Bumetanide 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bumetanide

Available from:

Viatris UK Healthcare Ltd

ATC code:

C03CA02

INN (International Name):

Bumetanide

Dosage:

1mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02020200; GTIN: 5016695280127

Patient Information leaflet

OTHER MEDICINES AND BUMETANIDE
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Do not take Bumetanide with:
• Lithium, normally used to treat manic depression
(see section ‘Do not take’ above)
If you are taking any of the following medicines, tell
your doctor or pharmacist before taking Bumetanide:
• some antibiotics used to treat infections such as
cephaloridine or gentamicin
•
amphotericin, normally used to treat fungal infections
• treatment for a heart condition such as digoxin
• treatment for high blood pressure such as sotalol, or
medicines known as ACE inhibitors such as captopril
• an anti-inflammatory medicine, normally used for
arthritis or other bone and muscle problems such
as indometacin, ibuprofen, diclofenac
If you are taking any of the above medicines your
doctor may need to adjust your dose of Bumetanide
or the dose of the other medicine you are taking.
PREGNANCY AND BREAST-FEEDING
Bumetanide should not be given to pregnant or
breast-feeding mothers unless the benefits to
the mother outweigh the risks to the baby. If you
are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice.
DRIVING AND USING MACHINES
This medicine should not normally have any effect on
your ability to drive or operate machines.
However,
this medicine may cause dizziness, tiredness, weakness
or cause confusion as side effects. You must not drive
or use machines if you get any of these side effects.
BUMETANIDE CONTAINS LACTOSE
If you have been told by your doctor that you have
an intolerance to some sugars contact your doctor
before taking this medicine.
3. HOW TO TAKE BUMETANIDE
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
At the start of treatment your doctor may monitor
your condition closely.
ADULTS
The usual recommended starting dose is 1 mg a
day. This dose can be taken in the morning or e

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bumetanide 1 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg of bumetanide.
Excipient with known effect:
Contains 134 mg lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, flat, bevelled- edged, scored, tablet marked “BU/1” on one
side and
“G” on the reverse, approx. diameter 8 mm.
The score line is only to facilitate breaking for ease of swallowing
and not to
divide into equal doses.
4.1
THERAPEUTIC INDICATIONS
Bumetanide is indicated for the treatment of oedema associated with
e.g.
congestive heart failure, renal dysfunction including nephrotic
syndrome and
cirrhosis of the liver in adults.
In oedema of renal or cardiac origin where high doses of a potent
short - acting
diuretic are required, Bumetanide 5 mg may be used in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Most patients require a daily dose of 1 mg given as a single morning
or early
evening dose. Depending on the patient’s response, a second dose can
be
given 6-8 hours later. In refractory cases, the dose can be increased
until a
satisfactory diuretic response is obtained, or infusions of bumetanide
can be
given.
_Dosage in the elderly _
Adjust the dosage according to the response. A dose of 0.5 mg
bumetanide per
day may be sufficient in some elderly patients.
_Paediatric population _
Not recommended for children under 12 years of age as there is limited
information on safety, efficacy and dosage in children.
Method of administration
For oral use.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance, sulfonamides or to any of
the
excipients listed in section 6.1.
Oliguria.
Anuria.
Increase in blood urea.
•
Although bumetanide can be used to induce diuresis in renal
insufficiency, any marked increase of blood urea or the development of
oliguria or anuria during treatment of severe progressive renal
disease
are indications for stopping treatment with b