Algesal (Thornton & Ross Ltd)

1. Name Of The Medicinal Product

Algesal®

2. Qualitative And Quantitative Composition

Each tube of Algesal contains Diethylamine Salicylate 10%w/w

3. Pharmaceutical Form

Off white, lavender-scented cream.

4. Clinical Particulars

4.1 Therapeutic Indications

For symptomatic relief of rheumatic and minor musculo-skeletal conditions including lumbago, fibrositis, sciatica, bruises and strains.

4.2 Posology And Method Of Administration

Adults (including the elderly) and children 6 years and over:

For cutaneous use. Apply three times daily to the affected area, massaging until cream is fully absorbed.

Children under 6 years: Not recommended.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients.

Algesal should not be used if the surface of the skin is broken.

Algesal contains terpene derivatives (ie camphor) as excipients, which can lower the epileptogenic threshold and, at excessive doses, lead to neurological accidents such as convulsions in infants and children. Therefore, Algesal should not be used by children who have a history of convulsions.

Hypersensitivity to aspirin or other non-steroidal anti-inflammatory drugs (including when taken by mouth) especially where associated with a history of asthma.

4.4 Special Warnings And Precautions For Use

Consult your doctor before use if you are pregnant, breastfeeding, asthmatic or on any other medicines. For external use only. Not to be used on broken skin. Avoid contact with eyes and sensitive areas of the skin. Always try on a small area first. Always use sparingly. Some people may experience discomfort, particularly those with sensitive skin or if used in hot weather/after a hot bath. Temporary skin redness/burning sensation may occur. Discontinue use if excessive irritation or unwanted effects occur. Not to be used on children under 6 years of age. If symptoms persist consult your doctor. Keep all medicines out of the reach and sight of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There have been reports that topical salicylates may potentiate the anticoagulant effects of warfarin. It is therefore advisable that caution should be exercised with patients who are on coumarin anticoagulants.

4.6 Pregnancy And Lactation

Pregnancy: There is inadequate evidence of safety in human pregnancy, Algesal should not be used in pregnancy unless there is no safer alternative.

Lactation: Not recommended.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Temporary skin reactions (redness, burning sensation and rashes) may occur.

4.9 Overdose

Overdose is unlikely when used as recommended. If applied to a large area of skin, or in the unlikely event of oral ingestion, the product may cause systemic adverse effects depending on the amount absorbed.

Treatment of overdose should be supportive and symptomatic.

If used to excess by elderly patients, there is a risk of terpene-related agitation and confusion.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Diethylamine salicylate is a topical analgesic, with the anti-inflammatory properties of salicylates.

5.2 Pharmacokinetic Properties

After topical application small amounts of salicylic acid are detectable in the plasma. Elimination in the urine occurs over a period of 48 hours.

5.3 Preclinical Safety Data

There are no additional preclinical safety data of relevance to the prescriber.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Ethylene glycol stearate, glycerol monostearate, stearic acid, triethanolamine, petrolatum, light liquid paraffin, microcrystalline wax, lavandin composition and purified water.

6.2 Incompatibilities

Not known.

6.3 Shelf Life

5 years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

50g: Aluminium tube with a white plastic screw cap.

100g: Aluminium tube with a white plastic screw cap.

6.6 Special Precautions For Disposal And Other Handling

Wash hands well after use.

ADMINISTRATIVE DATA

7. Marketing Authorisation Holder

Thornton & Ross Limited

Linthwaite

Huddersfield

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0342

9. Date Of First Authorisation/Renewal Of The Authorisation

21/02/2006

10. Date Of Revision Of The Text

12/11/2008