Differine

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ADAPALENE

Available from:

Galderma International Tour Europlaza - 20 Avenue Andre Prothin, La Defense 4, 92 927 Paris La Defense Cedex, France

ATC code:

D10AD03

INN (International Name):

ADAPALENE 0.1 % (W/W)

Pharmaceutical form:

CREAM

Composition:

ADAPALENE 0.1 % (W/W)

Prescription type:

POM

Therapeutic area:

ANTI-ACNE PREPARATIONS

Authorization status:

Authorised

Authorization date:

2007-03-14

Patient Information leaflet

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).
WARNINGS AND PRECAUTIONS
•
Do not use this medicine on areas where you have cuts or scrapes or on
sunburnt skin or if
you have a skin condition called eczema.
•
Avoid contact with the eyes, mouth or angles of the nose, and avoid
other very sensitive areas
of your body. If accidental contact does occur, immediately wash with
warm water.
•
Avoid exposure to strong sunlight and artificial UV light. Use of
sunscreen products and
protective clothing over the treated area is recommended.
•
If you experience sensitivity or irritation whe

Summary of Product characteristics

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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.
1g cream contains 1mg adapalene.
Excipients with known effect:
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Cream
White shiny cream
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
Differin Cream is proposed for the cutaneous treatment of mild to
moderate acne vulgaris where
comedones, papules and pustules predominate. Differin Cream is best
suited for use on dry and fair
skin. Acne of the face, chest or back is appropriate for treatment.
_ _
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION_ _
Differin Cream should be applied to the acne affected areas once a day
before retiring and after
washing. A thin film of cream should be applied, with the fingertips,
avoiding the eyes and lips (see
4.4
_Special warnings and special precautions for use_
, below). Ensure that the affected areas are dry
before application.
Since it is customary to alternate therapies in the treatment of acne,
it is recommended that the
physician assess the continued improvement of the patient after three
months of treatment with
Differin Cream.
With patients for whom it is necessary to reduce the frequency of
application or to temporarily
discontinue treatment, frequency of application may be restored or
therapy resumed once it is
judged that the patient can again tolerate the treatment.
If patients use cosmetics, these should be non-comedogenic and
non-astringent.
_Paediatric population:_
The safety and effectiveness of Differin Cream have not been studied
in
children below 12 years of age.
4.3
CONTRAINDICATIONS
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Pregnancy (see section 4.6).
Women planning a pregnancy.
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If a reaction suggesting sensitivity or severe irritation