ACNECIDE WASH 5 % W/W GEL

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
BENZOYL PEROXIDE HYDROUS
Available from:
Galderma (UK) Ltd
ATC code:
D10AE01
INN (International Name):
BENZOYL PEROXIDE HYDROUS
Dosage:
5 %w/w
Pharmaceutical form:
Gel
Prescription type:
Product not subject to medical prescription
Therapeutic area:
benzoyl peroxide
Authorization status:
Not Marketed
Authorization number:
PA0590/007/003
Authorization date:
1997-10-31

benzoyl peroxide

Wash 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 WASH 5 GEL

Market: IRL

Article: Leaflet

Flat size: 135x210

Fold size: 135x26,25

Font size: 8 pt

Pharmacode: TBD

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 Wash 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.

- 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 works in two ways. Firstly, it has an antibacterial effect against the bacteria that cause acne. Secondly, it cleanses

the skin by causing the skin to peel.

Acnecide 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 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

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 very sensitive areas of the body. If the preparation enters

the eye, wash thoroughly with water.

Acnecide should not be applied to damaged skin.

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).

Avoid contact with any coloured material including hairs and dyed fabrics as it may result in bleaching or discoloration.

If your condition does not improve or is aggravated discontinue use and consult your doctor or pharmacist.

Using other medicines

You should not use medicines with peeling, irritant and drying effects at the same time as Acnecide.

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 pregnant or may be pregnant or are breast-feeding, do not use Acnecide 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.

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 WASH 5 GEL

Market: IRL

Article: Leaflet

Flat size: 135x210

Fold size: 135x26,25

Font size: 8 pt

Pharmacode: TBD

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

Always use Acnecide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Acnecide is applied to the skin and is for EXTERNAL USE ONLY.

Unless otherwise directed, Acnecide should be applied once or twice daily to cover the affected skin areas. Wet the area to be

treated. Place a small amount of the gel on to the hands to wash the affected area. Contact time with the skin should be 1 to 5

minutes followed by thorough rinsing with water and drying. After use, wash hands thoroughly and replace the 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, wash thoroughly with water.

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 wash

If you apply too much Acnecide, no more rapid or better results will be obtained and severe irritation might develop.

In this event, treatment should be stopped and you should contact your doctor.

In the event that Acnecide is accidentally swallowed, contact your doctor.

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

immediately and consult your doctor or pharmacist.

If any of the side effects gets serious, or 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 or outer carton. The expiry date refers to the last

day of that month.

Do not store above 25ºC.

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 5% w/w benzoyl peroxide in a cleansing gel.

The other ingredients are acrylates copolymer, glycerol, carbomer 940, sodium C

olefin sulfonate, sodium hydroxide,

and purified water.

What Acnecide looks like and contents of the pack

Acnecide 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 (PA 590/7/3)

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 Wash 5 % w/w Gel

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

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

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Gel.

White to off white gel.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Acnecide Wash is intended for the cutaneous treatment of acne vulgaris of the face, chest and back, where comedones,

papules predominate.

4.2 Posology and method of administration

For cutaneous (topical) administration only.

Unless otherwise directed, Acnecide Wash should be applied once or twice daily to cover the affected skin areas.

the area to be treated, apply the preparation to the hands and wash the affected area with the gel.

Contact time with the

skin should be 1 to 5 minutes followed by thorough rinsing with water and drying.

4.3 Contraindications

Hypersensitivity to the ingredients of the preparation.

4.4 Special warnings and precautions for use

For external use only.

In normal use, a mild burning sensation will probably be felt on first application and a moderate 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.

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

discontinued.

If severe irritation occurs, patients should be directed to use the medication less frequently, to temporarily discontinue

use or to discontinue use altogether.

Acnecide Wash 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 Acnecide Wash to

the neck and other sensitive areas.

Due to the risk of sensitisation, Acnecide Wash should not be applied to damaged

skin.

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

2

4

/

1

1

/

2

0

1

7

C

R

N

2

1

9

9

9

7

8

p

a

g

e

n

u

m

b

e

r

:

1

The repeated exposure to sunlight or UV irradiation should be avoided.

Contact with any coloured material including hairs and dyed fabrics may result in bleaching or discoloration.

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 Wash.

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

Acnecide Wash.

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 Wash.

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).

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

2

4

/

1

1

/

2

0

1

7

C

R

N

2

1

9

9

9

7

8

p

a

g

e

n

u

m

b

e

r

:

2

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

Acnecide Wash is for cutaneous use 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 has been shown to have potent broad spectrum antimicrobial activity, particularly against

Propionibacterium acnes which is abnormally present in acne affected hair follicles.

Additionally benzoyl peroxide has

demonstrated exfoliative and comedolytic activities both of which are beneficial in the treatment of acne.

5.2 Pharmacokinetic properties

The percutaneous penetration of benzoyl peroxide in rat, rabbit, monkey and man is low.

The majority of the

penetrated benzoyl peroxide is converted into benzoic acid which after absorption into the systemic circulation is

rapidly eliminated by the kidney.

There is no evidence for any tissue accumulation.

There is no evidence that

cutaneous application of the proposed clinical doses of Acnecide Wash should be associated with any systemic adverse

reactions in humans.

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

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

2

4

/

1

1

/

2

0

1

7

C

R

N

2

1

9

9

9

7

8

p

a

g

e

n

u

m

b

e

r

:

3

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Acrylates copolymer

Glycerol

Carbomer 940 (Carbopol 980)

Sodium C

Olefin Sulfonate

Sodium Hydroxide

Purified Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

18 months.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

White high density polyethylene tube, fitted with a white polypropylene screw cap.

Pack sizes: 50g, 100 g.

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

Squeeze the tube or bottle gently to place on the hands a quantity of gel sufficient to wash the area to be treated.

Wash

hands thoroughly and replace the cap tightly after use.

7 MARKETING AUTHORISATION HOLDER

Galderma (UK) Limited

Meridien House

69-71 Clarendon Road

Watford

Herts

WD17 1DS

8 MARKETING AUTHORISATION NUMBER

PA0590/007/003

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

2

4

/

1

1

/

2

0

1

7

C

R

N

2

1

9

9

9

7

8

p

a

g

e

n

u

m

b

e

r

:

4

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation:

October 1997

Date of last renewal:

October 2007

10 DATE OF REVISION OF THE TEXT

September 2017

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

2

4

/

1

1

/

2

0

1

7

C

R

N

2

1

9

9

9

7

8

p

a

g

e

n

u

m

b

e

r

:

5

Similar products

Search alerts related to this product

View documents history

Share this information