Oilatum Shower Gel 70% w/w Gel - 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: 16/03/2012

SPC	Oilatum Shower Gel 70% w/w Gel

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 Shower Gel 70% w/w Gel

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gram of gel contains 700mg light liquid paraffin equivalent to 70% w/w.

For full list of excipients, see section 6.1.

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3. PHARMACEUTICAL FORM

Gel.

White, translucent, oily gel with an odour of perfume.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Oilatum Shower Gel 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 Shower Gel may be used as frequently as necessary. Oilatum Shower Gel should always be applied to wet skin, normally as a shower gel.

Shower as usual. Apply Oilatum Shower Gel liberally to wet skin and massage gently. Rinse briefly and lightly pat the skin dry.

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4.3 Contraindications

None.

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4.4 Special warnings and precautions for use

Use care to avoid slipping in the shower. Oilatum Shower Gel should not be used on greasy skin.

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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 is no evidence to confirm the safety of Oilatum Shower Gel in human pregnancy and lactation; however, topical preparations containing light liquid paraffin have been in widespread use for many years without apparent ill effects.

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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 on the stratum corneum. This prevents excessive evaporation of water from the skin surface thus improving hydration.

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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)

Polyethylene 617A

Macrogol 400 Dilaurate

Macrogol Ester (Polyoxyethylene 40 Sorbital Septaoleate)

2-Octadodecanol

Macrogol-2-Myristyl Ether Propionate

Polyphenylmethyl Siloxane Copolymer

Floral spice

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6.2 Incompatibilities

Not applicable.

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6.3 Shelf life

3 years.

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6.4 Special precautions for storage

Do not store above 25°C.

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6.5 Nature and contents of container

High-density polyethylene tubes of 25g, 65g, 125g and 150g.

Laminate tubes (polyethylene/ethylene vinyl alcohol copolymer (EVOH)/ polyethylene laminate, with a polyethylene shoulder) containing 30 g, 50 g and 150 g.

Not all pack sizes may be marketed.

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6.6 Special precautions for disposal and other handling

No special requirements.

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7. MARKETING AUTHORISATION HOLDER

GlaxoSmithKline (Ireland) Ltd

Stonemason Way

Rathfarnham

Dublin 16

Ireland

Trading as Stiefel

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8. MARKETING AUTHORISATION NUMBER(S)

PA 1077/125/002

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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION


Date of first authorization:	10^th June 1991
Date of last renewal:	10^th June 2006

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10. DATE OF REVISION OF THE TEXT

March 2012

Link to this document from your website:
http://www.medicines.ie/medicine/10128/SPC/Oilatum+Shower+Gel+70++w+w+Gel/

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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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