iMedi.co.uk

Acnecide 5percent W-W Gel / Benzoyl Peroxide 5percent W-W Gel

Package leaflet: Information for the user

Acnecide® 5% w/w gel

(benzoyl peroxide)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

-    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. See section 4.

-    You must talk to a doctor if you do not feel better or if you feel worse.

The name of your medicine is Acnecide® 5% w/w gel but it will be referred to as Acnecide throughout this leaflet.

What is in this leaflet

1.    What Acnecide is and what it is used for

2.    What you need to know before you use Acnecide

3.    How to use Acnecide

4.    Possible side effects

5.    How to store Acnecide

6.    Contents of the pack and other information

1.    What Acnecide is and what it is used for

•    Acnecide contains the active ingredient benzoyl peroxide which attacks the bacteria (germs) known as Propionibacterium acnes, one of the main causes of acne.

•    Your doctor or pharmacist has recommended this medicine to treat your acne. Acne appears as blackheads and whiteheads which people often refer to as pimples or spots.

•    Acne of the face, chest or back may be treated with this medicine.

2.    What you need to know before you use Acnecide

Do not use Acnecide if you are:

•    Allergic to benzoyl peroxide or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include a rash or itching.

Warnings and precautions

Talk to your doctor or pharmacist before using Acnecide.

•    Avoid contact with the eyes, mouth, angles of the nose and other mucous surfaces such as the lining of your nose. If accidental contact should occur, rinse thoroughly with warm water.

•    Acnecide should not be applied to damaged skin.

•    This product may bleach hair and coloured fabrics including clothing, towels and bed linen. Be careful to avoid contact of the gel with these materials. Please make sure that you wash your hands thoroughly after you have used it.

•    Caution should be exercised when applying Acnecide to the neck and other sensitive areas.

•    Avoid excessive exposure to sunlight or UV lamps.

Other medicines and Acnecide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

•    You should not use medicines with peeling, irritant and drying effects at the same time as Acnecide.

•    Do not use Acnecide with any other acne products that are used on the skin, unless your doctor or pharmacist has told you that you can, as this may cause your skin to become red and very sore.

Pregnancy and breast-feeding

•    If you are pregnant or think you may be pregnant or are breast-feeding, do not use this product unless your doctor has told you that you can.

•    Avoid using this product if you are breast-feeding unless your doctor has told you otherwise. If your doctor has recommended the use of this product while you are breast-feeding, you must not apply the gel onto your chest, this is to avoid exposure of your child to this product.

Ask your doctor or pharmacist for advice before taking any medicine.

Acnecide contains propylene glycol.

Propylene glycol may cause skin irritation.

3.    How to use Acnecide

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

•    Acnecide is for EXTERNAL USE ONLY.

•    Unless your doctor or pharmacist has told you otherwise,

-    Wash the affected area with a mild skin cleanser and water, and gently pat your skin dry.

-    Apply the gel once or twice a day to all the affected areas.

-    Any drying or peeling which may occur to your skin may be reduced if you alter the number of times you apply, i.e. to once a day or once every two days, until your skin adjusts to the product.

•    You should try to avoid exposure to strong sunlight while using Acnecide. If exposure is unavoidable, use a suitable sunscreen lotion and apply Acnecide in the evening. Remember to wash the affected area before use.

•    How long you will have to use Acnecide will depend on how quickly your condition improves. After you have used it for one month, you should see your doctor or pharmacist again. He or she can then check the improvement of your condition.

•    You should start treatment with the lower strength product. Provided your skin tolerates the lower strength gel, your doctor or pharmacist may recommend continued treatment with a higher strength gel to further help clear your acne.

If you use more Acnecide than you should or accidentally swallow the gel

•    If you should accidentally use too much gel, you may find that your skin becomes irritated. Wash off as much as you can, and when the irritation has gone down, start using it again as directed.

•    In the rare event that you accidentally swallow any of this product, seek medical advice.

If you forget to use Acnecide

•    Don't worry if you forget to use your gel at the right time. When you remember, start using the product again, in the same way as before.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If your skin becomes severely irritated, or severe redness, itching or peeling of the skin occurs, or you experience face swelling, discontinue use immediately and consult your doctor or pharmacist.

Acnecide may cause the following side effects:

Very common: may affect more than 1 in 10 people

-    Dry skin

-    Skin redness

-    Peeling of the skin

-    Burning sensation of the skin

Common: may affect up to 1 in 10 people

-    Itching of the skin (pruritus)

-    Pain of the skin (pain, stinging)

-    Skin irritation (irritant contact dermatitis)

Uncommon: may affect up to 1 in 100 people

-    Allergic contact dermatitis

Not known: frequency cannot be estimated from the available data

-    Swelling face

These symptoms are usually reversible if the treatment is reduced in frequency or discontinued.

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 Acnecide

•    Keep out of the sight and reach of children.

•    Do not use after the expiry date which is stated on the carton and tube label after 'Exp'. The expiry date refers to the last day of that month.

•    Do not store above 25°C. Do not freeze.

•    Store the tube away from direct heat.

•    If the medicine becomes discoloured or show any signs of deterioration, seek the advice of your pharmacist.

•    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.    Contents of the pack and other information

What Acnecide contains

The active ingredient in Acnecide is hydrous benzoyl peroxide equivalent to benzoyl peroxide.

Contains hydrous benzoyl peroxide equivalent to 5% w/w benzoyl peroxide.

The other ingredients are docusate sodium, disodium edetate, poloxamer 182, carbomer 940, propylene glycol, acrylates copolymer, glycerol, colloidal anhydrous silica, purified water and sodium hydroxide to adjust the pH.

What Acnecide looks like and contents of the pack

Acnecide is a white to off-white gel.

It is available in tube pack of 60g.

Manufactured by: Laboratoires Galderma, ZI- Montdesir, 74540 Alby-sur-Cheran, France.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, hA4 0NU, UK.

Acnecide® 5% w/w gel; PL 18799/2933    P

Package leaflet: Information for the user

Benzoyl peroxide 5% w/w gel

Read all of this leaflet carefully before you start using this medicine because it contains important

information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

-    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. See section 4.

-    You must talk to a doctor if you do not feel better or if you feel worse.

The name of your medicine is Benzoyl peroxide 5% w/w gel but it will be referred to as Benzoyl peroxide

throughout this leaflet.

What is in this leaflet

1.    What Benzoyl peroxide is and what it is used for

2.    What you need to know before you use Benzoyl peroxide

3.    How to use Benzoyl peroxide

4.    Possible side effects

5.    How to store Benzoyl peroxide

6.    Contents of the pack and other information

1.    What Benzoyl peroxide is and what it is used for

•    Benzoyl peroxide contains the active ingredient benzoyl peroxide which attacks the bacteria (germs) known as Propionibacterium acnes, one of the main causes of acne.

•    Your doctor or pharmacist has recommended this medicine to treat your acne. Acne appears as blackheads and whiteheads which people often refer to as pimples or spots.

•    Acne of the face, chest or back may be treated with this medicine.

2.    What you need to know before you use Benzoyl peroxide

Do not use Benzoyl peroxide if you are:

•    Allergic to benzoyl peroxide or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include a rash or itching.

Warnings and precautions

Talk to your doctor or pharmacist before using Benzoyl peroxide.

•    Avoid contact with the eyes, mouth, angles of the nose and other mucous surfaces such as the lining of your nose. If accidental contact should occur, rinse thoroughly with warm water.

•    Benzoyl peroxide should not be applied to damaged skin.

•    This product may bleach hair and coloured fabrics including clothing, towels and bed linen. Be careful to avoid contact of the gel with these materials. Please make sure that you wash your hands thoroughly after you have used it.

•    Caution should be exercised when applying Benzoyl peroxide to the neck and other sensitive areas.

•    Avoid excessive exposure to sunlight or UV lamps.

Other medicines and Benzoyl peroxide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

•    You should not use medicines with peeling, irritant and drying effects at the same time as Benzoyl peroxide.

•    Do not use Benzoyl peroxide with any other acne products that are used on the skin, unless your doctor or pharmacist has told you that you can, as this may cause your skin to become red and very sore.

Pregnancy and breast-feeding

•    If you are pregnant or think you may be pregnant or are breast-feeding, do not use this product unless your doctor has told you that you can.

•    Avoid using this product if you are breast-feeding unless your doctor has told you otherwise. If your doctor has recommended the use of this product while you are breast-feeding, you must not apply the gel onto your chest, this is to avoid exposure of your child to this product.

Ask your doctor or pharmacist for advice before taking any medicine.

Benzoyl peroxide contains propylene glycol.

Propylene glycol may cause skin irritation.

3.    How to use Benzoyl peroxide

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told

you. Check with your doctor or pharmacist if you are not sure.

•    Benzoyl peroxide is for EXTERNAL USE ONLY.

•    Unless your doctor or pharmacist has told you otherwise,

-    Wash the affected area with a mild skin cleanser and water, and gently pat your skin dry.

-    Apply the gel once or twice a day to all the affected areas.

-    Any drying or peeling which may occur to your skin may be reduced if you alter the number of times you apply, i.e. to once a day or once every two days, until your skin adjusts to the product.

•    You should try to avoid exposure to strong sunlight while using Benzoyl peroxide. If exposure is unavoidable, use a suitable sunscreen lotion and apply Benzoyl peroxide in the evening. Remember to wash the affected area before use.

•    How long you will have to use Benzoyl peroxide will depend on how quickly your condition improves. After you have used it for one month, you should see your doctor or pharmacist again. He or she can then check the improvement of your condition.

•    You should start treatment with the lower strength product. Provided your skin tolerates the lower strength gel, your doctor or pharmacist may recommend continued treatment with a higher strength gel to further help clear your acne.

If you use more Benzoyl peroxide than you should or accidentally swallow the gel

•    If you should accidentally use too much gel, you may find that your skin becomes irritated. Wash off as much as you can, and when the irritation has gone down, start using it again as directed.

•    In the rare event that you accidentally swallow any of this product, seek medical advice.

If you forget to use Benzoyl peroxide

•    Don't worry if you forget to use your gel at the right time. When you remember, start using the product again, in the same way as before.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If your skin becomes severely irritated, or severe redness, itching or peeling of the skin occurs, or you experience face swelling, discontinue use immediately and consult your doctor or pharmacist.

Benzoyl peroxide may cause the following side effects:

Very common: may affect more than 1 in 10 people

-    Dry skin

-    Skin redness

-    Peeling of the skin

-    Burning sensation of the skin

Common: may affect up to 1 in 10 people

-    Itching of the skin (pruritus)

-    Pain of the skin (pain, stinging)

-    Skin irritation (irritant contact dermatitis)

Uncommon: may affect up to 1 in 100 people

-    Allergic contact dermatitis

Not known: frequency cannot be estimated from the available data

-    Swelling face

These symptoms are usually reversible if the treatment is reduced in frequency or discontinued.

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 Benzoyl peroxide

•    Keep out of the sight and reach of children.

•    Do not use after the expiry date which is stated on the carton and tube label after 'Exp'. The expiry date refers to the last day of that month.

•    Do not store above 25°C. Do not freeze.

•    Store the tube away from direct heat.

•    If the medicine becomes discoloured or show any signs of deterioration, seek the advice of your pharmacist.

•    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.    Contents of the pack and other information

What Benzoyl peroxide contains

The active ingredient in Benzoyl peroxide is hydrous benzoyl peroxide equivalent to benzoyl peroxide. Contains hydrous benzoyl peroxide equivalent to 5% w/w benzoyl peroxide.

The other ingredients are docusate sodium, disodium edetate, poloxamer 182, carbomer 940, propylene glycol, acrylates copolymer, glycerol, colloidal anhydrous silica, purified water and sodium hydroxide to adjust the pH.

What Benzoyl peroxide looks like and contents of the pack

Benzoyl peroxide is a white to off-white gel.

It is available in tube pack of 60g.

Manufactured by: Laboratoires Galderma, ZI- Montdesir, 74540 Alby-sur-Cheran, France.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, hA4 0NU, UK.

Benzoyl peroxide 5% w/w gel; PL 18799/2933

Leaflet date: 19.05.2016