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Stiefel Ireland

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 Junior Emollient 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 Junior Emollient Bath Additive


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Paraffin, Light Liquid 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, odourless, oily liquid.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

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


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4.2 Posology and method of administration

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

Infant Bath

Add ½-2 capfuls to a basin of water. Apply gently over entire body with a sponge. Pat dry.

Adult or Child Bath

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

Skin Cleansing

Rub a small amount of oil into wet skin. Rinse and pat dry.

Oilatum Junior is most effective when it is used as a bath additive, particularly when the area of skin to be treated is extensive. In addition to its therapeutic benefits of hydration and emolliency, this method of use is particularly relevant in management of acute pruritic dermatoses where relaxation of tension appears to relieve symptoms.

Oilatum Junior acts as a skin cleanser, and should not be used with soap.

Patients should be advised to use care to avoid slipping in the bath. It is not necessary to use soap with Oilatum Junior.


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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 Oilatum Junior in pregnancy and 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

Oilatum Junior is a topical preparation which acts at the surface of the skin. Pharmacokinetic data are not applicable to this preparation.


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5.3 Preclinical safety data

The active ingredient, light liquid paraffin, has been in widespread use for many years. Clinical experience has demonstrated the safety of the preparation. Pre-clinical safety data are not relevant.


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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

Macrogol ester (Polyoxyethylene 40 Sorbital Septaoleate)


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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

This medicinal product does not require any special storage conditions.


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6.5 Nature and contents of container

High density polyethylene bottles of 25ml, 150ml and 300ml, fitted with screw caps.

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

Stonemasons Way

Rathfarnham

Dublin 16

Ireland

Trading as Stiefel


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8. MARKETING AUTHORISATION NUMBER(S)

PA 1077/125/3


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 6th February 1998

Date of last renewal: 6th February 2008


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10. DATE OF REVISION OF THE TEXT

04/03/2011



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Active Ingredients

 
   Light liquid paraffin

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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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