FIERY JACK CREAM - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Fiery Jack Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Glycol Salicylate BP 5.00 % w/w, Diethylamine Salicylate BP 5.00 % w/w, Capsicum Oleoresin BPC 1.25 % w/w, Methyl Nicotinate BP 1.00% w/w.

3 PHARMACEUTICAL FORM

Cream.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Symptomatic relief of muscular pain and stiffness including Sciatica, Lumbago, Fibrositis and Rheumatic pain.

4.2 Posology and method of administration

Posology

One or two applications per day should suffice to give relief.

Not recommended for children under 12 years.

Method of administration

Topical

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

Not to be used on broken skin.

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

4.4 Special warnings and precautions for use

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.

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.

Consult a Doctor if pain persists.

Keep out of reach 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.

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

4.6 Fertility, pregnancy and lactation

Pregnancy

There is inadequate evidence of safety in human pregnancy. Fiery Jack Cream should not be used in pregnancy unless there is no safer alternative.

Breast-feeding

Not recommended.

4.7 Effects on ability to drive and use machines None stated.

4.8 Undesirable effects

Temporary skin reactions of 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.

4.9 Overdose

None stated.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Glycol Salicylate: is an ingredient of a number of rubifacient creams.

Diethylamine Salicylate: is used topically at concentration of 5 or 10% in creams for rheumatic or muscular pain.

Capsicum Oleoresin: Capsicum is mainly used as an external counter irritant.

The Oleoresin is very irritant. The active ingredient Capsiacin has local analgesic properties.

Methyl Nicotinate: is used in ointments and creams for topical application as a rubifacient for the relief of pain and muscular rheumatism, lumbago and fibrositis.

5.2

5.3

Pharmacokinetic properties

Not applicable.

Preclinical safety data Not applicable.