Duac Once Daily 10mg/g + 50mg/g Gel

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

BENZOYL PEROXIDE; CLINDAMYCIN

Beschikbaar vanaf:

Glaxo SmithKline UK Limited

ATC-code:

D10AF51

INN (Algemene Internationale Benaming):

BENZOYL PEROXIDE; CLINDAMYCIN

farmaceutische vorm:

GEL

Samenstelling:

BENZOYL PEROXIDE 50 mg/g; CLINDAMYCIN 10 mg/g

Prescription-type:

POM

Therapeutisch gebied:

ANTI-ACNE PREPARATIONS

Autorisatie-status:

Authorised

Autorisatie datum:

2005-11-16

Bijsluiter

 
Page 1 of 6 

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

Productkenmerken

Page 1 of 9 

SUMMARY OF PRODUCT CHARACTERISTICS 

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._ _
_Elder