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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLINDAMYCIN PHOSPHATE; Benzoyl peroxide hydrous

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

D10AF; D10AF51

INN (International Name):

CLINDAMYCIN PHOSPHATE; Benzoyl peroxide hydrous

Dosage:

10mg/g + 50 milligram(s)/gram

Pharmaceutical form:

Gel

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Antiinfectives for treatment of acne; clindamycin, combinations

Authorization status:

Marketed

Authorization date:

2005-07-22

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 no

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Duac Once Daily 10mg/g + 50mg/g Gel.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1g of gel contains:
10mg clindamycin as clindamycin phosphate
50mg 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
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