BURINEX Tablet

Active ingredients: Bumetanide

Product name and form

Burinex 5 mg Tablets.

Pharmaceutical Form

Tablet.

A white, flat, circular, uncoated, bevelled-edge tablet marked with a score line and ‘5 mg’ on one face.

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

Qualitative and quantitative composition

Each tablet contains 5 mg of Bumetanide.

Excipient with known effect: Each tablet contains 92 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

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

Maize starch
Lactose monohydrate
Povidone
Polysorbate 80
Colloidal anhydrous silica
Agar powder
Talc
Magnesium stearate

Pack sizes and marketing

PVC/aluminium blister packs of 14 (physician’s sample), 30 and 56 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

KARO PHARMA AB, Box 16184, 103 24 Stockholm, Sweden

Marketing authorization dates and numbers

PA22650/001/002

Date of first authorisation: 01 April 1978
Date of latest renewal: 01 April 2008

Drugs

Drug
Countries
Austria, Canada, France, Ireland, Netherlands, New Zealand, Singapore