Gonne Balm
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gonne Balm
Lanes Modern Herbals Muscular Pain Cream Litozin Muscle Rub
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ingredient %w/w
Excipient: Wool Fat
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
White cream.
Clinical Particulars
4.1. Therapeutic Indications
A traditional remedy for the symptomatic relief of muscular aches and pains and stiffness including backache, lumbago and fibrositis
4.2 Posology and method of administration
For cutaneous use.
Adults and children aged 12 and over: Apply with gentle massage two or three times daily and also at night if necessary. For maximum effect bathe first with hot water to open the pores and ensure maximum penetration.
Not recommended for children under 12 years old.
Contraindications
4.3
Hypersensitivity to the active substances or to any of the excipients.
4.4 Special warnings and precautions for use
For external use on unbroken skin only.
Avoid contact with the eyes, mucous membranes and inflamed or broken skin. If symptoms worsen or do not improve after 7 days, a doctor should be contacted.
4.5 Interaction with other medicinal products and other forms of interaction
Excessive application concomitantly with NSAIDs should be avoided as this may increase side effects.
There is an increased risk of bleeding due to its antiplatelet effects.
There may be an enhancement of phenytoin or valproate effect with excessive use due to the methyl salicylate content.
4.6 Pregnancy and lactation
In the absence of sufficient data the use during pregnancy and lactation is not recommended.
4.7 Effects on ability to drive and use machines
The product has no influence on the ability to drive and use machines.
4.8. Undesirable Effects
Gonne balm is generally well tolerated. Hypersensitivity reactions may rarely occur (manifested as skin rashes).
4.9 Overdose
No cases of overdose have been reported.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Topical product for Joint and Muscular Pain, Preparations with acid salicylic derivative; ATC code: M02AC
5.1.1 Camphor: Counter irritant and mild analgesic when used topically.
5.1.2 Levomenthol: Cooling and analgesic when used topically.
5.1.3 Eucalyptus Oil: Counter irritant and mild analgesic when used topically.
5.1.4 Methyl Salicylate: Has analgesic properties. It is readily absorbed through the skin and relieves pain in rheumatic conditions.
5.1.5 Turpentine Oil: Rubefacient when used topically.
5.2 Pharmacokinetic properties
No data.
5.3 Preclinical safety data
5.3.1 Camphor: Camphor toxicity usually arises from ingestion, particularly in children. If used in accordance with the directions then problems are unlikely.
5.3.2 Levomenthol: Levomenthol may give rise to hypersensitivity reactions including contact dermatitis. Cases of toxicity have been reported following ingestion or application to the nostrils. With Gonne Balm, it would be very unlikely that an amount likely to cause toxicity problems could be ingested or inhaled.
5.3.3 Eucalyptus Oil: Eucalyptus Oil toxicity usually arises from ingestion, particularly in children. If used in accordance with the directions then problems are unlikely.
5.3.4 Methyl Salicylate: Methyl Salicylate toxicity is as for aspirin. Problems may include hypersensitivity resulting from skin eruptions. Salicylates have been shown to cross the placenta and have shown teratogenicity in animals. Salicylates are also believed to be implicated in the onset of Reyes Syndrome in children.
5.3.5 Turpentine Oil: Turpentine Oil toxicity usually arises from ingestion though some symptoms can appear after skin absorption of large amounts. Hypersensitivity reactions and local irritation have been reported.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Emulsifying Wax Wool Fat Water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4. Special Precautions for Storage
Do not store above 25 °C.
6.5 Nature and contents of container
28g and 35g in a screen printed, collapsible, lacquer lined aluminium tube with a membrane nozzle, fitted with a plastic flowerpot cap and contained in a carton along with a leaflet.
100g contained in a 4oz white, round jar fitted with a card lined tinplate cap and a wrap around label, contained in a carton along with a leaflet.
Not all pack sizes may be marketed
6.6 Special precautions for disposal
Any unused product or waste material should be disposed of in accordance with local requirements.
MARKETING AUTHORISATION HOLDER
7
G. R. Lane Health Products Ltd.
Sisson Road
Gloucester
GL2 0GR
United Kingdom
Tel: +44 (0)1452 524012
Fax: +44 (0)1452 507930
Email: info@laneshealth.com
8. Marketing Authorisation Number
PL 01074/0005
9. Date of First Authorisation/Renewal of Authorisation
12 September 1995
10 DATE OF REVISION OF THE TEXT
20/02/2009