PATIENT INFORMATION LEAFLETS (PIL)

1. PATIENT INFORMATION LEAFLETS(PIL) Estelle Viljoen March 2013

2. 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

3. 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

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

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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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 %)

16. General Hints • [Physician] = doctor or medical practitioner • [Drug] = Medicine • X = Proprietary Name • This medicine or X always = Proprietary Name

17. The end