Duac Once Daily gel (5% and 1%)

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Benzoyl peroxide; Clindamycin phosphate

Available from:

5% and 1%) (Stiefel Laboratories (UK) Ltd

ATC code:

D10AF51

INN (International Name):

Benzoyl peroxide; Clindamycin phosphate

Dosage:

50mg/1gram ; 10mg/1gram

Pharmaceutical form:

Cutaneous gel

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13060100; GTIN: 5011091104329 5011091105319 5000123114313 5000123114306

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DUAC
® ONCE DAILY 10MG/G + 50MG/G GEL
clindamycin + anhydrous benzoyl peroxide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
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.
WHAT IS IN THIS LEAFLET:
1.
What DUAC ONCE DAILY GEL is and what it is used for
2.
What you need to know before you use DUAC ONCE DAILY GEL
3.
How to use DUAC ONCE DAILY GEL
4.
Possible side effects
5.
How to store DUAC ONCE DAILY GEL
6.
Contents of the pack and other information
1.
WHAT DUAC ONCE DAILY GEL IS AND WHAT IT IS USED FOR
DUAC ONCE DAILY GEL contains two medicines: clindamycin and benzoyl
peroxide. DUAC ONCE
DAILY GEL belongs to a group of medicines known as ‘anti-acne
preparations’.
DUAC ONCE DAILY GEL is used for treating mild to moderate acne on your
skin.

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.
Used together in DUAC ONCE DAILY GEL, these work by:

fighting the bacteria that can cause acne

treating existing blackheads, whiteheads, and spots

lowering the number of red, inflamed acne spots
DUAC ONCE DAILY GEL is for use by adults and adolescents aged twelve
years or over.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DUAC ONCE DAILY GEL
DO NOT USE DUAC ONCE DAILY GEL:

if you are allergic to clindamycin, lincomycin, benzoyl peroxide or
any of the other ingredients of
DUAC ONCE DAILY GEL (listed in Section 6)
Do not use DUAC ONCE DAILY GEL if any of the above apply to you. If
you are

Summary of Product characteristics

OBJECT 1
DUAC ONCE DAILY 10MG/G + 50MG/G GEL
Summary of Product Characteristics Updated 26-Jan-2015 | Stiefel
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:
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
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).
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 g