Acnecide Wash 5 % w/w Gel

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

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Download Bijsluiter (PIL)
14-09-2023
Download Productkenmerken (SPC)
20-05-2022

Werkstoffen:

Benzoyl Peroxide

Beschikbaar vanaf:

Galderma International

ATC-code:

D10AE; D10AE01

INN (Algemene Internationale Benaming):

Benzoyl Peroxide

Dosering:

5 percent weight/weight

farmaceutische vorm:

Gel

Therapeutisch gebied:

Peroxides; benzoyl peroxide

Autorisatie-status:

Not marketed

Autorisatie datum:

1997-10-31

Bijsluiter

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
ACNECIDE WASH 5% W/W GEL
benzoyl peroxide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist
has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1. What Acnecide Wash is and what it is used for
2. What you need to know before you use Acnecide Wash
3. How to use Acnecide Wash
4. Possible side effects
5. How to store Acnecide Wash
6. Contents of the pack and other information
1. WHAT ACNECIDE WASH IS AND WHAT IT IS USED FOR
•
Acnecide Wash contains the active ingredient benzoyl peroxide which
attacks the bacteria
(germs) known as Propionibacterium acnes, one of the main causes of
acne
.
•
Acnecide Wash is used in the treatment of acne. It is used on the
face, chest or back
where the skin has a lot of blackheads, spots, and pimples.
•
Acnecide Wash 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 Wash 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 WASH
DO NOT USE ACNECIDE WASH 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
                                
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Productkenmerken

                                Health Products Regulatory Authority
19 May 2022
CRN00CX24
Page 1 of 4
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. Wet 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 sens
                                
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