PIL - Oxybutynin hydrochloride XL 5mg, 10mg Prolonged release Tablets: Change history
View Patient Information Leaflet (PIL - Oxybutynin hydrochloride XL 5mg, 10mg Prolonged release Tablets)
Last updated on this site: 07 Nov 2023
Description of update: To update sections 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9 of the SmPC and the PIL following reference product comparison with Ditropan tablets 5mg, PL 45043/0036 (MAH: Neon Healthcare Ltd., dated 14/06/2022). Additionally, to update ATC naming in section 5.1 of the SmPC.
PIL sections updated: 2, 4 and 6.
Last updated on this site: 07 Nov 2023
Description of update: To update sections 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9 of the SmPC and the PIL following reference product comparison with Ditropan tablets 5mg, PL 45043/0036 (MAH: Neon Healthcare Ltd., dated 14/06/2022). Additionally, to update ATC naming in section 5.1 of the SmPC.
PIL sections updated: 2, 4 and 6.
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Changes: (Updated: 07 Nov 2023)
Description of update: To update sections 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9 of the SmPC and the PIL following reference product comparison with Ditropan tablets 5mg, PL 45043/0036 (MAH: Neon Healthcare Ltd., dated 14/06/2022). Additionally, to update ATC naming in section 5.1 of the SmPC.
PIL sections updated: 2, 4 and 6.
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Changes: (Updated: 14 Aug 2023)
Description of update: To update section 4.8 of the SmPC and section 4 of the PIL for Oxybutynin hydrochloride XL 5mg and 10 mg prolonged release tablets in line with the PRAC recommendations (PSUSA/00002253/202207) for ADR palpitation.
PIL sections updated: 4, 6.
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Changes: (Updated: 10 May 2023)
Variation Description: This notification is submitted to amend the packaging components without the need to amend the SmPC.
Changes notified are as follows:
To register proposed mock-ups of Oxybutynin hydrochloride 5 mg/10 mg XL prolonged release Tablets for CUG and dimension change. Herewith we confirm that colour scheme/ design/ text will remain the same as per approved present layouts.
PIL:
Existing dimension 350 x 350 mm
Proposed dimension170 x 350 mm
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Changes: (Updated: 03 Apr 2023)
To update sections 4.4, 4.8, 5.1 and 5.2 of the SmPC in line with reference product, Lyrinel XL 5 mg prolonged release tablet (PL 00242/0385; MAH: Janssen-Cilag Ltd: dated 08/04/2020). Consequently, the PIL has been updated. In addition, section 4.4 of the SmPC and PIL has been updated to align the excipient information for lactose and sodium with the latest EC Excipient guidelines (version 10.2).
SmPC sections updated – 4.4, 4.8, 5.1, 5.2 and 10
PIL sections updated – Heading, 1, 2, 3, 4 and 6
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Changes: (Updated: 21 Sep 2022)
Initial upload