Burinex Tablets 1mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BUMETANIDE

Available from:

LEO Pharma A/S

ATC code:

C03CA02

INN (International Name):

BUMETANIDE

Pharmaceutical form:

TABLET

Composition:

BUMETANIDE 1 mg

Prescription type:

POM

Therapeutic area:

DIURETICS

Authorization status:

Authorised

Authorization date:

2006-11-01

Patient Information leaflet

Scale
100%
Get-up
MT
Item No.
022859
Rev. No.
XX
Sent by e-mail
Subject
Insert 125 x 180 mm
Date
08/05/14
Date
14/05/14
Date
Colour
Black
Sign.
JUG
Sign.
JUG
Sign.
0 2 2 8 5 9 - X X
4.
OMA
15/05/14
ARTWORK
Please return to:
LEO Pharma A/S
Internal Market Access
Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength
Burinex
®
1 mg tablets
Supplier / Place of production
France
Comments:
Page 1 of 2
Mock-up for registration purpose.
PACKAGE LEAFLET: INFORMATION FOR THE USER
BURINEX
®
1 MG TABLET
Bumetanide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others.
It may harm them, even if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
Hypokalaemia increases the sensitivity to heart
1.
What Burinex
®
is and what it is used for medicine (digitalis glycosides and
non-depolarising
2.
Before you take Burinex
®
neuromuscular blocking agents).
3.
How to take Burinex
®
4.
Possible side effects
Non-steroidal anti-inflammatory drugs (NSAID;
5.
How to store Burinex
®
anti-inflammatory medicines for arthritis and other
6.
Further information
bone and muscle problems) inhibit the effect of
1. WHAT BURINEX
®
IS AND WHAT IT IS USED FOR
bumetanide.
The active substance is bumetanide which is a
Bumetanide reduces lithium clearance resulting in
potent high ceiling diuretic with a rapid onset and
high levels of lithium in the blood, therefore
a short duration of action.
concomitant therapy requires close monitoring of
Burinex
®
is indicated whenever diuretic therapy is
the lithium levels in the blood by your doctor.
required in the treatment of too much water in your
body (oedema ) e.g. associated with congestive
Bumetanide may potentiate the effect of antihyper-

Summary of Product characteristics

Page 1 of 9
1.
NAME OF THE MEDICINAL PRODUCT
Burinex
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bumetanide, 1 mg
Excipient with known effect: Each tablet contains 52.3 mg lactose
monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
Tablet characteristics:
White, circular, flat tablets embossed with the number 133 on one side
and an Assyrian lion on the
other.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Burinex 1 mg Tablets are indicated in the management of oedema due to
congestive heart failure,
cirrhosis of the liver and renal disease including nephrotic syndrome
in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose should be titrated in each patient according to the
patients’ response and the required
therapeutic activity.
In most patients initial dose is 0.5-1 mg daily. The dose may be
increased to 2 mg 2-3 times daily
until a satisfactory diuretic response is obtained.
_Paediatric population: _
There is limited documentation on the use of Burinex in children below
12 years of age.
_Elderly _
The dosage recommendations for adults apply, however, in the elderly,
bumetanide is generally
eliminated more slowly. Dosage should be titrated until the required
response is achieved.
_Patients with liver or renal insufficiency_
Bumetanide is excreted partly via the kidneys and partly via hepatic
metabolism and biliary
excretion. The dose should be titrated according to the patient’s
response and required therapeutic
effect (see section 4.4).
_Method of administration _
2
The bioavailability is not affected by food intake.
4.3
CONTRAINDICATIONS

Hypersensitivity to bumetanide or to any of the excipients listed in
section 6.1

Severe electrolyte depletion

Persisting anuria

Hepatic encephalopathy including coma
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Hepatic impairment
Caution is advised if bumetanide is to be administered to patien