Nutraplus Cream: Clinical Particulars

1. Name of the medicinal product

Nutraplus 10% w/w Cream

2. Qualitative and quantitative composition

Each gram of cream contains 100mg of Urea

Excipients with known effect: Methyl parahydroxybenzoate (E218) 1.8 mg/g, Propyl parahydroxybenzoate (E216) 0.9 mg/g, Propylene glycol 45mg/g, Cetearyl alcohol 18.0 mg/g – 22.5 mg/g

For the full list of excipients see section 6.1

3. Pharmaceutical form

Cream

Smooth white, almost odourless cream (water in oil emulsion).

4. Clinical particulars

4.1 Therapeutic indications

An emollient, moisturising and protective cream for the treatment of dry or damaged skin

4.2 Posology and method of administration

Adults, paediatric population and older people

Apply evenly to the dry skin areas two to three times daily, or as directed by the physician or pharmacist.

4.3 Contraindications

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

The product should not be used extensively in patients with severe renal impairment.

4.4 Special warnings and precautions for use

Avoid contact with the eyes and mucous membranes. If irritation occurs, discontinue use temporarily and consult a physician.

Apply with caution only to damaged or inflamed skin or to the face.

The product should be used under medical supervision in babies.

4.5 Interaction with other medicinal products and other forms of interaction

Urea may enhance the efficacy of topical formulations of 5-fluorouracil and dithranol, and increase the release and the permeation into the skin of active ingredients from other topical products such as corticosteroids.

4.6 Fertility, pregnancy and lactation

There are no clinical data available concerning use in pregnancy.

There are no adequate experimental animal studies available concerning the effects on pregnancy, embryonic development, foetal development and/or post-natal development.

Caution must be exercised for use during pregnancy. However, indications of risks associated with topical applications of urea during pregnancy and while breast-feeding are not known.

In breast-feeding women, the product should be removed from the breast area before breast-feeding.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

Skin and subcutaneous tissue

Hypersensitivity reactions to the ingredients or skin irritation in the treatment of acute inflammatory skin disorders are possible.

Erythema, skin burning sensation and pruritus have been reported during post-marketing surveillance.

Treatment must be discontinued in case of erythema, skin burning sensation, pruritus, rash or hypersensitivity reactions after application.

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

Intoxication after the use of Nutraplus is not known and is not to be expected due to the composition of the preparation. Skin irritation caused by overdose subsides quickly when the preparation is discontinued.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Protectives and emollients.

ATC code: D02 AE01

Urea is a recognised hydrating agent that has been widely used topically to treat dry or damaged skin.

5.2 Pharmacokinetic properties

Not applicable. Nutraplus is a topical (cutaneous) preparation.

5.3 Preclinical safety data

No specific information is presented given the widespread use of topically applied urea on humans over many years.

6. Pharmaceutical particulars

6.1 List of excipients

Glycerol monostearate

Octyl palmitate

Myristyl lactate

Mineral oil

Promulgen D (contains Cetearyl alcohol and ceteareth-20)

Propylene glycol

Propyl parahydroxybenzoate (E216)

Methyl parahydroxybenzoate (E218)

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C.

As with all medicines, Nutraplus Cream should be stored out of the sight and reach of children.

6.5 Nature and contents of container

White, polyethylene tube with a white polypropylene screw cap as the closure.

Pack sizes: 60g and 100g

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorisation holder

Galderma (UK) Limited

Meridien House

69-71 Clarendon Road

Watford

Herts.

WD17 1DS

UK

8. Marketing authorisation number

PL 10590/0002

9. Date of first authorisation/renewal of the authorisation

04th June 1991

10. Date of revision of the text

31st July 2017