Acnecide 5% gel

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Benzoyl peroxide

Dostępny od:

Galderma (UK) Ltd

Kod ATC:

D10AE01

INN (International Nazwa):

Benzoyl peroxide

Dawkowanie:

50mg/1gram

Forma farmaceutyczna:

Cutaneous gel

Droga podania:

Cutaneous

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 13060100; GTIN: 5020465125600 5020465200383

Charakterystyka produktu

OBJECT 1
ACNECIDE 5% W/W GEL
Summary of Product Characteristics Updated 18-Jan-2018 | Galderma
(U.K) Ltd
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
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Topical Gel
White to off-white, smooth gel
4. Clinical particulars
4.1 Therapeutic indications
Topical therapy for the treatment of acne vulgaris
4.2 Posology and method of administration
For external use 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
For external use only.
Acnecide may cause swelling and blistering of the skin, if any of
these symptoms occur, medication has
to be discontinued.
A mild burning sensation will probably be felt on first application
and some 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, desquamating, or abrasive
agents.
Benz