Section 2 - Propylene glycol 30/0 w/w added to this section
Section 4.4 the following sentence has been added:
ELOCON Scalp Lotion contains propylene glycol which may cause skin irritation.
Section 4.8 changed from:
Local adverse reactions occasionally reported with Elocon include paresthesia, folliculitis, burning, pruritis, tingling, stinging, allergic contact dermatitis, hypopigmentation, hypertrichosis, secondary infection, striae, acneiform reactions and signs of skin atrophy.
Local adverse reactions reported infrequently with other topical corticosteroids include: irritation, perioral dermatitis, maceration of the skin and miliaria.
To:
Local side effects reported with Elocon include pruritis, tingling, stinging, application site
reactions, bacterial infection, folliculitis, furunculosis, acneiform reactions and signs of skin atrophy.
Additional local side effects reported infrequently with other topical corticosteroids include: burning, irritation, dryness, hypertrichosis, hypopigmentation,perioral dermatitis, allergic contact dermatitis,maceration of the skin, secondary infection, striae and miliaria.
Section 6.1
sodium phosphate monobasic monohydrate changed to sodium phosphate monobasic dihydrate
Section 9 - Date of renewal of authorisation updated.
Section 10 - Date of revision of text updated
|