Topamax Sprinkle 15 mg hard capsules
*Company:
Janssen Sciences IrelandStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 25 April 2024
File name
PI-Topamax (cps 15mg)-Ireland-English-IA_IB-PRAC Art.31.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.6 - Pregnancy and lactation
- 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 25 April 2024
File name
PIL-Topamax capsules-Ireland-English-IA_IB-PRAC Art.31.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to other sources of information section
File name
5962 Topamax DHCP Letter 01 Nov 2023 EM-142594 v4.pdf
Reasons for updating
- Add New Doc
Updated on 10 October 2022
File name
SPC-Topamax (cps 15mg)-Ireland-II_102 .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 (cps 15mg)-Ireland-English-II-098-CCDS v23_EDMS-ERI-147547264_18.0.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 capsules-Ireland-English-II-098.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 July 2021
File name
PIL-Topamax capsules-Ireland-English-II_094 clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 12 July 2021
File name
PI-Topamax (cps 15mg)-Ireland-English-II_094_EDMS-ERI-147547264_16.0.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 sprinkle 15mg-SPC-C27-19Dec2019-clean.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 September 2020
File name
Topamax sprinkle 15mg-SPC-C27-19Dec2019-clean.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
SPC Topamax Sp 15 consolid 093_EDMS-ERI-147547264_10.0_CL.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 CPS consolid 093_EDMS-ERI-147547262_9.0_CL.pdf
Reasons for updating
- New PIL for new product
Updated on 07 January 2020
File name
Topamax sprinkle 15mg-SPC-C27-19Dec2019-clean.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-Capsules-15-C24-05apr19-clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)