EPIDUO 0,1 %/2,5 % GEL

Riik: Lõuna-Aafrika Vabariik

keel: inglise

Allikas: South African Health Products Regulatory Authority (SAHPRA)

Saadav alates:

Galderma Laboratories S.A. (Pty) Ltd

Annus:

See ingredients

Ravimvorm:

GEL

Koostis:

EACH 1,0 g GEL CONTAINS ADAPALENE 1,0 mg BENZOYL PEROXIDE 25,0 mg

Volitamisolek:

Registered

Loa andmise kuupäev:

2014-02-10

Infovoldik

_Applicant/PHRC: _
GALDERMA LABORATORIES SOUTH AFRICA (PTY) LTD
_Product proprietary name: _
EPIDUO 0.1 %/ 2.5 %
_Dosage form and strength: _
Gel
1 mg (0,1 %) of adapalene and 25 mg (2,5 %) of benzoyl peroxide per 1
gram
Page 1 of 11
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
EPIDUO® 0,1 % / 2,5 % (GEL)
adapalene and benzoyl peroxide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING EPIDUO 0,1 %
/ 2,5 %.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.
•
Epiduo has been prescribed for you personally and you should not share
your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
WHAT IS IN THIS LEAFLET
1. What Epiduo 0,1 % / 2,5 % is and what it is used for
2. What you need to know before you take Epiduo 0,1 % / 2,5 %
3. How to use Epiduo 0,1 % / 2,5 %
4. Possible side effects
5. How to store Epiduo 0,1 % / 2,5 %
6. Contents of the pack and other information
S3
_Applicant/PHRC: _
GALDERMA LABORATORIES SOUTH AFRICA (PTY) LTD
_Product proprietary name: _
EPIDUO 0.1 %/ 2.5 %
_Dosage form and strength: _
Gel
1 mg (0,1 %) of adapalene and 25 mg (2,5 %) of benzoyl peroxide per 1
gram
Page 2 of 11
1. WHAT EPIDUO 0,1 % / 2,5 % GEL IS AND WHAT IT IS USED FOR
Epiduo is used for the treatment of acne.
This gel combines two active ingredients, adapalene and benzoyl
peroxide which work together but
in different ways:
Adapalene belongs to a group of products known as retinoids and acts
specifically on the skin
processes that cause acne.
The other active ingredient, benzoyl peroxide, works as an
antimicrobial agent and by softening and
peeling the outer layer of the skin.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE EPIDUO 0,1 % / 2,5 %
Always tell your health care provider if you are taking any other
medicine. If you are pregnant or
breast feeding your baby. please consult your health care provider for
advice before using this
medicine.
DO NOT USE EPIDUO
•
If you a

Toote omadused

_Applicant/PHRC: _
GALDERMA LABORATORIES SOUTH AFRICA (PTY) LTD
_Product proprietary name: _
EPIDUO 0.1 %/ 2.5 %
_Dosage form and strength: _
Gel
1 mg (0,1 %) of adapalene and 25 mg (2,5 %) of benzoyl peroxide per 1
gram
Page 1 of 10
PROFESSIONAL INFORMATION
SCHEDULING STATUS: S3
1. NAME OF THE MEDICINE
EPIDUO
® 0,1 % / 2,5 %
®
Gel
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of Epiduo 0,1 % / 2,5 % contains:
Adapalene 1 mg (0,1 %)
Benzoyl peroxide 25 mg (2,5 %)
_Excipients with known with known effect_: Propylene glycol (E1520; 4
%.)
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 in adults,
adolescents and children aged 9 years and over (See section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Applicant/PHRC: _
GALDERMA LABORATORIES SOUTH AFRICA (PTY) LTD
_Product proprietary name: _
EPIDUO 0.1 %/ 2.5 %
_Dosage form and strength: _
Gel
1 mg (0,1 %) of adapalene and 25 mg (2,5 %) of benzoyl peroxide per 1
gram
Page 2 of 10
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, lips and nostrils
(See section 4.4).
If irritation occurs, the patient should be directed to apply
non-comedogenic moisturisers, to use
Epiduo 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.
S
PECIAL POPULATIONS
_Paediatric population _
The safety and effectiveness of Epiduo have not been studied in
children below 9 years of age.
METHOD OF ADMINISTRATION
For external cutaneous use only.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to the active ing