Drug Development & Regulation

Patient Information Leaflet PIL

TRKullanma Talimatı
Also known as:Package leaflet · Patient leaflet · Patient package insert

The leaflet enclosed in a medicine's package that gives patients approved, plain-language information on what the medicine is used for and how to use it safely.

In depth

Derived from the SmPC and approved with the marketing authorization, it follows a standard structure: what the medicine is and what it is used for, what to know before using it, how to use it, possible side effects, how to store it, and contents of the pack. In the EU its readability must be confirmed by user testing with lay readers.

In Turkey it is called the 'Kullanma Talimatı (KT)' and is approved by TİTCK. Side-effect frequencies are given in lay terms linked to defined ranges (e.g., 'common' corresponds to between 1 in 100 and 1 in 10 patients).

Clinical pearl

Long lists of possible side effects can provoke anxiety, nocebo symptoms and nonadherence; explaining frequency terms and which symptoms need action supports safe use.

TRIn Turkish

Kullanma Talimatı

İlacın ambalajında bulunan ve hastaya ilacın ne için kullanıldığı ve nasıl güvenle kullanılacağı konusunda onaylı bilgiyi sade bir dille sunan metindir.

KÜB'den türetilir ve ruhsatla birlikte onaylanır; standart bir yapısı vardır: ilacın ne olduğu ve ne için kullanıldığı, kullanmadan önce dikkat edilmesi gerekenler, nasıl kullanılacağı, olası yan etkiler, saklama koşulları ve ambalaj içeriği. AB'de okunabilirliğinin sıradan okuyucularla yapılan kullanıcı testiyle doğrulanması gerekir.

Türkiye'de Kullanma Talimatı (KT) olarak adlandırılır ve TİTCK tarafından onaylanır. Yan etki sıklıkları, tanımlı aralıklara karşılık gelen sade ifadelerle verilir (örneğin 'yaygın', 100 hastada 1 ile 10 hastada 1 arasındaki sıklığa karşılık gelir).

Uzun yan etki listeleri kaygıya, nosebo belirtilerine ve tedaviye uyumsuzluğa yol açabilir; sıklık terimlerini ve hangi belirtilerde harekete geçilmesi gerektiğini açıklamak güvenli kullanımı destekler.

Diğer adları:KT · Prospektüs
Updated 24.09.2026 0 views Educational reference — verify against current sources before clinical use.

Read next

Summary of Product CharacteristicsKısa Ürün Bilgisi

The regulator-approved document that sets out the properties and authorized conditions of use of a medicinal product for healthcare professionals, forming the legal basis of its prescribing information.

 Marketing AuthorizationRuhsat

The license granted by a competent regulatory authority that allows a medicinal product to be placed on the market, based on assessment of its quality, safety and efficacy for defined indications and conditions of use.

 Side EffectYan Etki

An unintended effect of a medicine, occurring at normal doses, that arises from its pharmacological properties and may be harmful, neutral or occasionally beneficial.

 Nocebo EffectNosebo Etkisi

The occurrence or worsening of symptoms, including adverse effects, that results from negative expectations about a treatment rather than from its pharmacological action.

 Medication AdherenceTedaviye Uyum

The extent to which a patient's medication-taking behaviour corresponds with the recommendations agreed with the prescriber.

 Boxed WarningKutu İçi Uyarı

A warning displayed in a bordered box at the top of US prescribing information to highlight serious or life-threatening risks, or measures essential to reduce them.