BURINEX TABLET 1MG

Country: Malasja

Lingwa: Ingliż

Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredjent attiv:

BUMETANIDE

Disponibbli minn:

DKSH MALAYSIA SDN BHD

INN (Isem Internazzjonali):

BUMETANIDE

Unitajiet fil-pakkett:

100 Tablets

Manifatturat minn:

allphamed PHARBIL Arzeneimittel GmbH

Fuljett ta 'informazzjoni

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
BURINEX
_® _
TABLET 1MG
_ _
Bumetanide (1mg)
Page 1
WHAT IS IN THIS LEAFLET
1.
What Burinex® tablet is used for
2.
How Burinex® tablet works
3.
Before you use Burinex® tablet
4.
How to use Burinex® tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Burinex® tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT BURINEX® TABLET IS USED FOR
Burinex® is used as a diuretic for
treatment of oedema and/or high
blood pressure.
HOW BURINEX® TABLET WORKS
Bumetanide, the active ingredient in
Burinex® tablet is a diuretic (water
tablet). They help your kidneys
produce more urine over a short
period of time. This helps your body
to quickly get rid of more water.
BEFORE YOU USE BURINEX® TABLET
_- When you must not use it _
Do not use Burinex® if:
•
you are allergic to the active
substance or one or more of the
other ingredients
•
you have serious disturbances in
fluid and salt balance (electrolyte
disturbance)
•
you have kidney failure, where the
production of urine has ceased
•
you have a severe liver disease
•
you have too little sodium in your
blood
Pregnancy
Pregnancy: You should only take
Burinex® tablet if advised by your
doctor.
_ _
_- Before you start to use it _
Before you take Burinex® tablet, tell
your doctor if:
•
you are allergic to medicine for
urinary tract infections
(sulphonamides) or diuretics
(thiazides), as there is a risk that
you will also be allergic to
Burinex® tablet
•
you have metabolism disorders
(porphyria)
•
you have diabetes
•
you have gout, as Burinex® tablet
may worsen this condition
•
you have low blood pressure
•
you have a tendency to infection
or bleeding due to reduced
number of white blood corpuscles
and blood platelets
•
you take antibiotics (amino
glycosides) or take other medicine
which may impair your hearing
•
you are pregnant
When having blood and urine tests,
always inform that you are receiving
treatment with Buri

Karatteristiċi tal-prodott

Dimensions (W
x
H):
Machine drawing ID:
Material:
180 x 420 mm
-
Paper
CMO:
NEXT Pharma
allphamed PHARBIL Arzneimittel GmbH
Germany
KARO code:
Previous KARO code:
CMO code:
Component type:
Language:
Pharma code:
EAN/GTIN/NTIN/PC:
2002814_1
150122PIL04
-
Leaflet
English
-
-
Font:
Font size:
Euclid Circular A
8,5 pt (minimal)
Print colours:
Process
BLACK
Onlay:
Cut
BURINEX
TABLETS 1 MG
MY
ATTENTION:
If this supporting colour
swatch is present it
means THE ARTWORK IS
STILL IN PROGRESS and
therefore its
content
and technical
specs are
not ready for repro-
duction.
For Position
ONLY
New SKU + TT
Date: 06-09-2022
Reason for change:
Correction round: v1
Status:
IN PROGRESS
2002814_1
1. NAME OF THE MEDICINAL PRODUCT
Burinex
®
Tablet
Bumetanide
Carefully read this insert before administering this product. It
contains information about your treatment. If you have any
doubt or you are not sure about something, please ask your
physician or Pharmacist chemist.
Keep this insert as you might need to read it again.
Verify this product fully corresponds to the one prescribed by
your physician.
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
Tablets:
Bumetanide 1 mg
Pack sizes: 10, 20, 30, 50 and 100 tablets
Excipients the clinician should be aware of:
Lactose
For the full list of excipients, see section 6.1.
Not all pack sizes, strengths and formulations may be
marketed
Sale under prescription
3. PHARMACEUTICAL FORM
Tablets:
1 mg:
White, circular, flat tablets embossed with the number 133 on
one side.
The tablets have a score line.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Burinex
®
is indicated whenever diuretic therapy is required
in the treatment of oedema
e.g.
associated with congestive
heart failure, cirrhosis of the liver, renal diseases including
the nephrotic syndrome. Acute pulmonary oedema, drug
induced fluid retention, and drug poisoning that can be
treated by forced diuresis. Hypertension.
4.2 Posology and method of administration
Orally: 1 mg daily.
In refractory cases the dose can be increased gradually
till