When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Quantitative composition wording has been altered; please note the quantitative composition of the product has not been changed.
The quantities of some excipients are now given as follows:
Propylene glycol alginate 0.25% w/w
Cetyl alcohol 1.50% w/w
Stearyl alcohol (present in Promulgen G) 4.75% w/w
3. PHARMACEUTICAL FORM
The word “cream” has been added.
4.2 Posology and method of administration
The section previously relating to “Adults” is now given the heading “Adolescents and Adults”.
The following additional guidance has been given:
Initial application of the product may be varied at the physician’s instructions to reflect the patient’s skin type and to avoid undesirable effects.
Improvement can generally be seen after 4-6 weeks of treatment. However, longer use may be necessary.
4.3 Contra-indications
Patients with known hypersensitivity to any of the ingredients should not use this product.
4.4 Special Warnings and precautions for use
The following warnings have been added:
Propylene glycol alginate may cause skin irritation. Stearyl alcohol and cetyl alcohol may cause local skin reaction (e.g. contact dermatitis).
It is recommended that exposure to sun or sunlamps should be minimised.
Simultaneous use of other keratolytics such as salicylates or sulphur may increase occurrence of skin irritation.
During the first weeks of treatment, a sudden increase in peeling and reddening will occur in most patients; this is not harmful and will normally subside in a day or two if treatment is temporarily discontinued.
4.5 Interaction with other medicinal products and other forms of interaction
The following information has been added:
Simultaneous application of Brevoxyl and topical acne preparations containing vitamin A derivatives should be avoided.
4.6 Pregnancy and Lactation
The following discussion has been changed, new wording is written in bold.
The safety of benzoyl peroxide in human pregnancy is not established. During pregnancy and lactation Brevoxyl should be used only with special caution and after the physician’s assessment of benefit and risk. In the last month of pregnancy Brevoxyl should not be used.
There is no knowledge about the excretion of Brevoxyl in breast milk.
4.8 Undesirable effects
The following adverse reactions have been added:
The patient may also experience temporary pruritus, facial oedema, dermatitis or rash. As for other benzoyl peroxide preparations allergic contact dermatitis could occasionally occur.
5. PHARMACOLOGICAL PROPERTIES
5.3 Preclinical safety data
The final paragraph has changed from:
Benzoyl peroxide at high doses (>20 times the normal human dose) has been shown to increase the tumour growth initiated by dimethyl benzanthracene (DMBA) in mice. DMBA is a powerful chemical carcinogen to which patients are unlikely to be exposed. The relevance of these results to man is limited. Studies in mice have also shown that benzoyl peroxide does not increase the growth of tumours initiated by ultra violet light.
To:
No reproductive toxicology studies have been performed. Up to date there are no indications that the topical use of Brevoxyl causes damage to the unborn child.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Nomenclature has been updated from:
Promulgen G (which consists of stearyl alcohol and macrogol Ceteareth 20)
To
Promulgen G (which consists of stearyl alcohol and macrogol cetostearyl ether)
6.5 Nature and contents of container
A description of the product pack size (40g) has been added.
10. DATE OF REVISION OF THE TEXT
This has been updated to May 2009.