Circular · Safety Notice AIFD · Güvenlik Duyuruları 03.03.3025

03.03.3025 Fentanil iİçeren İlaçlar – Acil Güvenlilik Kısıtlaması

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EN: This is the official English version published by the authority (TİTCK), imported from the AIFD Legislation Portal archive. The binding text is the official Turkish version.

03.03.2025 Montelukast İçeren İlaçlar – Acil Güvenlilik Kısıtlaması -Görüş-Katkı_İNG

Turkish Ministry of Health Turkish Medicines and Medical Devices Agency

Number: E-24931227-510.01.04-5595362 28.02.2025 Subject: Montelukast-containing Medicines / Urgent Safety Restriction / Opinion- Contribution

FILE

Regarding all medicinal products containing montelukast, the Agency has evaluated the warnings of the European Medicines Agency (EMA), Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) regarding the request for stronger emphasis on the statements regarding neuropsychiatric events in the product information of medicinal products containing montelukast. A decision was taken to add the statements specified in the attached document to the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) of these medicinal products. Your opinions, suggestions and contributions, if any, regarding the decision taken should be submitted to the Pharmacovigilance and Controlled Substances Department, Pharmacovigilance Risk Management Unit until 10.03.2025, and no application should be made to the Pharmacological Evaluation Unit of the Drug Licensing Department until then. For your information and necessary action.

Prof. Dr. Ahmet AYAR Agency President

Attached: SmPC/PIL Text (1 page)

To be distributed to: 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: ZW56Q3NRS3k0ZmxXSHY3RG83M0FyM0Fy Document Tracking Address: https://www.turkiye.gov.tr/saglik- titck-ebys

Summary of Product Characteristics (SmPC)

4.4 Special warnings and precautions for use

Statements about neuropsychiatric events should be changed to be in boldface and boxed:

Neuropsychiatric events including behavioral changes, depression and suicidal tendencies have been reported in all age groups receiving montelukast (see section 4.8). Symptoms can be serious and may persist if treatment is not discontinued. Therefore, treatment with montelukast should be discontinued if neuropsychiatric symptoms occur during treatment. Advise patients and/or caregivers to be alert for neuropsychiatric events and tell patients to inform their doctor if these changes in behavior occur.

Patient Information Leaflet (PIL)

  1. What you need to know before you use

Statements about neuropsychiatric events should be changed to be in boldface and boxed:

Several neuropsychiatric events (e.g. changes in behavior and mood, depression and suicidal tendency) have been reported in patients of all ages treated with Montelukast (see section 4). If you develop such symptoms while taking Montelukast, you should contact your doctor.