Patient leaflet - BENZOYL PEROXIDE 5% W/W GEL,ACNECIDE 5% W/W GEL
Acnecide ® 5% w/w Gel
(benzoyl peroxide)
Patient Information Leaflet
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.
Your medicine is called Acnecide 5% w/w Gel but will be referred to as Acnecide throughout the leaflet.
What is in this leaflet
-
J1) What Acnecide is and what it is used for
-
^2| What you need to know before you use Acnecide
How to use Acnecide
Possible side effects
-
J5^ How to store Acnecide
-
^6| Contents of the pack and other information
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 (hypersensitive) 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
-
Acnecide may cause swelling and blistering of the skin, if any of these symptoms occur, use of the product should be discontinued.
-
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 repeated exposure to sunlight or other sources of UV light (e.g. sun bed).
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.
F3) 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 in a thin layer once or twice a day to all the affected areas. – If you have sensitive skin apply the gel once daily before going to bed.
-
– 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.
(benzoyl peroxide)
Patient Information Leaflet (continued)
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.
Tell your doctor immediately if you develop a severe allergic reaction:
Signs of severe allergic reactions may include:
-
Raised and itchy rash (hives)
-
Swelling of the face, eyes, lips, tongue or mouth (angioedema), having difficulty in breathing
-
Fainting
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
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 or pharmacist. This includes any possible side effects not listed on this leaflet. You can also report side effects directly 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 Acnecide
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Do not freeze. Protect from heat.
Do not use Acnecide after the expiry date which is stated on the tube or carton label. The expiry date refers to the last day of the month.
If your doctor tells you to stop using this medicine, return any unused gel to your pharmacist (chemist) for safe disposal. Only keep this 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 that are no longer required. These measures will help to protect the environment.
3
Contents of the pack and other information
What Acnecide contains:
Each gram of gel contains 5% w/w of benzoyl peroxide.
Other ingredients are docusate sodium, disodium edetate, poloxamer 182, carbomer 940, propylene glycol, acrylates copolymer, glycerol, colloidal anhydrous silica, purified water and sodium hydroxide.
What Acnecide looks like and contents of the pack
Acnecide is a white to off-white, smooth gel.
Each tube contains 60g of gel.
Manufacturer and Licence Holder
Manufactured by Laboratoires Galderma, ZI-Montdesir 74540 Alby-sur-Cheran, France and is 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.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
[P PL 15184/1585 Acnecide 5% w/w Gel
Acnecide is a registered trademark of Galderma S.A.
Revision date: 25/01/18
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet in a format suitable for you
Patient Information Leaflet
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.
Your medicine is called Benzoyl Peroxide 5% w/w Gel but will be referred to as Benzoyl Peroxide throughout the leaflet.
What is in this leaflet
-
J 1) What Benzoyl Peroxide is and what it is used for
-
^ 2| What you need to know before you use Benzoyl Peroxide
How to use Benzoyl Peroxide
Possible side effects
-
J 5^ How to store Benzoyl Peroxide
-
^ 6| Contents of the pack and other information
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.
What you need to know before you use Benzoyl Peroxide
Do not use Benzoyl Peroxide if you are:
-
Allergic (hypersensitive) 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.
-
Acnecide should not be applied to damaged skin.
-
Acnecide may cause swelling and blistering of the skin, if any of these symptoms occur, use of the product should be discontinued.
-
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 repeated exposure to sunlight or other sources of UV light (e.g. sun bed).
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 in a thin layer once or twice a day to all the affected areas.
-
– If you have sensitive skin apply the gel once daily before going to bed.
-
– 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.
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.
Patient Information Leaflet (continued)
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.
3
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.
Tell your doctor immediately if you develop a severe allergic reaction: Signs of severe allergic reactions may include:
-
Raised and itchy rash (hives)
-
Swelling of the face, eyes, lips, tongue or mouth (angioedema), having difficulty in breathing
-
Fainting
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
How to store Benzoyl Peroxide
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Do not freeze.Protect from heat.
Do not use Benzoyl Peroxide after the expiry date which is stated on the tube label or carton. The expiry date refers to the last day of the month.
If your doctor tells you to stop using this medicine, return any unused gel to your pharmacist (chemist) for safe disposal. Only keep this 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 that are no longer required. These measures will help to protect the environment.
3
Contents of the pack and other information
What Benzoyl Peroxide contains:
Each gram of gel contains 5% w/w of benzoyl peroxide.
Other ingredients are docusate sodium, disodium edetate, poloxamer 182, carbomer 940, propylene glycol, acrylates copolymer, glycerol, colloidal anhydrous silica, purified water and sodium hydroxide.
What Benzoyl Peroxide looks like and contents of the pack
Benzoyl Peroxide is a white to off-white, smooth gel.
Each tube contains 60g of gel.
Manufacturer and Licence Holder
Manufactured by Laboratoires Galderma, ZI-Montdesir 74540 Alby-sur-Cheran, France and is 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.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
[P PL 15184/1585 Benzoyl Peroxide 5% w/w Gel
Revision date: 25/01/18
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet in a format suitable for you