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Stiemycin 2% W/V Topical Solution

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Ref: 1011/070514/1/F

Stiemycin® 2% w/v Topical Solution

(erythromycin)

Patient Information Leaflet

Read all of this leaflet carefully before you start using this medicine

*    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 pass it on to others. It may harm them, even if their symptoms are the same as yours.

*    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Your medicine is called Stiemycin 2% w/v Topical Solution but will be referred to as Stiemycin throughout this leaflet.

In this leaflet:

Q What Stiemycin is and what it is used for Q Before you take this medicine ^ How to use Stiemycin Q Possible side effects Q How to store Stiemycin Q Further information

Q What Stiemycin is and what it is used for

Stiemycin contains a medicine called erythromycin. This is an antibiotic. Stiemycin is used to treat acne (spots). It works by fighting the bacteria that can cause the acne spots.

Stiemycin is for use by adults and adolescents with acne.

It is not for use by children.

Q Before you use Stiemycin

Do not use Stiemycin if:

*    you are allergic to erythromycin or any of the other ingredients of Stiemycin (listed in Section 6).

Do not use Stiemycin if the above applies to you. If you are not sure, talk to your doctor or pharmacist before you start using Stiemycin.

Take special care with Stiemycin

Before you use Stiemycin tell your doctor if:

*    you cannot tolerate or have previously had a skin reaction or allergy to erythromycin or any of the other ingredients of Stiemycin (listed in Section 6)

*    you have a history of inflammatory bowel disease or antibiotic-associated colitis (severe, prolonged or bloody diarrhoea following antibiotic use).

Only use Stiemycin on your skin. Take care not to get Stiemycin in your eyes, nostrils, mouth or on your lips. If you do, rinse well with water. Take care not to get Stiemycin on any irritated areas of skin, such as cuts, grazes, sunburn, or broken skin. Stiemycin contains propylene glycol, which may cause skin irritation.

Taking other medicines

Please tell your doctor or pharmacist if you are taking any other medicines, if

you have taken any recently, or if you start taking a new one. This includes

medicines bought without a prescription.

*    Stiemycin can affect how other medicines work. Take care not to use Stiemcyin at the same time as clindamycin-containing acne medicines that are used on the skin.

*    Tell your doctor if you are taking any other antibiotic medicine.

*    Take care not to apply Stiemycin at the same time as other acne products that are used on the skin, unless your doctor or pharmacist has told you that you can.

Pregnancy and breast-feeding

*    Tell your doctor if you are pregnant, planning to become pregnant or breastfeeding.

*    If you do become pregnant during treatment with Stiemycin tell your doctor.

*    Don't use Stiemycin on your breast if you are breast-feeding.

Effects of other ingredients (excipients)

Stiemycin contains propylene glycol, which may cause skin irritation.

0 How to use Stiemycin

Always use Stiemycin exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

What you need to know before using Stiemycin

*    Stiemycin should be applied only to your skin.

*    Do not drink the solution.

*    Do not use Stiemycin near a naked flame because it is flammable.

*    When you use the bottle for the first time you will need to break the seal.

To do this, remove the cap from the bottle and holding the bottle upright, press gently on the seal with a finger until you hear a ‘pop'.

The medicine is now ready to use.

How much to use

*    Apply Stiemycin twice a day, in the morning and the evening.

*    Using the product more frequently does not give better results.

*    It can take at least six to eight weeks before you see the full benefit of Stiemycin.

*    You should keep using the medicine according to your doctor's instructions up to a maximum of 6 months.

How to apply Stiemycin

*    Completely remove any make-up.

*    Wash the affected area with mild soap and warm water and gently dry.

*    Remove the cap.

*    Turn the bottle upside down and dab the pad onto the affected area.

*    Use the pad to spread the solution gently over the whole area and not just to each individual spot.

(erythromycin)

Patient Information Leaflet (continued)

After using Stiemycin

*    Always replace the cap securely after use to stop the medicine from leaking or evaporating.

*    Stiemycin contains ingredients to help the antibiotic reach the bottom of your hair follicles where the acne starts. These ingredients keep the skin wet for a few minutes after applying it.

*    Allow your face to dry completely before using any make-up.

*    You may notice a slight smell while it dries, this is normal.

*    Wash your hands after use.

If you forget to use Stiemycin

*    Don't apply a double dose to make up for forgotten doses.

*    Apply the next dose at the usual time.

If you accidently swallow Stiemycin:

The ingredients of Stiemycin are not expected to be harmful if swallowed in the small amounts normally applied to the face. If you do accidentally get Stiemycin in your mouth, rinse at once with plenty of water. Seek medical advice if you swallow more than a small amount.

0 How to store Stiemycin

Expiry Date

Do not use this medicine after the expiry date shown on the carton label or bottle label. If your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist (chemist) for safe disposal. Only keep this medicine, if your doctor tells you to. If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.

Storage

*    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

*    Do not store above 25°C.

Important

Remember this medicine is for you. It can only be prescribed by a doctor. Never give your medicine to other people. It may harm them, even if their symptoms are the same as yours. This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist (chemist). He/she will have additional information about this medicine and will be able to advise you.

Q Possible side effects

Like all medicines, Stiemycin can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Stop using Stiemycin and see a doctor straight away if:

*    you notice an allergic reaction (such as swelling of your face, eyes, lips or tongue, nettle rash or difficulty breathing).

*    you develop severe or prolonged diarrhoea.

The following very common side effects have been reported (at least 1 in 10 people are affected):

*    skin burning sensation

*    skin irritation

*    dry skin, especially at the start of treatment

*    application site stinging

*    redness of your skin, especially at the start of treatment.

Other side effects with frequencies that cannot be estimated from the available data include:

*    allergic reaction

*    diarrhoea, stomach pain, stomach discomfort,

*    itching, rash

*    swelling on the face

^ Tell your doctor or pharmacist if any of the side effects become severe or troublesome, or if you notice any side effects not listed in this leaflet.

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.

Q Further information

What Stiemycin contains

Each ml of solution contains 20mg of erythromycin.

Stiemycin also contains the following inactive ingredients ethanol absolute, propylene glycol and Lauromacrogol 400.

What Stiemycin looks like and the contents of the pack

Stiemycin is a colourless, transparent solution with ethanol odour.

Stiemycin is available in 25ml, 50ml (2x25ml) bottles.

Manufacturer and Licence Holder

Stiemycin are manufactured by Famar Nederland B.V., Industrieweg 1,5531 AD Bladel, The Netherlands and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM 15184/1011

Stiemycin is a registered trademark of Stiefel Laboratories, Inc. Revision date:    07/05/14

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Stiemycine®2% w/v Topical Solution

(erythromycin)

Patient Information Leaflet

Read all of this leaflet carefully before you start using this medicine

*    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 pass it on to others. It may harm them, even if their symptoms are the same as yours.

*    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Your medicine is called Stiemycine 2% w/v Topical Solution but will be referred to as Stiemycine throughout this leaflet.

In this leaflet:

0 What Stiemycine is and what it is used for 0 Before you take this medicine 0 How to use Stiemycine 0 Possible side effects 0 How to store Stiemycine 0 Further information

Taking other medicines

Please tell your doctor or pharmacist if you are taking any other medicines, if

you have taken any recently, or if you start taking a new one. This includes

medicines bought without a prescription.

*    Stiemycine can affect how other medicines work. Take care not to use Stiemcyin at the same time as clindamycin-containing acne medicines that are used on the skin.

*    Tell your doctor if you are taking any other antibiotic medicine.

*    Take care not to apply Stiemycine at the same time as other acne products that are used on the skin, unless your doctor or pharmacist has told you that you can.

Pregnancy and breast-feeding

*    Tell your doctor if you are pregnant, planning to become pregnant or breastfeeding.

*    If you do become pregnant during treatment with Stiemycine tell your doctor.

*    Don't use Stiemycine on your breast if you are breast-feeding.

Effects of other ingredients (excipients)

Stiemycine contains propylene glycol, which may cause skin irritation.

0 What Stiemycine is and what it is used for

Stiemycine contains a medicine called erythromycin. This is an antibiotic. Stiemycine is used to treat acne (spots). It works by fighting the bacteria that can cause the acne spots.

Stiemycine is for use by adults and adolescents with acne.

It is not for use by children.

Q Before you use Stiemycine

Do not use Stiemycine if:

*    you are allergic to erythromycin or any of the other ingredients of Stiemycine(listed in Section 6).

Do not use Stiemycine if the above applies to you. If you are not sure, talk to your doctor or pharmacist before you start using Stiemycine.

Take special care with Stiemycine

Before you use Stiemycine tell your doctor if:

*    you cannot tolerate or have previously had a skin reaction or allergy to erythromycin or any of the other ingredients of Stiemycine (listed in Section 6)

*    you have a history of inflammatory bowel disease or antibiotic-associated colitis (severe, prolonged or bloody diarrhoea following antibiotic use).

Only use Stiemycine on your skin. Take care not to get Stiemycine in your eyes, nostrils, mouth or on your lips. If you do, rinse well with water. Take care not to get Stiemycine on any irritated areas of skin, such as cuts, grazes, sunburn, or broken skin. Stiemycine contains propylene glycol, which may cause skin irritation.

0 How to use Stiemycine

Always use Stiemycine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

What you need to know before using Stiemycine

*    Stiemycine should be applied only to your skin.

*    Do not drink the solution.

*    Do not use Stiemycine near a naked flame because it is flammable.

*    When you use the bottle for the first time you will need to break the seal.

To do this, remove the cap from the bottle and holding the bottle upright, press gently on the seal with a finger until you hear a ‘pop'.

The medicine is now ready to use.

How much to use

*    Apply Stiemycine twice a day, in the morning and the evening.

*    Using the product more frequently does not give better results.

*    It can take at least six to eight weeks before you see the full benefit of Stiemycine.

*    You should keep using the medicine according to your doctor's instructions up to a maximum of 6 months.

How to apply Stiemycine

*    Completely remove any make-up.

*    Wash the affected area with mild soap and warm water and gently dry.

*    Remove the cap.

*    Turn the bottle upside down and dab the pad onto the affected area.

*    Use the pad to spread the solution gently over the whole area and not just to each individual spot.

(erythromycin)

Patient Information Leaflet (continued)

After using Stiemycine

*    Always replace the cap securely after use to stop the medicine from leaking or evaporating.

*    Stiemycine contains ingredients to help the antibiotic reach the bottom of your hair follicles where the acne starts. These ingredients keep the skin wet for a few minutes after applying it.

*    Allow your face to dry completely before using any make-up.

*    You may notice a slight smell while it dries, this is normal.

*    Wash your hands after use.

If you forget to use Stiemycine

*    Don't apply a double dose to make up for forgotten doses.

*    Apply the next dose at the usual time.

If you accidently swallow Stiemycine:

The ingredients of Stiemycine are not expected to be harmful if swallowed in the small amounts normally applied to the face. If you do accidentally get Stiemycine in your mouth, rinse at once with plenty of water. Seek medical advice if you swallow more than a small amount.

Q Possible side effects

Like all medicines, Stiemycine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Stop using Stiemycine and see a doctor straight away if:

*    you notice an allergic reaction (such as swelling of your face, eyes, lips or tongue, nettle rash or difficulty breathing).

*    you develop severe or prolonged diarrhoea.

The following very common side effects have been reported (at least 1 in 10 people are affected):

*    skin burning sensation

*    skin irritation

*    dry skin, especially at the start of treatment

*    application site stinging

*    redness of your skin, especially at the start of treatment.

Other side effects with frequencies that cannot be estimated from the available data include:

*    allergic reaction

*    diarrhoea, stomach pain, stomach discomfort,

*    itching, rash

*    swelling on the face

^ Tell your doctor or pharmacist if any of the side effects become severe or troublesome, or if you notice any side effects not listed in this leaflet.

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 help provide more information on the safety of this medicine.

0 How to store Stiemycine

Expiry Date

Do not use this medicine after the expiry date shown on the carton label or bottle label. If your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist (chemist) for safe disposal. Only keep this medicine, if your doctor tells you to. If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.

Storage

*    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

*    Do not store above 25°C.

Important

Remember this medicine is for you. It can only be prescribed by a doctor. Never give your medicine to other people. It may harm them, even if their symptoms are the same as yours. This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist (chemist). He/she will have additional information about this medicine and will be able to advise you.

Q Further information

What Stiemycine contains

Each ml of solution contains 20mg of erythromycin.

Stiemycine also contains the following inactive ingredients ethanol absolute, propylene glycol and Lauromacrogol 400.

What Stiemycine looks like and the contents of the pack

Stiemycine is a colourless, transparent solution with ethanol odour. Stiemycine is available in 25ml, 50ml (2x25ml) bottles.

Manufacturer and Licence Holder

Stiemycine are manufactured by Famar Nederland B.V., Industrieweg 1, 5531 Ad Bladel, The Netherlands and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM 15184/1011

Stiemycine is a registered trademark of Stiefel Laboratories, Inc. Revision date: 07/05/14

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Patient Information Leaflet

Read all of this leaflet carefully before you start using this medicine

*    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 pass it on to others. It may harm them, even if their symptoms are the same as yours.

*    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Your medicine is called Erythromycin 2% w/v Topical Solution but will be referred to as Erythromycin throughout this leaflet.

In this leaflet:

0 What Erythromycin is and what it is used for 0 Before you take this medicine 0 How to use Erythromycin 0 Possible side effects 0 How to store Erythromycin 0 Further information

Taking other medicines

Please tell your doctor or pharmacist if you are taking any other medicines, if

you have taken any recently, or if you start taking a new one. This includes

medicines bought without a prescription.

*    Erythromycin can affect how other medicines work. Take care not to use Stiemcyin at the same time as clindamycin-containing acne medicines that are used on the skin.

*    Tell your doctor if you are taking any other antibiotic medicine.

*    Take care not to apply Erythromycin at the same time as other acne products that are used on the skin, unless your doctor or pharmacist has told you that you can.

Pregnancy and breast-feeding

*    Tell your doctor if you are pregnant, planning to become pregnant or breastfeeding.

*    If you do become pregnant during treatment with Erythromycin tell your doctor.

*    Don't use Erythromycin on your breast if you are breast-feeding.

Effects of other ingredients (excipients)

Erythromycin contains propylene glycol, which may cause skin irritation.

0 What Erythromycin is and what it is used for

Erythromycin contains a medicine called erythromycin. This is an antibiotic. Erythromycin is used to treat acne (spots). It works by fighting the bacteria that can cause the acne spots.

Erythromycin is for use by adults and adolescents with acne.

It is not for use by children.

0 Before you use Erythromycin

Do not use Erythromycin if:

*    you are allergic to erythromycin or any of the other ingredients of Erythromycin (listed in Section 6).

Do not use Erythromycin if the above applies to you. If you are not sure, talk to your doctor or pharmacist before you start using Erythromycin.

Take special care with Erythromycin

Before you use Erythromycin tell your doctor if:

*    you cannot tolerate or have previously had a skin reaction or allergy to erythromycin or any of the other ingredients of Erythromycin (listed in Section 6)

*    you have a history of inflammatory bowel disease or antibiotic-associated colitis (severe, prolonged or bloody diarrhoea following antibiotic use).

Only use Erythromycin on your skin. Take care not to get Erythromycin in your eyes, nostrils, mouth or on your lips. If you do, rinse well with water. Take care not to get Erythromycin on any irritated areas of skin, such as cuts, grazes, sunburn, or broken skin. Erythromycin contains propylene glycol, which may cause skin irritation.

0 How to use Erythromycin

Always use Erythromycin exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

What you need to know before using Erythromycin

*    Erythromycin should be applied only to your skin.

*    Do not drink the solution.

*    Do not use Erythromycin near a naked flame because it is flammable.

*    When you use the bottle for the first time you will need to break the seal. To do this, remove the cap from the bottle and holding the bottle upright, press gently on the seal with a finger until you hear a ‘pop'.

The medicine is now ready to use.

How much to use

*    Apply Erythromycin twice a day, in the morning and the evening.

*    Using the product more frequently does not give better results.

*    It can take at least six to eight weeks before you see the full benefit of Erythromycin.

*    You should keep using the medicine according to your doctor's instructions up to a maximum of 6 months.

How to apply Erythromycin

*    Completely remove any make-up.

*    Wash the affected area with mild soap and warm water and gently dry.

*    Remove the cap.

*    Turn the bottle upside down and dab the pad onto the affected area.

*    Use the pad to spread the solution gently over the whole area and not just to each individual spot.

Patient Information Leaflet (continued)

After using Erythromycin

*    Always replace the cap securely after use to stop the medicine from leaking or evaporating.

*    Erythromycin contains ingredients to help the antibiotic reach the bottom of your hair follicles where the acne starts. These ingredients keep the skin wet for a few minutes after applying it.

*    Allow your face to dry completely before using any make-up.

*    You may notice a slight smell while it dries, this is normal.

*    Wash your hands after use.

If you forget to use Erythromycin

*    Don't apply a double dose to make up for forgotten doses.

*    Apply the next dose at the usual time.

If you accidently swallow Erythromycin:

The ingredients of Erythromycin are not expected to be harmful if swallowed in the small amounts normally applied to the face. If you do accidentally get Erythromycin in your mouth, rinse at once with plenty of water. Seek medical advice if you swallow more than a small amount.

Q Possible side effects

Like all medicines, Erythromycin can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Stop using Erythromycin and see a doctor straight away if:

*    you notice an allergic reaction (such as swelling of your face, eyes, lips or tongue, nettle rash or difficulty breathing).

*    you develop severe or prolonged diarrhoea.

The following very common side effects have been reported (at least 1 in 10 people are affected):

*    skin burning sensation

*    skin irritation

*    dry skin, especially at the start of treatment

*    application site stinging

*    redness of your skin, especially at the start of treatment.

Other side effects with frequencies that cannot be estimated from the available data include:

*    allergic reaction

*    diarrhoea, stomach pain, stomach discomfort,

*    itching, rash

*    swelling on the face

^ Tell your doctor or pharmacist if any of the side effects become severe or troublesome, or if you notice any side effects not listed in this leaflet.

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 help provide more information on the safety of this medicine.

0 How to store Erythromycin

Expiry Date

Do not use this medicine after the expiry date shown on the carton label or bottle label. If your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist (chemist) for safe disposal. Only keep this medicine, if your doctor tells you to. If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.

Storage

*    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

*    Do not store above 25°C.

Important

Remember this medicine is for you. It can only be prescribed by a doctor. Never give your medicine to other people. It may harm them, even if their symptoms are the same as yours. This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist (chemist). He/she will have additional information about this medicine and will be able to advise you.

Q Further information

What Erythromycin contains

Each ml of solution contains 20mg of erythromycin.

Erythromycin also contains the following inactive ingredients ethanol absolute, propylene glycol and Lauromacrogol 400.

What Erythromycin looks like and the contents of the pack

Erythromycin is a colourless, transparent solution with ethanol odour. Erythromycin is available in 25ml, 50ml (2x25ml) bottles.

Manufacturer and Licence Holder

Erythromycin are manufactured by Famar Nederland B.V., Industrieweg 1, 5531 AD Bladel, The Netherlands and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM 15184/1011 Revision date: 07/05/14

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.