Summary of medicine characteristics - BALMOSA CREAM
1 NAME OF THE MEDICINAL PRODUCT
BALMOSA CREAM
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients:
Menthol BP
2.0% w/w
Camphor BP
Methyl Salicylate Ph.Eur.
Capsicum Oleoresin BPC
4.0% w/w
4.0% w/w
0.035% w/w
Cream for cutaneous use
4.1 Therapeutic indications
Analgesic/rubefacient cream for the symptomatic relief of muscular rheumatism, fibrositis, lumbago, sciatica and unbroken chilblains.
4.2 Posology and method of administration
Adults and the elderly:
Apply topically. Massage gently into the affected area as required. Wash hands immediately after use.
Children under 12 years:
Not generally recommended.
4.3 Contraindications
Hypersensitivity to aspirin, other non-steroidal anti-inflammatory drugs, or any of the ingredients listed.
4.4 Special warnings and precautions for use For external use only.
If skin sensitivity reactions occur, discontinue use. Do not apply to inflamed or broken skin. Avoid contact with the eye and mucous membranes. Do not apply to the nostrils of infants. Do not use with occlusive dressings.
After use avoid exposing the affected area to excessive sunlight.
4.5 Interaction with other medicinal products and other forms of interaction None stated.
4.6 Pregnancy and lactation
With all salicylates there is animal evidence of teratogenicity. Use should be avoided during pregnancy and breast feeding.
4.7 Effects on ability to drive and use machines None stated.
4.8 Undesirable Effects
Skin sensitivity reactions are possible although rare. Topical application of large amounts of Balmosa Cream may result in systemic effects, including hypersensitivity and worsening of asthma.
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.
4.9 Overdose
4.9 OverdoseOverdosage is extremely unlikely from topical use.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Capsicum oleoresin is a rubefacient. Camphor exhibits counter-irritant and weak local anaesthetic activity. Menthol and methyl salicylate impart analgesic properties to the formulation.
5.2 Pharmacokinetic properties
Not applicable
5.3 Preclinical safety data
5.3 Preclinical safety dataThere are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Methylcellulose
White soft paraffin
Emulsifying wax
Liquid paraffin
Lanolin (anhydrous)
Phenonip
Purified Water
6.2 Incompatibilities
None stated.
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
Aluminium tube with a polyethylene cap containing 20g or 40g of the product.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNone stated.
7. MARKETING AUTHORISATION HOLDER
Selsdon Healthcare Limited
212–220 Addington Road
South Croydon
Surrey CR2 8LD
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 19863/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18 March 1983 / 22 May 1998