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BUMETANIDE Tablets (2018)

Active ingredients: Bumetanide

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.

Chemical substance
Description
Bumetanide

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
Authorization dates

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

30/08/2006

Marketing authorization number:

PL 04569/0433