Differin

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Toimeaine:

Adapalene 0.1%{relative};  

Saadav alates:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Rahvusvaheline Nimetus):

Adapalene 0.1% w/w

Annus:

0.1% w/w

Ravimvorm:

Topical cream

Koostis:

Active: Adapalene 0.1%{relative}   Excipient: Carbomer Cyclomethicone Disodium edetate dihydrate Glycerol Macrogol 1000 methyl glucose sesquistearate Methyl hydroxybenzoate Phenoxyethanol Propyl hydroxybenzoate Purified water Sodium hydroxide Squalane

Ühikuid pakis:

Tube, aluminium, epoxy lined, sample, 5 g

Klass:

Prescription

Retsepti tüüp:

Prescription

Valmistatud:

Helsinn Chemicals SA

Näidustused:

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

Toote kokkuvõte:

Package - Contents - Shelf Life: Tube, aluminium, epoxy lined, sample - 5 g - 3 years from date of manufacture stored at or below 25°C - Tube, aluminium, epoxy lined - 30 g - 3 years from date of manufacture stored at or below 25°C - Tube, aluminium, epoxy lined - 50 g - 3 years from date of manufacture stored at or below 25°C

Loa andmise kuupäev:

1997-07-31

Infovoldik

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

Toote omadused

NEW ZEALAND DATASHEET
1 PRODUCT NAME
DIFFERIN

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Adapalene 1 mg/g topical cream
3 PHARMACEUTICAL FORM
DIFFERIN topical cream is a smooth white cream containing 1 mg/g
adapalene.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
DIFFERIN topical cream 0.1% is indicated for the topical treatment of
comedo, papular and
pustular acne (acne vulgaris) of the face, chest or back.
4.2 Dosage and method of administration
A thin film of DIFFERIN topical cream 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 cream has been demonstrated in _311_ patients for up to _12
_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 cream
after three months of use.
The safety and effectiveness of DIFFERIN products have not been
studied in children below
12 years of age.
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.
4.4 Special warnings and precautions for use
FOR EXTERNAL USE ONLY
DIFFERIN topical cream 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 cream should not be used by
patients with eczema,
seborrhoeic dermatitis or severe acne involving large areas of the
body.
If a reaction suggesting severe irri