Acnecide 10% w/w Gel – patient leaflet, side effects, dosage

1. What Acnecide 10% gel is and what it is used for

• Acnecide 10% gel contains the active ingredient benzoyl peroxide which attacks the bacteria (germs) known as Cutibacterium acnes, one of the main causes of acne.
• Your doctor or pharmacist has recommended this medicine to treat your acne. Acne appears as blackheads, whiteheads, pimples and spots. Most often, the out-breaks occur on the face but can also appear on the back, chest, and shoulders.
• Acne of the face, chest or back may be treated with this medicine.

2. What you need to know before you use Acnecide 10% gel

Do not use Acnecide 10% gel 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 10% gel.

• 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 tho-roughly with warm water.
• Acnecide 10% gel should not be applied to damaged skin and infected skin.
• Acnecide 10% gel may cause swelling and blistering of the skin, if any of these symptoms occur, use of the product should be stopped.
• 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 10% gel to the neck and other sensitive areas.
• Avoid repeated exposure to sunlight or other sources of UV light (e.g. sun bed)

Children and adolescents aged less than 12 years

Acnecide 10% gel should not be used by children less than 12 years of age.

Other medicines and Acnecide 10% gel

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 10% gel.
• Do not use Acnecide 10% gel 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.

Driving and using machines.

Acnecide 10% gel has no or negligible effect on your ability to drive or use machines.

Acnecide 10% gel contains propylene glycol.

This medicine contains 40 mg of propylene glycol (E1520) per gram, which is equivalent to 4.0% w/w. It may cause skin irritation.

3. How to use Acnecide 10% gel

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 10% gel 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 Acnecide 10% gel in a thin layer once 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 every two days, until your skin adjusts to the product.
• You should try to avoid exposure to strong sunlight while using Acnecide 10% gel. If exposure is unavoidable, use a sun protection product with a protection factor of at least SPF 30 and UVA protection and apply Acnecide 10% gel in the evening. Remember to wash the affected area before use.
• How long you will have to use Acnecide 10% gel will depend on how quickly your condition improves. After you have used it for one month, you should see your doctor or pharmacist again, who can check the improvement of your skin condition.

Please note that excessive application will not improve effectiveness, but may increase the risk of skin irritation.

NOTICE VERSO 180x315 PLAN n° MT.09.DRA.0352.R02.2

If you use more Acnecide 10% gel 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 10% gel

• Do not 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. In other words, do not use a double dose to make up for a forgotten dose.

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.

Severe allergic reactions have occurred in a small number of people but their frequency is not known.

STOP using Acnecide 10% gel and 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 10% gel may also cause the following side effects:

If your skin becomes severely irritated, or severe redness, itching or peeling of the skin occurs, or if you experience facial swelling, stop use immediately and consult your doctor or pharmacist straight away.

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 (redness, inflammation, bumps, dry and cracked, or a burn-like rash on the skin at the site of exposure). These symptoms are usually reversible if the treatment is reduced in frequency or stopped.

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 the Yellow Card Scheme website (https://yellowcard.mhra.gov.uk) 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 10% gel

• 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 and carton. The expiry date refers to the last day of that month. After first opening the tube, use the medicine within 3 months.
• Do not store above 25°C.
• Store the closed tube away from direct heat.

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 10% gel contains

The active substance is benzoyl peroxide.

Every gram of Acnecide 10% gel contains 100 mg (10%) benzoyl peroxide (as hydrous benzoyl peroxide).

The other ingredients are docusate sodium, disodium edetate, poloxamer, carbomer, propylene glycol (E1520), acrylates copolymer, glycerol, colloidal anhydrous silica, purified water and sodium hydroxide to adjust the pH.

What Acnecide 10% gel looks like and contents of the pack

Acnecide 10% gel is a white to off-white gel. It is available in tubes of 30g and 40g from your pharmacist. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Galderma (UK) Limited, Evergreen House North, Grafton Place, London, NW1 2DX, UK

Tel: 0300 3035674 E-mail: medinfo.uk@galderma.com

PL 10590/0074

Manufacturer: Laboratoires Galderma, ZI- Montdésir, 74540 Alby-sur-Chéran, France.

This leaflet was last revised in May 2025.

1. 7. General advice for people with acne
2. • Try not to touch your face too much and do not pick or squeeze your spots as this can make them worse.
3. • Cleanse your skin and remove make-up with a mild cleanser and water, or an oil-free soap substitute. When cleansing your skin scrubbing too hard can irritate the skin and make your acne worse. Remember, poor washing does not cause blackheads.
4. • Baths and showers should not be too hot as this can strip skin of its natural oils and may make acne worse.
5. • Skin should always be moisturised following cleansing and after applying any treatments as some products can cause drying and redness of the affected skin.
6. • If you use make up, choose products that are oil-free or water-based. Products that are labelled as being ‘non-comedogenic’ (should not cause blackheads or whiteheads) or non-acnegenic (should not cause acne), are less likely to make acne worse.
7. • If you go out in the sun, use a sunscreen. Choose products labelled as oil-free, water based or non-comedogenic, to avoid clogging pores.
8. • Shave carefully. If you shave, you can try both electric and safety razors to see which works best. With safety razors, use a sharp blade. Also, it helps to soften your beard with soap and water before putting on shaving cream. Shave lightly and only when you have to.