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.
The Pharmacovigilance Risk Assessment Committee (PRAC), based on the evaluation of periodic safety update reports (PSURs) for medicinal products containing telmisartan (telmisartan), telmisartan/hydrochlorothiazide (telmisartan/hydrochlorothiazide), PSUSA/00002882/202503, reached the following conclusions.
In view of the available data on dizziness from clinical studies, literature, spontaneous reports, including 27 cases with a close temporal relationship, 12 cases with a positive reaction to withdrawal of the medicinal product (de-challenge) and 2 cases with a positive reaction to re-administration of the medicinal product (re-challenge), as well as a plausible mechanism of action and the effect inherent to the therapeutic class of medicinal products, the PRAC considers that a causal relationship between the use of telmisartan and dizziness is at least reasonably possible. The PRAC concluded that the instructions for medical use of medicinal products containing telmisartan should be amended accordingly.
Having considered the PRAC recommendations, the Committee for Medicinal Products for Human Use (CHMP) agreed with the overall conclusions and grounds for the recommendations.
Based on the scientific conclusions on telmisartan (telmisartan), telmisartan/hydrochlorothiazide (telmisartan/hydrochlorothiazide), the CHMP considers that the benefit/risk balance of medicinal products containing telmisartan (telmisartan), telmisartan/hydrochlorothiazide (telmisartan/hydrochlorothiazide) remains unchanged, provided that the proposed amendments to the instructions for medical use are made.
Changes to be made to the relevant sections of the instruction for medical use (new text underlined and in bold).
“Adverse reactions” section
The following adverse reaction should be added to the System Organ Class (SOC) “Nervous system disorders” with a frequency of “uncommon”:
Dizziness
Changes to the safety information of medicinal products containing telmisartan, telmisartan/hydrochlorothiazide, based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 24 – 27 November 2025
The European Medicines Agency (EMA) has published the minutes of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting of 24 – 27 November 2025. Following the meeting, a decision was made on the need to introduce safety-related changes to the registration materials / instructions for medical use of medicinal products containing telmisartan, telmisartan/hydrochlorothiazide.
Telmisartan – KINZALMONO, MICARDIS, PRITOR,
Telmisartan/hydrochlorothiazide – KINZALKOMB, PRITORPLUS – PSUSA/00002882/202503
Telmisartan is a specific angiotensin II receptor antagonist (AT1 type), indicated for the treatment of essential hypertension in adults and for reducing cardiovascular morbidity in adults with clinically manifest atherothrombotic cardiovascular disease or type 2 diabetes mellitus with documented target organ damage. Hydrochlorothiazide is a thiazide diuretic. The fixed-dose combination of telmisartan and hydrochlorothiazide is indicated for patients whose blood pressure is not adequately controlled with telmisartan or hydrochlorothiazide alone.
Based on the assessment of Periodic Safety Update Reports (PSURs), PRAC reviewed the benefit/risk balance of medicinal products containing telmisartan (telmisartan) and telmisartan/hydrochlorothiazide (telmisartan/hydrochlorothiazide), and provided the relevant recommendations.
Summary of recommendations and conclusions
- Based on the analysis of safety and efficacy data, the benefit/risk balance of medicinal products containing telmisartan and telmisartan/hydrochlorothiazide for the approved indications remains unchanged.
- At the same time, the instructions for medical use should be updated by adding dizziness as an adverse reaction with the frequency “uncommon.” Accordingly, the existing provisions of the instructions for medical use should be amended1.
- In the next PSUR, all registration certificate holders (RCHs) should continue to monitor cases of sprue-like enteropathy, provide any new data that have emerged during the reporting period, and consider the need to update the instructions for medical use, if necessary. In addition, all RCHs should provide a comprehensive review of cumulative and interval cases of headache, including an assessment of causality and a rationale for a possible update of the instructions for medical use, if necessary.
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1Update of the “Adverse reactions” section of the instructions for medical use. The risk assessment report and the PRAC recommendation are forwarded to the CHMP for a decision.
Results of the meeting of the Coordination Group for Mutual Recognition and Decentralized Procedures – Human (CMDh) of December 9–11, 2025, on medicinal products containing telmisartan, telmisartan/hydrochlorothiazide
Telmisartan, telmisartan/hydrochlorothiazide – PSUSA/00002882/202503
Telmisartan (telmisartan) is also registered for use in fixed-dose combinations. The PRAC concluded that the risk of dizziness in patients with essential hypertension whose blood pressure is not adequately controlled with telmisartan alone or hydrochlorothiazide alone should be included in the instructions for medical use of medicinal products containing telmisartan in fixed-dose combinations, if this adverse reaction is not yet included or is currently listed with a lower frequency.
List of medicinal products containing telmisartan and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 13.04.2026). (21 KB) (Downloaded: 29.04.2026 08:28:41)
TO ANALYZE THE PUBLISHED INFORMATION AND SUBMIT THE RELEVANT APPLICATION FOR AMENDMENTS TO THE REGISTRATION MATERIALS, THE APPLICANT MUST USE THE ORIGINAL TEXT AVAILABLE AT THE FOLLOWING LINKS:
