Oilatum Emollient 63.4% w/w Bath Additive - Summary of Product Characteristics (SPC)

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Stiefel Ireland
GlaxoSmithKline (Ireland) Ltd, Stonemason's Way, Rathfarnham, Dublin 16, Telephone: +353 1 495 5000 Fax: +353 1 495 5105 Medical Information Direct Line: +353 1 800 244 255 Medical Information Facsimile: +353 1 495 5242

Summary of Product Characteristics last updated on medicines.ie: 18/08/2011

SPC	Oilatum Emollient 63.4% w/w Bath Additive

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 excipient(s)
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

Oilatum Emollient 63.4% w/w Bath Additive

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Light Liquid Paraffin 63.4 % w/w

For a full list of excipients, see section 6.1

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3. PHARMACEUTICAL FORM

Bath Additive

Pale yellow oily liquid bath additive with a faint perfume

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Oilatum Emollient is indicated in the treatment of contact dermatitis, atopic dermatitis, senile pruritus, ichthyosis and related dry skin conditions.

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4.2 Posology and method of administration

Oilatum Emollient should always be used with water, either added to the water or applied to wet skin.

Adult Bath

Add 1-3 capfuls to an 8-inch (20cm) bath of water. Soak for 10-20 minutes. Pat dry.

Infant Bath

Add 1/2-2 capfuls to a small bath of water. Apply gently over entire body with a sponge. Pat dry.

Skin Cleansing

Rub a small amount into wet skin, rinse off and pat dry.

Where conditions permit, and particularly in cases of extensive areas of dry skin, Oilatum Emollient should be used as a bath oil, ensuring complete coverage by immersion.

In addition to the therapeutic benefits, this method of use provides a means of sedating tense patients, particularly relevant in cases of acute pruritic dermatoses where relaxation of tension appears to relieve symptoms.

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4.3 Contraindications

Known hypersensitivity to the ingredients.

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4.4 Special warnings and precautions for use

None.

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4.5 Interaction with other medicinal products and other forms of interaction

None.

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4.6 Pregnancy and lactation

There are no restrictions on the use of the product in pregnancy or lactation.

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4.7 Effects on ability to drive and use machines

None.

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4.8 Undesirable effects

None.

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4.9 Overdose

Not applicable.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Light liquid paraffin exerts an emollient effect by forming an occlusive oil film in the stratum corneum. This prevents excessive evaporation of water from the skin surface, aiding hydration and lubrication.

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5.2 Pharmacokinetic properties

Not applicable.

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5.3 Preclinical safety data

Not applicable.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Acetylated lanolin alcohols

Isopropyl palmitate

Macrogol 400 dilaurate

Polyoxyethylene 40 sorbital septaoleate

Perfume - Floral Spice

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6.2 Incompatibilities

Not applicable.

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6.3 Shelf life

5 years.

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6.4 Special precautions for storage

No special precautions for storage.

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6.5 Nature and contents of container

High density polyethylene bottles of 150ml, 250ml and 500ml capacity.

Not all pack sizes may be marketed.

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6.6 Special precautions for disposal and other handling

Patients should be advised to use care to avoid slipping in the bath.

If a rash or skin irritation occurs, treatment should be discontinued.

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7. MARKETING AUTHORISATION HOLDER

GlaxoSmithKline (Ireland) Ltd

Stonemasons Way

Rathfarnham

Dublin 16

Ireland

Trading as Stiefel

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8. MARKETING AUTHORISATION NUMBER(S)

PA 1077/125/001

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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorization: 01 October 1984

Date of last renewal: 01 October 2009

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10. DATE OF REVISION OF THE TEXT

14^th January 2011

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http://www.medicines.ie/medicine/3558/SPC/Oilatum+Emollient+63.4++w+w+Bath+Additive/

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Active Ingredients

Light Liquid Paraffin

Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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