Bumetanide 5mg tablets

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Bumetanide

Հասանելի է:

Mawdsley-Brooks & Company Ltd

ATC կոդը:

C03CA02

INN (Միջազգային անվանումը):

Bumetanide

Դոզան:

5mg

Դեղագործական ձեւ:

Oral tablet

Կառավարման երթուղին:

Oral

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 02020200

Տեղեկատվական թերթիկ

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

Ապրանքի հատկությունները

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bumetanide 5mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of bumetanide
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, round, flat uncoated tablet. Engraving: 7B2: plain with
breakline.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bumetanide is indicated when diuretic therapy is required in the
treatment of oedema,
such as that associated with congestive heart failure, cirrhosis of
the liver and renal
disease including nephrotic syndrome. Bumetanide 5 mg tablets are
indicated in the
treatment of acute and chronic renal failure in adults and may be used
in oedema of
cardiac or renal origin where high doses of a potent short acting
diuretic are required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
_ _
_Adults_
The dose should be carefully titrated according to patient response
and the required
therapeutic activity. As a general rule, in patients not controlled on
lower doses,
dosage should be started on 5mg, and increased by 5mg increments every
12-24 hours
until a satisfactory response is obtained or side effects appear. As a
single dose tablets
should normally be taken in the morning or in the early evening. At
higher doses
consideration should be given to a twice daily dosage rather than once
daily.Direct
substitution of bumetanide for frusemide in a 1:40 ratio at high doses
should be
avoided. Treatment should be initiated at a lower equivalent dose and
gradually
increased in 5mg increments._ _
_Paediatric population _
_The _
_medicinal _
_product _
_is _
_not _
_recommended _
_for _
_children _
_as _
_there _
_is _
_limited _
_information on safety, efficacy and dosage in children. _
_Elderly _
_ _
Dosage should be adjusted according to response. A dose of 0.5 mg per
day may be
sufficient in some elderly patients.
4.3
CONTRAINDICATIONS
Bumetanide can be used to induce diuresis in renal insufficiency.
Therapy should be
stopped if there is significant increase in blood