Summary of medicine characteristics - FIERY JACK OINTMENT
1 NAME OF THE MEDICINAL PRODUCT
Fiery Jack Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Oleoresin Capsicum 2.466 % w/w
Excipients with known effect
Arachis oil (peanut oil)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
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
To be applied once or twice daily and only to a limited area of skin over the painful lesion.
Not recommended for children under 12 years.
Method of administration
Topical
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Not to be used by people with delicate, sensitive, diseased skin.
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.
Care should be taken to avoid sensitive parts of the body and to thoroughly wash hands after each application.
For external use only.
Keep out of reach of children
Consult a doctor if pain persists.
Fiery Jack Ointment contains arachis oil (peanut oil). If you are allergic to peanut or soya, do not use this medicinal product.
4.5 Interaction with other medicinal products and other forms of interaction
No significant interactions have been reported.
4.6 Fertility, pregnancy and lactation
There is no, or inadequate evidence of safety in human pregnancy. Use in pregnancy only when there is no safer alternative.
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
4.8 Undesirable effectsNo significant other undesirable effects have been reported.
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
When used externally as directed, overdose is unlikely.
5.1 Pharmacodynamic properties
5.1 Pharmacodynamic propertiesCapsicum is mainly used externally as a counter irritant. The Oleoresin is very irritant. The active ingredient Capsaicin has local analgesic properties.
5.2 Pharmacokinetic properties Not applicable.
5.3 Preclinical safety data Not applicable.
6.1 List of excipients
Yellow Soft Paraffin, Hard Paraffin Wax, Arachis Oil, Lard.
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze
6.5 Nature and contents of container
6.5 Nature and contents of containerSlip lid tins containing 32 gm.
6.6 Special precautions for disposal Not applicable.
7 MARKETING AUTHORISATION HOLDER
Optima Consumer Health Ltd
Concept house,
Brackenbeck Road,
Bradford,
BD7 2LW, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 40575/0005
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
02/09/2005