EPIDUO GEL 0.1%2.5%

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Adapalene; Benzoyl peroxide

Available from:

GALDERMA SINGAPORE PRIVATE LIMITED

ATC code:

D10AD53

Dosage:

0.10%

Pharmaceutical form:

GEL

Composition:

Adapalene 0.10%; Benzoyl peroxide 2.50%

Administration route:

TOPICAL

Prescription type:

Prescription Only

Manufactured by:

LABORATOIRES GALDERMA

Authorization status:

ACTIVE

Authorization date:

2010-04-21

Patient Information leaflet

ADAPALENE / BENZOYL PEROXIDE
0.1% / 2.5% GEL
®
Product code: P24519-3
Product description: EPIDUO DS GEL
Market: EX2
Article: Leaflet
Flat size: 180x315
Fold size: 180x26,25
PMS 432U
DIELINES
Artwork approved by:
Date:
Signature:
Font size: 7 pt
Pharmacode: 418
Specification n° MT.09.MPS.1470
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_LAUNCHING DEPARTMENT - Z.I. Galderma_
_74540 ALBY-SUR-CHERAN - FRANCE_
POM ONLY
FOR TOPICAL USE ONLY
DESCRIPTION
Epiduo 0.1% / 2.5% gel is a white to very pale yellow opaque gel.
Each gram of gel contains: Adapalene 1mg (0.1%) and Benzoyl Peroxide 25mg (2.5%).
Excipient: Propylene glycol.
For a full list of excipients, see PHARMACEUTICAL PARTICULARS
  INDICATIONS
Cutaneous treatment of _Acne vulgaris _when comedones, papules and pustules are present.
POSOLOGY AND METHOD OF ADMINISTRATION
EPIDUO should be applied to the entire acne affected areas once a day in the evening on a clean and dry skin. A thin film of gel should be applied, with the fingertips, avoiding the eyes and lips
(see SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
If irritation occurs, the patient should be directed to apply non-comedogenic moisturizers, to use the medication less frequently (e.g. every other day), to suspend use temporarily, or to discontinue
use altogether.
The duration of treatment should be determined by the Doctor on the basis of the clinical condition. Early signs of clinical improvement usually appear after 1 to 4 weeks of treatment.
The safety and effectiveness of EPIDUO have not been studied in children below 9 years of age.
CONTRAINDICATIONS
Hypersensitivity to the a

Summary of Product characteristics

NOTICE RECTO 180x315
PLAN n° MT.09.DRA.0352.R02.2
PMS 432U
DIELINES
Artwork approved by:
Date:
Signature:
This approval applies to WHOLE TEXT, including barcodes,
pre-printed mentions and legal or special labelling constraints.
PLEASE CHECK PROOF CAREFULLY TO ENSURE ALL ELEMENTS ARE CORRECT.
Product code: MOCK UP
Product description: EPIDUO GEL
Market: EX2
Article: Leaflet
Flat size: 180x315
Fold size: 180x26,25
Font size: 7,5 pt
Pharmacode: TBD
_GRAPHIC DESIGNER: Guillaume ANDRÉ_
_INDUSTRIALIZATION DEPARTMENT_
_LABORATOIRES GALDERMA - Z.I. Galderma - 74540 ALBY-SUR-CHÉRAN -
FRANCE_
adapalene / benzoyl peroxide
0.1% / 2.5% GEL
®
POM ONLY
FOR TOPICAL USE ONLY
1. NAME OF THE MEDICINAL PRODUCT
Epiduo 0.1% / 2.5% gel
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of gel contains:
Adapalene 1 mg (0.1%)
Benzoyl Peroxide 25 mg (2.5%)
Excipient with known effect: Propylene glycol.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Gel.
A white to very pale yellow opaque gel.
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Cutaneous treatment of _Acne vulgaris_ when comedones, papules and
pustules are present (See
section 5.1).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Epiduo should be applied to the entire acne affected areas once a day
in the evening on a clean
and dry skin. A thin film of gel should be applied, with the
fingertips, avoiding the eyes and lips
(see section 4.4).
If irritation occurs, the patient should be directed to apply
non-comedogenic moisturizers, to
use the medication less frequently (e.g. every other day), to suspend
use temporarily, or to
discontinue use altogether.
The duration of treatment should be determined by the Doctor on the
basis of the clinical
condition. Early signs of clinical improvement usually appear after 1
to 4 weeks of treatment.
The safety and effectiveness of Epiduo have not been studied in
children below 9 years of age.
4.3.
CONTRAINDICATIONS
Pregnancy (see section 4.6).
Women planning a pregnancy.
Hypersensitivity to the active substances or t