Burinex 1mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BUMETANIDE

Available from:

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

ATC code:

C03CA02

INN (International Name):

BUMETANIDE 1 mg

Pharmaceutical form:

TABLET

Composition:

BUMETANIDE 1 mg

Prescription type:

POM

Therapeutic area:

DIURETICS

Authorization status:

Authorised

Authorization date:

2006-11-01

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BURINEX® 1 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 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 have low blood pressure.
•
If you have been told that yo

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Burinex 1mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bumetanide, 1 mg
Excipient with known effect: Each tablet contains 52.3 mg lactose
monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
Tablet characteristics:
White, circular, flat tablets embossed with the number 133 on one
side.
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 the management of oedema due to
congestive heart
failure, cirrhosis of the liver and renal disease including nephrotic
syndrome in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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.
_Paediatric population _
The medicinal product is not recommended for children as there is
limited information on the
safety, efficacy and dosage in children.
_Elderly _
The dosage recommendations for adults apply, however in the elderly,
bumetanide is
generally eliminated more slowly. Dosage should be titrated until the
required response is
achieved.
Page 2 of 9
_Patients with liver or renal insufficiency _
Bumetanide is excreted partly via the kidneys and partly via hepatic
metabolism and biliary
excretion. The dose should be titrated according to the patient’s
response and required
therapeutic effect (see section 4.4).
_Method of administration _
The bioavailability is not affected by food intake.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to bumetanide or to any of the excipients listed in
section 6.1
•
Severe electrolyte depletion
•
Persisting anuria
•
Hepatic encephalopathy including coma
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Hepatic impairment
Cautio