ACNEGEL 5.3 Per Cent Gel

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

BENZOYL PEROXIDE

Dostopno od:

Stiefel Laboratories (U.K.) Ltd.

INN (mednarodno ime):

BENZOYL PEROXIDE

Odmerek:

5.3 Per Cent

Farmacevtska oblika:

Gel

Status dovoljenje:

Withdrawn

Datum dovoljenje:

2009-05-08

Lastnosti izdelka

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Acnegel 5% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrous Benzoyl Peroxide equivalent to
anhydrous benzoyl peroxide 5% w/w.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Gel
A white creamy homogeneous gel.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
Acnegel is indicated for the treatment of mild to
moderate acne vulgaris.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Adults
Apply to the whole of the affected
area once or twice daily. Wash with soap and water prior to
application.
Paediatric use
The safety and efficacy of Acnegel has not been established in
children since acne vulgaris rarely presents in this age 
group.
Elderly patients
There are no
specific recommendations. Acne vulgaris does not present in
the elderly.
4.3 CONTRAINDICATIONS
Patients with known hypersensitivity to any
of the ingredients should not use the product.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Avoid contact with the eyes, mouth and
other mucous membranes. Care should be taken when applying
the product to 
the neck and other sensitive areas.
The product may bleach coloured or dyed fabrics.
The product should only be used with caution in areas of thin
or sensitive skin. Fair skinned individuals are likely to be 
particularly sensitive to irritation.
Benzoyl peroxide should not be used in patients with
fair or sensitive skin
if there is concurrent extensive exposure to 
sunlight or ultraviolet light.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 21/10/2005_
_CRN 2015884_
_page number: 1_
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION 
None known.
4.6 PREGNANCY AND LACTATION
There are no restrictions on the use of Acnegel during
pregnancy and l