ACNECIDE 5% W/W GEL

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
BENZOYL PEROXIDE
Available from:
Galderma (UK) Ltd
ATC code:
D10AE01
INN (International Name):
BENZOYL PEROXIDE
Dosage:
5 %w/w
Pharmaceutical form:
Gel
Prescription type:
Product not subject to medical prescription
Therapeutic area:
benzoyl peroxide
Authorization status:
Marketed
Authorization number:
PA0590/007/001
Authorization date:
1984-04-17

benzoyl peroxide

5% w/w gel

LAUNCHING DEPARTMENT - Z.I. Galderma

74540 ALBY-SUR-CHERAN - FRANCE

PMS 432U

DIELINES

Artwork approved by:

Date:

Signature:

Product code: MOCK UP

Product description: ACNECIDE 5 GEL 60

Market: IRL

Article: Leaflet

Flat size: 135x210

Fold size: 135x26,25

Font size: 8 pt

Pharmacode: TBD

Specification n° MT.09.MPS.0109

This approval applies to whole text

, including barcodes,

pre-printed mentions and legal or special labelling constraints.

PLEASE CHECK PROOF CAREFULLY TO ENSURE ALL ELEMENTS ARE CORRECT.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Acnecide 5% w/w Gel

Benzoyl Peroxide

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Acnecide carefully to get the best results from it.

- Keep this leaflet. You may need to read it again.

- Ask your pharmacist if you need more information or advice.

- You must contact a doctor if your symptoms worsen or do not improve within four weeks.

- If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Acnecide is and what it is used for

2. What you need to know before you use Acnecide

3. How to use Acnecide

4. Possible side effects

5. How to store Acnecide

6. Contents of the pack and other information

1. What Acnecide is and what it is used for

Acnecide contains the active substance 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. Please check by reading the list of ingredients in section 6. If you answer yes, you

must inform your doctor before starting treatment.

Please seek immediate medical attention if you experience symptoms of an allergic reaction. Signs or symptoms of a severe

allergic reaction may include a rash, with or without itching, swelling of the face, eyelids or lips and difficulty in breathing.

Take special care with Acnecide

Avoid contact with the eyes, mouth, angles of the nose or 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.

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).

Fair-skinned individuals are more likely to be susceptible to irritation when using Acnecide.

Using 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.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines

obtained without a prescription.

Pregnancy and breast-feeding

If you are or think you may be pregnant or are breast-feeding, do not use this product unless your doctor has told you that you can.

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

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

Important information about some of the ingredients of Acnecide

Acnecide contains propylene glycol which may cause skin irritation.

VERSION 2

P2XXXX-X

LAUNCHING DEPARTMENT - Z.I. Galderma

74540 ALBY-SUR-CHERAN - FRANCE

PMS 432U

DIELINES

Artwork approved by:

Date:

Signature:

Product code: MOCK UP

Product description: ACNECIDE 5 GEL 60

Market: IRL

Article: Leaflet

Flat size: 135x210

Fold size: 135x26,25

Font size: 8 pt

Pharmacode: TBD

Specification n° MT.09.MPS.0109

This approval applies to whole text, including barcodes,

pre-printed mentions and legal or special labelling constraints.

PLEASE CHECK PROOF CAREFULLY TO ENSURE ALL ELEMENTS ARE CORRECT.

3. How to use Acnecide

Adults and children

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.

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.

If your skin is likely to be exposed to strong sunlight use a suitable sun screen lotion and apply Acnecide in the evening.

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 product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Acnecide can cause side effects, although not everybody gets them.

Acnecide may cause the following side effects:

Very common (occur in more than 1 in 10 patients)

- Dry skin

- Skin reddening

- Skin peeling

- Burning sensation

Common (occur in less than 1 in 10 patients)

- Skin itching

- Skin pain

- Skin irritation

Uncommon (occur in less than 1 in 100 patients)

- Allergic contact reactions

If your skin becomes severely irritated, or redness or peeling occurs, or you experience face swelling, discontinue use imme-

diately and consult your doctor or pharmacist.

While you are using Acnecide

It is normal in the first weeks to experience a feeling of skin tension or a burning, stinging or itching sensation,

and a small amount of peeling or reddening of the skin. These effects are usually mild and can be relieved by the use of a

moisturising cream. They will go when treatment stops or the gel is applied less often.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 (see details below). By reporting side effects, you can help provide more

information on the safety of this medicine.

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail: medsafety@hpra.ie

5. How to store Acnecide

Keep out of the reach and sight of children.

Do not use Acnecide 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines

no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Acnecide contains

The active substance is hydrous benzoyl peroxide equivalent to benzoyl peroxide 5% w/w in an aqueous, non-alcoholic gel base.

The other ingredients are docusate sodium, disodium edetate, poloxamer 182, carbomer 940, propylene glycol, 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 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 (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts,

WD17 1DS, UK (PA 590/7/1)

Manufacturer: Laboratoires Galderma, ZI- Montdésir,

74540 Alby-sur-Chéran, France.

This leaflet was last approved in 06/2017.

VERSION 2

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Acnecide 5% w/w Gel

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Hydrous benzoyl peroxide equivalent to Benzoyl Peroxide 5 % w/w.

Excipients: Propylene glycol 40mg/g

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Gel.

White to off-white, smooth gel.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Acnecide is indicated in the management of acne vulgaris.

4.2 Posology and method of administration

Topical administration 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.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

For external use only.

Acnecide may cause swelling and blistering of the skin, if any of these symptoms occur, medication has to be

discontinued.

If no response occurs within four weeks the use of the product should be discontinued and a doctor consulted.

In any event a single course of treatment should not extend beyond three months.

This product should be kept from contact with eyes, mouth, angles of the nose or mucous membranes.

accidental contact occurs, rinse with water.

Repeated exposure to sunlight or UV radiation should be avoided.

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Fair-skinned individuals are likely to be particularly susceptible to irritation.

If undue redness or discomfort occurs the product should not be used until the doctor has been consulted.

Acnecide may bleach hair and coloured fabrics.

Concurrent use with PABA-containing sunscreens may result in transient discoloration of the skin.

10. Due to the risk of sensitisation Acnecide gel should not be applied to damaged skin.

11. Caution should be exercised when applying Acnecide Gel to the neck and other sensitive areas.

12. 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.

4.5 Interaction with other medicinal products and other forms of interaction

There are no known interactions with other medications which might be used cutaneously and concurrently with

Acnecide Gel.

However, drugs with desquamative, irritant and drying effects should not be used concurrently with

Acnecide Gel.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are limited data on the use of topical benzoyl peroxide in pregnant women. Animal studies do not indicate direct

or indirect harmful effects with respect to reproductive toxicity (see section 5.3). No effects during pregnancy are

anticipated since systemic exposure to benzoyl peroxide is very limited. However, benzoyl peroxide should be used

during pregnancy only if the expected benefit justifies the potential risk to the foetus.

Breast-feeding

It is not known 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.

4.7 Effects on ability to drive and use machines

Based on the pharmacodynamic profile and extensive clinical experience, performance related to driving and using

machines should not be affected during treatment with Acnecide Gel.

4.8 Undesirable effects

The adverse reactions resulting from clinical trials are all skin disorders. They are reversible when treatment is reduced

in frequency or discontinued or by the use of a moisturizing cream.

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).

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They are presented in the table below:

Swelling face and allergic reactions, including application site hypersensitivity and anaphylaxis (not known frequency)

have been reported during postmarketing surveillance.

In case of allergic contact dermatitis or swelling face, treatment should be stopped immediately.

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

4.9 Overdose

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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Benzoyl peroxide is an established and effective keratolytic and comedolytic agent with antibacterial properties.

It has been shown to be effective in reducing the local population of Propionibacterium acnes, leading to a reduction in

the production of irritant fatty acids in the sebaceous glands.

5.2 Pharmacokinetic properties

The pharmacokinetic characteristics for benzoyl peroxide have not been established and little is known about the

percutaneous penetration, metabolism and excretion of benzoyl peroxide, although it is likely that benzoic acid is a

major metabolite.

5.3 Preclinical safety data

An oral administration, fertility and embryo-foetal development study in Sprague-Dawley rats observed effects on

reproductive parameters at exposures considered sufficiently in excess of the maximum human exposure, indicating

little relevance to clinical use. There is no evidence of systemic toxicity caused by benzoyl peroxide in humans. In

animal studies by the cutaneous route, benzoyl peroxide is associated with a minimal to moderate skin irritation

potential including erythema and oedema. Phototoxic and photoallergic reactions have been reported for benzoyl

peroxide therapy.

Skin and subcutaneous tissue disorders

Very common

Dry skin

Erythema

Skin exfoliation (peeling)

Skin burning sensation

Common

Pruritus

Pain of skin (pain, stinging)

Skin irritation (irritant

contact dermatitis)

Uncommon

Allergic contact dermatitis

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6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Docusate sodium

Disodium edetate

Poloxamer 182

Carbomer

Propylene glycol

Acrylates copolymer

Glycerol

Colloidal anhydrous silica

Purified Water

Sodium hydroxide to adjust the pH

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Do not store above 25°C.

Do not freeze.

6.5 Nature and contents of container

White low density polyethylene tubes with white polypropylene screw caps. Pack sizes 30g and 60g.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Galderma (UK) Limited

Meridien House

69-71 Clarendon Road

Watford

Herts

WD17 1DS

8 MARKETING AUTHORISATION NUMBER

PA0590/007/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

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Date of first authorisation:

April 1984

Date of last renewal:

October 2007

10 DATE OF REVISION OF THE TEXT

September 2017

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