DIFFERIN CUTANEOUS SOLUTION 0.1% W/W
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
ADAPALENE
Available from:
Galderma (UK) Ltd
Dosage:
0.1%w/w %w/w
Pharmaceutical form:
Cutaneous Solution
Authorization date:
1993-10-19
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Differin Cutaneous Solution 0.1 % w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Adapalene 0.1 % w/w.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of acne vulgaris of the face, chest and
back where comedones, papules and pustules predominate.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
For topical (cutaneous) administration only.
A thin film of the solution should be applied once a day
before retiring and after washing to the acne-affected areas.
Ensure that the affected areas are dry before application.
Care should be taken to avoid eyes and lips.
It is recommended that the physician assess the continuation
of improvement of the patient after three months of
treatment with Differin Cutaneous Solution.
4.3 CONTRAINDICATIONS
Use in patients hypersensitive to any of the ingredients.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
1.
This product should not come into contact with the eyes, mouth,
angles of the nose, or mucous membranes.
Differin Cutaneous Solution should not be applied to
eczematous skin, cuts and abrasions. Hands should be
washed after use. If the solution enters the eye,
it should be washed immediately with warm water.
2.
If a reaction suggesting sensitivity or severe irritation occurs,
use of the medication should be discontinued. If the
degree of local irritation warrants, patients should be directed
to use the medication less frequently, to
discontinue use temporarily or to discontinue use altogether.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
There are no known interactions with other medicaments which may
be used topically and concurrently with this
IRISH MEDICINES BOARD
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