PIL- ClobaDerm® 500 micrograms/g Ointment (clobetasol propionate): Change history
View Patient Information Leaflet (PIL- ClobaDerm® 500 micrograms/g Ointment (clobetasol propionate))
Last updated on this site: 06 Nov 2023
Description of update:
• All PILs are updated, within section 1, with the following clinical paragraph:
Corticosteroid creams, ointments and other topical preparations come in four different strengths. These are known as mild, moderately potent, potent or very potent. Healthcare professionals will usually refer to topical corticosteroid potency rather than strength. A potent corticosteroid has a much stronger effect than a mild
corticosteroid. The percentage of active ingredient that is sometimes included on product packaging does not indicate potency. XXXX is classed as a very potent corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition.
• Due to the addition of the clinical paragraph, there is some movement of text generally within the PILs but the pictures under section 3 are now aligned to make best use of the available space.
• In accordance with the Windsor framework, ‘UK Only’ is added to all cartons and the location of POM has been moved to be associated with the UK Only text in accordance with Company guidelines.
• In accordance with MHRA guidelines, the safety flash is removed from all cartons as it has been over 12 months since it was first added.
• The historical sentence ‘Medicinal product subject to medical prescription.’, which means the same as POM has been removed from all labelling.
• For the tube labels all historically outlined text has been replaced to improve readability.
PIL sections updated: 1 and 6.
Last updated on this site: 06 Nov 2023
Description of update:
• All PILs are updated, within section 1, with the following clinical paragraph:
Corticosteroid creams, ointments and other topical preparations come in four different strengths. These are known as mild, moderately potent, potent or very potent. Healthcare professionals will usually refer to topical corticosteroid potency rather than strength. A potent corticosteroid has a much stronger effect than a mild
corticosteroid. The percentage of active ingredient that is sometimes included on product packaging does not indicate potency. XXXX is classed as a very potent corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition.
• Due to the addition of the clinical paragraph, there is some movement of text generally within the PILs but the pictures under section 3 are now aligned to make best use of the available space.
• In accordance with the Windsor framework, ‘UK Only’ is added to all cartons and the location of POM has been moved to be associated with the UK Only text in accordance with Company guidelines.
• In accordance with MHRA guidelines, the safety flash is removed from all cartons as it has been over 12 months since it was first added.
• The historical sentence ‘Medicinal product subject to medical prescription.’, which means the same as POM has been removed from all labelling.
• For the tube labels all historically outlined text has been replaced to improve readability.
PIL sections updated: 1 and 6.
-
Changes: (Updated: 06 Nov 2023)
Description of update:
• All PILs are updated, within section 1, with the following clinical paragraph:
Corticosteroid creams, ointments and other topical preparations come in four different strengths. These are known as mild, moderately potent, potent or very potent. Healthcare professionals will usually refer to topical corticosteroid potency rather than strength. A potent corticosteroid has a much stronger effect than a mild
corticosteroid. The percentage of active ingredient that is sometimes included on product packaging does not indicate potency. XXXX is classed as a very potent corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition.
• Due to the addition of the clinical paragraph, there is some movement of text generally within the PILs but the pictures under section 3 are now aligned to make best use of the available space.
• In accordance with the Windsor framework, ‘UK Only’ is added to all cartons and the location of POM has been moved to be associated with the UK Only text in accordance with Company guidelines.
• In accordance with MHRA guidelines, the safety flash is removed from all cartons as it has been over 12 months since it was first added.
• The historical sentence ‘Medicinal product subject to medical prescription.’, which means the same as POM has been removed from all labelling.
• For the tube labels all historically outlined text has been replaced to improve readability.
PIL sections updated: 1 and 6.
-
Changes: (Updated: 21 Sep 2022)
Initial upload