In accordance with paragraph 8 of Section IV of the Procedure for Expert Evaluation, the applicant must amend the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.
Having reviewed the data available in EudraVigilance on angiotensin II receptor blockers (ARBs), including cumulative reviews submitted by registration certificate holders (RCHs), PRAC decided that the RCHs of medicinal products containing azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan [single-component and combination medicinal products] must submit changes to the instructions for medical use as described below (new text underlined and in bold).
Taking into account the existing wording in the instructions for medical use of some medicinal products, registration certificate holders may need to adapt the text.
“Special precautions for use” section
For medicinal products containing olmesartan, irbesartan, valsartan, losartan, and candesartan.
Intestinal angioedema
Cases of intestinal angioedema have been reported in patients taking angiotensin II receptor blockers, [including <INN>] (see the section “Adverse reactions”). These patients experienced abdominal pain, nausea, vomiting, and diarrhea. The symptoms resolved after discontinuation of angiotensin II receptor blockers. If intestinal angioedema is diagnosed, the use of <INN> should be discontinued and appropriate monitoring started until the symptoms have completely resolved.
For medicinal products containing azilsartan, eprosartan, and telmisartan.
Intestinal angioedema
Cases of intestinal angioedema have been reported in patients taking angiotensin II receptor blockers (see the section “Adverse reactions”). These patients experienced abdominal pain, nausea, vomiting, and diarrhea. Symptoms resolved after discontinuation of angiotensin II receptor blockers. If intestinal angioedema is diagnosed, <INN> should be discontinued and appropriate monitoring started until the symptoms have completely resolved.
“Adverse reactions” section
For medicinal products containing olmesartan, irbesartan, valsartan, losartan, and candesartan: additions to the table of adverse reactions for the relevant antihypertensive medicinal product. For losartan, olmesartan, and irbesartan, the frequency should be “rare”. For valsartan and candesartan – “very rare”:
Subsection “Gastrointestinal disorders”
Intestinal angioedema
For medicinal products containing azilsartan, eprosartan, and telmisartan:
Description of selected adverse reactions:
Cases of intestinal angioedema have been reported following the use of angiotensin II receptor blockers (see the section "Special warnings and precautions for use").
List of medicinal products containing azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan [single-component and combination medicinal products] and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 24.12.2024).
TO ANALYZE THE PUBLISHED INFORMATION AND SUBMIT THE CORRESPONDING APPLICATION FOR AMENDMENTS TO THE REGISTRATION MATERIALS, THE APPLICANT MUST USE THE ORIGINAL TEXT POSTED AT THE LINKS:
