Reasons for adding or updating:

• Change to section 4.4 - Special warnings and precautions for use
• Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC: 01-May-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



 

Added to section 4.4

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with

 

symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Added to section 4.8

Vision, blurred - Not known

 

Reasons for adding or updating:

• Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Date of revision of text on the SPC: 14-Feb-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Added to Section 4.5

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid effects.

Reasons for adding or updating:

• New SPC for new product

Legal Category:POM

Black Triangle (CHM): NO