Transvasin Heat Spray

1. Name Of The Medicinal Product

Transvasin Heat Spray

Radian B Heat Spray

2. Qualitative And Quantitative Composition

2-Hydroxyethyl Salicylate 5% w/w

Diethylamine Salicylate 5% w/w

Methyl Nicotinate 1% w/w

For excipients, see 6.1

3. Pharmaceutical Form

Cutaneous spray, solution (Cutaneous Spray)

A pale yellow, clear liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of muscular and rheumatic pain.

4.2 Posology And Method Of Administration

There is no difference between the dosage for adults, children or the elderly.

Shake the can well before use. Holding the can about 6 inches from the skin surface, point nozzle arrow towards painful area. Spray evenly using short bursts. There is no need to massage.

4.3 Contraindications

Do not use on children under five years of age.

The spray is for external use only.

Do not allow the spray to enter the eyes.

Do not use on skin which is inflamed or broken or where there is known hypersensitivity to salicylates or any of the other constituents of the spray.

4.4 Special Warnings And Precautions For Use

If symptoms persist consult your doctor.

Discontinue use if excessive irritation occurs.

Avoid inhalation of the spray

Caution: The Spray is flammable. Do not use near fire or flame.

Pressurised container: Protect from sunlight and do not expose to temperatures exceeding 50°C.

Keep away from the eyes, nose and other sensitive areas.

Do not pierce or burn the can, even after use.

Do not spray on a naked flame or any incandescent material.

Do not use near, and do not place the container on, polished or painted surfaces.

Keep out of the reach and sight of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

As with all medicinal compounds care should be taken when administering the product to pregnant or lactating women.

4.7 Effects On Ability To Drive And Use Machines

No or negligible influence.

4.8 Undesirable Effects

After application a slight transient erythema may develop.

Contact dermatitis has been reported for hydroxyethyl salicylate.

4.9 Overdose

Overdose is unlikely when applied externally. Ingestion of very large amounts may result in symptoms of salicylate toxicity e.g. dizziness, tinnitus, deafness, nausea, vomiting, headache and mental confusion.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

M02A C Topical products for joint and muscular pain. Preparations with salicylic acid derivatives.

The active ingredients are commonly found in topical analgesic and rubefacient preparations. 2-Hydroxyethyl Salicylate is a rubefacient as is Methyl Nicotinate and Diethylamine Salicylate is a topical analgesic for rheumatic and muscular pain.

5.2 Pharmacokinetic Properties

Methyl Nicotinate percutaneous absorption may occur dependent on the vehicle base and is via the intercellular route. There is no evidence to suggest that percutaneous absorption of the other constituents occurs to any great extent.

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars

6.1 List Of Excipients

Isopropyl Alcohol

Butane Propellant

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Protect from sunlight and do not expose to temperatures exceeding 50°C.

6.5 Nature And Contents Of Container

Internally lacquered, three piece, tin plate aerosol can containing 125ml or 150ml of product with a standard aerosol valve and high density polyethylene cap.

6.6 Special Precautions For Disposal And Other Handling

None stated

7. Marketing Authorisation Holder

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0070

9. Date Of First Authorisation/Renewal Of The Authorisation

6 September 2002

10. Date Of Revision Of The Text

27/01/2011