Epimax Ointment SPC

Summary of Product Characteristics (SPC)

NAME OF THE PRODUCT

Epimax Ointment.

PHARMACEUTICAL FORM

Ointment

MAIN INGREDIENTS

liquid paraffin 40% w/w and yellow soft paraffin 30% w/w

THERAPEUTIC INDICATIONS

As an emollient and bath additive for the relief of dry skin in eczema, psoriasis and other dry skin conditions. As a soap substitute for skin washing.

POSOLOGY AND METHOD OF ADMINISTRATION

Adults and Children:

As an emollient – Epimax Ointment should be applied to the skin areas as frequently as required. Smooth into the skin in the direction of hair growth.

As a bath additive – melt about 4g (the size of a £2 coin) in hot water and add to the bath. Care should be taken as this can make the bath slippery.

As a skin cleanser/soap substitute – use as required instead of soap when washing or in the shower.

CONTRAINDICATIONS

There are no absolute contraindications to the use of Epimax Ointment other than hypersensitivity to any of its ingredients.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Avoid contact with the eyes.

Healthcare professionals should be aware that if this product comes into contact with dressings, clothing and bedding, the fabric can be easily ignited with a naked flame. Patients should be warned of this risk and advised to keep away from fire when using this product.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

None known.

PREGNANCY AND LACTATION

No special precautions required.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

None.

UNDESIRABLE EFFECTS

None known.

REPORTING ADVERSE REACTIONS

Adverse reactions should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk.

Adverse events should be reported to Dermato Logical on 0208 449 2931

PHARMACODYNAMIC PROPERTIES

Epimax Ointment contains no active ingredients and has no pharmacological action.

LIST OF EXCIPIENTS

Liquid Paraffin, Yellow Soft Paraffin, Cetomacrogol Emulsifying Wax (Cetostearyl Alcohol, Macrogol Cetostearyl Ether 22)

INCOMPATIBILITIES

None known.

SHELF LIFE

125g presentation – 36 months. 500g presentation – 36 months.

SPECIAL PRECAUTIONS FOR STORAGE

Store below 25°C. Do not Freeze

NATURE AND CONTENTS OF CONTAINER

125g and 500g tub container material plastic PP. Lid PE.

SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING

None

LEGAL CATEGORY

N/A

BASIC NHS PRICE

125g Epimax Ointment – £1.92 500g Epimax Ointment- £2.99

MARKETING AUTHORISATION NUMBER

MD Z999

MARKETING AUTHORISATION HOLDER

Dermato Logical Ltd.,

31-41 Worship Street,

London, England,

EC2A 2DX

Tel. 0208 449 2931

EpimaxTM is a registered trade mark

Date of text revision: 1.3.2018