Differin 0.1% w/w cream

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Adapalene

Inapatikana kutoka:

IMED Healthcare Ltd.

ATC kanuni:

D10AD; D10AD03

INN (Jina la Kimataifa):

Adapalene

Kipimo:

0.1 percent weight/weight

Dawa fomu:

Cream

Dawa ya aina:

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

Eneo la matibabu:

Retinoids for topical use in acne; adapalene

Idhini ya tarehe:

2019-02-01

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
DIFFERIN 0.1% W/W CREAM
adapalene
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 Differin is and what it is used for
2. What you need to know before you use Differin
3. How to use Differin
4. Possible side effects
5. How to store Differin
6. Contents of the pack and other information
1. WHAT DIFFERIN IS AND WHAT IT IS USED FOR
•
The active substance in Differin is adapalene which has
an anti-inflammatory effect reducing soreness and
irritation.
•
It is used on the face, chest or back for acne, where the
skin may have lots of blackheads, spots and pimples.
•
Differin is only absorbed into the body in very small
amounts, and has little effect, except on the surface of
the skin.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DIFFERIN
DO NOT USE DIFFERIN
•
If you are pregnant
•
If you are planning a pregnancy
•
If you are allergic to adapalene or any of the other
ingredients of this medicine (listed in section 6).
Please seek immediate medical attention if you experience
symptoms of an allergic reaction. Signs or symptoms of a
severe allergic reaction may include a rash, with or
without itching, swelling of the face, eyelids or lips and
difficulty in breathing.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Differin.
•
Do not use this medicine on areas where you have cuts
or scrapes, sunburn or if you have a skin condition
called eczema.
•
Avoid contact with the eyes, mouth or angles of the
nose, and avoid other ver

Tabia za bidhaa

Health Products Regulatory Authority
10 October 2022
CRN00D429
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Differin 0.1% w/w cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Adapalene 0.1% w/w
Excipient(s) with known effect:
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
_Product imported from France _
White cream
4 CLINICAL PARTICULARS
As per PA22743/005/001
5 PHARMACOLOGICAL PROPERTIES
As per PA22743/005/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Carbomer 934P
PEG-20 methyl glucose sesquistearate
Glycerol
Natural Squalane
Methyl Parahydroxybenzoate (E218)
Propyl Parahydroxybenzoate (E216)
Disodium edetate
Methyl glucose sesquistearate
Phenoxyethanol
Cyclomethicone
Sodium Hydroxide solution 10 per cent
Purified Water
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 packaging of the product as marketed
in the country of origin.
Health Products Regulatory Authority
10 October 2022
CRN00D429
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C.
Do not freeze.
6.5 NATURE AND CONTENTS OF CONTAINER
Tube with a white screw cap.
Pack size: 30 g
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/120/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 1
st
February 2019
10 DATE OF REVISION OF THE TEXT
October 2022