Burinex Tablets 5mg

Country: Malta

Language: English

Source: Medicines Authority

Available from:

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

ATC code:

C03CA02

INN (International Name):

BUMETANIDE 5 mg

Pharmaceutical form:

TABLET

Composition:

BUMETANIDE 5 mg

Prescription type:

POM

Therapeutic area:

DIURETICS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-07-11

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BURINEX® 1 MG TABLET
BURINEX® 5 MG TABLET
bumetanide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
•
In this leaflet Burinex
®
1mg tablets and Burinex
®
5 mg tablets will be called Burinex.
WHAT IS IN THIS LEAFLET
1.
What Burinex is and what it is used for
2.
What you need to know before you take Burinex
®
3.
How to take Burinex
4.
Possible side effects
5.
How to store Burinex
6.
Contents of the pack and other information
1.
WHAT BURINEX
® IS AND WHAT IT IS USED FOR
Burinex contain the active substance bumetanide. It is a diuretic
(water tablet).
It works by removing any excess water from your body. It will make you
go to the toilet more often.
Burinex is used in adults to treat oedema which occurs as a result of
heart, kidney or liver problems.
Oedema means that there is too much water in parts of your body.
Oedema can cause symptoms such
as swollen ankles or trouble breathing.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BURINEX
®
DO NOT TAKE BURINEX
•
If you are allergic to bumetanide or any of the other ingredients in
this medicine (listed in
section 6).
•
If you have been told that you have very low levels of potassium,
sodium or chloride in your
blood.
•
If you cannot pass water (urine) at all.
•
If you have severe liver problems or are in a coma caused by this
(hepatic encephalopathy.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Burinex
®
•
If you have severe liver problems.
•
If you have low blood pressure.
•
If you ha

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Burinex Tablets 5mg/ Burinex Tablets 1mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bumetanide, 1 mg
Excipient with known effect: Each tablet contains 52.3 mg lactose
monohydrate.
Bumetanide, 5 mg
Excipient with known effect: Each tablet contains 92.0 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
Tablet characteristics:
1 mg:
White, circular, flat tablets embossed with the number 133 on one
side.
The tablet can be divided into equal doses.
5 mg:
White, flat, circular (10 mm), uncoated bevelled edge tablet marked on
one face with a score line
and “5 mg”. The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Burinex 1 mg Tablets are indicated for the treatment of oedema due to
congestive heart failure,
cirrhosis of the liver and renal disease including nephrotic syndrome
in adults.
Burinex 5 mg Tablets are indicated for the treatment of renal, hepatic
or cardiac oedema in adults
when high doses of a potent, short-acting diuretic is required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
1 mg:
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.
Page 2 of 10
5 mg:
The dose should be carefully titrated for each patient on the basis of
the desired therapeutic effect
and the response obtained. As a general rule for patients who are not
under control with a low dose,
a starting dose of 5 mg can be applied, and if necessary, it can be
gradually increased until a
satisfactory response is obtained or adverse effects appear. A twice
daily dosing regimen instead of
once daily, can be preferentially considered.
_Paediatric population _
This medicinal product is not recommended for children as there is
limited information on the
safe