Burinex

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Bumetanide 1mg;  

Available from:

AFT Pharmaceuticals Ltd

INN (International Name):

Bumetanide 1 mg

Dosage:

1 mg

Pharmaceutical form:

Tablet

Composition:

Active: Bumetanide 1mg   Excipient: Agar Copovidone Hydrated silica Lactose monohydrate Magnesium stearate Maize starch Polysorbate 80 Purified talc

Units in package:

Blister pack, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Olon SpA

Therapeutic indications:

Indicated for the treatment of oedema, particularly that associated with congestive heart failure, hepatic and renal diseases including the nephrotic syndrome and acute pulmonary oedema.

Product summary:

Package - Contents - Shelf Life: Blister pack, - 100 tablets - 3 years from date of manufacture stored at or below 25°C protect from light 2 years from date of manufacture stored at or below 25°C protect from light. For finished product manufactured at Allphamed Pharbil Arzneimittel GmbH. 3 years from date of manufacture stored at or below 25°C protect from light. For finished product BN: 2010009 manufactured at Allphamed Pharbil Arzneimittel GmbH.

Authorization date:

1974-02-14

Patient Information leaflet

BURINEX
®
_(bue-rin-ex) _
BUMETANIDE 1 MG TABLETS
CONSUMER MEDICINE INFORMATION (CMI)
_PLEASE READ THIS LEAFLET CAREFULLY _
_BEFORE YOU START YOUR TREATMENT. _
KEEP THIS LEAFLET. You may want
to read it again.
WHAT IS IN THIS LEAFLET?
This leaflet answers some of the
common questions about Burinex
®
.
It does not contain all the available
information.
It
does
not
take
the
place of talking to your doctor or
pharmacist.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the risks of you taking Burinex
®
against the benefits this medicine
is expected to have for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE,
ASK YOUR DOCTOR OR PHARMACIST.
WHAT BURINEX
®
IS USED
FOR?
Burinex
®
is
a
medicine
which
makes the kidneys produce more
urine. It is effective for people who
have swollen feet and ankles due
to
fluid
which
has
built-up
as
a
result
of
heart,
liver
or
kidney
disease. It is also used when there
is too much fluid in the lungs.
Burinex
®
belongs
to
a
group
of
medicines called diuretics.
Your doctor may have prescribed
Burinex
®
for another reason. Ask
your doctor why Burinex
®
has been
prescribed for you.
Burinex
®
is
only
available
with
a
doctor’s prescription.
There is no evidence that Burinex
®
is addictive.
BEFORE YOU USE
BURINEX
®
_WHEN _
_YOU _
_MUST _
_NOT _
_USE _
_BURINEX_
_®_
_ _
DO NOT USE BURINEX
®
IF YOU:
•
HAVE
EVER
HAD
AN
ALLERGIC
REACTION TO BURINEX
®
(BUMETANIDE)
OR
TO
ANY
INGREDIENTS LISTED AT THE END
OF THIS LEAFLET
•
HAVE
KIDNEYS
THAT
ARE
SO
DISEASED THEY ARE UNABLE TO
PRODUCE URINE
•
ARE
DEHYDRATED
OR
SHORT
OF
ESSENTIAL SIMPLE CHEMICALS
IN YOUR BLOOD
•
DISEASE OF THE BRAIN CAUSED
BY
LIVER
ILLNESS
INCLUDING
COMA
DO
NOT
USE
BURINEX
®
after
the
expiry date (EXP) printed on the pack.
If you take this medicine after the
expiry date has passed, it may not
be as effective.
DO
NOT
USE
BURINEX
®
IF
THE
PACKAGING IS TORN, DOESN’T LOOK
QUITE
RIGHT
OR
SHOWS
SIGNS
OF
TAMPERING.
If any of these apply, return the
medicine
to
your
pharmacist
for
disposal.
DO NOT

Summary of Product characteristics

NEW ZEALAND DATA SHEET
1
NAME OF THE MEDICINE
Burinex
®
1 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg of bumetanide (i.e.
3-n-(butylamino)-4-phenoxy-5-sulphamoyl-benzoic acid).
Excipients with known effect:
Lactose monohydrate (see Section 4.4 Special warnings and precautions
for use)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Burinex
®
1 mg tablets are white, round flat, circular (diameter 8 mm), uncoated
with a bevelled edge, and
are marked on one face with a score line and the number “133”.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Burinex
®
is indicated for the treatment of oedema, particularly that associated
with congestive heart
failure, hepatic and renal diseases including the nephrotic syndrome
and acute pulmonary oedema.
4.2 DOSE AND METHOD OF ADMINISTRATION
ORAL ADMINISTRATION
Most patients will respond to 1 mg daily, administered as a single
dose, either in the morning or early
evening.
If the diuretic response to an initial dose of Burinex
®
is not adequate, and in view of its rapid onset and
short duration of action, a second or third dose may be given at 4 to
5 hour intervals up to a maximum
daily dose of 10 mg in refractory patients. An intermittent dose
schedule, whereby Burinex
®
is given on
alternate days or for 3 to 4 days with rest periods of 1 to 2 days in
between, is recommended as the safest
and most effective method for the continued control of oedema.
Page 1 of 11
4.3 CONTRAINDICATIONS
1.
Anuria: Although Burinex
®
can be used to induce diuresis in renal insufficiency, any marked
increase in blood urea nitrogen or creatinine or the development of
oliguria during therapy
of patients with progressive renal disease is an indication for the
discontinuation of treatment
with Burinex
®
.
2.
Hepatic encephaolopathy including coma.
3.
Severe electrolyte depletion.
4.
Hypersensitivity to active substance or to any of the excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Excessive doses or too-frequent admi