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Cepton Benzoyl Peroxide 5% W/W Gel

Document: leaflet MAH BRAND_PL 39974-0017 change

PATIENT INFORMATION LEAFLET

Cepton Benzoyl Peroxide 5% w/w Gel & Cepton Benzoyl Peroxide 10% w/w Gel

Throughout this leaflet Cepton Benzoyl Peroxide 5% w/w Gel is referred as Benzoyl Peroxide 5% and Cepton Benzoyl Peroxide 10% w/w Gel is referred as Benzoyl Peroxide 10%

What is in Benzoyl Peroxide?

Benzoyl Peroxide 5% w/w Gel contains 30g & 40g of 5% w/w Benzoyl Peroxide in a water-based gel.

Benzoyl Peroxide 10% w/w Gel contains 30g & 40g of 10% w/w Benzoyl Peroxide in a water-based gel.

Benzoyl Peroxide also contains the inactive ingredients:

Carbomer 980, Polyoxyethylene 23 lauryl ether, Propylene glycol, Sodium hydroxide and Purified water.

Benzoyl Peroxide is supplied in 30g & 40g tubes.

Benzoyl Peroxide stops the growth of the bacteria that cause acne.

Marketing Authorisation Holder:

Boston Healthcare Limited, 6 Navigation Court, Calder Park, Wakefield, West Yorkshire WF2 7BJ.

Manufacturer:

Pannoc Chemie N.V., Lammerdries 23, 2250 Olen, Belgium.

Uses

Benzoyl Peroxide is used for all stages of common acne. Benzoyl Peroxide attacks the bacteria (Propionibacterium acnes) that play an essential part in causing acne. Benzoyl Peroxide also sheds the dead cells from the skin surface and may cause dryness. You should not use Benzoyl Peroxide if you are hypersensitive to Benzoyl Peroxide or any other ingredients. Since this is an oxidising agent, you should not use at the same time as other topical agents, which would react with an oxidising agent.

What you should know before using Benzoyl Peroxide.

Benzoyl Peroxide is for topical use only. This means that it is put on the skin. Do not allow the gel to touch your eyes, mouth or the inside of your nostrils. If you expose your skin to sun for a long time, or to strong sun, you should use a high protection sunscreen preparation. You should also apply the gel less often than usual. Make sure that your skin is dry when you apply Benzoyl Peroxide to avoid unnecessary irritation.

Care should be taken to avoid contact with dyed fabrics as this product may adversely affect dye fastness.

Important information about some of the ingredients of Benzoyl Peroxide

This product also contains Propylene glycol which may cause skin irritation.

How to use Benzoyl Peroxide

Unless your doctor of pharmacist has told you otherwise start treatment with Benzoyl Peroxide 5% once a day. The evening is the best time. Wash the whole area that is affected by acne with soap and water, and then dry it thoroughly before gently rubbing in Benzoyl Peroxide.

Allow the gel to dry before going to bed, so as to avoid bleaching the bed cloths.

For particularly sensitive skin, it may be necessary to limit the application to every 2nd day.

For stubborn cases treatment may be continued with Benzoyl Peroxide 10%.

Ask your doctor or pharmacist

If your acne does not improve after 3 months, talk to your doctor or pharmacist.

Overdosage

If Benzoyl Peroxide is accidentally swallowed, then contact your nearest casualty department immediately.

Side-effects

Itching, reddening, burning and a feeling of tightness on the skin can occur with Benzoyl Peroxide during the first few days of treatment. These symptoms usually get better. If not you can stop treatment for a while or use a moisturising cream. If symptoms persist tell your doctor or pharmacist. In some cases it may cause face oedema (swelling of the face). In rare cases a rash (contact dermatitis) can occur. If it does, you should stop using the gel at once and go to your doctor or pharmacist.

You should ask your doctor or pharmacist about any change in your health or general sense of well-being that you notice while using Benzoyl Peroxide.

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.

Expiry date: The expiry date is printed on the pack. Do not use after this date.

Storage: Do not store above 25° C. Keep out of the reach and sight of children.

Cepton Benzoyl Peroxide 5% w/w Gel: PL 39974/0017 Cepton Benzoyl Peroxide 10% w/w Gel: PL 39974/0018

Date of last revision: June 2015