Australian approved name (AAN): Atropa belladonna
Common names and synonyms: Belladonna; Deadly nightshade
Plant part used: Aerial parts and roots
Mandatory components: Alkaloids calculated as hyoscyamine and atropine
Warnings and restrictions: The concentration of alkaloids calculated as hyoscyamine in the medicine must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%. The concentration of atropine in the medicine must be no more than 100 micrograms/kg or 100 micrograms/L or 0.00001%.
Schedule 2 – Pharmacy Medicine
a) for external use in preparations containing 0.03 per cent or less of total solanaceous alkaloids; or
b) for oral use:
i) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or
ii) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit, when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.
Allowable purpose of the ingredient: Active. Homeopathic