Irbesartan Zentiva 75 mg film-coated tablets
*Company:
Zentiva Pharma UK LimitedStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 21 May 2026
File name
For Med IE 74751 PIL_ 75MG_IE v2.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 05 May 2026
File name
PIL 75 MG IE CLEAN.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 05 May 2026
File name
SPC 75 MG IE CLEAN.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 - Intestinal angioedema: intestinal angioedema has been reported in patients treated with angiotensin II receptor antagonists, including irbesartan (see section 4.8). These patients presented with abdominal pain, nausea, vomiting and diarrhoea. Symptoms resolved after discontinuation of angiotensin II receptor antagonists. If intestinal angioedema is diagnosed, irbesartan should be discontinued and appropriate monitoring should be initiated until complete resolution of symptoms has occurred.
Section 5.3 - Studies in animals indicate that the radiolabelled irbesartan is detected in rat and rabbit foetuses. Irbesartan is excreted in the milk of lactating rats.
Updated on 31 January 2025
File name
SPC 75 MG IE clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 31 January 2025
File name
For EMC m1-3-2-pil-mock-up-75 mg.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 24 October 2024
File name
1.3.1 SPC 75mg FCT clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 October 2024
File name
FOR EMC NI 72521 PIL_IRBESARTAN ZTV 75MG_GB.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 21 February 2023
File name
66440 PIL_IRBESARTAN ZTV 75MG_GB-final.pdf
Reasons for updating
- New PIL for new product
Updated on 21 February 2023
File name
1.3.1 SPC 75mg FCT-clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Zentiva Pharma UK Limited
Address:
First Floor, Andrews House, College Road, Guildford, GU1 4QB, UKMedInfo@zentiva.comTelephone:
+353 818 882 243Medical Information Direct Line:
+353 818 882 243 ,