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.
Section 2
The name of one of the active ingredients has been changed from: ‘Lanolin (hypoallergenic)’
to: ‘Wool Fat (Lanolin (hypoallergenic)’.
‘For excipients, see 6.1.’ has been included.
Section 3
From: ‘Emulsified water in oil cream.’
To: ‘Cream. A smooth, homogeneous, white, water in oil cream with a lavender odour.’
Section 4.1
From: ‘In the treatment of napkin rash, eczema, bedsores, acne, minor burns, surface wounds, sunburn, chilblains.’
To: In the management of various dermatoses, including local skin reactions associated with incontinence.’
Section 4.4
‘If there is no improvement in the condition or aggravation thereof, the doctor should be consulted’ has been included.
Section 5.1
The wording ‘It is a constituent of many natural balsams and is one of the principal esters of Peru Balsam’ has been removed from under the subheading ‘Benzyl benzoate’.
‘Benzyl cinnamate: This is the other principal ester of Peru Balsam BPC 1973. It is synthesised from benzyl alcohol and cinnamon acid which has antibacterial and antifungal properties. Peru Balsam is categorised as having a mild antiseptic action because of cinnamon acid and its derivatives present.’ has been removed.
The wording ‘The grade (hypoallergenic) used is manufactured so as to exclude many sensitising substances present in the lanolin’ has been removed from under the subheading ‘Lanolin’.
Section 6.1
The pharmacopoeial designations have been removed.
The ingredient ‘Antioxidant (formulation consisting of Butylated hydroxyanisole (BHA), Citric acid and Propylene Glycol)’ has been changed to list ‘Propylene glycol, citric acid, butylated hydroxyanisole (E320)’ separately.
Section 6.5
The 15g pack size has been removed.
Section 9
The date of last renewal has been included: ’01 April 2003’.
Section 10
The date of revision of the text has been included: ‘July 2006’.