Burinex 5 mg Tablets

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Bumetanide

Mevcut itibaren:

Leo Laboratories Limited

ATC kodu:

C03CA; C03CA02

INN (International Adı):

Bumetanide

Doz:

5 milligram(s)

Farmasötik formu:

Tablet

Reçete türü:

Product subject to prescription which may be renewed (B)

Terapötik alanı:

Sulfonamides, plain; bumetanide

Yetkilendirme durumu:

Not marketed

Yetkilendirme tarihi:

1978-04-01

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
BURINEX
®
5 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
®
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 5 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 have low blood pressure.
• If you have been told

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Burinex 5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of Bumetanide.
Excipient with known effect: Each tablet contains 92 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
A white, flat, circular, uncoated, bevelled-edge tablet marked with a
score line and ‘5 mg’ on one face.
The score line is only to facilitate breakup for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Burinex 5 mg Tablets are indicated in adults in the management of
oedema due to congestive heart failure, hepatic
cirrhosis and renal disease, including nephrotic syndrome, where high
dose diuretic is required.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose should be carefully adjusted according to response. As a
general rule, dosage should be started at 5 mg daily
and then increased by 5 mg every 12-24 hours until the required
response is obtained or side effects appear.
Consideration should be given to a twice daily dosage, rather than a
once daily dosage.
_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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