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Anjiyotensin II Reseptör Blokerleri Acil Güvenlilik Kısıtlaması Görüş Katkı

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Anjiyotensin II Reseptör Blokerleri Acil Güvenlilik Kısıtlaması Görüş Katkı_İNG

Turkish Ministry of Health Turkish Medicines and Medical Devices Agency

Number: E-24931227-510.01.04-5591568 21.02.2025 Subject: Angiotensin II Receptor Blockers - Urgent Safety Restriction/Opinion - Contribution

FILE

The European Medicines Agency's (EMA) warning titled “Signal assessment report on intestinal angioedema with angiotensin II receptor blockers” regarding drugs containing angiotensin II receptor blockers has been evaluated by our Agency. The attached statements should be added to the Summary Product Characteristics (SmPC) and Patient Information Leaflet (PIL) of these drugs. Please be informed and take necessary actions to submit your opinions, suggestions and contributions, if any, regarding the decision taken to the Pharmacovigilance and Controlled Substances Department Pharmacovigilance Risk Management Unit until 28.02.2025, and not to apply to the Pharmacological Evaluation Unit within this period.

Prof. Dr. Ahmet AYAR Agency President

Attached: SmPC/PIL Text (2 pages)

Distribution: Pharmaceutical Industry Employers' Association Association of Research-Based Pharmaceutical Companies Turkish Pharmaceutical Industry Association Health Products Association Drug, Pharmacy, Health Science and Technologies Foundation
Association of Developmental Pharmaceutical Companies

This document has been signed with a secure electronic signature.

Document Verification Code: ZW56Q3NRS3k0M0FyQ3NRSHY3RG83SHY3 Document Tracking Address: https://www.turkiye.gov.tr/saglik- titck-ebys

SUMMARY OF PRODUCT CHARACTERISTICS

4.4 Special warnings and precautions for use

Olmesartan, irbesartan, valsartan, losartan and candesartan (single component or fixed-dose combination component):

Intestinal angioedema: Intestinal angioedema has been reported in patients treated with angiotensin II receptor blockers [including ] (see section 4.8). These patients complained of abdominal pain, nausea, vomiting and diarrhea. Their symptoms improved after discontinuation of the angiotensin Il receptor blocker. If intestinal angioedema is diagnosed, treatment with should be discontinued and appropriate monitoring initiated until complete resolution of symptoms.

Azilsartan, eprosartan and telmisartan (single component or fixed-dose combination component):

Intestinal angioedema: Intestinal angioedema has been reported in patients treated with angiotensin II receptor blockers (see section 4.8). These patients complained of abdominal pain, nausea, vomiting and diarrhea. Their symptoms improved after discontinuation of the angiotensin Il receptor blocker. If intestinal angioedema is diagnosed, treatment with should be discontinued and appropriate monitoring initiated until complete resolution of symptoms.

4.8 Undesirable effects

For olmesartan, irbesartan, valsartan, losartan and candesartan: addition to the adverse reaction table for the corresponding ARB. For losartan, olmesartan and irbesartan, the frequency should be “rare”. For valsartan and candesartan, the frequency should be “very rare”:

Gastrointestinal disorders

Intestinal angioedema

Azilsartan, eprosartan and telmisartan (single component or fixed-dose combined component):

Description of selected adverse reactions: Cases of intestinal angioedema have been reported after the use of angiotensin II receptor blockers (see section 4.4).

PATIENT INFORMATION LEAFLET

For all ARBs (olmesartan, azilsartan, candesartan, eprosartan, irbesartan, valsartan, losartan and telmisartan):

  1. What you need to know before you use

Warnings and precautions Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhea after taking . Your doctor will decide on further treatment. Do not stop taking on your own.

  1. Possible side effects

Addition to the adverse reaction table for olmesartan, irbesartan, valsartan, losartan and candesartan for the corresponding ARB. For losartan, olmesartan and irbesartan, the frequency should be “rare”. For valsartan and candesartan, the frequency should be “very rare”:

Intestinal angioedema: swelling of the bowels with symptoms such as abdominal pain, nausea, vomiting and diarrhea

For azilsartan, eprosartan and telmisartan:

Frequency 'unknown': Intestinal angioedema: Swelling of the bowels with symptoms such as abdominal pain, nausea, vomiting and diarrhea has been reported after use of similar products.