Burinex 1mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bumetanide, Quantity: 1 mg

Available from:

AFT Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: Agar; lactose monohydrate; maize starch; colloidal anhydrous silica; povidone; polysorbate 80; magnesium stearate; purified talc

Administration route:

Oral

Units in package:

100 tablets

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

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.

Product summary:

Visual Identification: White, flat, circular (8mm), uncoated, bevelled edge tab, marked on one face with a score line and the number 133.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1995-03-17

Patient Information leaflet

BURINEX®
1
BURINEX®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING BURINEX?
BURINEX contains the active ingredient bumetanide. BURINEX is used 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.
For more information, see Section 1. Why am I using BURINEX?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BURINEX?
Do not use if you have ever had an allergic reaction to BURINEX or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
BURINEX?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with BURINEX and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE BURINEX?
•
Use BURINEX only when prescribed by your doctor. Follow the
instructions provided and use BURINEX until your doctor tells
you to stop.
•
The usual dose of BURINEX is one tablet (1 mg) every day; however,
your doctor may recommend a different dose for you.
More instructions can be found in Section 4. How do I use BURINEX?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BURINEX?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
BURINEX.
•
If you become pregnant while using BURINEX, inform your doctor
immediately.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine or change the dose, unless your doctor
has told you to.
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how BURINEX affects you.
•
BURINEX may cause dizziness in some

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – BURINEX
®
(BUMETANIDE) TABLETS
1.
NAME OF THE MEDICINE
Bumetanide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Burinex® tablet contains 1 mg bumetanide.
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 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Burinex® 1 mg tablets are white, flat, circular (diameter 8 mm) and
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 – 4 days with rest periods of 1 – 2 days
in between, is recommended as the safest
and most effective method for the continued control of oedema.
4.3.
Contraindications
•
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 discontinuation of
treatment with Burinex®
•
Hepatic encephalopathy including coma
•
Severe electrolyte depletion
•
Hypersensitivity to the active substance (bumetanide) or to any of the
excipients (see SECTION 6.1
LIST OF EXCIPIENTS). Reports of successful treatment with Burinex®
foll