This information is intended for use by health professionals

1. Name of the medicinal product

Emcrem Cream

2. Qualitative and quantitative composition

Active substances:

White Soft Paraffin 15.0% w/w

Liquid Paraffin 6.0% w/w

Excipient(s): Cetostearyl alcohol (7.2%w/w), chlorocresol (0.1%w/w)

For a full list of excipients, see section 6.1

3. Pharmaceutical form

Cream

A smooth, white to off white cream.

4. Clinical particulars
4.1 Therapeutic indications

Emcrem is an emollient, moisturising and protective cream for the follow-up treatment with topical steroids or in spacing such treatment. It may also be used as diluent for topical steroids. Emcrem is recommended for the symptomatic treatment of red inflamed, damaged, dry or chapped skin, the protection of raw skin areas and as a pre-bathing emollient for dry/eczematous skin to alleviate drying areas.

4.2 Posology and method of administration

For topical use.

Adults, Elderly and Children:

The cream should be applied to the dry skin areas as often as is required and rubbed well into the skin.

4.3 Contraindications

There are no absolute contraindications to the use of the cream other than hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

Some of the ingredients in the cream may cause a reaction:-

Cetostearyl alcohol – may cause local skin reactions (e.g. contact dermatitis).

Chlorocresol – may cause an allergic reaction.

4.5 Interaction with other medicinal products and other forms of interaction

None stated

4.6 Pregnancy and lactation

None stated

4.7 Effects on ability to drive and use machines

None stated

4.8 Undesirable effects

Skin reactions including pruritus, rash, erythema, skin exfoliation, burning sensation, hypersensitivity, pain, dry skin and dermatitis have been reported with product use.

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 national reporting system in the United Kingdom: Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

4.9 Overdose

None stated

5. Pharmacological properties
5.1 Pharmacodynamic properties

ATC Code: D02A

Emolllients and Protectives

The ingredients provide emollient, moisturising action on dry or chapped skin.

5.2 Pharmacokinetic properties

Not applicable due to topical administration and direct action on the skin.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical particulars
6.1 List of excipients

Macrogol Cetostearyl Ether

Cetostearyl Alcohol

Chlorocresol

Anhydrous Sodium Dihydrogen Phosphate

Dilute Phosphoric acid

Purified water

6.2 Incompatibilities

None Known

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

50g aluminium epoxy phenolic lined tube with polypropylene screw cap.

500g polypropylene plastic pump pack with polypropylene/HDPE dip tube and cap, or

500g polypropylene jar (container) with a polypropylene dispenser head and cover, the pump system consists of a polyethylene follower plate, a polypropylene pump cylinder, a polyethylene piston with a glass and a polyethylene valve.

6.6 Special precautions for disposal and other handling

Not Applicable

7. Marketing authorisation holder

Glenmark Pharmaceuticals Europe Limited

2B Draycott Avenue

Kenton, Middlesex

HA3 0BU

United Kingdom

8. Marketing authorisation number(s)

PL 25258/0237

9. Date of first authorisation/renewal of the authorisation

16/03/2011

10. Date of revision of the text

15/08/2016