Emulsifying Ointment Bp

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Document: spc-doc_PL 04917-0058 change

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Emulsifying Ointment BP.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

30%

50%

20%

Emulsifying Wax White Soft Paraffin Liquid Paraffin Wax as prepared in section 6.1

3. PHARMACEUTICAL FORM

Ointment

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

For external use only.

Used to prepare Aqueous Cream BP and Buffered Cream BP.

4.2. Posology and method of administration

The product is used by the pharmacist to prepare Aqueous Cream and Buffered Cream and therefore is not sold with any clinical indications or dosage schedules.

4.3. Contraindications

Hypersensitivity to any of the ingredients.

Emulsifying ointment has been found to have major sunscreen activity in clinically normal skin. Preparations containing emulsifying ointment should not be used before phototherapy or in phototesting procedures.

4.4 Special warnings and precautions for use

For external use only.

Emulsifying wax (which contains sodium lauryl sulphate and cetostearyl alcohol) may cause local skin reactions (e.g. stinging, burning, itching, redness and contact dermatitis), particularly in children with atopic eczema.

The package leaflet/label should include the following information:

Contains sodium lauryl sulfate which may cause local skin reactions (e.g. stinging and contact dermatitis).

The risk of fire should be considered when using large quantities of any paraffin-based emollient. Emulsifying ointment in contact with dressings and clothing is easily ignited by a naked flame. The risk is greater when this preparation is applied to large areas of the body and clothing or dressings become soaked with the emollient. Patients should be told to keep away from fire or flames and not to smoke when using this preparation.

This preparation may make skin and surfaces slippery - particular care is needed when bathing.

4.5. Interaction with other medicinal products and other forms of interaction

None known.

4.6. Pregnancy and lactation

The safety of Emulsifying Ointment during pregnancy and lactation has not been established.

4.7. Effects on ability to drive and use machines

Does not affect ability to drive or use machines.

4.8. Undesirable effects

Immune system disorders: Occasional allergic reactions

Skin and subcutaneous tissue disorders: Emulsifying ointment may exacerbate acne and/or folliculitis. Emulsifying wax contains sodium lauryl sulphate and cetostearyl alcohol which may be associated with local skin reactions (e.g. stinging, burning, itching, redness and contact dermatitis) particularly in patients with eczema. See section 4.4. Rash

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 at www.mhra.gov.uk/yellowcard.

4.9. Overdose

Overdose is considered unlikely with this product when used as indicated. Symptoms of accidental oral ingestion may include gastrointestinal symptoms, particularly diarrhoea and should be treated symptomatically.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

The active ingredients white soft paraffin and liquid paraffin are recognised emollients and in mixture with emulsifying wax will produce a stable cream when mixed with water - as in the preparation of Aqueous Cream.