away within 7 days talk to your doctor.

If you have thrush more than twice in six months you must see your doctor, f If anyone accidentally swallows some of the cream: Talk to a doctor or go to your nearest hospital casualty department straight away.

Take your medicine and this leaflet with you.

Possible side effects ~ ~

Most people will not have problems, but some may get some, f If you get any of these serious side effects, stop using the cream. See a doctor at once:

•    Difficulty breathing, feeling dizzy, fainting, red raised itchy skin rash (severe allergic reactions) If you get any of the following side effects' see your pharmacist or doctor:

•    Irritation, discomfort, pain or a burning or stinging sensation

•    Other allergic skin reactions such as itchy rash, swelling, peeling or flaking of the skin, blisters

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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.

How to store this medicine

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton. The date refers to the last day of the month. If you have any cream left after that date return it to your nearest pharmacy for safe disposal.

What is in this medicine

This cream contains Clotrimazole 1 % w/w which is the active ingredient.

As well as the active ingredient, the cream also contains sorbitan stearate, polysorbate 60, cetyl palmitate, stearyl alcohol, cetyl alcohol, 2-octyldodecanol, benzyl alcohol, purified water. The pack contains 20 g of white cream.

Who makes this medicine

Manufactured for The Boots Company PLC ] Nottingham NG2 3AA by Pliva Hrvatska d.o.o. (Pliva Croatia Ltd.), Prilaz baruna Filipovica 25,10 000 Zagreb, Croatia. Marketing Authorisation held by TEVA UK Limited Eastbourne BN22 9AG Leaflet prepared April 2015 If you would like any further information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA.

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only)

Please be ready to give the following information: Product name: Boots Thrush 1 % w/w Cream Reference number 00289/1476 This is a service provided by the Royal National Institute of Blind People. 63687-Q

Main Headings: Sub Headings: Body Copy:

lOpt

8pt

PACK MOCK OP

Product Name:    Boots Thrush 1% w/w Cream

Product Licence No.: 00289/1476

Wording Ref:    WiRAAppuMd vldated22/12/2014(BTC154558vQ

Status:    Internally Approved

fack Details:    Aluminium tube with polypropylene screw-on

cap containing 20g of cream

Pack Size:

20 g - stand alone product

Addition of information on ADR Yellow Card Reporting paragraph under the 'Possible side effects' section.

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ARTWORK TEXT SIZE

Information for the user

Thrush 1 % w/w Cream

(Clotrimazole)

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

This medicine is available without prescription to treat the external symptoms of thrush. However, you still need to use it 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

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What this medicine is for

This medicine contains Clotrimazole which belongs to a group of medicines called anti-fungals, which act to treat infections caused by fungi.

It can be used to treat the external symptoms of thrush (vulval candidiasis). It may also be used by the woman’s sexual partner to treat associated penile thrush (candidal balanitis).

Thrush is a common infection caused by a yeast (or fungus), which may live harmlessly in the vagina without you even noticing it. However, in certain circumstances, it may develop into an infection in the vagina and symptoms may spread to the surrounding area. These symptoms may include one or more of the following:

•    Itching of the vagina and surrounding area (the vulva)

•    Redness and swelling of the tissues of the vagina and vulva

•    Soreness of the vagina and vulva

•    A white, non-smelling discharge from the vagina

Thrush may be aggravated by sexual intercourse, but is not a sexually transmitted disease. Sometimes however, thrush can be passed to your partner through sexual intercourse.

If your partner has penile thrush he may have one or more of the following symptoms:

•    Soreness and redness of the penis

•    Tightness of the foreskin

•    A white non-smelling penile discharge

Before you use this medicine

This medicine can be used by adults between the ages of 16 and 60 years.

However, some people should not use this medicine or should seek the advice of their pharmacist or doctor first.

XDo not use:

•If you are allergic to any of the ingredients in the medicine or any other anti-fungal medicine

•If you are pregnant or breastfeeding,

unless your doctor tells you to

f Talk to your pharmacist or doctor:

•If this is the first time you have had these symptoms

•    If you have had thrush more than twice in the last 6 months

•    If you are under 16 years, or 61 years or older

•If you or your partner have ever been exposed to a sexually transmitted disease •If you have lower stomach pain, or pain or a burning sensation on passing urine

•    If you are a man and:

-    Your sexual partner does not have thrush

-    You have an abnormal discharge or leakage from your penis

-    You have sores, ulcers or blisters on your penis

•    If you are a woman and:

-    You have abnormal or irregular vaginal bleeding, or a blood-stained discharge

-    You have sores, ulcers or blisters on your vulva or vagina

Other important information

Information about some of the ingredients in this medicine: Cetyl alcohol and stearyl alcohol in the cream may cause local skin reactions (e.g. contact dermatitis). The ingredients in the cream may affect the latex used in contraceptives such as condoms and diaphragms. This may reduce the effectiveness of the contraceptives.

You should therefore use other methods of contraception for at least 5 days after using the cream.

You can help the treatment to work if you follow these simple self-help tips:

i • Although the infected area will"itch, do not ] scratch as this will damage the surface of the i skin and cause the infection to spread further ¹ • Keep the affected areas of skin clean | • Pay particular attention to drying the skin i but avoid excessive rubbing | To help prevent thrush from coming back i once you have treated it, follow these | simple steps: i • Wash daily

| • Wear cotton underwear and loose fitting i clothing

¹ • Try to avoid wearing tights, nylon | underwear and tight fitting clothing i • After going to the toilet, wipe yourself from | the front to the back, as a thrush infection i may be transferred from the bowel | • Try to avoid washing with perfumed soaps i or using vaginal deodorants i • Do not rub hard with sponges or flannels | and avoid hot baths with strong perfumed i oils

| • Change your sanitary protection regularly

j If you take other medicines

i Before you use this medicine, make sure | that you tell your pharmacist about ANY i other medicines you might be using at the ' same time. If you are unsure about | interactions with any medicines, talk to your i pharmacist. This includes medicines | prescribed by your doctor and medicine you i have bought for yourself, including herbal ¹ and homeopathic remedies.

/How to use this medicine

| Check the tube seal is not broken before i first use.

| If it is, do not use the cream.

¹ Pierce tube seal with end of cap.

For use on the skin only. For women, apply the cream to the vulva and surrounding area. For men, apply the cream to the penis. Do not use on children under 16 years, or if you are an adult of 61 years or older, unless your doctor tells you to.

Do not use more than the amount recommended above.

If symptoms do not go away within 7 days talk to your doctor.

If you have thrush more than twice in six months you must see your doctor, f If anyone accidentally swallows some of the cream: Talk to a doctor or go to your nearest hospital casualty department straight away.

Take your medicine and this leaflet with you.

Possible side effects ~ ~

Most people will not have problems, but some may get some, f If you get any of these serious side effects, stop using the cream. See a doctor at once:

•    Difficulty breathing, feeling dizzy, fainting, red raised itchy skin rash (severe allergic reactions) If you get any of the following side effects' see your pharmacist or doctor:

•    Irritation, discomfort, pain or a burning or stinging sensation

•    Other allergic skin reactions such as itchy rash, swelling, peeling or flaking of the skin, blisters

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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.

How to store this medicine

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton. The date refers to the last day of the month. If you have any cream left after that date return it to your nearest pharmacy for safe disposal.

What is in this medicine

This cream contains Clotrimazole 1 % w/w which is the active ingredient.

As well as the active ingredient, the cream also contains sorbitan stearate, polysorbate 60, cetyl palmitate, stearyl alcohol, cetyl alcohol, 2-octyldodecanol, benzyl alcohol, purified water. The pack contains 20 g of white cream.

Who makes this medicine

Manufactured for The Boots Company PLC ] Nottingham NG2 3AA by Pliva Hrvatska d.o.o. (Pliva Croatia Ltd.), Prilaz baruna Filipovica 25,10 000 Zagreb, Croatia. Marketing Authorisation held by TEVA UK Limited Eastbourne BN22 9AG Leaflet prepared April 2015 If you would like any further information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA.

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only)

Please be ready to give the following information: Product name: Boots Thrush 1 % w/w Cream Reference number 00289/1476 This is a service provided by the Royal National Institute of Blind People. 63687-Q

Main Headings: Sub Headings: Body Copy:

lOpt

8pt

PACK MOCK OP

Product Name:    Boots Thrush 1% w/w Cream

Product Licence No.: 00289/1476

Wording Ref:    MiRAAppirad vldated22/12/2014(BTC154558vQ

Status:    Internally Approved

fack Details:    Aluminium tube with polypropylene screw-on

cap containing 20g of cream

Pack Size:

20 g - stand alone product

Addition of information on ADR Yellow Card Reporting paragraph under the 'Possible side effects' section.

ARTWORK OMLY

Technical ft Non Printing Items Cutter ■ Guides

REG0066223

Version 2.3

Approved

■ TECHNICAL 1MF0: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls ■IjHh your print tolerances.

STTJDIQ USE ONLY

This is a representation of an electronic record that was signed electronically and this

PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE