Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Benzoyl peroxide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Acnecide 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 and whiteheads which people often refer to as pimples or spots. Acne of the face, chest or back may be treated with this medicine.
e Acnecide Do not use Acnecide if you are: Allergic (hypersensitive) to 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 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. e 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. This medicine contains 40 mg of propylene glycol (E1520) per gram, which is equivalent to 4.0 % It may cause skin irritation.
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 i.e. to once a day or once every two Any drying or peeling which may occur to your skin may be reduced if you alter the number of times you 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 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. –
Galderma Laboratories
Printing Colors
Product code: P200907-1 Product description: ACNECIDE 5 GEL Market: GBR Article: Leaflet Font size: 9 pt Flat size: 180×315 Fold size: 180×26,25 Pharmacode: 4615
PMS 432U
LABORATOIRES
GALDERMA
Galderma
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FRANCE 74540 ALBY-SUR-CHERAN
DIELINES
NOTICE VERSO 180×315 PLAN 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.
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 Dryskin 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) 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 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. –
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Acnecide 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. Do not store above 25°C. Do not freeze. 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.
What Acnecide contains peroxide 5% w/w in an aqueous, non-alcoholic gel base. The active substance is hydrous benzoyl peroxide equivalent to The other ingredients are docusate sodium, disodium edetate, poloxamer 182, carbomer 940, propylene glycol (E1520), 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 tubes of 15g, 30g and 60g from your pharmacist or on prescription from your doctor. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Galderma (U.K.) Limited, Evergreen House North, Grafton Place, London, England, NW1 2DX (PL 10590/0006) Manufacturer: Laboratoires Galderma, Montdésir, 74540 Alby-sur-Chéran, France.
GALDERMA Galderma Laboratories
Printing Colors
Product code: P200907-1 Product description: ACNECIDE 5 GEL Market: GBR Article: Leaflet Font size: 9 pt Flat size: 180×315 Fold size: 180×26,25 Pharmacode: 4615
PMS 432U
G AL
RM
DIELINES
P200907-1
This leaflet was last revised in 10/2022.
Acnecide 5% w/w Gel comes as gel. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Acnecide 5% w/w Gel is benzoyl peroxide.
Medicines with the same active substance, strength and form include: Acnecide 10% w/w Gel, Acnecide Face 2.5% w/w Gel, Acnecide Face 5% w/w Gel. In total there are 5 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Acnecide 5% w/w Gel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Topical therapy for the treatment of acne vulgaris
For external use only.
Adults and children:
Before each application, the skin should be cleaned and dried. Apply in a thin layer once or twice daily or as directed to the affected areas. Persons with sensitive skin should be directed to apply the gel once daily before going to bed. The extent of any drying or peeling may be adjusted by modifying the dosage schedule.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
For external use only.
Acnecide may cause swelling and blistering of the skin, if any of these symptoms occur, medication has to be discontinued.
A mild burning sensation will probably be felt on first application and some reddening and peeling of the skin will occur within a few days. During the first weeks of treatment a sudden increase in peeling will occur in most patients. This is not harmful and will normally subside within a day or two if treatment is temporarily discontinued. If severe irritation occurs, patients should be directed to use the medication less frequently, to temporarily discontinue use or to discontinue use altogether.
Patients should be advised that excessive application will not improve efficacy, but may increase the risk of skin irritation.
Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy may occur, which sometimes may be severe, especially with the use of peeling, desquamating, or abrasive agents.
Benzoyl peroxide gel should not come into contact with the eyes, mouth, angles of the nose or mucous membranes. If the preparation enters the eye, wash thoroughly with water. Caution should be exercised when applying the drug to the neck and other sensitive areas.
As Acnecide may cause increased sensitivity to sunlight, sunlamps should not be used and deliberate or prolonged exposure to sunlight or UV radiation should be avoided or minimised. When strong sunlight cannot be avoided, patients should be advised to use a sunscreen product and wear protective clothing.
Contact with any coloured material including hair and dyed fabrics may result in bleaching or discoloration.
Due to the risk of sensitisation, benzoyl peroxide gel should not be applied on damaged skin.
This medicine contains 40 mg of propylene glycol (E1520) in each gram, which is equivalent to 4.0 % w/w. It may cause skin irritation.
No interaction studies have been performed; however, drugs with desquamative, irritant and drying effects should not be used concurrently with benzoyl peroxide gel.
Pregnancy
There is no safety concern relating to the effects of cutaneously applied benzoyl peroxide on reproductive function, fertility, teratogenicity, embryotoxicity, or peri- and post- natal development from animal data. In widespread clinical use for the cutaneous treatment of acne vulgaris, at concentrations up to 10% w/w for several decades, benzoyl peroxide has never been associated with such effects. Acnecide should only be used by a pregnant woman if clearly needed.
Breast-feeding
It is unknown whether benzoyl peroxide/metabolites are excreted in human milk. A risk to the new-borns/infants cannot be excluded. Caution should be exercised when benzoyl peroxide is administered to a nursing woman and the preparation should not be applied on the chest to avoid accidental transfer to the infant.
Acnecide Gel has no or negligible influence on the ability to drive and use machines.
The adverse reactions resulting from clinical trials are all skin disorders. They are reversible when treatment is reduced in frequency or discontinued.
The following categories are used to indicate the frequency of occurrence of adverse effects:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥ 1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (Frequency not assessable based on the available data).
They are presented in the table below:
Skin and subcutaneous tissue disorders
Very common (≥1/10)
Dry skin
Erythema
Skin exfoliation (peeling)
Skin burning sensation
Common
(≥1/100 to <1/10)
Pruritus
Pain of skin (pain, stinging), Skin irritation (irritant contact dermatitis)
Uncommon (≥1/1,000 to <1/100)
Allergic contact dermatitis
Swelling face and allergic reactions, including application site hypersensitivity and anaphylaxis (not know frequency) have been reported during post-marketing surveillance.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
Benzoyl peroxide gel is a preparation indicated for topical treatment only. If the medication is applied excessively, no more rapid or better results will be obtained and severe irritation might develop. In this event, treatment must be discontinued and appropriate symptomatic therapy should be instituted.
Ask anything about Acnecide 5% w/w Gel. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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