Topamax Sprinkle 15mg *

Pharmacy Only: Prescription DHPC

Acute myopia and secondary angle closure glaucoma syndrome

A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving topiramate. Symptoms include acute onset of decreased visual acuity and/or ocular pain. Ophthalmologic findings can include some or all of the following: myopia, mydriasis, anterior chamber shallowing, ocular hyperaemia (redness), choroidal detachments, retinal pigment epithelial detachments, macular striae, and increased intraocular pressure. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. Symptoms typically occur within 1 month of initiating topiramate therapy. In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with topiramate has been reported in paediatric patients as well as adults. Treatment includes discontinuation of topiramate, as rapidly as possible in the judgment of the treating physician, and appropriate measures to reduce intraocular pressure. These measures generally result in a decrease in intraocular pressure.

SE/H/0110/001-004,007-009/II/098, Addition of a description of safety data in SmPC section 5.1 from a clinical study of topiramate as monotherapy compared with levetiracetam as monotherapy in paediatric subjects with new or recent-onset epilepsy.

Section 6: Addition of Northern Ireland