ALGESAL Cream Ref.[6371] Active ingredients: Diethylamine salicylate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Thornton & Ross Limited, Linthwaite, Huddersfield, HD7 5QH, United Kingdom

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.

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 sight and reach of children.

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Excipient warnings:

This medicine contains fragrance with d-limonene and linalool, which may cause allergic reactions.

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.

Salicylates (as NSAIDs) may increase blood levels and therefore toxicity of methotrexate by delaying its excretion.

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.

Effects on ability to drive and use machines

Not applicable.

Undesirable effects

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

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Incompatibilities

Not known.

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