ECZEDERM 8.5% / 5% W/W CREAM - summary of medicine characteristics

Summary of medicine characteristics - ECZEDERM 8.5% / 5% W/W CREAM

SUMMARY OF PRODUCT CHARACTERISTICS

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.

4.2 Posology and method of administration

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).

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

4.5 Interaction with other medicinal products and other forms of interaction

None known. No interaction studies have been undertaken.

4.6 Fertility, 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.

4.7 Effects on ability to drive and use machines

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 (10%)

Common ( 1% < 10%)

Uncommon ( *0.1% < 1%)

Rare

(

0.01%<0.1%)

Very Rare (

0.001%<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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

5.3 Preclinical safety data

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.

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

Ferndale Pharmaceuticals Ltd, Unit 740, Thorp Arch Estate, Wetherby, West Yorkshire, LS23 7FX, United Kingdom.

8 MARKETING AUTHORISATION NUMBER(S)

PL 20685–0048