Search for:

Search Medicine or Company Name Search Full Document

Advanced Search

Stiefel Laboratories (UK) Limited
Eurasia Headquarters, Concorde Road, Maidenhead, Berkshire, SL6 4BY, UK Telephone: +44 (0)1628 612 000 Fax: +44 (0)1628 612 001 Need to contact this company?

Summary of Product Characteristics last updated on the eMC: 21/08/2009

SPC	Polytar Emollient

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

Go to top of the page

1. NAME OF THE MEDICINAL PRODUCT

Polytar Emollient

Go to top of the page

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Tar Blend 25.00% w/w, Light Liquid Paraffin 35.00% w/w

Tar Blend comprises:

Pine tar BP 30% w/w, Cade oil BPC 30% w/w, Coal Tar Solution BP 10% w/w, Arachis Oil extract of Coal Tar BP 30% w/w.

Go to top of the page

3. PHARMACEUTICAL FORM

Liquid bath additive.

Go to top of the page

4. CLINICAL PARTICULARS

Go to top of the page

4.1 Therapeutic indications

Topical.

Polytar Emollient is indicated in the treatment of psoriasis, eczema, atopic and pruritic dermatoses. The use of Polytar Emollient may be combined with ultraviolet radiation and other adjunctive therapy. Polytar Emollient is also of value in removing loose psoriatic scales and paste following dithranol treatment.

Go to top of the page

4.2 Posology and method of administration

Adults, children and the elderly:

Two to four capfuls of Polytar Emollient should be added to an 8 inch bath and the patient instructed to soak for 20 minutes.

Go to top of the page

4.3 Contraindications

None.

Go to top of the page

4.4 Special warnings and precautions for use

Patients should be instructed to guard against slipping when entering or leaving the bath. If skin irritation occurs and persists, discontinue use and consult your doctor. Tar products may stain baths and fabrics.

Go to top of the page

4.5 Interaction with other medicinal products and other forms of interaction

None known.

Go to top of the page

4.6 Pregnancy and lactation

There is no, or inadequate evidence of the safety of Polytar Emollient in human pregnancy and lactation but it has been in wide use for many years without apparent ill consequence.

Go to top of the page

4.7 Effects on ability to drive and use machines

None.

Go to top of the page

4.8 Undesirable effects

Tar products may cause skin irritation, rashes and rarely, photosensitivity. In the event of such a reaction, discontinue use and consult your doctor.

Go to top of the page

4.9 Overdose

Not applicable.

Go to top of the page

5. PHARMACOLOGICAL PROPERTIES

Go to top of the page

5.1 Pharmacodynamic properties

Tar preparations have keratoplastic and antipruritic activity and are widely used as topical therapy for a range of dermatoses. The use of emollient bath oils in the management of widespread dry and itching skin is well established. Mineral oil exerts its emollient effect by skin absorption. The combination of tar blend with an emollient therefore provides a pharmacological active product with emollient properties.

Go to top of the page

5.2 Pharmacokinetic properties

Not applicable.

Go to top of the page

5.3 Preclinical safety data

None stated.

Go to top of the page

6. PHARMACEUTICAL PARTICULARS

Go to top of the page

6.1 List of excipients

Octyiphenoxypolythoxy Ethanol

Sorbitan Monooleate