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Pinewood Healthcare

Ballymacarby, Clonmel, Co. Tipperary, Co. Tipperary, Ireland

Telephone: +353 61 86000
Fax: +353 61 36311
WWW: http://www.pinewood.ie
Medical Information Direct Line: +353 52 61 86000

Medical Information e-mail: Medicalinfo@pinewood.ie
Customer Care direct line: +353 61 86000
Medical Information Fax: +353 52 61 36820

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Summary of Product Characteristics last updated on the eMC: 04/05/2011

SPC	Emulsifying Ointment BP

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

Emulsifying Ointment BP

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Emulsifying Wax	30%
White Soft Paraffin	50%
Liquid Paraffin	20%

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3. PHARMACEUTICAL FORM

Ointment

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For external use only.

Used to prepare Aqueous Cream BP and Buffered Cream BP.

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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.

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4.3 Contraindications

None.

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4.4 Special warnings and precautions for use

Emulsifying wax contains cetostearly alcohol with may cause local skin reaction (e.g. contact dermatitis)

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4.5 Interaction with other medicinal products and other forms of interaction

None known.

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4.6 Pregnancy and lactation

Can be used during pregnancy and lactation.

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4.7 Effects on ability to drive and use machines

Does not affect ability to drive or use machines.

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4.8 Undesirable effects

None known.

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4.9 Overdose

None Known.

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5. PHARMACOLOGICAL PROPERTIES

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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.

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5.2 Pharmacokinetic properties

Not applicable.

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5.3 Preclinical safety data

No further information of significance to prescriber.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

None used.

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6.2 Incompatibilities

None.

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6.3 Shelf life

36 months

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6.4 Special precautions for storage

Store below 25°C. Do not freeze.

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6.5 Nature and contents of container

Plastic jar with tight lid	50 g
Plastic jar with tight lid	100 g
Plastic jar with tight lid	250 g
Plastic jar with tight lid	500 g
Plastic jar with tight lid	4000 g