SmPC - Metoprolol tartrate 100mg Tablets: Change history
View Summary of Product Characteristics (SmPC - Metoprolol tartrate 100mg Tablets)
Last updated on this site: 07 Aug 2026
Description of update: To update sections 4.4 and 4.5 of the SmPC and section 2 of the leaflet to implement the wording agreed by the CMDh following the outcome of the PSUR procedure (PSUSA/00002039/202503) for Metoprolol - a causal relationship between the increased risk of severe hypoglycaemia and the concomitant use of metoprolol and sulfonylureas.
Date of approval: 23/07/2026
SmPC sections updated: 4.4, 4.5 and 10
Last updated on this site: 07 Aug 2026
Description of update: To update sections 4.4 and 4.5 of the SmPC and section 2 of the leaflet to implement the wording agreed by the CMDh following the outcome of the PSUR procedure (PSUSA/00002039/202503) for Metoprolol - a causal relationship between the increased risk of severe hypoglycaemia and the concomitant use of metoprolol and sulfonylureas.
Date of approval: 23/07/2026
SmPC sections updated: 4.4, 4.5 and 10
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Changes: (Updated: 07 Aug 2026)
Description of update: To update sections 4.4 and 4.5 of the SmPC and section 2 of the leaflet to implement the wording agreed by the CMDh following the outcome of the PSUR procedure (PSUSA/00002039/202503) for Metoprolol - a causal relationship between the increased risk of severe hypoglycaemia and the concomitant use of metoprolol and sulfonylureas.
Date of approval: 23/07/2026
SmPC sections updated: 4.4, 4.5 and 10
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Changes: (Updated: 21 Sep 2022)
Initial upload