Duac Once Daily gel (3% and 1%)

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Clindamycin phosphate; Benzoyl peroxide

Հասանելի է:

3% and 1%) (Stiefel Laboratories (UK) Ltd

ATC կոդը:

D10AE51

INN (Միջազգային անվանումը):

Clindamycin phosphate; Benzoyl peroxide

Դոզան:

10mg/1gram ; 30mg/1gram

Դեղագործական ձեւ:

Cutaneous gel

Կառավարման երթուղին:

Cutaneous

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 13060100; GTIN: 5000123114061 5000123114290

Տեղեկատվական թերթիկ

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DUAC
® ONCE DAILY 10 MG/G + 30 MG/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 ar

Ապրանքի հատկությունները

OBJECT 1
DUAC ONCE DAILY 10 MG/G + 30 MG/G GEL
Summary of Product Characteristics Updated 02-Mar-2018 | Stiefel
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.
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