Key points to note:
• Consistency with the SmPC and compliance with article 59(1) must first
be achieved (see below, Using Templates)
• Complex language and medical jargon cause difficulty in understanding
by patients.
o Translate all the information into lay language.
o Make sure you use colloquial English (for leaflets for the UK).
o Use short sentences and/or bullet points.
o Many of the phrases in the QRD template can confuse so
consider more colloquial terms for the UK.
• Do not use the system organ class arrangement for side effects as
patients are unable to follow this logic. Side effects should be grouped
by seriousness to enable patients to understand when to take action
and what that action should be.
• Make sure risks are communicated clearly to patients. Guidance has
already been published in “Always Read the Leaflet” and examples of
best practice in this area are available. Explanations (including
frequency with respect to the side effects) are known to be helpful to
readers and can put the risk in context.