Bumetanide 1mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
01-11-2018
Summary of Product characteristics
(SPC)
04-11-2019
Active ingredient:
Bumetanide
Available from:
C P Pharmaceuticals 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
Patient Information leaflet
Top of page cut-off to middle of registration mark: 23mm. Registration
Pitch: 210mm -0.45mm (Sheet depth / cut-off length: 210mm)
Pharma code 771 BUMETANIDE
1 MG AND 5 MG TABLETS
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. Do
not pass it on to others. It may harm them,
even if their symptoms 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.
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
WHAT BUMETANIDE IS AND WHAT IT IS USED FOR
•
Bumetanide is a type of medicine called a
diuretic which increases the amount of water
(urine) passed
•
Bumetanide is used to treat excess fluid
accumulation in the body (oedema) which can
be caused by heart, liver, or kidney disease.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
BUMETANIDE
DO NOT TAKE BUMETANIDE IF YOU:
•
are allergic (hypersensitive) to bumetanide or
any of the other ingredients of this medicine
•
are in the first 3 months of pregnancy or
breast-feeding
•
suffer from severe liver disease, or are in a
coma due to severe liver problems
•
suffer from a severe imbalance of water and
salts in the body
•
are producing less urine than usual, or no urine
at all.
WARNINGS AND PRECAUTIONS
Tell your doctor before you start to take this
medicine if you:
•
are on a low salt diet
•
have kidney problems.
Your doctor may give you regular blood and urine
tests whilst you are taking this medicine.
If you see another doctor or go into hospital, let
him or the staff know what medicines you are
taking.
OTHER MEDICINES AND BUMETANIDE
Tell y
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Summary of Product characteristics
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
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