Topamax 100mg film-coated tablets *
Pharmacy Only: Prescription DHPC

  • Company:

    Janssen Sciences Ireland
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

COM Updated on 19 October 2022

File name

634fde0e1eec1.pdf

Reasons for updating

  • Add New Doc

Updated on 10 October 2022

File name

6344303b5f243.pdf

Reasons for updating

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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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.

Updated on 21 February 2022

File name

PI-Topamax (fct 100mg)-Ireland-English- II-098-CCDS v23_EDMS-ERI-147547257_18.0_1645443236.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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.

Updated on 21 February 2022

File name

PIL-Topamax tablets-Ireland-English-II-098_1645442713.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to improve clarity and readability

Free text change information supplied by the pharmaceutical company

Section 6: Addition of Northern Ireland

Updated on 12 January 2022

File name

PIL-Topamax tablets-Ireland-English-IA_Site Transfer to Recipharm_1641997935.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Change to section 6 - manufacturers, Change of revision date

Updated on 12 July 2021

File name

PIL-Topamax tablets-Ireland-English-II_094 clean_1626103598.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect

Updated on 12 July 2021

File name

PI-Topamax (fct 100mg)-Ireland-English- II_094_EDMS-ERI-147547257_16.0_1626103573.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 29 September 2020

File name

Topamax FCT 100mg-SPC-C27-19Dec2019-clean_1601394111.pdf

Reasons for updating

  • Other

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 22 September 2020

File name

PIL Topamax FCT consolid 093_EDMS-ERI-147547259_9.0_CL_1600794557.pdf

Reasons for updating

  • New PIL for new product

Updated on 22 September 2020

File name

SPC Topamax 100 consolid 093_EDMS-ERI-147547257_10.0_CL_1600794198.pdf

Reasons for updating

  • Other

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 07 January 2020

File name

Topamax FCT 100mg-SPC-C27-19Dec2019-clean_1578408658.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 09 April 2019

File name

IE-SPC-Tablets-100-C24-05apr19-clean_1554805918.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)