Acnisal 2%W/W Cutaneous Solution
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Acnisal 2%w/w Cutaneous Solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Salicylic acid Ph Eur 2.0% w/w For excipients, see 6.1
3. PHARMACEUTICAL FORM
Cutaneous solution
An opaque off-white cutaneous emollient solution
4 CLINICAL PARTICULARS
4.1. Therapeutic Indications
Acnisal is for the management of acne. It helps prevent new comedones (blackheads and whiteheads) papules and pustules (acne pimples).
4.2. Posology and Method of Administration
For topical administration.
Adults:
Acnisal is used to wash the affected area 2 to 3 times daily. Lather with warm water, massage into skin, rinse and dry.
Children:
As for adults.
Elderly:
As for adults.
Acnisal is contra-indicated in persons with a sensitivity to salicylic acid.
4.4 Special warnings and precautions for use
For external use only. Avoid contact with the mouth, eyes and other mucous membranes to avoid irritation.
As with other topical preparations containing salicylic acid, excessive prolonged use may result in symptoms of salicylism (see section 4.9 Overdose).
4.5. Interactions with other Medicinal Products and other Forms of Interaction
None known.
4.6 Fertility, pregnancy and lactation
Whilst there are no known contra-indications to use of Acnisal during pregnancy and lactation, the safety has not been established. Acnisal should therefore be used with caution or following professional advice.
4.7. Effects on Ability to Drive and Use Machines
None known.
4.8 Undesirable effects
Salicylic acid is a mild irritant and may cause skin irritation. If undue skin irritation develops or increases adjust the usage schedule or consult your physician.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Symptoms of systemic salicylate poisoning have been reported after the application of salicylic acid to large areas of skin and for prolonged periods. Salicylism may also occur in the unlikely event of large quantities being ingested. Salicylism is unlikely to occur if Acnisal is used as indicated.
5.1. Pharmacodynamic Properties
Human comedones, naturally or coal tar induced, are firmly anchored and are dislodged with great difficulty. Most classic “peeling” agents are ineffective: they are merely irritants which cause scaling, creating the illusion of comedolysis. While salicylic acid is an irritant its efficacy is dependent on specific pharmacological effects. It seems to detach horny cells from each other by weakening the intercellular cement. As a result, the comedones tend to undergo disorganisation. The effect is probably a good deal more complex. Salicylic acid penetrates skin readily and increases turnover which also favours exfoliation of the comedo. In concentrations of 0.5 to 2% it significantly reduces the formation of microcomedones, which are the precursors of all other acne lesions.
5.2. Pharmacokinetic Properties
There is no evidence of any systemic absorption from the use of Acnisal.
5.3 Preclinical safety data
None presented.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Purified water Benzyl alcohol Sodium chloride
Sodium C14-C16 olefin sulphonate Lauramide DEA (monoamide 716) PEG-7 Glyceryl cocoate Acrylic styrene copolymer
6.2. Incompatibilities
Not applicable
3 years.
6.4. Special Precautions for Storage
Store below 25°C
6.5. Nature and Content of Container
Acnisal is supplied in a white HDPE bottle with a white polypropylene screw cap. Each bottle contains either 30ml or 177ml of Acnisal.
6.6. Instructions for Use, Handling and Disposal
No special requirements
7. MARKETING AUTHORISATION HOLDER
Alliance Pharmaceuticals Ltd
Avonbridge House
Bath Road
Chippenham
Wiltshire
SN15 2BB
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 16853/0070
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
19 August 2004
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DATE OF REVISION OF THE TEXT
19/01/2015