BUSPIRONE Tablet

Active ingredients: Buspirone

Product name and form

BUSPIRONE 5mg TABLETS.

Pharmaceutical Form

Tablet.

White, uncoated, flat bevelled edge with A5 on one side and plain on the other.

Qualitative and quantitative composition

Each dosage form contains 5mg buspirone hydrochloride.

Excipients with known effect: each tablet contains 60.80mg Lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Buspirone is an azaspirodecanedione. The exact mechanism of buspirone anxioselective action is not fully known. From animal studies it is known to interact with serotonin, noradrenaline (norepinephrine), acetylcholine and dopamine systems of the brain.

List of Excipients

Lactose monohydrate
Magnesium stearate
Purified talc
Polyvidone K-25
Potato starch

Pack sizes and marketing

250µm white opaque PVC/20µm aluminium foil blister packs.

Blister pack sizes: 20, 21, 28, 30, 56, 60, 84, 90, 100, 112, 126

Marketing authorization holder

Actavis UK Limited (Trading styles: Actavis), Whiddon Valley, BARNSTAPLE, N Devon EX32 8NS

Marketing authorization dates and numbers

PL 0142/0455

24 July 2002 / 23 January 2009