Home | About the eMC | Help | Mobile

eMC - trusted, up to date and comprehensive information about medicines

Search medicine/company name only

Search full document

Medicine name A-Z | Active ingredient A-Z | Pharmaceutical company A-Z | Latest medicine updates | Yellow card report

THE BOOTS COMPANY PLC
1 Thane Road West, Beeston, Nottingham, NG2 3AA Telephone: +44 (0)1159 595 165 Fax: +44 (0)1159 592 565 Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 15/03/2010

SPC	Boots Pain Relief Heat Rub

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
11. DOSIMETRY
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Go to top of the page

1. NAME OF THE MEDICINAL PRODUCT

Transvasin Heat Rub Cream

Boots Pain Relief Heat Rub

Go to top of the page

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Hexyl Nicotinate	2% w/w
Ethyl Nicotinate	2% w/w
Tetrahydrofurfuryl Salicylate	14% w/w

Go to top of the page

3. PHARMACEUTICAL FORM

Cream

Go to top of the page

4. CLINICAL PARTICULARS

Go to top of the page

4.1 Therapeutic indications

For the relief of rheumatic and muscular pain and the symptoms of sprains and strains.

Go to top of the page

4.2 Posology and method of administration

Route of administration: Cutaneous

Directions for use

Massage gently into the affected area until the cream is entirely absorbed. Apply at least twice daily until the symptoms abate.

Adults, Children and the Elderly

Quantities are not critical and are not specified on the data sheet. The amount used should be consistent with the directions for use, and will vary with the size of the treated area.

Go to top of the page

4.3 Contraindications

Sensitivity to the product or any of its ingredients.

Go to top of the page

4.4 Special warnings and precautions for use

Transvasin/Boots Pain Relief Heat Cream should not be applied to broken or sensitive skin, for example around the eyes or scrotal skin. Avoid use on mucous membranes.

For external use only.

Transvasin/Boots Pain Relief Heat Cream is a rubefacient and within a few minutes of application a sensation of warmth is felt, followed by a reddening of the skin. This erythema does not indicate intolerance.

Discontinue use if rash develops.

Hands should be washed immediately after use.

Not for use with occlusive dressings.

Patients are advised against excessive exposure to sunlight of treated areas in order to avoid the possibility of photosensitivity.

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

Although there have been no reports of adverse effects, as with all medicines, care should be taken when administering to pregnant or lactating women.

Go to top of the page

4.7 Effects on ability to drive and use machines

None known.

Go to top of the page

4.8 Undesirable effects

Reported effects have taken the form of localised sensitisation reactions and have invariably subsided following withdrawal of the medication.

Go to top of the page

4.9 Overdose

As this is a topical application, with small amounts of actives, adverse systemic effects are unlikely, even after oral ingestion.

Treatment:

No special measures are necessary.

Go to top of the page

5. PHARMACOLOGICAL PROPERTIES

Go to top of the page

5.1 Pharmacodynamic properties

Hexyl Nicotinate and Ethyl Nicotinate are rubefacients. Tetrahydrofurfuryl Salicylate is used for musculoskeletal, joint, peri-articular and soft tissue disorders.

Go to top of the page

5.2 Pharmacokinetic properties

None stated.

Go to top of the page

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Go to top of the page

6. PHARMACEUTICAL PARTICULARS

Go to top of the page

6.1 List of excipients

Purified Water Ph Eur

Methylhydroxybenzoate Ph Eur

Cetostearyl Alcohol BP

Stearic Acid 1973 BPC

Polysorbate 20 Ph Eur

Sorbitan Monostearate BP

Perfume

Go to top of the page

6.2 Incompatibilities

None known

Go to top of the page

6.3 Shelf life

36 months.

Go to top of the page

6.4 Special precautions for storage

Do not store above 25°C.

Go to top of the page

6.5 Nature and contents of container

Collapsible aluminium tubes with membrane, containing 3, 3.5, 5, 7.5, 10, 30, 40, 45, 80 or 120g of product with a polyamide-imide lacquer internal coating and polypropylene piercer cap packed in a cardboard outer.

Go to top of the page

6.6 Special precautions for disposal and other handling

Not applicable.

Go to top of the page

7. MARKETING AUTHORISATION HOLDER

Thornton & Ross Ltd

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

Go to top of the page