DIFFERIN Cream (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Differin 0.1% w/w Cream.
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. ...
Pharmaceutical form
Cream. White shiny cream.
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 ...
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 ...
Contraindications
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.
Special warnings and precautions for use
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 ...
Interaction with other medicinal products and other forms of interaction
There are no known interactions with other medications which might be used cutaneously and concurrently with Differin Cream; however, other retinoids or drugs with a similar mode of action should not be ...
Fertility, pregnancy and lactation
Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result ...
Effects on ability to drive and use machines
Differin Cream has no influence on the ability to drive and use machines.
Undesirable effects
Differin may cause the following adverse drug reactions: Skin and subcutaneous tissue disorders Common (≥1/100 to <1/10): Dry skin, skin irritation, skin burning sensation, erythema Uncommon (≥1/1000 to ...
Overdose
Differin Cream is not to be taken orally and is for cutaneous use only. If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling or discomfort ...
Pharmacodynamic properties
Pharmacotherapeutic Group: D10A Anti-Acne Preparations for Topical Use ATC code: D10AD03 Adapalene is a retinoid-like compound which in, in vivo and in vitro models of inflammation, has been demonstrated ...
Pharmacokinetic properties
Absorption of adapalene through human skin is low, in clinical trials measurable plasma adapalene levels were not found following chronic cutaneous application to large areas of acneic skin with an analytical ...
Preclinical safety data
In animal studies, adapalene was well tolerated on cutaneous application for periods of up to six months in rabbits and for up to two years in mice. The major symptoms of toxicity found in all animal species ...
List of excipients
Carbomer 934P Macrogol-20 methyl glucose sesquistearate Glycerol (E422) Natural squalane Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Disodium edetate Methyl glucose sesquistearate ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 25°C. Do not freeze. Keep out of the sight and reach of children.
Nature and contents of container
Collapsible Aluminium tube coated internally with an epoxy-phenolic resin and fitted with a white Polypropylene screw cap. Pack sizes 5g (Sample Pack), 30g, 45g and 50g. Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
A thin film of the cream should be applied, avoiding eyes, lips and mucous membranes. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts., WD17 1DS, UK
Marketing authorization number(s)
PL 10590/0029
Date of first authorization / renewal of the authorization
9 January 1998
Date of revision of the text
May 2018
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