Bumetanide 1mg tablets

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Bumetanide

Dostupno od:

Niche Generics Ltd

ATC koda:

C03CA02

INN (International ime):

Bumetanide

Doziranje:

1mg

Farmaceutski oblik:

Oral tablet

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 02020200; GTIN: 5060020121067

Uputa o lijeku

WHAT IS IN THIS LEAFLET
1. What Bumetanide Tablets are and what they are used for
2. What you need to know before you take Bumetanide
Tablets
3. How to take Bumetanide Tablets
4. Possible side effects
5. How to store Bumetanide Tablets
6. Contents of the pack and other information
1.WHAT BUMETANIDE TABLETS ARE AND WHAT
THEY ARE USED FOR
Bumetanide Tablets 1 mg contain the active substance
bumetanide. Bumetanide is one of a group of medicines
called diuretics (water tablets). They make the kidneys
remove water from the body.
Bumetanide Tablets are used to treat oedema, which is a
build-up of fluid in the body. This may occur in many
situations, for instance, with liver and kidney problems, or
with heart failure (when the heart doesn’t pump
efficiently).
2.WHAT YOU NEED TO KNOW BEFORE YOU TAKE
BUMETANIDE TABLETS
DO NOT TAKE BUMETANIDE TABLETS:
■
If you are allergic to bumetanide, sulfonylureas or any
of the other ingredients of Bumetanide Tablets (listed in
section 6).
■
If you have severe progressing kidney disease,
especially if you are excreting a very low amount of
urine or if you cannot excrete any urine at all.
■
If you have serious problems with your liver.
■
If you have been told that you have low levels of certain
chemicals (electrolytes) in your blood.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Bumetanide Tablets:
■
If you are on a low-salt diet or have been told you have
an imbalance of body chemicals (electrolytes).
Bumetanide can cause disturbances of these body
chemicals and your doctor may want to monitor your
blood and urine, particularly if you have muscle cramps,
numbness, headache, feel faint, weak, dizzy or sick. If
you are elderly, your doctor may reduce your dose.
■
If you are a diabetic or if you have ever had diabetes
your doctor may ask for periodic checks on urine and
blood glucose.
■
If you suffer from any kidney disease, or are taking any
drugs that may affect the kidneys, your doctor may
closely monitor your body fluids and kidney functions.

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bumetanide Tablets 1mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1mg of bumetanide.
Excipient with known effect: Contains 50.6 mg of lactose monohydrate
For the full list of excipients,see section6.1.
3
PHARMACEUTICAL FORM
Tablet
White to off-white, round, normal convex, uncoated tablet of
approximately 6 mm, plain on
one side with a breakline and ‘1’ centrally above ‘BMT’ on the
other side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bumetanide Tablets 1mg are indicated in adults whenever diuretic
therapy is required
in the treatment of oedema, for example that associated with
congestive heart failure,
cirrhosis of the liver and renal disease including the nephrotic
syndrome.
In oedema of cardiac or renal origin where high doses of a potent
short acting diuretic
are required, Bumetanide Tablets 5mg may be used in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose should be carefully titrated in each patient according to the
patient’s response and
the required therapeutic activity.
_Adults: _
Most patients require a daily dose of 1mg which can be given as a
single morning or early
evening dose. Depending on the patient’s response, a second dose can
be given six to eight
hours later. In refractory cases, the dose can be increased until a
satisfactory diuretic response
is obtained, or infusions of Bumetanide can be given.
The maximum daily dosage is 10mg.
_Paediatric population: _
The medicinal product is not recommended for children under 12 years
of age as there is
limited information on safety, efficacy and dosage in children.
_ _
_Elderly: _
Adjust dosage according to response; a dose of 0.5mg of bumetanide per
day may be
sufficient in some elderly patients.
Method of administration
For oral administration.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance, sulfonylureas or any of the
excipients listed in
section 6.1.
•
Oligur