E45 Itch Relief Cream

Summary of Product Characteristics Updated 08-Jun-2020 | Forum Health Products Limited

1. Name of the medicinal product

E45 Itch Relief Cream

2. Qualitative and quantitative composition

Active ingredient

Percentage (w/w)

Lauromacrogols

3.0 %

Urea

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

Posology

Adults:

E45 Itch Relief Cream should be applied to each affected area twice a day. The duration of treatment depends on the clinical response.

Elderly:

There is no indication that the dosage needs to be modified for the elderly.

Paediatric Populations

Children and infants over the age of 1 month:

There is no indication that the dosage needs to be modified for children or babies.

Method of administration

Topical application to the skin.

4.3 Contraindications

Patients with known hypersensitivity lauromacrogols, urea or to any of the excipients listed in section 6.1. 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.

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

4.5 Interaction with other medicinal products and other forms of interaction

Urea may increase penetration through the skin barrier of other topically applied medicines (e.g. corticosteroids, dithranol and fluorouracil) when used at the same time.

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

Adverse events which have been associated with urea; lauromacrogols are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

System Organ Class

Frequency

Adverse Events

Immune System Disorders

Not known

Hypersensitivity

Skin and Subcutaneous Tissue Disorders

Not known

Application site pustules; skin burning sensation; pruritus; erythema

Reporting of Suspected Adverse Reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Symptoms

Overdose is very unlikely with a topical cream.

If overdose is suspected in young children or babies, seek the advice of a healthcare professional, since blood-urea concentrations may increase.

Management

In the unlikely event of an overdose, treatment should be symptomatic and supportive.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antipruritics, Incl. Antihistamines, Anaesthetics, etc.; Other Antipruritics;

ATC Code: D04AX

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 Special precautions for disposal and other 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(s)

PL 00327/0122

9. Date of first authorisation/renewal of the authorisation

19 October 1999

10. Date of revision of the text

05 May 2020

Company Contact Details
Forum Health Products Limited
Address

Crown House, 2-8 Gloucester Road, Redhill, Surrey, RH1 1FH

Telephone

+44 (0)1737 857 700

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01737 857700

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http://www.forum.co.uk

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+44 (0) 1737 857701

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01737 857700