BUMETANIDE Tablet Ref.[6685] Active ingredients: Bumetanide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts, EN6 1TL

Product name and form

Bumetanide 1 mg Tablets.

Pharmaceutical Form

Tablet.

White, flat, bevelled-edged, scored, tablet marked “BU/1” on one side and “G” on the reverse, approx. diameter 8 mm.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each tablet contains 1 mg of bumetanide.

Excipient with known effect: Contains 134 mg lactose (as lactose monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient

Bumetanide is a potent loop diuretic with a rapid onset and a short duration of action. The primary site of action is the ascending limb of the loop of Henle where it exerts inhibiting effects on electrolyte reabsorption, causing its diuretic and natriuretic action.
List of Excipients

Lactose monohydrate
Maize starch
Maize starch, pregelatinised
Cellulose, microcrystalline
Magnesium stearate

Pack sizes and marketing

PVC/PVdC/Al calendar blister packs: 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168 and 180 tablets.

High density polyethylene containers with tamper-evident polypropylene caps: 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168 and 180 tablets.

Polypropylene containers with tamper-evident polyethylene caps with optional polyethylene ullage filler: 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168 and 180 tablets.

Not all pack types/sizes may be marketed.

Marketing authorization holder

Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts, EN6 1TL

Marketing authorization dates and numbers

PL 04569/0433

30/08/2006

 
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