DIFFERIN adapalene 1mg/g gel tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

adapalene, Quantity: 1 mg/g

Available from:

Galderma Australia Pty Ltd

INN (International Name):

Adapalene

Pharmaceutical form:

Gel

Composition:

Excipient Ingredients: propylene glycol; methyl hydroxybenzoate; poloxamer; phenoxyethanol; disodium edetate; purified water; carbomer 940; sodium hydroxide

Administration route:

Topical

Units in package:

5g (sample), 50 g, 30g

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the topical treatment of comedo, papular and pustular acne (acne vulgaris) of the face, chest or back.

Product summary:

Visual Identification: A smooth white aqueous gel; Container Type: Tube; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1995-11-29

Patient Information leaflet

DIFFERIN Gel & Cream 1mg/g Version 2
1
DIFFERIN
® GEL & CREAM
_ _
_Adapalene 1mg/g (0.1%) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DIFFERIN.
It does not contain all the available
information. It does not use the place
of talking to your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you using DIFFERIN against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR MEDICINE.
YOU MAY NEED TO READ IT AGAIN.
WHAT DIFFERIN IS USED
FOR
DIFFERIN contains the active
substance adapalene that belongs to a
group of medicines called retinoids.
DIFFERIN is used for the treatment of
acne (blackheads, whiteheads and
pimples) of the face, chest or back. The
product acts against the abnormal skin
processes associated with acne.
Your doctor, however may prescribe it
for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DIFFERIN
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with a
doctor’s prescription.
DIFFERIN is not addictive.
BEFORE YOU USE
DIFFERIN
_WHEN YOU MUST NOT USE IT _
DO NOT USE DIFFERIN:

if you have an allergy to any
medicine containing adapalene
if you have an allergy to
the active
substance or
any of the excipients listed
at the end of this leaflet
Some of the symptoms of an allergic
reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue or
other parts of the body

rash, itching or hives of the skin
DO NOT USE DIFFERIN AFTER THE
EXPIRY (EXP) DATE PRINTED ON THE
PACK OR IF THE PACKAGING IS TORN OR
SHOWS SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharmacist for disposal.
_BEFORE YOU START TO USE IT_
TELL YOUR DOCTOR IF YOU HAVE ALLERGIES
TO ANY OTHER MEDICINES, FOODS,
PRESERVATIVES OR DYES.
DIFFERIN gel contains methyl
hydroxybenzoate (E218) which may
cause allergic reaction

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
DIFFERIN
® (ADAPALENE) TOPICAL GEL
1
NAME OF THE MEDICINE
Adapalene
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DIFFERIN topical gel is a smooth white gel containing 1 mg/g
adapalene.
EXCIPIENTS WITH KNOWN EFFECT
Methyl hydroxybenzoate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
Topical gel
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DIFFERIN
®
gel 0.1% is indicated for the topical treatment of comedo, papular and
pustular
acne (acne vulgaris) of the face, chest or back.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
A thin film of DIFFERIN Topical Gel should be applied to the affected
areas once a day before
bedtime and after washing avoiding the eyes lips and mucous membranes.
The affected areas
should be dry before application.
Clinical improvement is expected to be evident in four to eight weeks
of treatment, with further
improvement to be expected with continued use. Cutaneous safety of
DIFFERIN topical gel
has been demonstrated in 85 patients for up to 26 weeks of treatment.
Since it is customary
to alternate therapies in the treatment of acne vulgaris, it is
recommended that the physician
assess continued treatment of the patient with DIFFERIN topical gel
after three months of use.
4.3
CONTRAINDICATIONS
Not to be used in patients who are hypersensitive to the active
substance or any of the
excipients.
Pregnancy
Women planning a pregnancy
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_FOR EXTERNAL USE ONLY _
DIFFERIN
gel
should
not
come
into
contact
with
the
eyes,
lips,
mouth
and
mucous
membranes, angles of the nose or broken skin (cuts and abrasions),
sunburn or eczematous
skin, nor should it be used in patients with severe acne involving
large areas of the body. If
product enters the eye, wash immediately with warm water. Because of a
potential for
increased irritation DIFFERIN topical gel should not be used by
patients with eczema,
seborrhoeic dermatitis or severe acne involving large areas of the
body.
If a reaction sug