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
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Presentation Transcript
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PATIENT INFORMATION LEAFLETS (PIL) Estelle Viljoen
March 2013<br>
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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<br>
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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<br>
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WHAT X CONTAINS Information should be in line with formulation in the application for registration
Active ingredient and quantity(ies)
Other ingredients – list only<br>
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WHAT X IS USED FOR The pharmacotherapeutic group
Indications in line with the Package Insert
(In terminology understandable to the patient)<br>
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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<br>
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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<br>
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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<br>
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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<br>
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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<br>
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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<br>
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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<br>
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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<br>
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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<br>
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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 %)<br>
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General Hints [Physician] = doctor or medical practitioner
[Drug] = Medicine
X = Proprietary Name
This medicine or X always = Proprietary Name<br>
