RCflECIDE* Wash 5%w/w Gel

benzoyl peroxide

Package leaflet: Information for the user Acnecide Wash 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.

What is in this leaflet

1.    What Acnecide Wash is and what it is used for

2.    What you need to know before you use Acnecide Wash

3.    How to use Acnecide Wash

4.    Possible side effects

5.    How to store Acnecide Wash

6.    Contents of the pack and other information

1.    What Acnecide Wash is and what it is used for

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

•    Acnecide Wash is used in the treatment of acne. It is used on the face, chest or back for acne, where the skin has a lot of blackheads, spots and pimples.

•    Acnecide Wash is only absorbed into the body in very small amounts and has little effect, except on the surface of the skin.

2.    What you need to know before you use Acnecide Wash Do not use Acnecide Wash 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 Wash.

•    Avoid contact with the eyes, mouth, angles of the nose or other very sensitive areas of the body. If the preparation enters the eye, wash thoroughly with water.

•    Avoid repeated exposure to sunlight or other sources of UV light (e.g. sun bed).

•    Avoid contact with any coloured material including hair and dyed fabrics as it may result in bleaching or discolouration.

•    If your condition does not improve or gets worse discontinue use and consult your doctor or pharmacist. 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 Wash. Pregnancy and breast-feeding

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

•    Do not apply Acnecide Wash onto your chest, if you are breast feeding.

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

3.    How to use Acnecide Wash

•    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 Wash is for EXTERNAL USE ONLY.

•    Unless your doctor or pharmacist has told you otherwise:

-    Acnecide Wash should be used twice daily to cover the affected skin areas.

-    Wet the area to be treated

-    Wash hands before use and place a small amount of Acnecide Wash on to the hands to wash the affected area.

-    Contact time with the skin should be 1 to 2 minutes followed by thorough rinsing with water and drying.

-    After use, wash hands thoroughly and replace cap tightly.

•    Avoid contact with the eyes, mouth, angles of the nose or other very sensitive areas of the body. If the preparation enters the eye, was thoroughly with water. In the event that Acnecide Wash is accidently swallowed, contact your doctor.

If you use more Acnecide Wash than you should

•    If you use too much Acnecide Wash you will not get rid of your acne any quicker, but your skin may become irritated. If this occurs, treatment should be stopped and you should contact your doctor.

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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 Wash

•    Keep this medicine out of the sight and reach of children.

•    Do not use this medicine after the expiry date which is stated on the tube or outer carton. The expiry date refers to the last day of that month.

•    Store in the original container. Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information What Acnecide Wash contains

The active substance is benzoyl peroxide 5% w/w as hydrous benzoyl peroxide in a cleansing gel. The other ingredients are acrylates copolymer, glycerol, carbomer 940, sodium C₁₄-C₁₆ olefin sulfonate, sodium hydroxide (for pH adjustment), and purified water.

What Acnecide Wash looks like and contents of the pack

Acnecide Wash is a white to off-white gel which is available in a 50g and 100g tube, from your pharmacist. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts. WD17 1DS. UK (PL 10590/0026)

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

This leaflet was last revised in 12/2013.

GAL