Burinex 1 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bumetanide

Available from:

Leo Laboratories Limited

ATC code:

C03CA; C03CA02

INN (International Name):

Bumetanide

Dosage:

1 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Sulfonamides, plain; bumetanide

Authorization status:

Marketed

Authorization date:

1978-04-01

Patient Information leaflet

INS007-01: 190 × 250 mm - Page 1 of 2
0 5 7 1 9 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
BURINEX
®
1 MG TABLETS
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
®
1 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 1 mg tablets 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 (hypersensitive) 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Burinex 1 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg of Bumetanide.
Excipient with known effect: Each tablet contains 52.3 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
A white, flat, circular, uncoated scored tablet marked with the number
133 on the scored face and an Assyrian lion on
the reverse.
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 adults in the management of
oedema due to congestive heart failure, hepatic
cirrhosis and renal disease, including nephrotic syndrome.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual daily dosage is 0.5 to 2 mg as a single or divided dose. The
dosage may be increased if necessary and should
be carefully adjusted according to patient response.
_Paediatric population_
The medicinal product is not recommended for children as there is
limited information on safety, efficacy and dosage
in children.
_Elderly_
The dosage recommendations for adults apply, but 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
Depending on the liver or renal function, the dose should be titrated
according to the patient’s response and required
therapeutic effect (see section 4.4).
Method of administration
For oral administration.
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