Comprehensive Guide on Patient Information Leaflets (PIL)

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This guide covers the basic principles and format of Patient Information Leaflets (PIL), emphasizing the importance of clear and concise information in compliance with regulations. It details what should be included in PIL, such as product contents, usage instructions, contraindications, and special care considerations. The guide aims to ensure patients receive crucial information in a terminology they understand, enhancing safety and effectiveness of medication use.

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PATIENT INFORMATION LEAFLETS (PIL) Estelle Viljoen March 2013

The Basic PRINCIPLES Concise information In compliance with the Package Insert In terminology understandable to the patient Each product, in terms of the Regulations should have a PIL

Format of the PIL SCHEDULING STATUS and PROPRIETARY NAME AND PHARMACEUTICAL FORM must correspond with the Package Insert The correct INTRODUCTORY BOX in line with the Scheduling Status should be used

WHAT X CONTAINS Information should be in line with formulation in the application for registration Active ingredient and quantity(ies) Other ingredients list only

WHAT X IS USED FOR The pharmacotherapeutic group Indications in line with the Package Insert (In terminology understandable to the patient)

BEFORE YOU TAKE/USE/ARE GIVEN X Do not take/use/receive X Take special care with X Taking/using/receiving with food and drink Pregnancy and Breast-Feeding Driving and Using Machinery Important information about some of the ingredients of X Taking/using/giving other medicines with X

BEFORE YOU TAKE/USE/ARE GIVEN X (continued) Do not take/use/receive - Information should be in line with the contra-indications in the Package Insert

BEFORE YOU TAKE/USE/ARE GIVEN X (continued) Take special care with X/Special care should be taken with X (refer Guidelines for wording re injectables Information from the following sections in the Package Insert should be reflected here: - Warnings and - Special Precautions

BEFORE YOU TAKE/USE/ARE GIVEN X (continued) Taking/using/receiving X with food and drink Example: Do not take with grapefruit juice Pregnancy and Breast-feeding Basic information from the package insert + Mandatory statement

BEFORE YOU TAKE/USE/ARE GIVEN X (continued) Driving and Using Machinery Information in line with Package Insert Important information about some of the ingredients of X Example: Contains lactose and the possibility of lactose intolerance

BEFORE YOU TAKE/USE/ARE GIVEN X (continued) Taking/using/are given other medicines with X -Mandatory statement re using other medicines on a regular basis -Interactions from the Package Insert

HOW TO TAKE/USE/GIVE X This section should be started with: Do not share medicines . Always take exactly as prescribed . The usual dose is . If you take/use more X than you should - Mandatory statement If you forget to take/use X - missed a dose of X Effect when treatment with X is stopped

POSSIBLE SIDE-EFFECTS This section should be started with: X can have side-effects. Mandatory statement: Not all side-effects reported for X .. Side-effects described and advice given where appropriate The section should be closed with: If you notice any side-effects not mentioned in this leaflet, please inform your doctor or pharmacist

FORMAT OF THE PIL (continued) PRESENTATION OF X IDENTIFICATION OF X REGISTRATION NUMBER NAME AND ADDRESS OF HOLDER OF THE REGISTRATION CERTIFICATE DATE OF PUBLICATION OF THE PIL All to be in line with the Package Insert

General Hints Instructions should be specific to the dosage form e.g. give/take/apply Layman s terminology In accordance with the SI system, i.e A decimal comma A space between the numerical value and the unit (also %)