ACNECIDE 5% W/W GEL

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

BENZOYL PEROXIDE

Commercializzato da:

Galderma (UK) Ltd

Codice ATC:

D10AE01

INN (Nome Internazionale):

BENZOYL PEROXIDE

Dosaggio:

5 %w/w

Forma farmaceutica:

Gel

Tipo di ricetta:

Product not subject to medical prescription

Area terapeutica:

benzoyl peroxide

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

1984-04-17

Foglio illustrativo

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

Scheda tecnica

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
1.
For external use only.
2.
Acnecide may cause swelling and blistering of the skin, if any of
these symptoms occur, medication has to be
discontinued.
3.
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.
4.
This product should be kept from contact with eyes, mouth, angles of
the nose or mucous membranes.
If
accidental contact occurs, rinse with water.
5.
Repeated exposure to sunlight or UV radiation should be avoided.
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