SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Nutraplus Duo 10%/5% w/w Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

One gram of cream contains 100 mg of Urea and 50 mg of Lactic acid. For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Cream

A homogenous, white, oil-in-water cream

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

To be applied topically for the correction of hyperkeratosis and dryness in ichthyosis and allied conditions characterised by dry, rough, scaly skin.

4.2    Posology and method of administration

For external use only.

Adults, elderly and children:

A thick layer of Nutraplus Duo is applied twice daily after washing the affected area. The cream is left on the skin for 3-5 minutes and then rubbed lightly in. Excess cream should be wiped off the skin with a tissue, not washed off. Frequency of application can be reduced as the patient progresses. In hyperkeratosis of the feet apply Nutraplus Duo as above after soaking the feet in warm water for 15 minutes and drying with a rough towel.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Nutraplus Duo is acidic and hypertonic and can cause smarting if applied to raw areas, fissures or mucous membranes. Where this is a barrier to therapy the use of Nutraplus Duo diluted 50% with aqueous cream B.P. for one week should result in freedom from smarting upon use of Nutraplus Duo.

4.5    Interaction with other medicinal products and other forms of interaction

Low pH of cream might affect stability of other drugs.

4.6    Fertility, pregnancy and lactation

There is no specific data available regarding the use in pregnant women and during lactation.

4.7    Effects on ability to drive and use machines

Nutraplus Duo has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Nutraplus Duo is acidic and hypertonic and can cause smarting if applied to raw areas, fissures or mucous membranes.

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. Website: www.mhra.gov.uk/yellowcard

4.9 Overdose

Unlikely. In the case of smarting, wash the cream off.

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Carbomide products ATC code: D02AE

Urea at a concentration of 10% has keratolytic, anti microbial, anti pruritic and hydrating effects on the skin. Lactic acid has keratolytic, hydrating and anti microbial properties also. Treatment of ichthyotic patients shows a parallel between clinical improvement and increase in the otherwise depressed binding capacity of the horny layer.

5.2    Pharmacokinetic properties

Not applicable.

5.3    Preclinical safety data

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Glyceryl Monostearate Betaine Monohydrate

Diethanolamine Cetylphosphate (''Amphisol'')

Hard Fat

Cholesterol

Sodium chloride

Purified water

Incompatibilities

The low pH due to lactic acid means care in choice of other packages or other drugs admixed.

6.3 Shelf life 2 years

6.4 Special precautions for storage

Do not store above 25°C. Do not refrigerate or freeze.

6.5 Nature and contents of container

Tubes

White low density polyethylene tubes fitted with white polypropylene screw caps

Package sizes: 15, 20, 30, 50, 100 g.

Pump dispenser

White polypropylene bottle fitted with a white polyethylene closure and a natural polyethylene follower plate.

Package sizes: 400, 500 g.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7    MARKETING AUTHORISATION HOLDER

Galderma (UK) Limited Meridien House 69-71 Clarendon Road Watford Herts.

WD17 1DS UK

MARKETING AUTHORISATION NUMBER(S)

PL 10590/0055

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

20/04/2011

10    DATE OF REVISION OF THE TEXT

20/11/2013