ACNECIDE WASH 5 % W/W GEL

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

BENZOYL PEROXIDE HYDROUS

Disponibbli minn:

Galderma (UK) Ltd

Kodiċi ATC:

D10AE01

INN (Isem Internazzjonali):

BENZOYL PEROXIDE HYDROUS

Dożaġġ:

5 %w/w

Għamla farmaċewtika:

Gel

Tip ta 'preskrizzjoni:

Product not subject to medical prescription

Żona terapewtika:

benzoyl peroxide

L-istatus ta 'awtorizzazzjoni:

Not Marketed

Data ta 'l-awtorizzazzjoni:

1997-10-31

Fuljett ta 'informazzjoni

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 (list

Karatteristiċi tal-prodott

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 sensitisation, Acnecide Wash should not be applied
to damaged
skin.
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