Spring Intro 2023

Grouping of side effects

• “Like all medicines, this medicine can cause side effects, although not everybody gets them” (as introduction)

• The most serious side effects need to be listed prominently first with clear instructions to the patients on what action to take (e.g. to stop taking the medicine and/or seek urgent medical advice)

• Then a list of all other side effects starting with most frequent (without repeating the most serious effects included above)

• The frequency convention should not appear in a table before the list of side effects as this takes up space and has shown in user testing to be misleading to patients

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Benefit information

• Reinforces the value of taking a medicine

• Provides context for ‘negative’ risk information

• prescription medicines • preventative medicines: when the patient is asymptomatic • long-term treatments

• Short non-promotional statement at the beginning of the PIL

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