Summary of Product Characteristics (SmPC) - Emcrem cream
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 Fertility, 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
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
31/08/2016