11. PATIENT INFORMATION LEAFLETS

A Patient Information Leaflet (PIL) is a small document that comes inside every medicine pack. It provides clear and simple instructions for safe and effective use of that medicine. PILs are prepared from the official Summary of Product Characteristics (SPC) and explain everything a patient needs to know about their medication.

PILs usually include:

  • What the medicine is used for
  • How to use it correctly
  • When it should not be used
  • Possible side effects
  • Ingredients and storage conditions

Guidelines Before Taking the Medicine

  • Read the entire leaflet carefully
  • Keep the leaflet for future use
  • Ask your healthcare provider if you have questions
  • Do not share your medicine with others
  • Report any severe or unusual side effects

Contents of a Patient Information Leaflet

1. Identification of the Medicine

  • Name of the medicine
  • Active ingredients
  • Dosage form
  • Strength

2. Therapeutic Indications

  • Medical conditions for which the medicine is approved
  • Expected benefits

3. Information Before Taking the Medicine

  • When the medicine should not be used
  • Precautions and warnings
  • Drug and food interactions
  • Advice for pregnancy and breastfeeding
  • Effect of medicine on driving or machine use

4. Dosage Instructions

  • Route and method of administration
  • Frequency of dosing
  • Duration of treatment
  • Special instructions (e.g., shake well, take with food)

5. Description of Side Effects

All expected side effects should be listed by:

  • Severity (serious or mild)
  • Frequency (common, uncommon, rare)

Actions to take in case of side effects must also be included.

6. Additional Information

  • Excipients used in the formulation
  • Description of the product (color, shape)
  • Available pack sizes
  • Storage conditions
  • Name and address of manufacturer

Layout and Design Guidelines for PILs

A good design makes the leaflet easy to read and patient-friendly. Two major experts — Kitching and Baker Able — have given widely accepted guidelines.

Kitching’s Guidelines (1990)

  • Line length should be 50–89 mm
  • Minimum 2.5 mm space between lines
  • Unjustified text is easier to read
  • Serif fonts improve readability
  • Minimum font size: 12 pt
  • The first line of each paragraph may be indented
  • Avoid all-capital titles
  • Italics reduce comprehension
  • Use positive statements
  • Headings must stand out clearly
  • Arabic numbers (1, 2, 3) are easier than Roman numerals
  • Numerals are clearer than number words (“9” easier than “nine”)
  • Pictograms help explain complex tasks (e.g., inserting eye drops)

Baker Able Leaflet Design (BALD) Criteria

Baker Able expanded Kitching’s guidelines and added more design elements.

  • Line length: 50–80 mm
  • Spacing between lines: >2.8 mm
  • Use serif fonts, type size >12 pt
  • Indent first line of paragraphs
  • Use lowercase titles
  • Limit italics to 0–3 words
  • Use standard headings
  • Arabic numbers preferred
  • Boxed text: 0–1 box per leaflet
  • Use up to 4 colors
  • White space coverage: >40% of the page
  • Paper quality: >90 gsm

Advisory Labels

Advisory labels provide quick, important instructions on the medicine container or packaging. They help patients use the medicine safely.

1. Medication-Specific Labels

  • Clear usage instructions
  • Correct dosage information
  • Important warnings

2. Emergency Contact Labels

  • What to do in case of a serious reaction
  • Emergency helpline numbers

3. Storage and Disposal Labels

  • Storage temperature and light conditions
  • Moisture precautions
  • Guidelines for safe disposal

Additional Content Areas in PILs

A complete patient information leaflet may also include:

  • Title and purpose of the leaflet
  • Condition overview and common symptoms
  • Treatment options including non-drug approaches
  • Clear instructions on medication use and lifestyle changes
  • Follow-up care and when to seek help
  • Contact information for healthcare providers
  • Additional online resources or support groups

Design Principles for PILs

  • Use readable font types (Arial, Helvetica, or serif fonts)
  • Use large fonts (12–14 pt)
  • Use bold headings and subheadings
  • Use bullet points for clarity
  • Include diagrams or simple illustrations where needed
  • Use clear icons for warnings or instructions
  • Maintain consistent structure throughout the leaflet
  • Include enough white space to avoid clutter
  • Keep high contrast between text and background

Detailed Notes:

For PDF style full-color notes, open the complete study material below:

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