DUAC Once Daily Gel

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Hydrous Benzoyl Peroxide; CLINDAMYCIN PHOSPHATE

Boleh didapati daripada:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

Hydrous Benzoyl Peroxide; CLINDAMYCIN PHOSPHATE

Unit dalam pakej:

25gm mcg/mL; 30 mcg

Dikeluarkan oleh:

Glaxo Operations UK Ltd. (trdg as Glaxo Wellcome Operations)

Risalah maklumat

_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
DUAC ONCE DAILY GEL
_ _
Clindamycin phosphate/ benzoyl peroxide (10 mg/ 50 mg)
1
WHAT IS IN THIS LEAFLET
1.
What DUAC is used for
2.
How DUAC works
3.
Before you use DUAC
4.
How to use DUAC
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of DUAC
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT DUAC IS USED FOR
Treating mild to moderate acne
on your skin.
DUAC is for use by adults and
adolescents aged twelve years or
over.
HOW DUAC WORKS
DUAC belongs to a group of
medicines known as ‘anti-acne
preparations’.
•
Clindamycin is an antibiotic
which stops the bacteria
involved in acne from
reproducing.
•
Benzoyl peroxide reduces
blackheads and whiteheads. It
also kills the bacteria involved
in acne.
BEFORE YOU USE DUAC
-
_When you must not use it _
Do not use DUAC if you are
allergic to clindamycin,
lincomycin, benzoyl peroxide or
any of the ingredients of DUAC.
Do not give this medicine to
children under twelve years old.
It is not known if it works or if it
is safe for them.
If you are not sure, talk to your
doctor or pharmacist before you
start using DUAC.
Do not use this medication if you
have sensitive skin or if you are
sensitive to benzoyl peroxide.
This product may cause irritation,
characterized by redness,
burning, itching, peeling, or
possible swelling.
-
_Before you start to use it _
_ _
Check with your doctor or
pharmacist before using this
medicine if:
•
You have ever had any
intestinal inflammation.
Clindamycin therapy has been
associated with severe colitis
which may end fatally. It should
be reserved for serious infections
where less toxic antimicrobial
agents are inappropriate. It should
not be used in patients with
nonbacterial infections, such as
most upper respiratory tract
infections.
Its use in newborns is
contraindicated.
_Pregnancy, breast-feeding and _
_fertility _
There is only limited information
about the safety of DUAC in
pregnant women.
If you are preg

Ciri produk

CONFIDENTIAL
DUAC ONCE DAILY GEL
1.
NAME OF THE MEDICINAL PRODUCT
Duac Once Daily 10 mg/g + 50 mg/g Gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of gel contains:
10mg clindamycin as clindamycin phosphate
50mg anhydrous benzoyl peroxide as hydrous benzoyl peroxide
For a 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
Duac Once Daily Gel is indicated for the topical treatment of mild to
moderate acne vulgaris,
particularly inflammatory lesions, in adults and adolescents aged 12
years and above (see sections 4.4
and 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use only.
_Posology _
_Adults and Adolescents(aged 12 years and above) _
Duac Once Daily 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).
CONFIDENTIAL
The safety and efficacy of Duac Once Daily Gel has not been studied
beyond 12 weeks in acne
vulgaris clinical trials. Treatment with Duac Once Daily Gel should
not exceed more than 12 weeks
of continuous use.
_Paediatric population _
The safety and efficacy of Duac Once Daily Gel has not been
established in children under 12 years
of age, therefore Duac Once Daily Gel is not recommended for use in
this population.
_Elderly patients _
No specific recommendations.
Method of administration
Duac Once Daily 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.