Acnecide Wash 5% gel

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Benzoyl peroxide

Dostupné z:

Galderma (UK) Ltd

ATC kód:

D10AE01

INN (Medzinárodný Name):

Benzoyl peroxide

Dávkovanie:

50mg/1gram

Forma lieku:

Cutaneous gel

Spôsob podávania:

Cutaneous

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 13060100; GTIN: 5020465200376 5020465201670

Príbalový leták

_LAUNCHING DEPARTMENT - Z.I. Galderma_
_74540 ALBY-SUR-CHERAN - FRANCE_
PMS 432U
DIELINES
Artwork approved by:
Date:
Signature:
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.
BENZOYL PEROXIDE
WASH 5% W/W GEL
Product code: P24221-2
Product description: ACNECIDE W5 GEL 50
Market: GBR
Article: Leaflet
Flat size: 135x210
Fold size: 135x26,25
Font size: 9 pt
Pharmacode: 545
Specification n° MT.09.MPS.0109
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 for acne, where the
skin has a lot of blackheads, spots and pimples.
•
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

Súhrn charakteristických

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 the 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 Wash is intended for the cutaneous treatment of acne vulgaris
of the face,
chest and back, where comedones and 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 2 minutes followed by thorough rinsing with water and drying.
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.
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. If severe irritation
occurs, patients should be directed to use the medication less
frequently, to temporarily
discontinue use or to discontinue use altogether.
Patients should be advised that excessive application will not improve
efficacy, but may increase
the risk of skin irritation.
Concomitant topical acne therapy should be used with caution because a
possible cumulative
irritancy may occur, which sometimes may be severe, especially with
the use of peeling,
desqua