DUAC

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

BENZOYL PEROXIDE AS HYDROUS; CLINDAMYCIN AS PHOSPHATE

MAH:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC_code:

D10AF01

pharmaceutical_form:

GEL

composition:

CLINDAMYCIN AS PHOSPHATE 1 %W/W; BENZOYL PEROXIDE AS HYDROUS 5 %W/W

administration_route:

TOPICAL

prescription_type:

Required

manufactured_by:

GLAXO OPERATIONS UK LIMITED (TRADING AS GLAXO WELLCOME OPERATIONS)

therapeutic_group:

CLINDAMYCIN

therapeutic_area:

CLINDAMYCIN

therapeutic_indication:

Mild to moderate acne vulgaris, particulary inflammatory lesions.

authorization_date:

2014-05-31

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Duac Gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of gel contains:
10 mg clindamycin as clindamycin phosphate
50 mg anhydrous benzoyl peroxide as hydrous benzoyl peroxide
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel
White to slightly yellow homogeneous gel
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mild to moderate acne vulgaris, particularly inflammatory lesions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use only.
Posology
_Adults and Adolescents (aged 12 years and above) _
Duac gel should be applied once daily in the evening, to the entire
affected area.
Patients should be advised that excessive application will not improve
efficacy, but may increase
the risk of skin irritation. If excessive dryness or peeling occurs,
frequency of application should be
reduced or application temporarily interrupted (see section 4.4).
An effect on inflammatory and non-inflammatory lesions may be seen as
early as week 2-5 of
treatment (see section 5.1).
The safety and efficacy of Duac Gel has not been studied beyond 12
weeks in acne vulgaris clinical
trials.
Treatment with Duac Gel should not exceed more than 12 weeks of
continuous use.
_Pediatric population _
The safety and efficacy of Duacgel has not been established in
children under 12 years of age,
therefore Duac gel is not recommended for use in this population.
_Elderly patients _
No specific recommendations.
_Method of administration _
Duac Gel should be applied in a thin film after washing gently with a
mild cleanser and fully
drying. If the gel does not rub into the skin easily, too much is
being applied.
Hands should be washed after application
4.3
CONTRAINDICATIONS
Duac Gel must not be administered to patients with known
hypersensitivity to:
- clindamycin
- lincomycin
- benzoyl peroxide
- any of the excipients in the formulation, listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Contact with the mouth, eyes, lips and mucous