Duac Once Daily 10mg/g + 30mg/g Gel

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

BENZOYL PEROXIDE, HYDROUS, CLINDAMYCIN PHOSPHATE

Tillgänglig från:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ATC-kod:

D10AF51

INN (International namn):

BENZOYL PEROXIDE HYDROUS 30 mg/g CLINDAMYCIN PHOSPHATE 10 mg/g

Läkemedelsform:

GEL

Sammansättning:

BENZOYL PEROXIDE HYDROUS 30 mg/g CLINDAMYCIN PHOSPHATE 10 mg/g

Receptbelagda typ:

POM

Terapiområde:

ANTI-ACNE PREPARATIONS

Bemyndigande status:

Withdrawn

Tillstånd datum:

2013-04-01

Bipacksedel

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 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. I

Produktens egenskaper

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 12
1.
NAME OF THE MEDICINAL PRODUCT
Duac Once Daily 10 mg/g + 30 mg/g Gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of gel contains:
10 mg (1 % w/w) clindamycin as clindamycin phosphate
30 mg (3 % w/w) 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- coloured gel.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Duac Once Daily 10 mg/g + 30 mg/g 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 10 mg/g + 30 mg/g 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).
The safety and efficacy of Duac Once Daily 10 mg/g + 30 mg/g Gel has
not been studied beyond 12
weeks in acne vulgaris clinical trials. Treatment with Duac Once Daily
10 mg/g + 30 mg/g Gel
should not exceed more than 12 weeks of continuous use.
_Paediatric population_
The safety and efficacy of Duac Once Daily 10 mg/g + 30 mg/g Gel has
not been established in
children under 12 years of age, therefore Duac Once Daily 10 mg/g + 30
mg/g Gel is not
recommended for use in this population.
_Elderly patients_
No specific recommendations.
Page 3 of 12
Method of administration
Duac Once Daily 10 mg/g + 30 mg/g Gel should be applied in a thin film
after washing gently with
a mild cleanser and fully drying. If the gel does not r