Furosemide 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Furosemide

Available from:

Phoenix Healthcare Distribution Ltd

ATC code:

C03CA01

INN (International Name):

Furosemide

Dosage:

500mg

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: 44 mm.
PAGE 1: FRONT FACE (INSIDE OF REEL)
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 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.
1. What Furosemide is and what it is used for
2. What you need to know before you take Furosemide
3. How to take Furosemide
4. Possible side effects
5. How to store Furosemide
6. Contents of the pack and other information.
WHAT FUROSEMIDE IS AND WHAT IT IS USED FOR
Furosemide belongs to a group of medicines known as diuretics (water
tablets).
You should only use this high-dose formulation if you have severely
reduced kidney function (glomerular filtration rate (GFR) < 20
ml/min).
Furosemide is used to treat reduced urine production (oliguria) in
chronic
kidney failure.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FUROSEMIDE
DO NOT TAKE FUROSEMIDE
•
If you are allergic to furosemide, sulphonamides or any of the other
ingredients of this medicine (listed in section 6),
•
If you have normal or mildly to moderately reduced kidney function
with
a GFR greater than 20 ml/min, because of the risk of severe fluid and
salt (electrolyte) loss,
•
If you have kidney failure and your kidneys do not produce urine at
all
(anuria),
•
If you have liver failure with alterations of consciousness (hepatic
coma and pre-coma),
•
If you have potassium deficiency,
•
If you have sodium deficiency,
•
If you have too little blood (hypovolaemia) or body water
(dehydration),
•
If you are breast-feeding (see Pregnancy and breast-feeding below),
•
If you have cardiac glycoside poisoning. Cardiac glyc

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Furosemide 500mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Furosemide BP 500 mg.
Excipient(s) with known effect: Lactose, Ultralake tartrazine E102
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Yellow coloured round, flat uncoated tablets embossed with FW & 151 on
one
side of the tablets and a crossline on the other side of the tablets.
The score line is only to facilitate breaking for ease of swallowing
and not to
divide into equal doses.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
The management of oliguria due to acute or chronic renal failure.
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _
Posology:
In patients with chronic renal insufficiency an initial daily dose of
250mg is
employed. If a satisfactory diuresis is not produced then the dose may
be increased in
steps of 250mg at 4 - 6 hourly intervals up to a maximum daily dose of
1,500mg in 24
hours. In exceptional cases up to 2,000mg in 24 hours may be given.
Method of administration:
For oral administration.
_ _
4.3
CONTRAINDICATIONS
- Hypersensitivity to furosemide or to any of the excipients listed in
section
6.1
-Hypersensitivity to amiloride, sulphonamides or sulphonamide
derivatives.
- Hypovolaemia and dehydration (with or without accompanying
hypotension)
(see section 4.4)
- Severe hypokalaemia: severe hyponatraemia (see section 4.4).
- Comatose or pre-comatose states associated with hepatic cirrhosis
(see
section 4.4).
- Anuria or renal failure with anuria not responding to furosemide,
renal
failure as a result of poisoning by nephrotoxic or hepatotoxic agents
or renal
failure associated with hepatic coma
- Impaired renal function with a creatinine clearance below 30ml/min
per 1.73
m
2
body surface area (see section 4.4).
- Addison's disease (see section 4.4).
- Children and adolescents under 18 years of age (safety in this age
group has
not yet been established).
- Digitalis intoxication (see section 4.5).
- Concomitant potassium