Eczederm 8.5% / 5% W/W Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eczederm 8.5% / 5% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
White Soft Paraffin Ph Eur 8.5% w/w Liquid Paraffin Ph Eur 5.0% w/w
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cream.
A smooth white cream.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Eczederm 8.5% / 5% w/w Cream is an emollient, moisturising and protective cream 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. Eczederm 8.5% / 5% w/w Cream can be used as an adjunct to topical steroids, where a steroid-sparing effect is desirable. It can be used to space treatments with topical steroids. Eczederm 8.5% / 5% w/w Cream can also be used as a follow-up to treatment with topical steroids.
Posology and method of administration
4.2
Posology
For use by adults, children and the elderly.
There are no special dosage recommendations for either elderly patients or children.
Method of administration For cutaneous use only.
The cream should be applied to the dry skin areas as often as is required and rubbed well into the skin
4.3 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
One of the ingredients in Eczederm 8.5% / 5 %w/w, cetostearyl alcohol, may cause local skin reactions (e.g. contact dermatitis).
4.5 Interaction with other medicinal products and other forms of interaction
None known. No interaction studies have been undertaken.
4.6 Pregnancy and lactation
Pregnancy
No special precautions or dosage requirements are indicated for use during pregnancy.
Lactation
No special precautions or dosage requirements are indicated for use during lactation.
Effects on ability to drive and use machines
4.7
Eczederm 8.5%/5%w/w Cream has no or negligible influence on the ability to drive and use machines
4.8 Undesirable effects
|
System Organ Class |
Very Common (S 10%) |
Common ( S 1% < 10%) |
Uncommon ( ^0.1%<1%) |
Rare (So.01%<0.1%) |
Very Rare (So.001%<0.01%) |
|
Skin and Subcutaneous Tissue Disorders |
Skin reaction |
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
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC Code: D02A C Emollients and Protectives
The ingredients provide emollient or moisturising action on dry or chapped skin.
5.2 Pharmacokinetic properties
Not applicable due to topical administration and direct action on the skin.
Preclinical safety data
5.3
There are no pre-clinical data of relevance to the prescriber that are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Chlorocresol Cetomacrogol 1000 Cetostearyl alcohol Isopropyl alcohol
Anhydrous sodium dihydrogen phosphate Dilute phosphoric acid Purified water
6.2 Incompatibilities
None known.
6.3 Shelf life
2 years.
6.4 Special precautions for storage
Do not store above 25 °C.
Store in the original container.
6.5 Nature and contents of container
Aluminium epoxy-phenolic resin lined tubes with polypropylene screw cap containing 10 g cream for use as a professional sample only.
Aluminium epoxy-phenolic resin lined tubes with polypropylene screw cap containing 50 g cream.
HDPE jar with polypropylene screw cap containing 500 g cream.
HDPE bottle with polypropylene pump dispenser containing 500 g cream.
6.6 Special precautions for disposal
No special requirements
7 MARKETING AUTHORISATION HOLDER
QP Services UK Limited 46 High Street,
Yatton,
Somerset,
BS49 4HJ,
United Kingdom.
8 MARKETING AUTHORISATION NUMBER(S)
PL 29498/0004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION 08/11/2007
10 DATE OF REVISION OF THE TEXT
06/01/2016