Eucerin Intensive Lotion 10% W/W Cutaneous Emulsion
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eucerin Intensive Lotion 10% w/w Cutaneous Emulsion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Urea 10% w/w
Contains castor oil, polyoxyl hydrogenated.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Cutaneous emulsion.
A white, shiny smooth viscous emulsion.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of ichthyosis, xeroderma (especially in the elderly), hyperkeratosis and other chronic dry skin conditions such as atopic eczema (dermatitis).
4.2 Posology and method of administration
Eucerin Intensive Lotion 10% w/w Cutaneous Emulsion should be applied twice daily or as directed by a doctor to the affected areas and gently massaged into the skin. It should not be allowed to come into contact with the eyes. It should not be applied on large areas in patients with renal insufficiency.
The duration of use depends on the particular condition of the skin and should be established on an individual basis.
Contraindications
4.3
Eucerin Intensive Lotion 10% w/w Cutaneous Emulsion should not be used in patients with a known hypersensitivity to any of the ingredients. It should not be used to treat excoriated acute inflammation of the skin. It should not be used on large areas in patients with renal insufficiency.
4.4 Special warnings and precautions for use
A doctor should be consulted if symptoms persist.
Application of the product to broken skin should be avoided.
4.5 Interaction with other medicinal products and other forms of interaction
Urea may potentiate the release of active substances from topical preparations and their penetration into the skin. This is known in particular for corticosteroids, dithranol and fluorouracil.
4.6 Pregnancy and lactation
There are no known risks.
4.7 Effects on ability to drive and use machines
No effects would be anticipated.
4.8 Undesirable effects
Local skin irritation may occasionally occur particularly if the product is applied in acute inflammatory skin conditions or to sensitive skin. If the condition is aggravated or if there is no improvement the doctor should be consulted.
4.9 Overdose
Excessive topical use or overdose may cause skin irritation. This tends to resolve quickly and automatically when use of the product is discontinued.
Accidental ingestion of the lotion is unlikely to produce toxic effects as oral doses of up to 100g/day urea (present in four 250 ml bottles of lotion) are considered safe.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC Code: DO2A E Carbamide products Urea acts as a hydrating and keratolytic agent.
5.2 Pharmacokinetic properties
Only a small percentage of the amount of the urea applied to the skin penetrates to the epidermis and dermis. Urea is primarily excreted unchanged in the urine. A small amount is also eliminated in the sweat.
5.3 Preclinical safety data
In man, doses of up to 80g/day iv or 100g/day p.o. urea are considered safe. Such high doses of urea are not absorbed following topical use, even when the whole body is treated exclusively externally.
Whilst only very limited preclinical data are available, there is no evidence to suggest that urea would have teratogenic, carcinogenic or mutagenic potential in therapeutic use.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Benzyl Alcohol
PEG-45/dodecyl glycol copolymer (Elfacos ST 9)
Methoxy PEG-22/dodecyl glycol copolymer (Elfacos E 200)
Sorbitan isostearate, PEG-2 hydrogenated castor oil, ozokerite, hydrogenated castor oil (Arlacel 582)
PEG-7 hydrogenated castor oil (Cremophor WO 7)
Light Liquid Paraffin Isopropyl Palmitate Medium-chain Triglycerides Octyldodecanol Glycerol 85%
Sodium Lactate Solution Lactic Acid Magnesium Sulphate Dimethicone Purified Water
6.2 Incompatibilities
Not applicable
6.3 Shelf life
Three years.
6.4 Special precautions for storage
Do not store above 25 °C.
6.5 Nature and contents of container
HDPE bottle with PP closure with a LDPE insert or PP flip top closure. Pack sizes: 30 ml, 150 ml and 250 ml Not all pack sizes may be marketed.
Special precautions for disposal and other handling
6.6
No special requirements.
7. MARKETING AUTHORISATION HOLDER
Beiersdorf UK Limited,
2010 Solihull Parkway,
Birmingham Business Park,
Birmingham B37 7YS.
8. MARKETING AUTHORISATION NUMBER
PL 14160/0004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/03/2009
10 DATE OF REVISION OF THE TEXT
13/09/2010