Similar documents in the United States are called the ‘patient package insert’ or ‘medication guide’. A document, typically a few pages in length, containing written medical information for patients that accompanies approved medicines. Information contained in the leaflet include active ingredient and indication, contraindications, warning and precautions, dosage and administration, possible side effects, storage of the medicine, marketing authorisation holder and manufacturer. Many forms of written medical information are reviewed and approved by regulators. However in the United States, patients may also receive a pharmacy leaflet when picking up a prescription medication. These documents are not regulator approved, but contain information that is similar in scope to official information and is written by third party vendors (not the manufacturer).
Also called PIL.
Example: Xydalba (Dalbavancin) PDF page 22 (source)
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