Bumetanide Tablets

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

BUMETANIDE

Dostupné z:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC kód:

C03CA02

INN (Medzinárodný Name):

BUMETANIDE 1 mg

Forma lieku:

TABLET

Zloženie:

BUMETANIDE 1 mg

Typ predpisu:

POM

Terapeutické oblasti:

DIURETICS

Stav Autorizácia:

Withdrawn

Dátum Autorizácia:

2006-11-15

Príbalový leták

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BUMETANIDE 1 MG TABLETS
bumetanide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THE
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 your 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.
WHAT IS IN THIS LEAFLET
1.
What Bumetanide is and what it is used for
2.
What you need to know before you take Bumetanide
3.
How to take Bumetanide
4.
Possible side effects
5.
How to store Bumetanide
6.
Contents of the pack and other information
1.
WHAT BUMETANIDE IS AND WHAT IT IS USED FOR
Bumetanide 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.
Bumetanide 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 BUMETANIDE
DO NOT TAKE BUMETANIDE
-
if you are allergic (hypersensitive) to bumetanide or to any of the
other ingredients of 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 cause by this
(hepatic encephalopathy).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Bumetanide
-
if you have severe liver problems.
-
if you have low blood pressure.
-
if you have been told that you have abnormal levels of p

Súhrn charakteristických

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bumetanide 1 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg bumetanide.
Excipients with known effect
This product contains 105.5 mg lactose.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, round, flat, scored tablets.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bumetanide is 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).
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Method of administration
For oral administration.
_ _
4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substance 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
Caution is advised if bumetanide is to be administered to patients
with severe hepatic impairment.
Hypotension
Caution should be exercised when bumetanide is used in patients with
hypotension.
Electrolyte imbalance
Electrolyte and fluid i