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

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Clindamycin; Anhydrous Benzoyl Peroxide

Fáanlegur frá:

PCO Manufacturing Ltd.

ATC númer:

D10AF; D10AF51

INN (Alþjóðlegt nafn):

Clindamycin; Anhydrous Benzoyl Peroxide

Skammtar:

10+50 milligram(s)/gram

Lyfjaform:

Gel

Lækningarsvæði:

Antiinfectives for treatment of acne; clindamycin, combinations

Leyfisdagur:

2020-11-13

Upplýsingar fylgiseðill

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DUAC
® ONCE DAILY 10 MG/G + 50 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

Vara einkenni

Health Products Regulatory Authority
13 November 2020
CRN00C00Y
Page 1 of 2
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.
_Product imported from Greece:_
White to slightly yellow homogeneous gel
4 CLINICAL PARTICULARS
As per PA1077/120/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/120/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Carbomer
Dimeticone
Disodium lauryl sulfosuccinate
Disodium edetate
Glycerol
Silica, colloidal hydrated
Poloxamer 182
Purified water
Sodium hydroxide
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the tube and outer package of the product on the market
in the country of origin.
Shelf life of medicinal product after dispensing 2 months.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in a refrigerator (2° C - 8° C). Do not freeze.
Health Products Regulatory Authority
13 November 2020
CRN00C00Y
Page 2 of 2
Storage conditions after dispensing
Do not store above 25° C.
6.5 NATURE AND CONTENTS OF CONTAINER
Tube in an outer carton.
Pack size: 30 g
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/457/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 13
th
November 2020
10 DATE OF REVISION OF THE TEXT