E45 Itch Relief Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
E45 Itch Relief Cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Lauromacrogols
Urea
Percentage (w/w)
3.0 % 5.0%
3. PHARMACEUTICAL FORM
Cream
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of pruritus, eczema, dermatitis, and scaling skin conditions where an antipruritic and/or hydrating effect is required. It may also be used for the continued treatment and follow-up treatment of these skin diseases.
4.2 Posology and method of administration
Adults, the elderly, children and infants over the age of 1 month: E45 Itch Relief Cream should be applied to each affected area twice a day. The duration of treatment depends on the clinical response.
4.3 Contraindications
Patients with known hypersensitivity to any of the ingredients. It should not be used to treat acute erythroderma, acute inflammatory, oozing or infected skin lesions.
4.4 Special warnings and precautions for use
E45 Itch Relief Cream may cause irritation if applied to broken or inflamed skin.
4.5 Interactions with other Medicinal products and other forms of interaction
None known.
4.6 Pregnancy and lactation
There are no specific restrictions concerning its use during pregnancy, but it is not to be used on the breasts immediately prior to breast feeding during lactation.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
E45 Itch Relief Cream has been reported to cause a burning sensation, erythema, pruritus or the formation of pustules. Contact allergy has also been reported.
4.9 Overdose
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Urea is a physiological product derived from human protein metabolism. It is found naturally in the skin and when applied topically it can increase the horny layer’s capacity to retain water. E45 Itch Relief Cream has been shown to increase skin hydration and when used as recommended provides hydration for 24 hours. Patients with eczema and psoriasis have been shown to have decreased levels of urea in their skin. Urea is not allergenic and is well-tolerated at a concentration of 5%.
Lauromacrogols have the properties of a topical anaesthetic and have an antipruritic effect. The local tolerability of lauromacrogols is good.
E45 Itch Relief Cream has also been shown to increase the lipid content of the epidermis thus, soothing and smoothing the skin.
5.2 Pharmacokinetic properties
Little urea is absorbed after topical application. It is mainly excreted in the urine, and to a lesser extent in perspiration.
There is no evidence of systemic availability of lauromacrogols after topical administration.
5.3 Preclinical safety data
No specific studies have been performed with E45 Itch Relief Cream. Urea and lauromacrogols have been used therapeutically for many years in humans. Information from animal studies are unlikely to provide any further relevant information.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Dimeticone, phenyl dimeticone, liquid paraffin, cetyl palmitate, stearic palmitic acid, octyldodecanol, glycerol 85%, polysorbate, carbomer, trometamol, benzyl alcohol, purified water.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
24 months
6.4. Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Aluminium tubes with double internal lacquer of epoxy phenol resin and closure made of polyoxyethylene. Content: 10g, 35g, 50g, 60g, 75g, 100g and 110g.
Plastic pump dispensers. Content: 175g, 200g and 500g.
A pump pack, made of polypropylene and polyethylene, consisting of a piston pump system with an airless dispenser. Pack size: 500g
Not all pack sizes are necessarily marketed.
6.6. Instruction for use and handling
None stated.
7. MARKETING AUTHORISATION HOLDER
Crookes Healthcare Limited Trading as Crookes Healthcare 1 Thane Road West Nottingham NG2 3AA United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 00327/0122
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
19 October 1999
10
DATE OF REVISION OF THE TEXT
08/08/2014