PIL- Telmisartan/Hydrochlorothiazide 40mg/12.5mg, 80mg/12.5mg, 80mg/25mg Tablets: Change history
View Patient Information Leaflet (PIL- Telmisartan/Hydrochlorothiazide 40mg/12.5mg, 80mg/12.5mg, 80mg/25mg Tablets)
Last updated on this site: 21 Aug 2026
Description of update: To update section 4.8 of the SmPC and section 4 of the leaflet to implement the wording agreed by the PRAC following the outcome of the PSUR procedure (PSUSA/00002882/202503) - to add side effect dizziness with frequency uncommon. Additional editorial updates to SmPC sections 4.2 (80 mg/12.5 mg only), 4.4 (40 mg/12.5 mg only), 4.8 and PIL section 2.
Date of approval: 18/08/2026
PIL sections updated: 2, 4 and 6
Last updated on this site: 21 Aug 2026
Description of update: To update section 4.8 of the SmPC and section 4 of the leaflet to implement the wording agreed by the PRAC following the outcome of the PSUR procedure (PSUSA/00002882/202503) - to add side effect dizziness with frequency uncommon. Additional editorial updates to SmPC sections 4.2 (80 mg/12.5 mg only), 4.4 (40 mg/12.5 mg only), 4.8 and PIL section 2.
Date of approval: 18/08/2026
PIL sections updated: 2, 4 and 6
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Changes: (Updated: 21 Aug 2026)
Description of update: To update section 4.8 of the SmPC and section 4 of the leaflet to implement the wording agreed by the PRAC following the outcome of the PSUR procedure (PSUSA/00002882/202503) - to add side effect dizziness with frequency uncommon. Additional editorial updates to SmPC sections 4.2 (80 mg/12.5 mg only), 4.4 (40 mg/12.5 mg only), 4.8 and PIL section 2.
Date of approval: 18/08/2026
PIL sections updated: 2, 4 and 6
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Changes: (Updated: 27 Apr 2026)
Description of update: Type IB (C.2.a) variation application to update sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 of the SPC and sections 1, 2, 3 and 4 of the leaflet in-line with the product information of reference product (MicardisPlus 40 mg/12.5 mg, 80 mg/12.5 mg and 80 mg/25 mg tablets; MAH: Boehringer Ingelheim International GmbH, Germany; procedure number: EMEA/H/C/000413).
Date of approval: 22/04/2026
PIL sections updated: 1, 2, 3, 4 and 6
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Changes: (Updated: 13 May 2025)
Update to SmPC sections 4.4, 4.8 and PIL sections 2 and 4 in line with PRAC recommendations (EPITT No 20104) for intestinal angioedema.
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Changes: (Updated: 22 Sep 2022)
initial upload